MS2058 PDF

MALAYSIAN MS 2058:2009
STANDARD
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CODE OF PRACTICE FOR GOOD

ENGINEERING MAINTENANCE
MANAGEMENT OF ACTIVE MEDICAL
DEVICES
(FIRST REVISION)
ICS: 11.040.01
Descriptors: medical electrical equipment, code of practice, Biomedical Engineering, maintenance,
services, active medical device
© Copyright 2009
DEPARTMENT OF STANDARDS MALAYSIA
DEVELOPMENT OF MALAYSIAN STANDARDS
The Department of Standards Malaysia (STANDARDS MALAYSIA) is the national

standardisation and accreditation body.
The main function of the Department is to foster and promote standards,

standardisation and accreditation as a means of advancing the national economy,
promoting industrial efficiency and development, benefiting the health and safety of
the public, protecting the consumers, facilitating domestic and international trade and
furthering international cooperation in relation to standards and standardisation.
Malaysian Standards are developed through consensus by committees which

comprise of balanced representation of producers, users, consumers and others with
relevant interests, as may be appropriate to the subject in hand. To the greatest
extent possible, Malaysian Standards are aligned to or are adoption of international
standards. Approval of a standard as a Malaysian Standard is governed by the
Standards of Malaysia Act 1996 (Act 549). Malaysian Standards are reviewed
periodically. The use of Malaysian Standards is voluntary except in so far as they are
made mandatory by regulatory authorities by means of regulations, local by-laws or
any other similar ways.
The Department of Standards appoints SIRIM Berhad as the agent to develop

Malaysian Standards. The Department also appoints SIRIM Berhad as the agent for
distribution and sale of Malaysian Standards.
For further information on Malaysian Standards, please contact:
Department of Standards Malaysia OR SIRIM Berhad

Century Square, Level 1 & 2 (Company No. 367474 - V)
Block 2300, Jalan Usahawan 1, Persiaran Dato’ Menteri
63000 Cyberjaya P.O. Box 7035, Section 2
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MALAYSIA Selangor D.E.
Tel: 60 3 8318 0002 Tel: 60 3 5544 6000

Fax: 60 3 8318 1455 Fax: 60 3 5510 8095
http://www.standardsmalaysia.gov.my http://www.sirim.my
E-mail: central@standardsmalaysia.gov.my
MS 2058:2009
CONTENTS
Page
Committee representation ………………………………………………………………........... iii

Foreword………………..……………………………………………………………..…............ iv
1 Scope……….………………………………………………………………………….… 1
2 Normative references …….…………………………………………………………… 1
3 Definitions……………………………………………………………………………….. 1
4 General………….………….…………………………………………………………… 5
5 Responsibilities…………………………………………………………………………. 6
6 Scheduled maintenance…………………………………………………………..…... 8
7 Unscheduled maintenance …………………………………………….………..…..... 13
8 Acceptance testing...………….……………………………………………………….. 14
9 Mechanisms to avoid failure or breakdown during use …………………………... 15
10 Uptime…………………………………………………………………………………… 16
11 Quality assurance program (QAP)….……..…………………………………………. 17
12 Maintenance management information system (MMIS)..…………….……………. 18
13 Management of warranties………………………………………………………….… 18
14 Decommissioned equipment………………………………………………………….. 19
15 Disposal of equipment…………………………………………………………………. 19
16 Processes for handling hazardous/contaminated equipment …………………….. 20
17 Incidents and hazards …………………………………………………………………. 20
18 User training ……………………………………………………………………………. 21
19 Stock of genuine spares ………………………………………………………………. 21
20 On-site library …………………………………………………………………………... 22
21 Workshop setup………………………………………………………………………… 22
22 Advisory service………………………………………………………………………... 24
23 Procurement of equipment ………………………………………………………….... 26
Tables
1 List of common test equipment………………………………………………….……. 24

A1 Competency levels and device specialisation classification matrix………………. 31
A2 Radiology and imaging equipment specialisation classification (sample)………… 32
A3 Laboratory equipment specialisation classification (sample)………….…………… 33
A4 Diagnostic equipment specialisation classification (sample)………………………. 35
A5 Therapeutic equipment specialisation classification (sample) ……………..……... 38
A6 Biomedical Engineering maintenance competency levels and skills matrix……… 42
A7 Biomedical Engineering breakdown maintenance levels…………………………… 43
A8 Management skills level matrix………………………………………………………… 44
A9 Biomedical Engineering career development matrix ……………………………… 45
© STANDARDS MALAYSIA 2009 - All rights reserved i

MS 2058:2009
CONTENTS (continued)
Page
Figures
A1 Competency level………………………………………………………………………. 30
B1 Asset label number…………………………………………………………………….. 48
B2 Maintenance status………………………………………………….…………………. 48
B3 Equipment under warranty…………………………………………………………….. 49
B4 Proposed for disposal/exemption…………………………………………………….. 49
B5 Danger tag ……………………………………………………………………………… 50
B6 Equipment under observation…………………..…………………..………………… 50
J1 Example layout for a maximum of two personnel…………….…………………….. 65
J2 Example layout for a maximum of six personnel……………………………….…… 66
Annexes
A Biomedical Engineering competency and career development

guidelines ………………………………………………………………………………. 28
B Examples of equipment tags …………………………………………………………. 48
C Example of PPM checklist based on manufacturer’s service manual……………. 51
D Example of work order form……………………………………………..……………. 54
E Recommended uptime target for equipment……………………..…………………. 55
F Calculation of uptime …………………………..…………………………………….... 58
G MMIS for Biomedical Engineering Services ………………………………………… 59
H Key performance indicator (KPI) …………………………………………………….. 63
J Example of workshop setup…………………………………………………………… 65
ii © STANDARDS MALAYSIA 2009 - All rights reserved

MS 2058:2009
Committee representation
The Industry Standards Committee on Medical Devices and Facilities for Healthcare (ISC R) under whose authority
this Malaysian Standard was developed, comprises representatives from the following organisations:
Association of Malaysian Medical Industries

Association of Private Hospitals of Malaysia
Atomic Energy Licensing Board
Biomedical Engineering Association Malaysia
Department of Standards Malaysia

Federation of Malaysian Manufacturers
Institute for Medical Research
Malaysia Medical Device Association
Malaysian Association of Standards Users
Malaysian Medical Association
Malaysian Nuclear Agency
Malaysian Organization of Pharmaceutical Industry
Malaysian Rubber Board
Malaysian Rubber Export Promotion Council
Medical Device Bureau
Ministry of Health Malaysia
Pharmaceutical Association of Malaysia
Radiation Physics, Biophysics and Medical Physics Sub-Group of Institute of Physics Malaysia
SIRIM QAS International Sdn Bhd
Universiti Kebangsaan Malaysia (Faculty of Allied Health Sciences)
Universiti Teknologi Malaysia (Faculty of Science)
The Technical Committee on Code of Practice of Active Medical Devices and Low-Voltage Electrical
Equipment/System for Healthcare Facilities which developed this Malaysian Standard consists of representatives
from the following organisations:
Association of Private Hospitals of Malaysia

Biomedical Engineering Association Malaysia
Faber Medi-Serve Sdn Bhd/Healthtronics Malaysia Sdn Bhd
Healthcare Technical Services Sdn Bhd (KPJ)
Hospital Universiti Kebangsaan Malaysia
Independent Expert
Malaysian Medical Association
Ministry of Health Malaysia (Medical Device Bureau)
Ministry of Health Malaysia (Engineering Services Division)
Pantai Medivest Sdn Bhd
Radicare (M) Sdn Bhd
SIRIM Berhad (Secretariat)
Sistem Hospital Awasan Taraf Sdn Bhd
Universiti Kebangsaan Malaysia (Faculty of Allied Health Sciences)
Universiti Malaya (Department of Biomedical Engineering)
Universiti Sains Malaysia (Medical Campus)
Universiti Teknologi Malaysia (Faculty of Electrical Engineering)
University Malaya Medical Centre
© STANDARDS MALAYSIA 2009 - All rights reserved iii

MS 2058:2009
FOREWORD
This Malaysian Standard was developed by the Technical Committee on Code of Practice of
Active Medical Devices and Low-Voltage Electrical Equipment/System for Healthcare
Facilities under the authority of the Industry Standards Committee on Medical Devices and
Facilities for Healthcare.
This Malaysian Standard is the first revision of MS 2058, Code of Practice for Good
Engineering Maintenance Management of Active Medical Devices.
Major modifications in this revision are as follows:
a) Incorporation of new definition on “active medical device”;
b) the definition for “breakdown maintenance” was modified;
c) amendment to the definition of “emergency maintenance”;
d) incorporation of new definition on “healthcare facility”;
e) incorporation of new definition on “medical device”;
f) sub-clause 5.2 p) regular monitoring of hazards and alerts relating to medical devices,
was added;
g) amendment to sub-clause 6.6.1 a);
h) amendment to first paragraph of 6.7.1.2;
i) amendment to sub-clause 21.5 g);
j) amendment to first paragraph of 22.1;
k) incorporation of sub-clause 22.1 g);
l) amendment to sub-clause 23.1 f);
m) amendment to sub-clause 23.3;
n) incorporation of new Figure A1;
o) amendment to examples of equipment tags in Annex B;
p) amendment to PPM checklist examples in Annex C; and
q) incorporation of new Figure J2, to give an example workshop setup for a maximum of
six personnel.
This Malaysian Standard cancels and replaces MS 2058:2008.
Compliance with a Malaysian Standard does not of itself confer immunity from legal
obligations.
iv © STANDARDS MALAYSIA 2009 - All rights reserved

MS 2058:2009
CODE OF PRACTICE FOR GOOD ENGINEERING MAINTENANCE

MANAGEMENT OF ACTIVE MEDICAL DEVICES
1. Scope
This Malaysian Standard applies to all active medical device placed for use in any healthcare
facility or any other facility which requires maintenance. This standard is not applicable for
medical equipment placed and used in any facility not intended to be used on human.
2. Normative references
The following normative references are indispensable for the application of this document.
For dated references, only the edition cited applies. For undated references, the latest edition
of the normative reference (including any amendments) applies.
MS IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety
and essential performance
MS IEC 60364-7-710, Electrical installations of buildings - Part 7-710: Requirements for

special installations or locations - Medical locations
MS IEC 61010-1, Safety requirements for electrical equipment for measurement, control, and
laboratory use - Part 1: General requirements
MS IEC 62353, Medical electrical equipment - Recurrent test and test after repair of medical
electrical equipment
MS 838, Code of practice for radiation protection (Medical X-ray diagnosis)
Atomic Energy Licensing Act 304
GHTF Document N15:2006, Principles of Medical Devices Classification
Registration of Engineers Act 1967 Revision 2002
3. Definitions
For the purposes of this standard, the following definitions apply.
3.1 Acceptance testing
Acceptance testing is qualitative and quantitative tests carried out on the medical device upon
completion of installation and prior to use for clinical service, to ensure its safety and
performance is in accordance with manufacturer’s specifications, purchase agreement, and
statutory requirements.
© STANDARDS MALAYSIA 2009 - All rights reserved 1

MS 2058:2009
3.2 Active medical device
Any medical device, operation of which depends on a source of electrical energy or any
source of power other than that directly generated by the human body or gravity and which
acts by converting this energy. Medical devices intended to transmit energy, substances or
other elements between an active medical device and the patient, without any significant
change, are not considered to be active medical devices (Source: GHTF Document N15
dated June 27 2005).
3.3 Authorised agency
Any agency approved by the Ministry of Health Malaysia.
3.4 Biomedical Engineering Services
Any in-house or third party personnel or organisation recognised by an authorised agency

responsible to carry out, implement and/or manage Biomedical Engineering activities.
3.5 Breakdown maintenance
The actions taken to restore the defect in the operation or the usage of equipment
usually detected by the user who takes the equipment out of clinical use.
3.6 Corrective maintenance
The actions performed to restore an item to a specified condition when it fails to function as
per manufacturer’s specification. Corrective maintenance includes routine corrective
maintenance, breakdown maintenance and emergency maintenance.
3.7 Competence
Competence is a standardised requirement for an individual to properly perform a specific job.

It encompasses a combination of knowledge, skills and behaviour utilised to improve
performance. More generally, competence is the state or quality of being adequately or well
qualified, having the ability to perform a specific job/role.
3.8 Downtime (for a particular piece of equipment)
The percentage of time during which a particular medical equipment is not available from a
minimum number of "common functional units" in a ward, a department or a specific area.
Downtime does not include upgrading time or the time when the medical equipment is not
required to be available.
3.9 Emergency maintenance
Emergency maintenance is performed as necessary, such as when no other medical device

substitutes are available and action taken in the quickest and most efficient manner to ensure
restoration of affected services.
2 © STANDARDS MALAYSIA 2009 - All rights reserved

MS 2058:2009
3.10 Equipment user/user
3.10.1 Home user
An individual who owns and uses medical equipment for personal care.
3.10.2 Operator of medical equipment
An individual who handles or operates medical equipment in a healthcare facility, such as

doctors, nurses, medical assistants, radiologists, etc.
3.11 Established organisation
Recognised local or international body in Biomedical Engineering.
3.12 Healthcare facility
Any premises in which one or more members of the public receive healthcare services, which
includes:
a) medical, dental, nursing, midwifery, allied health, pharmacy, and ambulance services
and any other service provided by a healthcare professional;
b) accommodation for the purpose of any service provided;
c) any service for the screening, diagnosis, or treatment of persons suffering from, or
believed to be suffering from, any disease, injury or disability of mind or body;
d) any service for preventive or promotion of health purposes;
e) any service provided by any healthcare para-professional;
f) any service for curing or alleviating abnormal condition of the human body by the
application of any apparatus, equipment, instrument or device or any other medical
technology; or
g) any health-related services.
3.13 Healthcare facility authority
The management of healthcare organisation.
3.14 In service
Medical equipment placed at user location and functioning to manufacturer’s specification.
3.15 Key performance indicator (KPI)
Measurable indicator used in the development of a quality assurance program.

MS 2058:2009
3.16 Medical device
Medical device is defined as any instrument, apparatus, implement, machine, appliance,

implant, in vitro reagent or calibrator, software, material or other similar or related article,
intended by the manufacturer to be used, alone or in combination, for human beings for one
or more of the specific purpose(s) of;
a) diagnosis, prevention, monitoring, treatment or alleviation of diseases;
b diagnosis, monitoring, treatment, alleviation of or compensation for injury;
c) investigation, replacement, modification, or support of the anatomy or of a physiological

process;
d) supporting or sustaining life;
e) control of conception;
f) disinfection of medical devices;
g) providing information for medical or diagnostic purposes by means of in vitro
examination of specimens derived from the human body;
and which does not achieve its primary intended action in or on the human body by
pharmacological, immunological or metabolic means, but which may be assisted in its
function by such means.
3.17 Preventive maintenance
A planned maintenance program which specifies frequency, tasks and activities to be done in
order to ensure that all equipment is operating as per manufacturer’s specifications and is in
safe working condition.
3.18 Scheduled Maintenance
Scheduled maintenance is planned maintenance program to ensure an optimum

performance, safe operation, minimum downtime, and maximum useful life from each
equipment system.
3.19 Self-inspection
Self-inspection is an organised method of internal review that allows a manager to view

critical areas and available resources. The self-inspection focuses on the mission, resources,
training, and personnel within the department.
3.20 Service uptime
The percentage of time during which a particular Biomedical Engineering Service is available
from a minimum number of "common functional units" in a ward, a department or a specific
area. Uptime includes upgrading time and the time when the biomedical equipment is not
required to be available.
3.21 Unscheduled maintenance

Unscheduled maintenance involves those actions necessary to restore normal function,
safety, performance, and reliability to malfunctioning equipment.

MS 2058:2009
3.22 Uptime (for a particular piece of equipment)
The percentage of time during which a particular piece of medical equipment is performing or
is available to perform its intended function. Uptime includes upgrading time and the time
when the medical equipment is not required to be available.
3.23 Uptime target
The list of uptime percentage predetermined based on healthcare facility authority agreed
benchmark for medical equipment to achieve, to reflect effectiveness of maintenance and

medical equipment reliability.
3.24 Warranty
Scope of services and liability coverage by the supplier of medical equipment within a
contractual/defined period.
4. General
4.1 Maintenance consists of scheduled maintenance and unscheduled maintenance. The
former includes servicing undertaken by the user in the sequence and intervals indicated in
the instructions for use, a periodic maintenance performed by the Biomedical Engineering
Services, by an outside maintenance firm preferably approved by the manufacturer, or by the
manufacturer himself or his agent.
4.2 The equipment maintenance program ensures equipment is serviceable, safe, and
properly configured. The maintenance of equipment shall include:
a) technical assistance in evaluating and selecting equipment before it is purchased, and

to ensure the equipment has optimum performance and fulfils safety criteria;
b) initial inspections, scheduled preventive maintenance, safety evaluations, and

calibration of equipment and supporting utilities;
c) a responsive repair service that minimises equipment downtime;
d) a quality assurance program for continuous improvement;
e) assistance in training medical personnel on how to operate equipment safely and

effectively; and
f) upkeep of documentation that meets both regulatory and accreditation requirements

and the needs of the overall equipment management program.
4.3 The reason for servicing equipment is to maintain its usability in such a way that:
a) the equipment functions in the intended manner;
b) the equipment is safe for the patient and for the user; and
c) the interruptions of use are minimised.

MS 2058:2009
5. Responsibilities
These responsibilities are furnished as minimum requirements and are not intended to limit
management functions to the areas.
5.1 The healthcare facility authority shall ensure the healthcare facility comply with
international/national electrical safety standards (e.g. MS IEC 60364-7-710). Healthcare
facilities shall ensure that the active medical devices to be purchased conform to MS IEC
60601-1.
5.2 The Biomedical Engineering Services shall:
a) implement and manage the organisation’s equipment maintenance program;
b) obtain required facilities and equipment for the organisation’s maintenance program;
c) ensure equipment is maintained in a serviceable condition at all times;
d) plan for equipment support in the conceptual phase of each new equipment system;
e) develop an equipment management plan;
f) develop and publish local policies and operating instructions (OI) as required;
g) develop references from the maintenance management report to evaluate the

effectiveness of the maintenance programs;
h) establish a work control and priority system to ensure uninterrupted service to

supported activities;
i) establish a periodic maintenance and inspection schedule and ensures maintenance

personnel perform scheduled maintenance;
j) manage the appropriate use and supply of spare parts;
k) outsource maintenance service of those systems when there are no adequate training,
tools, test equipment, and staff;
l) ensure that all ionising radiation emitting equipment maintenance comply with the
Atomic Energy Licensing Act 304 and MS 838;
m) develop a self-inspection checklist and perform at least an annual self-inspection to

ensure that required functions are properly managed;
n) perform a customer survey at least annually to determine the adequacy, quality, and
effectiveness of maintenance support and the degree of compliance;
o) assist in investigation of equipment adverse events and near incidents when requested;
and
p) regular monitoring for hazards and alerts relating to medical devices.

MS 2058:2009
5.3 The Biomedical Engineer/Technician shall:

a) comply with competency requirements as stipulated in Annex A;
b) register with the Board of Engineers as per specified in the Registration of Engineers
Act 1967 Revision 2002 as appropriate;
c) attend relevant trainings and/or continuing professional development (CPD) trainings

with recognised and authorised professional bodies; and
d) manage and administer Biomedical Engineering Services as per 5.2.
5.4 Equipment users shall:

a) ensure only equipment authorised by the Biomedical Engineering Services is used. For
an example of the equipment authorisation certificate/sticker/report, refer Annex B;
b) ensure equipment is used only for its intended purpose;
c) operate equipment in accordance with user’s manuals;
d) care for and upkeep the equipment to ensure it is always operating properly and in
serviceable condition;
e) immediately report equipment malfunctions or damage to the biomedical maintenance

services;
f) ensure appropriate user maintenance is performed;
g) not attempt repairs beyond the operating techniques described in the user’s manual;
h) ensure equipment requiring user calibration is calibrated before use;
i) replace user maintenance consumables as and when required;
j) routinely clean and dust equipment;
k) be aware of conditions that may injure the patient or damage the equipment;
l) report to the Biomedical Engineer/Technician of any anomalies such as erratic meter

responses, electrical flashing or arcing, or unusual sounds that may indicate
malfunction;
m) initiate a request for maintenance;
n) immediately impound any equipment and consumables involved in an incident and

notify the relevant department;
o) clean equipment in compliance with local infection control policies;
p) properly place the equipment during use, store and protect the equipment; and
q) report equipment adverse events and near incidents to appropriate parties.

MS 2058:2009
5.5 Home users shall ensure that only competent individual/organisation carry out
maintenance on their equipment, in accordance with this standard. In the event that the home
user brings the equipment to the healthcare facility, it will/will not be subjected to maintenance
by the Biomedical Engineering services depending on the policy of the healthcare facility,
where applicable.
6. Scheduled maintenance
6.1 The scheduled maintenance program consists of a series of planned maintenance

requirements and inspections. The program is designed to ensure that medical equipment is
maintained in the highest possible state of operational throughout its life cycle. The program
has the following purposes:
a) simplify complex maintenance tasks;
b) provide a readily manageable maintenance program;
c) facilitate scheduling and controlling maintenance actions;
d) provide a means for detecting impending equipment failures; and
e) forecast and plan manpower and material requirements.
6.2 Scheduled maintenance can be divided into three categories.
6.2.1 Planned Preventive Maintenance (PPM)

PPM is planned maintenance of equipment that is designed to improve equipment life and
avoid any unplanned maintenance activity. PPM includes lubrication, cleaning, adjusting, and
PPM Kit replacement (if applicable) to extend the life of equipment and facilities.
6.2.2 Calibration
Calibration is the measurement and adjustment of various device parameters to ensure its
accuracy within prescribed standards.
6.2.3 User maintenance
Responsibility of the equipment user department to carry out the basic maintenance on
routine basis such as daily, weekly or monthly activities to ensure condition and functionality
of the equipment are maintained as recommended by the manufacturer.
6.3 The minimum scheduled maintenance frequencies shall be developed based on the
following guidelines.
6.3.1 The manufacturer’s recommended frequencies as established in equipment servicing

or operation manual.
6.3.2 Established industry norms such as frequencies recommended by any established

organisation in Biomedical Engineering recognised authorised agencies.
6.3.3 Area of use, equipment user experience and patient risk assessment subject to user
recommendation and approval by the Ministry of Health Malaysia.

MS 2058:2009
6.3.4 Biomedical Engineering Services personnel shall perform the scheduled maintenance
at these minimum frequencies and may increase scheduled frequencies when appropriate.
6.3.5 Scheduled maintenance frequencies shall not be reduced without written approval of
the healthcare facility authority. The schedule changes shall not adversely affect patient care
or user and patient safety.
6.4 The individual equipment scheduled maintenance activity checklist shall be established
from the following sources:
a) scheduled maintenance checklist as recommended by the manufacturer as stated in

user, service or operation manual; or
b) generic scheduled maintenance checklist as recommended by established organisation

in Biomedical Engineering recognised by authorised agencies for equipment without
manufacturer recommendation; and
c) additional checklist developed by healthcare facility authority based on standard

operating procedures for any user maintenance.
6.5 The scheduled maintenance workload shall be programmed and distributed evenly
throughout the year, taking into consideration the following constraints:
a) peak workloads and periods when personnel may be absent due to training, leaves,
holidays, deployments, exercises, etc;
b) availability of test equipment and special tools, taking into consideration the test
equipment calibration requirement;
c) user department constraints; and
d) whenever possible, the scheduled PPM and calibration execution date shall be
concurrently programmed in order to increase efficiency.
6.6 Plan preventive maintenance (PPM)
6.6.1 PPM is a comprehensive program of planned and scheduled maintenance on all

relevant equipment in healthcare institutions, provided with the following objectives:
a) fewer machine breakdowns, resulting in reduced equipment downtime;
b) better conservation of assets and increased life expectancy of assets, thereby eliminating
premature replacement of system and equipment;
c) reduced overtime costs and more economical use of maintenance workers due to working
on a scheduled basis instead of an ad hoc basis to repair breakdowns;
d) timely, corrective maintenance repairs circumvent fewer large-scale repairs;
e) reduced cost of repairs by reducing secondary failures. When parts fail in service, they
usually damage other parts;
f) identification of equipment with excessive maintenance costs; indicating the need for
corrective maintenance, user training, or replacement of obsolete equipment; and

MS 2058:2009
g) improved safety and quality of the equipment.
6.6.2 PPM is the joint responsibility of equipment user and Biomedical Engineering
Services.
6.6.3 The Biomedical Engineering Services personnel shall perform the following
qualitative, preventive and quantitative activities as stated in PPM checklist on each regular
inspection/maintenance of equipment where applicable (an example of a PPM is in Annex C).
6.6.3.1 The quantitative task

The measurable tasks in specific values or ranges as specified by the manufacturer to

determine the equipment functionality, safety and performances. Example of such tasks are:
a) Performance test
Test as recommended by the manufacturer or as recommended by standard practices

using appropriate test equipment as specified by the manufacturer. All qualitative
measurement results shall be recorded onto the PPM checklist by the Biomedical
Engineering Services personnel. (For an example of PPM checklist please refer Annex
C).
b) Medical electrical safety test
The medical equipment electrical safety test shall conform to MS IEC 62353. It describes
electro-medical equipment according to the type of protection provided against electric
shock (defined as Class I, II, or III), and the degree of protection provided against electric
shock (defined as Type B, BF, or CF). During PPM inspections, the Biomedical
Engineering Services personnel shall perform a general safety inspection on all
equipment and an electrical safety test, if applicable. In addition to pass or fail, numerical
results of the electrical safety inspections shall be recorded.
c) Preventive maintenance task
Task that is performed to prevent future defects or deteriorations of equipment, such as

the following:
i) Clean the equipment in areas not normally accessible to the user, and clean internal
components including blowers, filters, fans, and coils (remove corrosion, dirt,
solutions, dust, lint, blood, or deposits.).
ii) Lubricate the unit, including motors, gears, bearings, casters, and other moving
components. Use only non petroleum-based, non-flammable lubricants on equipment
that uses oxygen.
iii) Inspect and service or replace as necessary, batteries and battery compartments.
iv) Service or replace all consumable devices such as filters and tubing.
v) Align and tighten all moving components not specifically covered in the calibration
procedures, such as doors, drawers, panels, shelves, catches, latches, casters, and
hinges.
vi) Replace the PPM kit if applicable or as recommended by the manufacturer.

MS 2058:2009
6.6.3.2 The qualitative task
The non-measurable tasks to ensure the quality of the equipment component or fixtures are in
good conditions, such as:
a) verify or test the equipment component, sub-component, accessories and any other
related feature on its physical and functionality conditions; and
b) check or examine fittings/connectors, alarms/interlocks, label, cables, etc.

6.6.4 The Biomedical Engineering Services shall propose the maintenance time required
and provide annual PPM schedule for all equipment. The user shall be given a copy of the
yearly plan schedules.
6.6.5 The user shall inform Biomedical Engineering Services if there is any change in
equipment location and any unavailability of equipment due to usage for the purposes of PPM
rescheduling.
6.6.6 Biomedical Engineering Services shall request for approval from the user department
for any rescheduling of PPM.
6.6.7 PPM should be performed with the component and accessories designated to the
item being serviced.
6.6.8 Equipment which fails testing and/or inspection shall not be used until deficiencies
are corrected. User shall be notified of the anticipated time of repair. Portable equipment shall
be removed from use until repairs are completed. Equipment shall be tagged as “out of
service” and user will confirm by signing the tag. Sample of tag is per Annex B.
6.6.9 When an item of equipment is well functioning but fails to meet the appropriate safety
standards, affix a danger tag to the equipment until the problem is corrected. Sample of tags
are as per Annex B.
6.6.10 The Biomedical Engineering Services personnel shall notify the user about the
danger tag and remove the equipment from use.
6.6.11 PPM record shall be maintained for the life of the device.
6.6.12 During scheduled maintenance, Biomedical Engineering Services personnel shall

evaluate the condition of equipment and verify that the equipment is fit to be used.
6.6.13 PPM work instruction shall refer to the manufacturer’s service manual. In the
absence of the manufacturer’s work instruction, document from an established organisation
shall be referred.
6.7 Calibration
6.7.1 Calibration is the measurement and adjustment of various device parameters to

ensure its accuracy within prescribed standards. Calibration can be divided into two
categories.

MS 2058:2009
6.7.1.1 Equipment functionality calibration
The calibration performed by Biomedical Engineering Services personnel or equipment user

in accordance to manufacturer specifications as part of PPM activities if any of the
quantitative result deviate from specified range. No certificate is required, however the
calibration result shall be recorded in the PPM checklist or equipment log either written
manually or by attaching the printed result (if feature available). This calibration can be
classified into:
a) built-in self calibration, designed as part of equipment feature; and

b) manual calibration using appropriate calibration equipment, tools or test equipment.
For specialised medical devices such as vaporisers and X-ray equipment, calibration
certificates shall be maintained.
6.7.1.2 Calibration of measuring or test equipment
The calibration shall be carried out by approved or authorised calibration centre conforming to
nationally/internationally recognised accreditation body.
Biomedical Engineering Services personnel are to ensure test equipment used for calibration
of equipment is calibrated according to manufacturer’s specifications.
6.7.2 Biomedical Engineering Services personnel shall record and document all
calibrations on the appropriate form or work sheet (PPM checklist). All calibration records and
certificates shall be filed and kept by Biomedical Engineering Services and copy shall be
provided to the user upon request.
6.7.3 Biomedical Engineering Services personnel shall enter the appropriate information for
a completed calibration into the MMIS system or on the work order form.
6.7.4 The Biomedical Engineering Services personnel shall affix the calibration
certificate/PPM tag/sticker in a location visible to the user.
6.8 User maintenance
6.8.1 User maintenance is important for effective operation of medical equipment. It helps
prevent deterioration, defects and will increase the life of the equipment and its components.
6.8.2 The healthcare facility shall establish a schedule for routine inspection and user
maintenance based on either manufacturer recommendation or standard practices.
6.8.3 The user shall have a user maintenance program to assure clean, sanitised, safe
and functioning equipment. Part of the user maintenance activities are regular cleaning,
disinfection, inspection, proper storage, etc.
a) Cleaning and disinfecting
Equipment shall be cleaned and sanitised using recommended procedures given by the
manufacturer or departmental standard operating procedures (if any).

MS 2058:2009
b) Inspection
The user shall ensure the equipment is inspected before each use and after cleaning;
and check equipment functionality, tightness of connections and condition of parts
(including accessories).
c) Storage
All equipments are to be stored in a clean and proper location to protect them from
damage, contamination, dust, sunlight, extreme temperatures, excessive moisture,
damaging chemicals, etc.
6.8.4 User that performs user maintenance at any circumstances shall not attempt to
repair beyond those specified in the operation manual. User shall report all defects or faults
and all repairs or adjustments are only to be carried out by Biomedical Engineering Services.
6.8.5 User maintenance training shall be given to the user either by the
manufacturer/agent or Biomedical Engineering Services as required or as requested by the
user.
7. Unscheduled maintenance
7.1 Biomedical Engineering Services shall ensure that all requests for unscheduled
maintenance are entered into the MMIS system.
7.2 Biomedical Engineering Services shall assign work based on a priority system to each
request.
7.3 While the priority of repair is determined locally, factors such as the type and
importance of the equipment, availability of alternate equipment, and the effect of downtime
on the medical service should be considered.
7.4 If the repair involves ordering repair parts, the Biomedical Engineering Services shall
list all required parts on the work order and enter this information into the MMIS system. See
Annex D for an example of work order form.
7.5 Biomedical Engineering Services shall document the parts needed on the work order.
7.6 Biomedical Engineering Services shall establish a method to monitor the status of work
orders awaiting parts. The equipment shall be tagged to indicate the serviceability and
facilitate traceability. An example of the tag is shown in Annex B.
7.7 Biomedical Engineering Services shall initiate the appropriate request for contract
services if the equipment requires contract, warranty, or third party repair service.
7.8 After completing any unscheduled maintenance, Biomedical Engineering Services shall
perform safety test in accordance with MS IEC 62353, performance and calibration check of
the equipment.
7.9 Biomedical Engineering Services shall perform an electrical safety test, if the
unscheduled maintenance involves replacement of defective electrical components or
dismantling of equipment before releasing the equipment to the user.

MS 2058:2009
7.10 The Biomedical Engineering Services shall brief the user on work carried out upon
completion of repair prior to acceptance by the user. Both parties shall sign the work order to
verify the completion of work.
7.11 The Biomedical Engineering Services shall file the work order sheet to ensure
traceability.
7.12 Types of unscheduled maintenance
7.12.1 Corrective maintenance

The defect in the operations or usage of equipment detected by the user or staff of
Biomedical Engineering Services during operation or scheduled maintenance.
The Biomedical Engineering Services shall initiate a request for maintenance.
7.12.2 Breakdown maintenance
The defect in the operation or the usage of equipment is detected by user who takes the
equipment out of service. The user shall initiate a request for maintenance.
7.12.3 Emergency maintenance
7.12.3.1 Emergency maintenance services shall be made available at all times to cater for
emergency breakdowns. Maintenance staff list and contact information shall be made
available to the users.
7.12.3.2 The user shall initiate a request for emergency maintenance.
7.12.3.3 On receiving a call for emergency maintenance the designated Biomedical

Engineering Service staff shall promptly organise inspection and repair.
7.12.3.4 In the event that an emergency maintenance cannot be successfully done to the
equipment within the required time, the user shall be informed such that alternative measures
can be taken by the user to minimise clinical service disruption.
8. Acceptance testing
Acceptance testing shall be carried out for all newly introduced (new or used) equipment
before it is placed into clinical service and shall include visual inspection, electrical safety test
and performance test.
8.1 The user shall notify Biomedical Engineering Services on the arrival of new equipment.
8.2 The user shall ensure that the correct item(s) are delivered in good condition based on
the purchase document. The supplier shall provide a copy of the purchase document to the
Biomedical Engineering Services during or prior to the acceptance testing.
8.3 The supplier shall declare the manufacturing date, and the date of the first release of the
model into market.

MS 2058:2009
8.4 The supplier shall carry out acceptance testing in the presence of Biomedical
Engineering Services and the user. The results of the acceptance testing shall be verified by
the Biomedical Engineering Services. Results shall be documented and handed over together
with all relevant certificates to the Biomedical Engineering Services.
8.5 When a contractor installation is required, Biomedical Engineering Services shall verify
correct installation is done based on the required specification.
8.6 Biomedical Engineering Services shall review the relevant contracts and literature for
warranty provisions, and advice the user to complete the warranty registration data, if
applicable, and forward it to the manufacturer.
8.7 Biomedical Engineering Services shall give unique identification for newly introduced
equipment. The equipment shall be registered into a master list.
8.8 The supplier shall provide complete copies of the following items to Biomedical
Engineering Services:
a) user manual;
b) service or maintenance manuals;
c) circuit diagrams and drawings;
d) parts list;
e) PPM checklist according to manufacturer’s recommendation; and
f) other necessary documents/items.
8.9 The supplier shall provide a list of required test equipment and special tools to
Biomedical Engineering Services.
8.10 The user should ensure that initial inspection and acceptance test have been
conducted on leased, loaned, consigned, or privately owned equipment to be used within
healthcare facility.
8.11 If rectifications on the equipment are required to pass the acceptance test, the
rectifications shall be carried out by the supplier or relevant parties and the equipment shall
be subjected to acceptance test again.
8.12 Biomedical Engineering Services shall monitor the warranty period of the equipment.
9. Mechanisms to avoid failure or breakdown during use

Biomedical Engineering Services shall provide mechanisms to avoid failure or breakdown of
equipment during patient treatment, diagnosis and therapy.
Biomedical Engineering Services shall review health alerts, equipment failures, incident
reports, use errors, component failures and carry out corrective action.

MS 2058:2009
9.1 Prepare, review and adjust preventive maintenance program and periodically assess
the effectiveness of the program.
9.2 Perform equipment audit (when necessary), document review and advise users on
proper handling during inspection visits.
9.3 Communicate and feedback to user on equipment maintenance status.
9.4 Coordinate with the user in the event of utility shutdown.

9.5 Provide training for user and Biomedical Engineering Services personnel to reduce
hazards and to avoid potential risk/incident. Such training shall exclude clinical application.
9.6 Take prompt action in response to recall or hazard information.
9.7 Perform comprehensive maintenance.
9.8 Provide effective and responsive equipment repair including on-call services.
9.9 Undertake supervision, quality control and documentation of inspection, performance

testing, preventive maintenance and repair services.
9.10 Advise user on the removal or disposal of hazardous, unserviceable, or unwanted

equipment, accessories or consumables.
9.11 Annual evaluation report shall include equipment failures statistics and
recommendation.
9.12 Assist in any recalls of equipment that may be required.
10. Uptime
Achieve uptime targets as specified in Biomedical Engineering Services KPI for all equipment
in service.
10.1 Biomedical Engineering Services shall identify applicable uptime target for the
equipment with reference to KPI. A list of recommended uptime target is as per Annex E.
Uptime calculation is as per Annex F.
10.2 Biomedical Engineering Services shall record applicable uptime target in equipment
register.
10.3 Biomedical Engineering Services shall administer and monitor equipment compliance
with uptime targets.
10.4 All maintenance time shall be recorded in MMIS.
10.5 Biomedical Engineering Services shall produce reports on uptimes for all equipment
on a periodic basis for review.

MS 2058:2009
11. Quality assurance program (QAP)

QAP shall be developed for continuous improvement on Biomedical Engineering Services in
healthcare facilities.
11.1 Biomedical Engineering Services shall identify the KPI of the services and set
appropriate standards to be achieved. Example of the indicators are as follows:
a) percentage of PPM schedule completed as scheduled;

b) percentage of asset meeting uptime target; and
c) percentage of response time meeting target.
11.2 Standards set should be measurable qualitatively and quantitatively. These

measurable standards should be set at the optimum achievable level, instead of the ideal
level and it should be appropriate to the Biomedical Engineering Services.
11.3 KPI shall be agreed by the healthcare facility authority and Biomedical Engineering
Services.
11.4 The QAP shall consist of:
a) Structure
The Biomedical Engineering Services shall define the structure in which the QAP will
work in terms of:
i) physical setting;
ii) selection of equipment;
iii) working environment; and
iv) documentation and information systems.
b) Processes
Identify the methodology of the QAP as below:
i) identification of problem;
ii) prioritisation of problem;
iii) problem analysis;
iv) identification of remedial actions;
v) implementation of remedial actions; and
vi) re-evaluation of the effectiveness of the remedial actions.

MS 2058:2009
c) Outcome
Outcome refers to the end result.
11.5 The healthcare facility authority shall review the QAP proposed by the Biomedical
Engineering Services and comment accordingly.
11.6 Biomedical Engineering Services shall provide healthcare facility authority the agreed
information and maintain accurate records, procedures and other documents in the QAP. The
data collected shall be analysed for further improvement of the structure and processes.
12. Maintenance management information system (MMIS)

MMIS is used to manage all aspects of the Biomedical Engineering Services.
12.1 Biomedical Engineering Services shall progressively develop and apply MMIS.
12.2 Biomedical Engineering Services shall train all relevant parties to use MMIS.
12.4 The MMIS should consist, but not limited to, the following modules and be accessible
to authorised users:
a) asset register module with links to other modules;
b) work order module;
c) planned preventive maintenance module;
d) maintenance history module; and
e) supplier-client register module.
12.6 Data back-up shall be carried out at periodic intervals.
12.7 An example of MMIS data and report is listed in Annex G.
12.8 Healthcare facilities without Biomedical Engineering Services shall maintain a manual
maintenance management system.
13. Management of warranties

The purpose of warranty management is to ensure that all faults occurring within the warranty
period are detected, reported and repaired under warranty provisions where applicable as
well as to ensure that all planned preventive maintenance covered under the warranty
provision is carried out within the warranty period as per agreed schedule.
13.1 The warranty provider shall provide PPM schedule and warranty register shall be
updated and maintained accordingly by Biomedical Engineering Services.

MS 2058:2009
13.2 Biomedical Engineering Services shall refer to device warranty documents to

determine the extent of scope of work and the responsibilities of each party.
13.3 PPM covered under the warranty provisions shall be monitored accordingly and
notification shall be given to warranty provider to comply with warranty provisions. The user
shall be informed if warranty provider fails to comply with warranty provisions.
13.4 PPM and corrective maintenance carried out by warranty provider shall be supervised
and monitored. The details of maintenance work carried out by the warranty provider or its
appointed party shall be recorded accordingly.
13.5 The warranty provider shall be responsible to ensure the medical device is in good
working condition upon warranty expiry. Any fault reported during warranty period shall be
rectified by the warranty provider or any party appointed by the warranty provider.
13.6 The user department shall inform the Biomedical Engineering Services at least 30
days prior to warranty expiry of any faults of the device that require rectification by the
warranty provider.
14. Decommissioned equipment
Decommissioned equipment is medical equipment that has been taken out of service pending
disposal.
14.1 The user shall provide notification and the list of decommissioned equipment to the
Biomedical Engineering Services and asset register shall be updated accordingly.
14.2 Biomedical Engineering Services and user shall ensure all equipment is safe for
disposal.
14.3 Any ionising radiation equipment shall be decommissioned as per the Atomic Energy
Licensing Act 304.
14.4 Biomedical Engineering Services shall remove all decommissioned equipment from
use. All decommissioned equipment shall be placed into a designated area.
14.5 All decommissioned equipment shall be updated into MMIS.
15. Disposal of equipment

15.1 The user shall obtain appropriate approval for disposal of equipment from healthcare
facility authority.
15.2 The disposal of potentially hazardous equipment, material or components such as

batteries, X-ray tubes, vacuum tubes, pressure vessels, radioactive materials and devices
that contain toxic materials such as lead, beryllium, mercury or other heavy metals,
polychlorinated biphenyls and asbestos, shall be carried out according to established
procedures as laid out in relevant national/international standards or national regulations.

MS 2058:2009
16. Processes for handling hazardous/contaminated equipment

Decontamination is the process of handling hazardous/contaminated equipment that may
involve cleaning, disinfecting and sterilisation and may vary according to the equipment.
Failure to decontaminate equipment properly may lead to post-operative infection and the
spread of diseases. Failure to maintain equipment decontamination and sustain proper
working practices can raise health and safety issues for staff and patients.
16.1 Procedure for handling hazardous/contaminated equipment

16.1.1 The user shall decontaminate any equipment such as aspirators, dialysis related
equipment, surgical related equipment, laboratory equipment, or any equipment suspected to
be hazardous or being contaminated prior to any maintenance activity.
16.1.2 The user shall declare in the maintenance request that the decontamination has been
performed.
16.1.3 The decontamination process shall follow established procedures and be carried
out by trained personnel.
16.1.4 Biomedical Engineering Services shall identify and set their own KPI for these
activities. For examples of KPI in all government hospitals and institutions please refer to
Annex H.
17. Incidents and hazards

This procedure shall be followed in order to carry out investigation and corrective actions on
incidents and notified hazards.
17.1 The user shall report immediately all incidents related to medical equipment to the
safety officer and Biomedical Engineering Services and prepare a written report within 24
hours.
17.2 Respective equipment, its accessories and consumables shall be taken out of use,
tagged and stored in a secured area.
17.3 All incidents involving the failure of equipment shall be investigated and all parties
including Biomedical Engineering Services shall cooperate fully with the investigating body.
17.4 Biomedical Engineering Services shall manage equipment hazard alerts and recall
notices provided by equipment suppliers and/or established organisations as per the
following:
a) Biomedical Engineering Services shall check equipment register for equipment items
identified in hazard alerts and recall notices;
b) Biomedical Engineering Services shall disseminate hazard alert and recall notices to
relevant user and take appropriate action to eliminate identified hazards; and
c) Biomedical Engineering Services shall take appropriate action to arrange for recall of
items as required.

MS 2058:2009
17.5 In the event of an incident that involve the same model of equipment in any country or
location, the manufacturer or supplier shall inform the healthcare facility authority, user and
Biomedical Engineering Services and take corrective action to ensure the equipment is safe
to use.
18. User training

Users shall be trained on the proper and correct usage and operation of the equipment.
18.1 Biomedical Engineering Services shall offer or coordinate training when a new
equipment system is first issued and periodically as requested.
18.2 When the need arises, either requested or planned, Biomedical Engineering Services
shall provide or coordinate training to users to cover among others the following:
a) safety precautions in operating the equipment;
b) proper operation including features unique to the particular manufacturer or model of

equipment;
c) user maintenance;
d) cleanliness and decontamination awareness;
e) operational verification procedures;
f) recognition and correction of common operational problems;
g) recognition of defective equipment and potential hazards; and
h) proper reporting procedures for maintenance requests.
18.3 Biomedical Engineering Services and users shall maintain training records.
18.4 Biomedical Engineering Services shall periodically analyse the maintenance record to
see the need for further user training. Biomedical Engineering Services who see such
problems should document the discrepancies, and offer user training to the relevant user
department and equipment users.
18.5 Biomedical Engineering Services, the manufacturer, qualified third parties, or medical
staff members can provide user training.
18.6 When procuring new equipment, healthcare facility authority shall include a
requirement in the contract that the manufacturer or its representative shall provide training
for both Biomedical Engineering Services and users.
19. Stock of genuine spares

Stock of genuine spares is to guarantee the availability of genuine spare parts from the
equipment manufacturer to meet uptime target and availability of equipment for minimal
interruption of clinical services.

MS 2058:2009
19.1 Biomedical Engineering Services shall survey all equipment and identify required
spare parts.
19.2 Biomedical Engineering Services shall source required genuine or equivalent spare
parts.
19.3 Biomedical Engineering Services shall recommend with supporting document to the
healthcare facility authority or appointed authority on the use of equivalent genuine or original
equipment manufacturer (OEM) spare parts authorisation.
19.4 Biomedical Engineering Services shall report to the healthcare facility authority or
appointed authority in the event that the manufacturers do not assist in providing supporting
document.
19.5 Biomedical Engineering Services shall maintain adequate stock of required genuine
spare parts and practice good store management.
20. On-site library

Biomedical Engineering Services shall maintain and manage an on-site library at an
accessible and designated area. The library should consist of documents such as:
a) operation and maintenance manuals;
b) drawings;
c) software;
d) relevant standards and regulations;
e) training materials; and
f) other related documents.
21. Workshop setup

Setting-up of an adequately equipped workshop facility for maintenance of medical
equipment, safe storage for equipment under maintenance and efficient space utilisation.
21.1 Healthcare facility authority shall determine the requirement for establishing a
Biomedical Engineering Services workshop.
21.2 In the event that a workshop is required, healthcare facility authority shall set up the
workshop based on the size of the healthcare institution and the healthcare services available
in the institution.
21.3 The workshop area shall be adequate in size (preferably 120 ft2 to 150 ft2 if
documentation storage and parts storage is included into the immediate work area for every
personnel). Refer Annex J for examples of workshop setup. Figure J1 indicates layout for a
maximum of two personnel and Figure J2 indicates layout for a maximum of 6 personnel.

MS 2058:2009
21.4 The workshop should be equipped with proper tools, and test equipment inventory
(refer to Table 1 for lists of common test equipment that may be needed); and personal
protective equipment (PPE) to perform the maintenance services.
21.5 Biomedical Engineering Services workshop may consist of the followings, where
applicable:
a) Environmentally controlled room: used to calibrate and maintain intricate sensitive

equipment such as anaesthesia equipment, fiber optic systems, lasers, and ventilators.
b) Equipment storage area: secure area to store equipment awaiting parts or maintenance
without excessive dust, moisture, and other adverse environmental elements.
c) Repair parts storage area: secure area to properly store repair parts.
d) Administrative area: a well-lit area for administrative functions and customer service
(preferably one administration workstation for every two maintenance personnel).
e) General work area: a well-lit area for technician workbenches (preferably one workbench
for every maintenance personnel).
f) Proper mercury handling facility and procedure shall be established where applicable and
in compliance with relevant regulations.
g) Equipment maintenance facility requirements may include multiple 240 V outlets and at
least one each 415 V, 60 A single and three-phase AC power outlet. Requirements also
include earth leakage circuit breaker (ELCB), telephone service, emergency eyewash,
internet and LAN connectivity, medical air, nitrous oxide and scavenging system (if it has
analgesia or anaesthetic devices), vacuum system, ventilation and temperature control,
and wash sink.
21.6 Keep the maintenance area clean and orderly. Equipment and work surfaces should be
cleaned, waste removed and disposed off properly on a regular basis.
21.7 Ensure work flow and status of pending repair works are clearly indicated and
recorded.
21.8 Accessibility
21.8.1 Locate the workshop facility where equipment can be brought in without
unnecessary handling and exposure to bad weather.
21.8.2 Preferably the workshop shall be in the proximity of the critical clinical area of the
healthcare facility.
21.9 Facilities for proper cleaning of equipment and hand washing shall be provided to
prevent unnecessary exposure of potential hazard and infectious agents.
21.10 Ventilation in the work area shall comply with regulatory requirements related to the
adequate dissipation of vapours associated with chemicals (fluids, agents, substances,
compounds, etc.) that are used in the work area.
21.11 All recommended requirement are applicable to any party involved in carrying out
Biomedical Engineering maintenance.

MS 2058:2009
Table 1. List of common test equipment
Type Equipment
General Function Generator
Electrical Safety Analysers
Oscilloscopes
Digital Multimetres
Pressure Gauges
Digital Tachometer
DC Power Supply
Patient Simulator
Calibrated Weights
Digital Thermometer
Digital Luxmeter
Specialty Ventilator Analyser
Electrosugical Unit Analyser
Defibrillator Analyser
Radiation Detector / Survey Meter
Infusion Pump Analyser
kVp Meter
Collimator test tool
22. Advisory service

22.1 Advice on the following maintenance provisions shall be obtained from the Biomedical
Engineering Services during the entire lifecycle of medical devices:
a) selection of equipment;
b) equipment installation;
c) discontinuation of use of equipment;
d) replacement of equipment;
e) any adverse events;
f) condition appraisal of equipment; and
g) disposal.

MS 2058:2009
22.1.1 Proposal for removal of equipment from operation
Equipment may be proposed for removal from operation when it satisfies one or more of the
followings:
a) beyond economical repair:
i) cost of repair exceeds depreciated value; or
ii) accumulated maintenance cost plus the estimated cost of impending upcoming
repairs exceeds the depreciated value of the equipment;
b) worn out - when the equipment would not function properly even though repairs are
carried out;
c) unreliable - when it is not meeting up to its acceptable level of performance for its
intended use;
d) obsolescence - when it is obsolete due to any of the following factors:
i) a new model of the same equipment has a design change resulting in a better
efficiency and increased capacity;
ii) a new concept for the service provided by the equipment is introduced;
iii) new safety requirements render the equipment unsafe; or
iv) spare parts are no longer available;
e) changes in local policies for device use;
f) absence of manufacturer/supplier support;
g) increased capacity is required due to expanded operations or less labour available;
h) possible benefits of new model (features, usability, more clinically effective, lower running
costs); or
i) exceeded lifespan of the equipment as recommended by recognised organisation.
22.2 Recall
Upon receiving recall notice, Biomedical Engineering Services shall advise the user and take
appropriate action to the affected equipment. The equipment shall be isolated from use and
tagged with appropriate label.
22.3 Upon request, Biomedical Engineering Services shall provide updated information
regarding latest technology to user department. This information shall assist user for
equipment procurement program.
22.4 As and when required, Biomedical Engineering Services shall provide advice to user
department on equipment replacement plan.

MS 2058:2009
22.5 Biomedical Engineering Services shall communicate relevant information about

equipment failures and use errors to the relevant parties, as appropriate.
23. Procurement of equipment

Healthcare facility authority shall ensure local policies for procurement of medical equipment
addresses safety, quality, and performance are observed.
Policies should include the need to establish advisory groups to ensure the procurement
requirements take into account the needs of all parties involved in the use, commissioning,
decontamination, maintenance and decommissioning of medical equipment.
23.1 Biomedical Engineering Services shall provide advice upon request by healthcare
facility authority prior to procurement, such as:
a) installation requirements, utility services and commissioning procedure;
b) reliability and previous performance;
c) past history of problems with the device or type of device;
d) compatibility with other relevant equipment and systems;
e) safety publications, manufacturer’s advisory notices or other relevant publications related

to the equipment;
f) training needs (user and technical training);
g) warranty coverage; and
h) other support facilities
23.2 All equipment supplied to the healthcare facility shall conform to relevant
international/national electrical safety standard; i.e. MS IEC 60601-1 for medical electrical
equipment and MS IEC 61010-1 for laboratory equipment; and relevant product standards.
23.3 The medical equipment to be procured shall comply with Malaysian power supply rating
of 240 V with a tolerance of +10 % -5 %, 50 Hz (single phase) and 415 V with a tolerance of
+10 % -5 %, 50 Hz (three-phase).
23.4 The condition for purchase shall include provision for future modification of equipment
and provision for software upgrades.
23.5 The criteria for selection shall be based on efficacy, effectiveness, performance, safety,
reliability, features, ease of use, cost-effectiveness, service, training and continuous support
for the user and equipment maintenance.
23.6 Supplier shall provide complete copies of the following items to the healthcare facility
authority and Biomedical Engineering Services:
a) user manual;
b) service or maintenance manuals;

MS 2058:2009
c) circuit diagrams and drawings;
d) relevant software inclusive of access codes;
e) parts list;
f) PPM checklist according to manufacturer recommendation; and
g) other necessary documents/items.

23.7 Supplier shall provide complete technical training to the Biomedical Engineering
Services and user training.
23.8 Final payment shall be paid to the supplier upon meeting the terms and conditions of
contract/purchase order and clearance from Biomedical Engineering Services.

MS 2058:2009
Annex A
(normative)
Biomedical Engineering competency and career development guidelines
A1. Introduction
Biomedical Engineering is one of several professional disciplines contributing to safe,

effective and economical health care. The role and primary responsibility of a Biomedical
Engineering services are management of medical device technologies, including adherence
to recognised safety, quality, cost, and efficiency standards.
Biomedical Engineering is a learned profession that combines expertise and responsibilities in

engineering, science, technology, and medicine. Since public health and welfare are
paramount considerations in each of these areas, Biomedical Engineers shall uphold an
appropriate level of competencies embodied in its professional practice, research, patient
care, and training. The level of competencies shall reflect the standards of professional and
personal practice for Biomedical Engineers.
A2. Competency levels of Biomedical Engineer and Technician

The Biomedical Engineering maintenance competency levels are categorised into four
technical levels and one management level. To determine the individual competency levels,
the guidelines shall be cross referred to the medical device maintenance specialisation
classification, competency skills, breakdown maintenance level and management skills level
of the Biomedical Engineer or technician. The details of the competency levels are as per the
relevant matrix (refer Figure A1 and Tables A1 to A9).
A3. Career development plan for Biomedical Engineer and Technician

To ensure the career development and progress of the Biomedical Engineer and Technician
in achieving various levels of competencies, a systematic career development plan shall be
followed by the Biomedical Engineering Services organisation as a guideline. Details of the
career development plan are as per the Biomedical Engineering career development matrix in
Table A9.
A4. Assessment of competence and commitment

The biomedical engineer shall have their competence and commitment assessed through a
Professional Competency Examination, conducted by the recognised Competency Certifying
Body (CCB), authorised by the Engineering Services Division of the Ministry of Health
Malaysia. The examination will be against the competence and commitment standards
developed as per this Malaysian Standard and relevant national regulation. The decision
whether or not to accept an applicant for competency examination registration shall be made
by the CCB authorised by the Ministry of Health Malaysia, which is responsible for governing
the competency registration. Details of the competency certification requirements are as per
Table A9.

MS 2058:2009
A4.1 The professional competency review shall include three components:
a) a review of experiences documentary evidence; or
b) continuous professional development in Biomedical Engineering; and

c) an examination.

Licensed to UNIVERSITI PUTRA MALAYSIA (UPM) / Downloaded on : 29-Nov-2011 09:34:02 AM / Single user license only, copying and networking proh
Figure A1. Competency level
MS 2058:2009
© STANDARDS MALAYSIA 2009 - All rights reserved
Table A1. Competency levels and device specialisation classification matrix
Biomedical Engineering maintenance competency levels

Medical device maintenance specialisation classification
Level 1 Level 2 Level 3b Level 4c Managementd
1 Basic level medical device (refer to Tables A2 to A5e) X X X Optional X
2 Intermediate level medical device (refer to Tables A2 to A5e) - X X Optional Optional
3 High level medical device (refer to Tables A2 to A5e) - - Optional X

a
Optional
a
Area of specialisation to be declared based on specific model of medical devices.
b
For Level 3 competency, the person is given an option to expand their specialisation level based on their training advancement and experiences.
c
For Level 4 competency, the person at vendor and manufacturer are given an option to exclude the lower specialisation level.
d
For management level, the manager is required to obtain a minimum competency on general/basic level medical device specialisation.
e
The sample of medical devices specialisation are given in Tables A2 to A5 and subject to changes based on its complexity and cost of the equipment.
MS 2058:2009
31
32
MS 2058:2009
Table A2. Radiology and imaging equipment specialisation classification (sample)*
Basic Intermediate High

Densitometres Laser imagers Calibrators, radiosotope
Densitometres, bone, X-ray, dual-energy
Radiation survey metres, Geiger-Muller Cameras, gamma
absorptiometry
Densitometres, X-ray film Radiation survey metres, ionization chamber Computers, radiotherapy planning system
Dosimetres, radiation Radiographic systems, film Counters, gamma
Mixers, X-ray film chemistry Radiographic systems, film Injectors, contrast media, magnetic resonance imaging
Radiation monitors Radiographic units, chest Linear accelerators

Sensitometres, radiographic Radiographic units, dental Radiographic systems, digital
X-ray film duplicators Radiographic units, dental intraoral Radiographic units, mammographic
X-ray qa test cassette Radiographic units, mobile Radiographic/fluoroscopic systems, angiographic/interventional
X-ray film processors Scanner, ultrasound Radiographic/fluoroscopic systems, cardiovascular

X-ray film handling equipment, automatic, daylight Radiographic/fluoroscopic systems, general-purpose
Radiographic/fluoroscopic units, mobile

Radiographic/tomographic systems, linear
Radiotherapy simulation systems
Radiotherapy units, cobalt
Radiotherapy units, orthovoltage
Scanning systems, computed tomography
Scanning systems, magnetic resonance imaging, full-body
* Subject to changes based on its complexity and cost.

Table A3. Laboratory equipment specialisation classification (sample)*

Baths, freezing Analyzers, laboratory, blood gas/pH Analyzers, laboratory, microbiology
Baths, tissue flotation Analyzers, laboratory, blood, urea nitrogen Analyzers, laboratory, radioimmunoassay
Baths, water Analyzers, laboratory, body fluids Chromatography systems
Bilirubinometres Analyzers, laboratory, haematology Cytometer
Blood cell processors Analyzers, laboratory, clinical chemistry Dna sequencing systems
Carbon dioxide monitors, laboratory incubator Analyzers, laboratory, immunoassay Iontophoresis units, sweat test
Centrifuges Analyzers, point of-care, whole blood Microscopes, electron
Chambers, anaerobic Homogenizers, tissue Synthesizers, DNA/RNA
Clippers Microtomes Tissue processors
Concentrators, specimen Osmometres Spectrometres, mass, laboratory
Densitometres, laboratory Spectrophotometres Analyzers, laboratory, breath
Diluters Tissue embedding equipment Analyzers, laboratory, semen
Dispensers, paraffin Microscopes, light, laboratory Analyzers, laboratory, urine
Dissectors Urodynamic measurement systems Spectrofluorometres
Distilling unit Titrators Separators, plasma
Dryers Refractometres, laboratory Viscosimetres, plasma
Dryers, slide Nephelometres
Evaporators Electrophoresis systems
Extractors, plasma Counters, scintillation
Fluorometres Counters, colony
Hot plates
MS 2058:2009
Incinerators, pathology
Incubators, laboratory
Insufflators
Keratomes
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34
MS 2058:2009
Table A3. Laboratory equipment specialisation classification (sample)* (continued)

Loupes
Mixers, blood tube
Mixers, clinical laboratory
pH metres
Pipetters
Pumps, laboratory
Rotators
Scales, clinical, laboratory
Sedimentation rate units
Shakers, laboratory
Sharpeners, microtome knife
Slide stainers
Specimen cutters
Stirrers
Synoptophores
Timers, coagulation
Ureterotomes
Washer
Water bath circulators
Water purification systems, ultraviolet
Table A4. Diagnostic equipment specialisation classification (sample)*

Air samplers Analyzers physiologic, peristaltic motility, gastrointestinal
Audiometres Analyzers, physiologic middle ear, impedence tympanometry
Balances, electronic Analyzers, physiologic, middle ear
Balances, mechanical Analyzers, physiologic, pulmonary function, adult
Battery chargers Analyzers, physiologic, pulmonary function, neonatal/pediatric
Calibrators, mass spectrometer Analyzers, physiologic, visual function
Cameras Apnoea monitors
Cardiotocographs Biofeedback systems
Charts, eye, visual acuity Blood gas monitors, carbon dioxide
Counters, needle Blood gas monitors, oxygen
Dialysate conductivity metres Blood-flow detectors, ultrasonic
Disinfectors Brachytherapy systems, remote after loading
Dispensers, fluid Carbon dioxide monitors, exhaled gas
Dissectors Carbon dioxide/oxygen monitors, transcutaneous
Dynamometres Cardiac output units
ECG monitors Multiple medical gas monitors, respired/anaesthetic
EEG monitors Nerve function monitors
Electrocardiographs Oxygen monitors
Electrocautery units Physiologic monitoring systems
Electroencephalographs Respiration monitors
Electromyographs Stimulators, electrical, neuromuscular, diagnostic
MS 2058:2009
Electroretinographs Uterine activity monitors
EMG monitors, telemetric Urodynamic measurement systems
Eye movement monitors Spirometres
Fetal heart detectors Plethysmographs
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MS 2058:2009
Table A4. Diagnostic equipment specialisation classification (sample)* (continued)

Flowmetres, blood
Gas sampling units
Gasometres
Lensometres
Metal detectors
Microgasometres
Ophthalmometres
Oximetres, pulse
Perimetres, ophthalmic
Phonocardiographs
Plethysmographs
Power supplies, line-voltage stabilization
Printers, video
Prism bars
Projectors, cine
Recorders
Retinoscopes
Scales
Scanners, long term recording, ECG
Sphygmomanometres, aneroid
Sphygmomanometres, electronic
Sphygmomanometres,mercury
Television monitors
Testers, pulp
Thermometres
Table A4. Diagnostic equipment specialisation classification (sample)* (concluded)

Treadmills
Ureterotomes
Uroflowmetres
Vectorcardiographs
Video image processors
View boxes, ultraviolet
Visual field plotters
MS 2058:2009
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MS 2058:2009
Table A5. Therapeutic equipment specialisation classification (sample)*

Acrylic curing units, dental Anaesthesia unit vaporizers Angioplasty systems, atherectomy
Acupuncture kits Anaesthesia units Cataract extraction units, phacoemulsification
Amalgamators Autotransfusion units Circulatory assist units, intra aortic balloon
Analgesia units, inhalation Bronchoscopes Circulatory assist units, venous return
Aspirators Cameras, endoscopic Lasers, argon
Baths, dialysate warming Cameras, video, endoscope Lasers, carbon dioxide
Baths, paraffin, physical therapy Chairs, examination/treatment, dentistry Lasers, diode
Bed, tilt Choledochoscopes Lasers, dye, photodynamic therapy
Calipers Colonoscopes Lasers, ER:YAG, surgical
Cast cutter vacuums Colposcopes Lasers, excimer, ophthalmic
Cast cutters, electric Compressors, medical-air Lasers, HO:YAG, surgical
Casting furnaces, dental Cryosurgical units Lasers, ND:YAG
Casting units, dental Cystometres Lithotripters
Chairs, examination/treatment Cystoscopes Microscopes, scanning laser, optical
Compression unit, sequential Defibrillator Microwave therapy system, tissue ablation, endometrial
Counters, intravenous drop Dermatoscopes Stimulators, electrical, brain, convulsive therapy
Crimpers Dialyzer reprocessing units Thyroid uptake systems
Ultrasound therapy/neuromuscular stimulation systems,
Dental delivery units Duodenoscopes
physical therapy
Dental engines Ear/nose/throat treatment units
Dental hand instruments, surgical Electrosurgical units
Dermatomes Gastroscopes
Desensitizers Gonioscopes
Drills Heart-lung bypass units
Table A5. Therapeutic equipment specialisation classification (sample)* (continued)
Dynamometer exercise systems, computerised Haemodialysis units

Epilators Humidifiers, heated
Ergometres, bicycle Hysteroscopes
Exercisers, continuos passive motion Incubators
Fibrillators Intubation scopes, flexible fiberoptic
Film digitizers Laparoscopes
Flowmetres, gas Laryngoscopes
Forceps Microscopes, light, operating
Hand drills, surgical Microwave therapy systems, diathermy
Handpieces Nasopharyngoscopes
Headlights Nephroscopes
Hearing aids Oxygen concentrators
Heating pads Pacemaker programmers
Heating units Pacemakers, cardiac, external, electrodes, transvenous
Heating units, thermal probe Peritoneal dialysis units
Hemofiltration units Radiofrequency therapy systems, diathermy
Infusion pumps Rhinoscopes
Injectors, contrast media Sigmoidoscopes
Injectors, medication/vaccine, needleless Smoke evacuation system, surgical
Insufflators Stimulators, electrical neuromuscular
Stimulators, electrical, peripheral nerve, analgesic,
Irrigation / distention systems, arthroscopic
trancutaneous
Keratomes Synoptophores
MS 2058:2009
Lights Television systems, endoscope
Loupes Tonometres, ophthalmic
Magnets, eye Ultrasonic surgical unit
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40
MS 2058:2009
Table A5. Therapeutic equipment specialisation classification (sample)* (continued)
Massage machines, physical therapy Ureterorenoscopes

Mattress systems, alternating-pressure Ureteroscopes
Microsurgical instruments Ventilators
Modular medical facilities, mobile dental Video image processors, endoscopic
Moist heat therapy packs Vitrectomy units
Nebulizers Washers, flexible endoscope
Ophthalmoscopes Water purification systems
Otoscopes
Perimetres, dental
Photometer
Phototherapy units
Polymer applicator, dental
Presses, flask, dental
Pressure infusors
Pressure measuring units compartmental
Pressure reducers, intraocular

Proctoscopes
Prophylactic unit, dental
Pumps, breast
Pumps, enteral feeding
Pumps, extracorporeal perfusion
Resuscitators
Sandlaster, dental
Saws
Scalers, dental, ultrasonic
Scissors, dissecting
Table A5. Therapeutic equipment specialisation classification (sample)* (concluded)
Slit lamps
Stimulators, caloric, physical therapy, fluidised
medium
Tables, examination/treatment
Tables, operating
Tourniquets, pneumatic
Tracheal tube introducers
Traction units
Training manikins, cardiopulmonary resuscitation
Transilluminators
Trimmers. Model, dental
Ultrasonic cleaning system
Vacuum extractors, obstetrical
Vacuum-mixing devices, dental
Vibrators
Warming units
Water purification systems
Welding units, orthodontic
Wire drivers
Apheresis units
*subject to changes based on its complexity and cost.
MS 2058:2009
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MS 2058:2009
Table A6. Biomedical Engineering maintenance competency levels and skills matrix
Competency levels
Skills
Level 1 Level 2 Level 3 Specialist Management
Understanding of the anatomy, physiologic and biomedical equipment classification for specific medical √ √ √ √ √
Theory
device (refer to table A2 to A5).
Understanding of specific medical devices operations and its applications. √ √ √ √ √

Operations
Identify and verify operation of all safety features for specific medical devices. √ √ √ √ √
√ √ √ √ √
Be able to perform an effective electrical safety procedure on the specific medical device.
Safety
√ √ √ √ √
Understanding of test fixtures and test equipment specific to the medical device.
Understanding of manufacturer Planned Preventive Maintenance (PPM) procedures and follows √ √ √ √ √
appropriate steps to complete the task for specific medical devices.
Servicing
√ √ √ √ √
Be able to perform an effective performance testing and calibration on the specific medical device.
First line repair: Be able to identify and perform breakdown and corrective maintenance of the medical √ √ √ √ √
devices at the point of care.
Second line repair: Be able to identify intermediate corrective actions required for the corrective √ √ √
maintenance of the specific medical device up to module/board levels at maintenance workshop either - optional
Repair
internal or external.
Third line repair: Be able to identify advance corrective actions required for the breakdown maintenance √ √
of the specific medical device up to component levels and complete overhaul at specialised or - - optional
manufacturer facilities.
Be able to complete accurately the necessary Biomedical Engineering related documentation. √ √ √ √ √
Understanding of Biomedical Engineering Maintenance Services management Level 1. Refer to √ √ √ √

-
Management Level Matrix.
Managing Understanding of Biomedical Engineering Maintenance Services management Level 2. Refer to √ √
- optional optional
management level matrix (Table A8).
Understanding of Biomedical Engineering Maintenance Services management Level 3. Refer to
- - - optional √
management level matrix (Table A8).
Table A7. Biomedical Engineering breakdown maintenance levels
Breakdown maintenance levels

Breakdown maintenance scope of repair
First line Second line Third line
√ √ √
1 Breakdown Response
√ √ √
2 Equipment resetting and general checking
√ √ √
3 Common repair such as replacement of light bulbs, batteries, probes, electrode, tubing, and equipment consumables.
√ √ √
4 Troubleshoot and repair minor defect related to power supply.
√ √ √
5 Spare parts identifications
√ √
6 Repair and replacement of equipment modules, assemblies or boards (PCB)
√ √
7 Ensure equipment requiring calibration is calibrated before use on a patient.
√ √
8 Repair and replacement of component or subcomponent of the equipment PCB
√
9 Performing complex maintenance tasks that call for special skills, tools, or equipment
√
10 Software re-programming of medical device
√
11 Performing specialized calibration on medical device
√
12 Modification and upgrading of medical device system & software.
√
13 Total overhaul or refurbishment of medical device
NOTE. Refer to Table A1 to A5 for specific medical device except for first line breakdown maintenance levels.
MS 2058:2009
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MS 2058:2009
Table A8. Management skills level matrix
Management levels
Management skills
Management 1 Management 2 Management 3
1 General technical support and facilities √ √ √
2 Schedule maintenance management √ √ √
3 Unscheduled maintenance management √ √ √
4 Communication skills √ √ √
5 Biomedical Engineering Services documentations √ √ √
6 Hospital Biomedical Engineering Services administrative functions √ √ √
7 Education and training for Biomedical Engineering - √ √
8 Staff supervision and monitoring - √ √
9 Relevant contractual management and implementation - √ √

10 Standard, quality and risk management - √ √
11 An advisory service on available Biomedical Engineering technology - √ √
12 Planning, evaluation, procurement and asset management of medical devices - √ √
Service management: To provide organisation with vision, leadership and resources to achieve planned service √
13 - -
goals and objectives.
14 Biomedical Engineering research and development. - - √

Table A9. Biomedical Engineering career development matrix
Biomedical maintenance competency levels
Entry levels Level 1 Level 2 Level 3 Equipment specialist Management
1 2 3
Qual Exp Cert Qual Exp Cert Qual Exp Cert Qual Exp Cert Qual Exp Cert
√ √ √ √ √ Passed
Passed A and/or
Passed A,
Any of B, C, D
Degree in Biomedical Passed Passed 3 B and Any 3 5
1 6 mth 1 year C1, C2, with
Engineering A A and B years of C1, C2, years years
C3 or C4 Relevant
C3 or C4 4
or D Mgmt
Cert
√ √ √ √ √ Passed
Passed A and/or
Passed A,
Any of B, C, D
Degree in Electronic Passed Passed 3 B and Any 3 5
2 9 mth 2 years C1, C2, with
C3 or C4 Relevant
C3 or C4 4
and D Mgmt
Cert
√ √ √ √ √ Passed
Passed A and/or
Passed A,
Any of B, C, D
Degree in other relevant Passed Passed 5 B and Any 3 5
3 1 year 3 years C1, C2, with
engineering A A and B years of C1, C2, years years
C3 or C4 Relevant
C3 or C4 4
and D Mgmt
Cert
√ √ √ √ √ Passed
Passed A and/or
Passed A,
Any of B, C, D
Diploma in Biomedical Passed Passed 7 B and Any 3 10
C3 or C4 Relevant
C3 or C4 4
and D Mgmt
Cert
√ √ √ √ √
MS 2058:2009
Passed
Passed A and/or
Passed A,
Any of B, C, D
Diploma in Electronic Passed Passed 7 B and Any 3 10
C3 or C4 Relevant
C3 or C4 4
and D Mgmt
Cert
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MS 2058:2009
Table A9. Biomedical Engineering career development matrix (continued)
Biomedical maintenance competency levels
Entry levels Level 1 Level 2 Level 3 Equipment specialist Management
1 2 3
Qual Exp Cert Qual Exp Cert Qual Exp Cert Qual Exp Cert Qual Exp Cert
Passed
Passed A and/or
Passed A ,
Diploma in other Any of B, C, D
Passed Passed 7 B and Any 10 10
6 relevant engineering X 2 years X 5 years X X C1, C2, X with
A A and B years of C1, C2, years years
field C3 or C4 Relevant
C3 or C4 4
and D Mgmt
Cert
Certificate in
Passed Passed
7 Biomedical X 1 year X 7 years
A A and B
Engineering
Certificate in
Passed Passed
8 Electronic X 1 year X 7 years
A A and B
Engineering
Certificate in other
Passed Passed
9 relevant engineering X 2 years X 7 years

A A and B
field
Passed 10 Passed
10 Lower qualifications X 2 years X
A years A and B
1
This means “qualification”.
2
This means “experience”.
3
This means “certificate”.
4
This means “management”.
Table A9. Biomedical Engineering career development matrix (concluded)
Certification category Biomedical Engineering maintenance competency certifications description
Basic Biomedical Equipment Maintenance Certification. Provided by competent certifying body

A
recognised by MOH. (Certificate of Competency Biomedical Engineering Maintenance Level 1)
Intermediate Biomedical Equipment Maintenance Certification. Provided by competent certifying body

B
recognised by MOH. (Certificate of Competency Biomedical Engineering Maintenance Level 2)
Biomedical Equipment Specialisation Maintenance Certification in Radiology (Ionizing & Non-Ionizing) &
C1 Imaging medical devices. Provided by competent certifying body recognised by MOH. (Certificate of
Competency Biomedical Engineering Maintenance Level 3 - Radiology and Imaging)
Biomedical Equipment Specialisation Maintenance Certification in Laboratory equipment and devices.

C2 Provided by competent certifying body recognised by MOH. (Certificate of Competency Biomedical
Engineering Maintenance Level 3 - Laboratory)
Biomedical Equipment Specialisation Maintenance Certification in Diagnostic medical devices. Provided

C3 by competent certifying body recognised by MOH. (Certificate of Competency Biomedical Engineering
Maintenance Level 3 -Diagnostics)
Biomedical Equipment Specialisation Maintenance Certification in Therapeutic medical devices.

C4 Provided by competent certifying body recognised by MOH. (Certificate of Competency Biomedical
Engineering Maintenance Level 3 - Therapeutic)
Advanced Biomedical Equipment Specialisation Maintenance Certification in any specialisation of
MS 2058:2009
medical devices. Provided by equipment manufacturer and endorsed by competent certifying body
D
recognised by MOH. [Certificate of Competency Biomedical Engineering Maintenance Level 4 (by Medical
Device Model)]
47
MS 2058:2009
Annex B
(informative)
Examples of equipment tags

Figure B1. Asset label number
BEMS ASSET MAINTENANCE STATUS
PPM
Date Next Due Date*
Done By
Electrical Safety Test Pass N/A
Performance Test Pass N/A
Fit to use Yes No
*Subject to changes as in HSIP
Figure B2. Maintenance status

MS 2058:2009
ASSET UNDER WARRANTY
Commissioning Date
Warranty Expiry Date
PPM Frequency
Figure B3. Equipment under warranty
Proposed for Decommissioning

/Disposal
Proposal Reference No
Submission Date
Decommissioning Cert. No
Figure B4. Proposed for disposal/exemption

MS 2058:2009
DANGER !
EQUIPMENT IS OUT
OF ORDER
Figure B5. Danger tag
EQUIPMENT
UNDER
OBSERVATION
DO NOT USE ON
PATIENT
From: …….(date, time)
To: ………. (date, time)
Figure B6. Equipment under observation

MS 2058:2009
Annex C
(informative)
Example of PPM checklist based on manufacturer’s service manual
CHECKLIST NO:
KEMENTERIAN KESIHATAN MALAYSIA 16231-003
BEMS Planned Preventive Maintenance Checklist
Electrocardiographs, Multichannel, Interpretative
PPM YTD : ( 1 / 1 )
TYPE CODE : 16-231
PART 1 ASSET DETAILS
WORK ORDER NO ASSET NO
MANUFACTURER GE Medical System MODEL MAC 1200
FREQUENCY 3 MONTHLY ( ) 6 MONTHLY ( ) 12 MONTHLY ( ? ) PPM HOURS 1.00
PART 2 SPECIAL PRECAUTION
If there is evidence of body fluid contamination, submit the device for cleaning and decontamination before inspecting it.
Wear appropriate Personnel Protection Equipment (PPE) during work.
Wear grounded electrostatic wristband when handling PCB or electronic components.
Refer to the safety procedure for additional precautions and guidance as per manufacturer guidelines.
Make sure the test equipment used are duly calibrated.
PART 3 TEST APPARATUS

Tick ( √ ) where appropriate
DESCRIPTION ASSET NO / SERIAL NO CALIBRATION DUE ON
ELECTRICAL SAFETY ANALYZER
ECG SIMULATOR
________________________________
________________________________
________________________________
PART 4 QUALITATIVE TASKS

PASS FAIL NA PASS FAIL NA
1. Chassis - verify physical integrity, 10. Indicators/ Displays - verify proper
( ) ( ) ( ) ( ) ( ) ( )
cleanliness and condition illumination and operation
2. Mount/ Fasteners - verify physical

( ) ( ) ( ) ( ) ( ) ( )
integrity 11. Alarm/ Audible Signal - verify operation
3. Casters/Brakes - if mounted, verify ( ) ( ) ( ) ( ) ( ) ( )
physical integrity 12. Printer -Verify operation and condition
4. Power Cord - verify proper insulation
( ) ( ) ( )
and integrity
( ) ( ) ( )
5. Strain Relief - verify physical integrity at
both ends of line cord
( ) ( ) ( )
6. Leads/ Electrodes- Verify integrity and
condition
7. Circuit Breaker/ Fuse - verify integrity of

( ) ( ) ( )
external circuit breaker and/or rating of
external fuse
8. Fittings/ Connectors - check all ( ) ( ) ( )

fittings/connectors
9. Controls/ Switches/ Keypad - verify

( ) ( ) ( )
proper operation of controls
PART 5 PREVENTIVE MAINTENANCE TASKS

DONE NOT DONE ** NA DONE NOT DONE ** NA
1. Cleanliness - clean interior and exterior
( ) ( ) ( ) 3. Battery - check and replace if necessary ( ) ( ) ( )
of the equipment
2. Clean leads & electrode ( ) ( ) ( )
Notes:
*For all parts, NA is defined as NOT APPLICABLE
**If you have ticked 'NOT DONE', then justify in Part 8
KKM/BEMS/0117 Version 1.00 , 1st January 2008

MS 2058:2009
CHECKLIST NO:
Electrocardiographs, Multichannel, Interpretative PPM YTD : ( 1 / 1 )
TYPE CODE : 16-231
WORK ORDER NO
PART 6 QUANTITATIVE TASKS

Set Measured
Description UOM Limit/Tolerance PASS FAIL NA

Values Values
1 Paper Speed (refer Part 8) mm/sec 25 24 - 26 ( ) ( ) ( )
mm/sec 50 48 - 52 ( ) ( ) ( )
2 Pulse Rate Accuracy bpm 60 58 - 62 ( ) ( ) ( )
bpm 80 78 - 82 ( ) ( ) ( )
bpm 120 118 - 122 ( ) ( ) ( )

MS 2058:2009
CHECKLIST NO:
Electrocardiographs, Multichannel, Interpretative PPM YTD : ( 1 / 1 )
TYPE CODE : 16-231
WORK ORDER NO
PART 7 ELECTRICAL SAFETY TEST
ELECTRICAL SAFETY TEST, (attach report)

(In accordance to IEC 60601)
PASS FAIL NA
PART 8 NOTES
Part 6, Item 1
By using an ECG simulator, supply of 60 bpm ECG to the unit and tracing set to 25mm/sec and 50mm/sec, the disctance between the peak to peak should
be 25mm and 50mm respectively or within the tolerance limit.
Reference:
MAC 1200/MAC 1200 ST service manual
CORRECTIVE MAINTENANCE REQUIRED FUNCTIONING NOT FUNCTIONING
WORK ORDER NO ____________________________________________ NEXT PPM DATE _________________
PPM has been performed in accordance to the checklist and the equipment is functioning to the intended purpose.
COMPLETED BY :
DATE :

54
MS 2058:2009
Annex D
(informative)
Example of work order form

MS 2058:2009
Annex E
(informative)
Recommended uptime target for equipment

Uptime
Operating Uptime
Operating Equipment
1. Therapeutic Equipments Group hours/week Equipment <
hours 5 to 10
(Days) 5 years
years
Aneasthesia units and vaporisers C 24 7 99 % 95 %
Aneasthesia ventilator C 24 7 99 % 95 %
Aspirators C 24 7 99 % 95 %
Alternating pressure mattress P 12 6 96 % 92 %
Defibrillators C 24 7 99 % 95 %
Diathermy unit C 24 7 99 % 95 %
Dental Equipment P 24 7 96 % 92 %
Electrosurgical units C 24 7 99 % 95 %
Heamodialysis units C 24 7 99 % 95 %
Humidifiers C 24 7 99 % 95 %
Hypo/hyperthermia units C 24 7 99 % 95 %
Incubators C 24 7 99 % 95 %
Infusion controllers/pumps C 24 7 99 % 95 %
Lasers C 24 7 99 % 95 %
Lithotripters C 12 6 99 % 95 %
Pacemakers C 24 7 99 % 95 %
Peritoneal dialysis unit C 24 7 99 % 95 %
Phototheraphy units C 24 7 99 % 95 %
Radiant warmers P 24 7 96 % 92 %
Radiographic dye injection C 24 7 99 % 95 %
Resuscitators C 24 7 99 % 95 %
Radiotheraphy equipments P 12 6 96 % 92 %
Surgical drills and saws C 24 7 99 % 95 %
Stimulators P 12 6 96 % 92 %
Surgical tables C 24 7 99 % 95 %
Traction units P 12 6 96 % 92 %
Ventilators C 24 7 99 % 95 %
Ultrasonic nebulizers P 12 7 96 % 92 %
Ultrasonic therapy P 12 6 96 % 92 %

MS 2058:2009
Uptime
Operating Uptime
Operating Equipment
2. Diagnostic equipments Group hours/week Equipment
hours 5 to10
(Days) < 5 years
years
Apnoea monitors C 24 7 99 % 95 %
Ambulatory ECG recorded and scanners P 24 7 96 % 92 %
Blood pressure units (non invasive
C 12 6 96 % 92 %
inversive electronic units)
Capnographs C 24 7 99 % 95 %
Cardiac output units P 24 7 96 % 92 %

Diagnostic radiologic imaging units C 24 7 99 % 95 %
Electrocardiographs P 12 6 96 % 92 %
Electroencephalographs P 12 6 96 % 92 %
Electromyographs P 12 6 96 % 92 %
Endoscopes / Bronscopes (fiber optic) C 24 7 96 % 92 %
Evoked potential units P 12 6 96 % 92 %
Electronic thermometer P 12 6 96 % 92 %
Foetal monitors C 24 7 99 % 95 %
Nuclear Medicine Equipments P 24 7 96 % 92 %
Oximetres C 24 7 99 % 95 %
Oxygen monitors and analysers C 24 7 99 % 95 %
Phonocardiographs P 12 6 96 % 92 %
Physiologic monitoring systems ad
C 24 7 99 % 95 %
monitors
Pulmonary function analysers P 12 6 99 % 92 %
Surgical lights C 12 6 99 % 95 %
Surgical microscopes C 24 7 99 % 95 %
Transcutaneous O2 and CO2 monitors C 24 7 99 % 95 %
Treadmills P 12 6 96 % 92 %
Ultrasound imaging units / systems P 12 6 96 % 92 %
Vectorcardiographs P 12 6 96 % 92 %

MS 2058:2009
Uptime
Operating Uptime
Operating Equipment
3. Laboratory Equipments Group hours/week Equipment
hours 5 to10
(Days) < 5 years
years
Analysers P 12 6 96 % 92 %
Amino acid P 12 6 96 % 92 %
Bilirubinometres P 12 6 96 % 92 %
Blood gas P 12 6 96 % 92 %
Calcium P 12 6 96 % 92 %
Clinical chemistry P 12 6 96 % 92 %
Coagulation P 12 6 96 % 92 %
Counter, gamma P 12 6 96 % 92 %
Electrolyte P 12 6 96 % 92 %
Immunoassay P 12 6 96 % 92 %
Glucose P 12 6 96 % 92 %
Heamatology P 12 6 96 % 92 %
Platelet aggregation P 12 6 96 % 92 %
Spectrophotometres P 12 6 96 % 92 %
Atomic absorption P 12 6 96 % 92 %
Atomic absorption units P 12 6 96 % 92 %
Automatic blood grouping systems P 12 6 96 % 92 %
Automatic microbiological systems P 12 6 96 % 92 %
Blood bank centrifuges P 12 6 96 % 92 %
Centrifuges P 12 6 96 % 92 %
Cytometres P 12 6 96 % 92 %
Chromatographs gas/liquid P 12 6 96 % 92 %
Electrophonesis equipment P 12 6 96 % 92 %
Flame photometres P 12 6 96 % 92 %
Microscopes P 12 6 96 % 92 %
pH metres P 12 6 96 % 92 %
C = Critical equipment (including life support)

P = Patient support equipment
NOTE. Operating hours and operating days are indicative only. Medical services at healthcare institutions are
provided at all times and the equipments may be used/operated at any time of the day or available for use at
any time.

MS 2058:2009
Annex F
(normative)
Calculation of uptime
TIME
UPTIME DOWNTIME UPGRADING
MAINTENANCE
DELAY TIME
TIME
SCHEDULED UNSCHEDULED ADMINISTRATIVE

SUPPLY DELAY TIME
MAINTENANCE TIME MAINTENANCE TIME DELAY TIME
UPTIME
UPTIME TARGET = x 100 %
UPTIME + DOWNTIME
where,
UPTIME is total time equipment is normally required to be in clinical use; and
DOWNTIME is the time the equipment is unavailable for clinical use due to failure or out
of calibration.
NOTES:
1. Upgrading time is time during which equipment is undergoing upgrading or replacement or when the equipment
is out of service for renovations or upgrading.
2. For equipments that are required only during normal office working hours, the Uptime Targets shall be based on
a maximum uptime of 2 340 h (i.e. 52 weeks X 45 h/week) per year.
3. For equipments that are required 24 hr everyday the Uptime Targets shall be based on a maximum uptime of
8 760 h (i.e. 365 days X 24 h/day) per year.
4. For other requirements the maximum uptime per year shall be determined based on the same principle

MS 2058:2009
Annex G
(informative)
MMIS for Biomedical Engineering Services
No. Report title Content

1. Asset listing − Asset number
− Asset description
− Department
− Section/division
− Location code
− Location description
− Category
− Type
− Brand & model
− Manufacturers serial no.
− Cost
− Date received/purchased
− Supplier name
− File reference number
− Accessories
− Signature of responsible officer
− Date of signature
− Location
− Location changed to
− Date of location change
− Signature of location change
− Checked
− Date checked
− Signature for checking
− Number of
− Description
− Quantity
− Manufacturer
− Service agent
− Responsibility
− Area/department serviced
− Warranty start date
− Warranty completion date
− Commissioning parameters
− Membership of functional group
− Functional group dependant
− Registration certificate number
− Disposal reference
− Date disposed
− Signature for disposal
− Notes
− Service history
2. Asset summary listing − Asset number

− Department
− Section/division
− Asset number
− Type
− Cost
− Date received/purchased
− Area/department serviced
− Membership of functional group
− Functional groups dependant
MS 2058:2009
− Scheduled preventive maintenance reference
− Registration certificate number
− Disposal reference
− Date disposed
− Beyond economical repair tag
3. Work requests − Requisition number

− Requested by name
− Requested by position
− Requested by department
− Requested by telephone no.
− Date of request
− Time of request
− Location of fault
− Asset number
− Works requested
− Works request received by name
− Works request received by date
− Works request received by time
− Works request completion verification by name
− Works request completion verification by date
− Works request completion verification by time
− Works request assessment cause code
− Works request assessment by name
− Works request assessment by date
− Works request assessment by time
− Works request type code
4. Work orders − Requisition number

− Requested by name
− Requested by position
− Requested by telephone no.
− Date of request
− Time of request
− Asset number
− Works requested
− Works request received by name
− Works request received by date
− Works request received by time
− Spare parts used part number

− Spare parts used number used
− Spare parts used cost
− Works order number
− Works carried out by name
− Works carried out start date
− Works carried out start time
− Works carried out finish date
− Works carried out finish time
− Works carried out man hours

− Response time
− Down time
− Up time
− Request entered date
− Request entered time
− Priority code
5. Works orders summary − Requisition number

− Date of request
− Asset number
− Works requested

MS 2058:2009
− Response time
− Down time
− Up time
− Number of works order
6. Works order summary in − Requisition number

progress − Requested by department
− Date of request
− Asset number
− Works requested

− Response time
7. Works order completed − Requisition number

summary − Requested by department
− Date of request
− Asset number
− Works requested
− Response time
− Down time
− Up time
− Number of works order
8. Works order outstanding − Requisition number

summary − Requested by department
− Date of request
− Asset number
− Works requested
− Response time
− Down time
9. Common functions unit − CFU reference

register − CFU description
− CFU causal assets listing
− CFU total number of causal assets in CFU
− CFU uptime target year 1, < 5 years old
− CFU uptime target year 1, 5 to 10 years old
− CFU uptime target year 2, < 5 years old
− CFU uptime target year 2, 5 to 10 years old
− CFU uptime target year 2, > 10 years old
− CFU uptime target year 3 to 15, < 5 years old
− CFU uptime target year 3 to 15, 5 to 10 years old
− CFU uptime target year 3 to 15, > 10 years old
− CFU status
− CFU current uptime
10. Common functions unit − CFU membership listing

status − CFU disrupted from date
− CFU disrupted from time
− CFU disrupted to date
− CFU disrupted to time
− CFU target uptime
− CFU uptime
− CFU status

MS 2058:2009
11. Stock register − Stock number

− Stock description
− Stock type
− Minimum stock
− Maximum stock
− Stock balance
− Normal suppliers
12. Planned preventive − PPM reference

maintenance schedules − Planner name
− Task name
− Task description
− Tools required
− Parts required
− Access restrictions
− Safety instructions
− Estimated hours
− Schedule interval
− Schedule start date
− Contractor
13. Contract out register − Contract out service reference

− Contractor
− Contract description
− Contract start date
− Contract expiry date

MS 2058:2009
Annex H
(informative)
Key performance indicator (KPI)
ACTIVITIES REQUIREMENTS KPI

a) Total preventive maintenance
1. To carry out scheduled and a) Compliance to relevant Malaysian

unscheduled maintenance for statutory regulations. schedule (monthly).
all medical devices.
b) All recommendations from b) Outstanding preventive
manufacturers are to be followed. maintenance (backlog).
To provide effective and
responsive repair on all
equipment and provision of on- c) Compliance to all safety c) Response time.
call and emergency services. requirements as stated in the IEC
60601 and collaterals, MS 838 for d) Number of emergency calls
To carry out acceptance radiological equipment and relevant attended.
testing as well as safety and standards for nuclear and
performance characteristics on radiotherapy equipment. e) Number of safety and
all incoming new equipment. functional checks performed.
d) At least 2 h on-site response time
for repair calls, and shall not exceed f) Number of safety tests and
15 min on site response time for safety checks performed per
emergency calls. year.
e) 24 h on-call basis.
f) Calibration, performance, functional

and safety checks to the
manufacturer's recommendation
shall be conducted after each repair
work.
g) Guidelines on acceptance testing
and in service testing of equipment,
Ministry of health.
h) Compliance to guidelines on
Biomedical Engineering
maintenance competency and
career development.
2. To provide mechanisms to Implement mechanism to avoid failure or a) % Uptime

avoid failure or breakdown breakdown during use.
during diagnosis or therapy. b) Number of occurrence or
breakdown during procedure
or use.

MS 2058:2009
ACTIVITIES REQUIREMENTS KPI

3. To carry out all works a) Critical (including life support): i. % uptime
necessary to provide uptime − 99% equipment uptime < 5 years
ii. Uptime guarantee.
guarantee on maintenance − 95% equipment uptime 5 to 10
uptime years
− 90% service uptime for common
functional units.
b) Patient Support machines :

− 96% equipment uptime < 5 years
− 92% equipment uptime 5 to 10

years
− 80% service uptime for common
functional unit.
4. To implement the Hospital a) Quality assurance program. a) Implementation of the program.

Engineering Quality Assurance
plan. b) Attain relevant MS/ISO quality b) MS/ISO certification.
management standards certification.
5. To establish a Associated basic modules for a) Equipment inventory updated six

computerised documentation maintenance management work, i.e. work monthly.
system. To provide quarterly order, equipment register, stock control,
reports on maintenance budgetary control, and preventive b) Number of equipment tagged
activities. maintenance. and entered in inventory.
To notify departments of c) Number of warranty notifications.

warranty expirations.
6. To dispose/remove Compliance to national/international Number of equipment disposed

unwanted equipment. standard and regulation on disposal of according to guidelines.
medical devices
7. To implement procedures Relevant MS/international Standards. Number of hazardous work carried

for dealing with hazardous out according to procedures.
matter and handling
contaminated equipment.
8. To cooperate in the Produce report on the status of the Number of reported equipment
investigation of related maintenance history of the equipment related incident.
incidents
9. To train users on daily Identify the need for training on specific Number of user training conducted.
user maintenance procedure equipment and action taken.
(excludes clinical procedure
related to the equipment)
10. To maintain a stock of a) To assist in maintaining the uptime Availability of critical and
genuine spares. targets. recommended spares.
b) Adequate supplies of maintenance
kits.
11. Establish a library of user All equipment engineering workshop shall Number of service manuals not
and service manuals. have a documented list of service available for critical care
manuals. equipments.

MS 2058:2009
Annex J
(informative)
Example of workshop setup
Dimensions in feet and inches

6' - 0" 4' - 0"
3' - 0"
Parts/ Equipment
2' - 0"
Cleaning Area
consumables Storage
storage
5' - 0"
1' - 6"
File
3' - 0"
rack
Referances/
manuals
Rack
10' - 0"
Admin workstation
5' - 0"
Workbench
2' - 6" 2' - 0"
Figure J1. Example layout for a maximum of two personnel

MS 2058:2009
Dimensions in feet

8’ 16'
2’
14’
4’ Storage Cabinet
6’
O
R
24’
K
B Storage
Cabinet
20’
E
N
LOCKER
17’ C

H Solder
5’
Station
Electronic 4’
Component
8’
9’
Ready Equipment SINK
16’
P.P.E Area Shower
9’
Toilet
Fume Hood
Cabinet
5’ 13’ 5’ 6’
29’
Figure J2. Example layout for a maximum of six personnel

Acknowledgements
Members of Technical Committee on Code of Practice of Active Medical Devices and

Low-Voltage Electrical Equipment/System for Healthcare Facilities
Ir Dr Syed Mustafa Kamal (Chairman) Ministry of Health Malaysia (Engineering

Services Division)
Ms Salbiah Yaakop (Secretary) SIRIM Berhad
Ms Shamila Ariaratnam Association of Private Hospitals of Malaysia

Ir Zuhari Yusoff/ Biomedical Engineering Association of
Mr Abdul Rachit Md Ismail Malaysia
Ms Haslin Ismail/ Faber Medi-Serve Sdn Bhd/Healthtronics
Ms Siti Noor Syahreen Kamaruddin Malaysia Sdn Bhd
Mr Abd Rashid Md Yusop Healthcare Technical Services Sdn Bhd (KPJ)
Dr Sabarul Afian Mokhtar Hospital Universiti Kebangsaan Malaysia
Prof Ir Dr Mohamed Amin Alias Independent expert
Ms Sasikaladevi a/p Tangavelu Ministry of Health Malaysia
(Medical Device Bureau)
Ms Zarina Abdul Hamid/ Pantai Medivest Sdn Bhd
Ir Nik Azran Abd. Hadi
Ms Fatimah Mohamad Nor Radicare (M) Sdn Bhd
Ir Gnana Sakaran R Sistem Hospital Awasan Taraf Sdn Bhd
Dr Ahmad Nazlim Haji Yusoff Universiti Kebangsaan Malaysia (Faculty of
Allied Health Sciences)
Assoc Prof Dr Fatimah Ibrahim/ Universiti Malaya (Department of Biomedical
Mr Mohd Yazed Ahmad Engineering)
Assoc Prof Dr Nik Abdullah Nik Mohamad Universiti Sains Malaysia (Medical Campus)
Assoc Prof Dr Jasmy Yunus Universiti Teknologi Malaysia (Faculty of
Electrical Engineering)
Ms Nor Haliza Yusof/ University Malaya Medical Centre
Mr Kamarul Azraii Noh

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MALAYSIAN MS 2058:2009

CODE OF PRACTICE FOR GOOD

The Department of Standards Malaysia (STANDARDS MALAYSIA) is the national

The main function of the Department is to foster and promote standards,

Malaysian Standards are developed through consensus by committees which

The Department of Standards appoints SIRIM Berhad as the agent to develop

For further information on Malaysian Standards, please contact:

Department of Standards Malaysia OR SIRIM Berhad

Tel: 60 3 8318 0002 Tel: 60 3 5544 6000

Committee representation ………………………………………………………………........... iii

1 List of common test equipment………………………………………………….……. 24

© STANDARDS MALAYSIA 2009 - All rights reserved i

A Biomedical Engineering competency and career development

ii © STANDARDS MALAYSIA 2009 - All rights reserved

Association of Malaysian Medical Industries

Department of Standards Malaysia

Association of Private Hospitals of Malaysia

© STANDARDS MALAYSIA 2009 - All rights reserved iii

Major modifications in this revision are as follows:

a) Incorporation of new definition on “active medical device”;

b) the definition for “breakdown maintenance” was modified;

c) amendment to the definition of “emergency maintenance”;

d) incorporation of new definition on “healthcare facility”;

e) incorporation of new definition on “medical device”;

g) amendment to sub-clause 6.6.1 a);

h) amendment to first paragraph of 6.7.1.2;

i) amendment to sub-clause 21.5 g);

j) amendment to first paragraph of 22.1;

k) incorporation of sub-clause 22.1 g);

l) amendment to sub-clause 23.1 f);

m) amendment to sub-clause 23.3;

n) incorporation of new Figure A1;

o) amendment to examples of equipment tags in Annex B;

p) amendment to PPM checklist examples in Annex C; and

This Malaysian Standard cancels and replaces MS 2058:2008.

iv © STANDARDS MALAYSIA 2009 - All rights reserved

CODE OF PRACTICE FOR GOOD ENGINEERING MAINTENANCE

MS IEC 60364-7-710, Electrical installations of buildings - Part 7-710: Requirements for

MS 838, Code of practice for radiation protection (Medical X-ray diagnosis)

Atomic Energy Licensing Act 304

GHTF Document N15:2006, Principles of Medical Devices Classification

Registration of Engineers Act 1967 Revision 2002

3.1 Acceptance testing

© STANDARDS MALAYSIA 2009 - All rights reserved 1

3.2 Active medical device

3.3 Authorised agency

Any agency approved by the Ministry of Health Malaysia.

3.4 Biomedical Engineering Services

Any in-house or third party personnel or organisation recognised by an authorised agency

3.5 Breakdown maintenance

3.6 Corrective maintenance

Competence is a standardised requirement for an individual to properly perform a specific job.

3.8 Downtime (for a particular piece of equipment)

3.9 Emergency maintenance

Emergency maintenance is performed as necessary, such as when no other medical device

2 © STANDARDS MALAYSIA 2009 - All rights reserved

3.10 Equipment user/user

3.10.1 Home user

3.10.2 Operator of medical equipment

An individual who handles or operates medical equipment in a healthcare facility, such as

doctors, nurses, medical assistants, radiologists, etc.

3.11 Established organisation

Recognised local or international body in Biomedical Engineering.