Risk Management Report , Page 1 of 21

Wenzhou Bokang Instruments Co., Ltd.

No.1500 Haining Road, Haibin, Longwan, Wenzhou 325024, China

Risk and security Management Report

（Comply to ISO 14971:2012）

Product Name： Stethoscope

1. Product Type： BK3001、BK3002、BK3003、BK3004、BK3005、

BK3006、BK3007、BK3008、BK3009、
BK3012、BK3013

Issue Date： 2016/03/28~ 2016/07/08

Document No.: BK-RA-07, Version:C

Issued By：王运良

Wenzhou Bokang Instruments Co., Ltd. BK-RA-07

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Table of Contents
1. Scope
2. Definition
3. General requirements for risk management
3.1 Risk management process
3.2 Responsibilities and authority
4. Risk analysis
4.1 Intended use/ intended purpose and identification of characteristics related to
the safety of the medical devices.
4.2 Identification of hazards
4.3. Estimation of the risks for each hazardous situation
5. Risk evaluation
6. Risk Control
6.1 Risk reduction
6.2 Risk control option analysis
6.3 Implementation of risk control measures
6.4 Residual risk evaluation
6.5 Risk/benefit analysis
6.6 Risk arising from risk control measures
6.7 Completeness of risk control
7. Evaluation of overall residual risk acceptability
8. Risk management report
9. Production and post-production information

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1、 Scope
This risk management is carried out for Stethoscope to identify the hazards
associated with medical devices, to estimate and evaluate the
associated risks, to control these risks, and to monitor the
effectiveness of controls. This report is applicable to all stages of the life-cycle of
a medical device in accordance with ISO 14971:2012.
2、 Definition
2.1 Harm: Physical injury and/or damage to health or property.
2.2 Hazard: A potential source of harm.
2.3 Hazardous situation: Circumstance in which people, property, or the
environment are exposed to on or more hazard(s).
2.4 Risk: The probable rate of occurrence of a hazard causing harm and the
degree of severity of the harm.
2.5 Post-production: Part of the life-cycle of the product after
the design has been completed and medical device has been
manufactured.
2.6 Residual risk: Risk remaining after risk control measures have been taken.
2.7 Risk Analysis: The investigation of available information to identify hazards
and to estimate risks.
2.8 Risk assessment: Overall process comprising a risk analysis and a risk
evaluation.
2.9 Risk assessment: Overall process comprising a risk analysis and a risk
evaluation.
2.10 Risk estimation: Process used to assign values to the probability of
occurrence of harm and the severity of that harm.
2.11 Risk evaluation: Process of comparing the estimated risk against given risk
criteria to determine the acceptability of the risk.
2.12 Risk management: Systematic application of management policies,
procedures and practices to the tasks of analyzing, evaluating, controlling
and monitoring risk.
2.13 Safety: Freedom from unacceptable risk of harm.
2.14 Risk evaluation: Process of comparing the estimated risk against given risk
criteria to determine the acceptability of the risk.
2.15 Risk management: Systematic application of management policies,
procedures and practices to the tasks of analyzing, evaluating, controlling
and monitoring risk.
2.16 Safety: Freedom from unacceptable risk of harm.
2.17 Severity: Measure of the possible consequences of a hazard.
2.18 Verification: Confirmation, through the provision of objective evidence,
that specified requirements have been fulfilled.

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3、 General requirements for risk management

3.1 Risk management process

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3.2 Responsibility and authority

3.2.1 Risk Management Plan preparation 风险管理计划准备:章步才

/Technique
3.2.2 Plan approval 计划确认: 王运良/ QM
3.2.3 Risk analysis 风险分析: 章步才/ Technique
3.2.4 Risk evaluation 风险评估: 章步才/ Technique
3.2.5 Risk control: 风险控制章步才/ Technique
3.2.6 Verification: 确认王运良/ QM
3.2.7 Post-production information feedback:后期制作信息反馈 王雪梅/
Manufacture
3.2.8 Control of Risk management file 风险管理文件控制: 王雪梅/
Technique
3.2.9 Assessment (inspector) :评定 项友华/ Technique

4、 Risk analysis
4.1 Risk analysis process

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4.2 Intended use/ intended purpose and identification of characteristics related

to the safety of the medical devices (Step 1).
4.2.1 Overview
A Auscultating for the sound change of heart, lung, organ,
and so on.
Use method: 1. open the packaging, take out the stethoscope‘s
subassembly: connect chest piece, binaural and Y tube. 2. adjust
elasticity of spring according to face:
it will be loose if open the spring to both sides(on the contrary, it will
be tight), adjust until it is comfortable on your ears. 3. tap the
diaphragm, confirm the position of interface, audition the sound. big
head of single can auscultate directly; confirm the rotation stem of
dual stethoscope is on one interface, if you want to use other head,
rotate the chest piece 180°. 4. according to the parts,
object and special request of ausculatatory, you can choose big, small
head or multi-functional stethoscope in order to acoustic clearly,
actually
4.2.2 Device Name: Stethoscope
4.2.3 Standards concerned :
ISO 14971:2012 Medical devices - Risk management
4.2.4 Indication for use :
Auscultating for the sound change of heart, lung, organ, and so on.

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Questions that can be used to identify medical device characteristics
that could impact on safety- Relations to ISO 14971 Annex C
No. Questions A/NA The relevance to product
Auscultating for the sound change of
heart, lung, organ,and so on.

Use method: 1. open the packaging,

What is the intended use and how is the
1 A
medical device to be used?
Is the medical device intended to be
2 NA
implanted?
Is the medical device intended to be in
3 A
contact with the patient or other persons?
What materials or components are utilized
4 in the medical device or are used with, or
are in contact with, the medical device?
Is energy delivered to or extracted from the
5 A
patient?
Are substances delivered to or extracted
6 NA
from the patient?
Are biological materials processed by the
7 medical device for subsequent re-use,
transfusion or transplantation?
Is the medical device supplied sterile or
8 intended to be sterilized by the user, or are
other microbiological controls applicable?
Is the medical device intended to be
9 routinely cleaned and disinfected by the
user?
Is the medical device intended to modify
10
the patient environment?
take out the
stethoscope‘s subassembly: connect
chest piece, binaural
and Y tube. 2. adjust elasticity of
spring according to face:
it will be loose if open the spring to
both sides(on the
contrary, it will be tight), adjust until it is
comfortable on
your ears. 3. tap the diaphragm,
confirm the position of
interface, audition the sound. big head
of single can
auscultate directly; confirm the rotation
stem of dual
stethoscope is on one interface, if you
want to use other
head, rotate the chest piece 180°. 4.
according to the parts,
object and special request of
ausculatatory, you can
choose big, small head or
multi-functional stethoscope in
order to acoustic clearly, actually.
This device no intended to be
implanted
This device is intended to contact the
patient.
chest piece, diaphragm, diaphragm
A ring, Y tube, binaural
set, soft ear tips
From patient.
NA Not applied.
This device does not supply sterile or
NA
intended to be sterilized by the user.
Accessories must be cleaned before
A
use
Not intended to modify the patient
NA
environment.

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Auscultating for the sound change of
11 Are measurements taken? A heart, lung, organ,
and so on.
12 Is the medical device interpretative? NA Not applied.
Is the medical device intended for use in
13 conjunction with other medical devices, NA Not applied.
medicines or other medical technologies?
Are there unwanted outputs of energy or
14 NA Not applied.
substances?
Is the medical device susceptible to
15 NA Not applied.
environmental influences?
Does the medical device influence the
16 NA Not applied.
environment?
Are there essential consumables or
17 A Soft ear tips, diaphragm
accessories associated with the device?
The routine cleaning is required for
18 Is maintenance or calibration necessary? A
this device.
19 Does the medical device contain software? NA Not applied.
Does the medical device have a restricted
20 NA no
shelf-life?
Are there any delayed or long-term use
21 NA Not applied.
effects?
To what mechanical forces will the medical
22 A Impact
device be subjected?
What determines the lifetime of the medical
23 A Use Time
device?
Is the medical device intended for single
24 NA Not applied.
use?
Is safe decommissioning or disposal of the
25 NA Not applied.
medical device necessary?
Does installation or use of the device Special training is required for the use
26 A
require special training or special skills? and/or operation of this device.
How will information for safe use be It has been indicated in manual and
27 A
provided? control panel.
Will new manufacturing processes need to
28 NA Not applied.
be established or introduced?
Is successful application of the medical
User need to operate the product
29 device critically dependent on human A
correctly.
factors such as the user interface?
Can the user interface design features User need to operate the product
29.1 A
contribute to use error? correctly.
Is the medical device used in an
User need to operate the product
29.2 environment where distractions can cause A
correctly.
use error?
Does the medical device have connecting
29.3 A Accessories
parts or accessories?
Does the medical device have a control
29.4 NA
interface?
Does the medical device display
29.5 NA
information?
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Is the medical device controlled by a
29.6 NA Not applied.
menu?
Will the medical device be used by persons
29.7 NA Not applied.
with special needs?
Can the user interface be used to initiate
29.8 NA Not applied.
user actions?
Does the medical device use an alarm
30 NA Not applied.
system?
In what way(s) might the medical device be
31 NA Not applied.
deliberately misused?
Does the medical device hold data critical
32 NA Not applied.
to patient care?
Is the medical device intended to be mobile
33 A This device is portable.
or portable?
Does the use of the medical device depend
34 A
on essential performance?

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1.1 Identification of Hazards

1.1.1 Hazard checklist-ISO 14971 table E.1
A Energy hazards
A.1 ELECTROMAGNETIC ENERGY Y N Hazard
A.1.1 Line Voltage V
A.1.2 Enclosure Leakage current V
A.1.3 Earth Leakage current V
A.1.4 Patient Leakage current V
A.1.5 Electric Fields V
A.1.6 Magnetic Fields V
A.2 RADIATION ENERGY Y N Hazard
A.2.1 Ionizing radiation V
A.2.2 Non-ionizing radiation V
A.3 MECHANICAL ENERGY Y N Hazard
A.3.1 Gravity – Falling V H01
A.3.2 Gravity – suspended masses V H02
A.3.3 Vibration V H03
A.3.4 Stored energy V
A.3.5 Moving parts V
A.3.6 Torsion, shear and tensile force V H04
A.3.7 Moving and positioning of patient V
A.3.8 Acoustic energy(ultrasonic, infrasound, sound) V H05
A.3.9 High pressure fluid injection V
A.3.10 High temperature V
A.3.11 Low temperature V

B BIOLOGICAL AND CHEMICAL HAZARDS

B.1 Biological hazards Y N Hazard
B.1.1 Bacteria V
B.1.2 Viruses V
B.1.3 Other agents (e.g. prions) V
B.1.4 Re- or cross-infection V H06
Chemical: Exposure of airway, tissues, environment or property
B.2 Y N Hazard
e.g. to foreign materials
B.2.1 acids or alkalis, V
B.2.2 residues, V
B.2.3 contaminates, V
B.2.4 additives or processing aids, V
B.2.5 cleaning, disinfecting or testing agents, V H07
B.2.6 degradation products, V
B.2.7 medical gasses, V
B.2.8 anaesthetic products V
B.3 Toxicity of chemical constituents hazards Y N Hazard
B.3.1 Allergenicity/ irritancy V
B.3.2 Pyrogenicity (induce fever) V

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C OPERATIONAL HAZARDS
C.1 FUNCTION Y N Hazard
C.1.1 Incorrect or inappropriate output or functionality V
C.1.2 Incorrect measurement V H08
C.1.3 Erroneous data transfer V
C.1.4 Loss or deterioration of function V
C.2 USE ERROR Y N Hazard
C.2.1 Attention failure V
C.2.2 Memory failure V
C.2.3 Rule-based failure V
C.2.4 Knowledge-based failure V
C.2.5 Routine violation V

D. INFOMATION HAZARDS
D.1 LABELING Y N Hazard
D.1.1 Incomplete instructions for use V H09
D.1.2 Inadequate description of performance characteristics V H09
D.1.3 Inadequate specification of intended use V
D.1.4 Inadequate disclosure of limitations V
D.2 OPERATATING INSTRUCTIONS Y N Hazard
D.2.1 Inadequate specification of accessories to be used with the device V H10
D.2.2 Inadequate specification of pre-use checks V H11
D.2.3 Over-complicated operating instructions V
D.3 WARNINGS Y N Hazard
D.3.1 Warnings of side effects V
D.3.2 Warnings of hazards likely with re-use of single-use devices V
D.4 SPECIFICATION OF SERVICE AND MAINTENANCE Y N Hazard
D.4.1 Inadequate specification of when service and maintenance is required V H12

1.1.2 Initiating events and circumstances checklist-ISO 14971 table E.2

A. Incomplete requirements Inadequate specification of: Y N Hazard
A.1 design parameters V H13
A.2 operating parameters V H13
A.3 performance requirements V H13
A.4 in-service requirements (e.g. maintenance, reprocessing) V H13
A.5 end of life V H14
B. Manufacturing processes Y N Hazard
B.1 Insufficient control of changes to manufacturing processes V H15
B.2 Insufficient control of materials/materials compatibility information V H16
B.3 Insufficient control of manufacturing processes V H17
B.4 Insufficient control of subcontractors V H18
C. Transport and storage Y N Hazard
C.1 Inadequate packaging V H19
C.2 Contamination or deterioration V H20
C.3 Inappropriate environmental conditions V H21
D. Environmental factors Y N Hazard
D.1 Physical {e.g. heat, pressure, time} V H22
D.2 Chemical (e.g. corrosions, degradation, contamination) V H23
D.3 Electromagnetic fields (e.g. susceptibility to electromagnetic disturbance) V
D.4 Inadequate supply of power V
D.5 Inadequate supply of coolant V

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E. Cleaning, disinfection, and sterilization Y N Hazard
Lack of, or inadequate specification for, validated procedures for
E.1 V H26
cleaning, disinfection and sterilization
E.2 Inadequate conduct of cleaning, disinfection and sterilization V H27
F. Disposal and scrapping Y N Hazard
F.1 No or inadequate information provided V H28
F.2 Use error V H29
G. Formulation Y N Hazard
G.1 Biodegration V
G.2 Biocompatibility V
G.3 No information or inadequate specification provided V
G.4 Inadequate warning of hazards associated with incorrect formulations V
G.5 Use error V
Human factors Potential for use errors triggered by design flaws,
H. Y N Hazard
such as
H.1 confusing or missing instructions for use V H30
H.2 complex or confusing control system V
H.3 ambiguous or unclear device state V
ambiguous or unclear presentation of settings, measurements or other V
H.4
information
H.5 misrepresentation of results V
H.6 insufficient visibility, audibility or tactility V
poor mapping of controls to actions, or of displayed information to actual V
H.7
state
H.8 controversial modes or mapping as compared to existing equipment V
H.9 use by unskilled/untrained personnel V H31
H.10 insufficient warning of side effects V H32
inadequate warning of hazards associated with re-use of single-use V
H.11
devices
H.12 incorrect measurement and other metrological aspects V H33
H.13 incompatibility with consumables/accessories/other medical devices V H34
H.14 slips, laps and mistakes V H35
I. FAILURE MODES Y N Hazard
I.1 Unexpected loss of electrical/mechanical integrity V
Deterioration in function (e.g. gradual occlusion of fluid/gas path, or
I.2 change in resistance to flow, electrical conductivity) as a result of ageing, V
wear and repeated use
I.3 Fatigue failure V
I.4 Inadequate warnings of hazards associated with incorrect formulations V
I.5 Use error V

Conclusion:
It has been concluded through the process of risk analysis that this is a low risk device
and any risks that existed were eliminated or reduced through safety testing, proper
choice of materials, sterilization validation, and thorough instructions for use. The risk
analysis was evaluated in regarding the European Medical Device Directives (MDD),
Annex 1, Chapter 1, point 1 and 2.”

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Estimation of the risks for each hazardous situation(Step 3)
The identified hazards shall be estimated using the criteria below. Reasonably foreseeable sequences
or combinations of events that can result in a hazardous situation shall be considered and the resulting
hazardous situations shall be recorded.

1.1.3 Five qualitative Severity levels：1 ~ 5

Rating Example
Catastrophic 5 public death or damage
Critical 4 death, Permanent or whole damage to patient
Infection/Contamination , Long term or partial damage
Serious 3
Bio-incompatible, toxic,
Minor 2 Allergy, Temporary damage , Burn
Negligible 1 Actually no damage, Low efficacy

1.1.4 Semi-quantitative Probability levels：1 ~ 6

Rating probability range
Frequent 6 Daily, 1 in 1
Probable 5 Weekly, 1 in 10
Occasional 4 Monthly, 1 in 30
Remote 3 Quarterly, 1 in 100
Improbable 2 Yearly, 1 in 300
Incredible 1 Never happen

1.1.5 Semi-quantitative risk matrix

Severity
1-Negligible 2-Minor 3-Serious 4-Critical 5-Catastrophic
Probability
6- Frequent ALARP ALARP IR IR IR
5- Probable ALARP ALARP ALARP IR IR
4- Occasional BAR ALARP ALARP ALARP IR
3- Remote BAR ALARP ALARP ALARP ALARP
2- Improbable BAR BAR ALARP ALARP ALARP
1- Incredible BAR BAR BAR BAR ALARP

1.1.6 Risk Acceptable Criteria

From the estimation of risk above, we shall classify the risk as 3 categories:
IR ：IR; Intolerable region –[Level 17-30]
ALARP ：ALARP; As low as reasonably practicable – [Level 5-16]
BAR ：BAR; Broadly acceptable region – [Level 0-4]

2、 Risk Evaluation
Step 4. Risk Evaluation
From the estimated hazard data at step 3, we can decide if risk reduction is needed
or not.
Where the level is under 4, BAR, it can go step 9 directly. However, the possible
risk reduction can be adopted.

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3、 Risk Control
3.1 Risk reduction
When risk reduction is required, risk control activities shall be performed as
follows,
3.2 Option analysis (Step 5)
The risk control measures shall be used one or more of the followings in the
priority order listed.
3.2.1 Inherent safety by design
3.2.2 Protective measures in the medical devices itself or in the manufacturing
process
3.2.3 Information for safety
3.3 Implementation of risk control measures (Step 6)
The risk control measures adopted at stage5 shall be implemented and verified.
3.4 Residual risk evaluation (Step 7)
After the risk control measures are applied, the residual risk evaluation shall be
performed in accordance with the same criteria as in step 3.
3.5 Risk/benefit analysis (Step 8)
Decide if the overall residual risks posed by the medical devices are
acceptable.
3.6 Other generated hazards (Step 9)
Risk control measures taken in step 5 may have inherent hazard. If any new
hazards are introduced by any risk control measures, the associated risk(s)
shall be assessed.

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Results of risk analysis (Step2~Step9)

Step2. Step4 Step5. Step6. Step8 Step9
No. Step3. Risk Step7. Risk
of Estimation Reduction Residual Unaccept Other
Option analysis Implementation
Hazard Description of Hazard is not able hazard
P S L Risk Control measure Result of verification P S L
needed? risk? introduced?
H01 Gravity (falling, suspended masses) 3 2 6 Yes Drop Test Drop Test Report 2 2 4 No No
H02 Gravity (suspended mass) 3 2 6 Yes Drop Test Drop Test Report 2 2 4 No No
H03 Vibration 3 2 6 Yes Transport vibration test Vibration Test Report 2 2 4 No No
H04 Torsion, tensile force 3 3 9 Yes Design housing Mechanical tensile test 1 3 3 No No
Acoustic energy(ultrasonic, infrasound, Using decibel meter
H05 3 2 6 Yes Noise test report 2 2 4 No No
sound) measurement noise
H06 Cross-infection 3 2 6 Yes Instruction for use 2 2 4 No No
Incorrect or inappropriate output or
H07 3 2 6 Yes Machine test Machine test report 2 2 4 No No
functionality
H08 Loss or deterioration of function 3 2 6 Yes Life time test Life time test report 2 2 4 No No
H09 Incomplete instructions for use 3 2 6 Yes Instruction for use Instruction for use 2 2 4 No No
Inadequate specification of
H10 accessories to be used with the 3 2 6 Yes Instruction for use Instruction for use 2 2 4 No No
device
H11 Warnings of side effects 3 2 6 Yes Instruction for use Instruction for use 2 2 4 No No
Specification of service and
H12 3 2 6 Yes Instruction for use Instruction for use 2 2 4 No No
maintenance
Inadequate specification of: design
parameters, operating parameters,
H13 3 2 6 Yes Machine test Machine test report 2 2 4 No No
performance requirements, in-service
requirements,
H14 Inadequate specification of end of life 3 3 9 Yes Life time test Life time test report 2 2 4 No No
Insufficient control of changes to
H15 3 2 6 Yes Process changes Process changes 2 2 4 No No
manufacturing processes

Step2. Step3. Step4 Step5. Step6. Step7. Step8 Step9

No.
of Estimation Reduction Residual Unaccept Other
Option analysis Implementation
Hazard Description of Hazard is not able hazard
F S L Risk Control measure Result of verification F S L
needed? risk? introduced?
Insufficient control of
H16 materials/materials compatibility 3 2 6 Yes Design changes Design changes 2 2 4 No No
information

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Insufficient control of manufacturing
H17 3 2 6 Yes Process Control Process Control 2 2 4 No No
processes
H18 Insufficient control of subcontractors 3 2 6 Yes Supplier control Supplier control 2 2 4 No No
H19 Inadequate packaging 3 2 6 Yes Packaging controls Packaging controls 2 2 4 No No
H20 Contamination or deterioration 3 2 6 Yes Instruction for use Instruction for use 2 2 4 No No
H21 Inappropriate environmental conditions 3 2 6 Yes Instruction for use Instruction for use 2 2 4 No No
H22 Physical {e.g. heat, pressure, time} 3 3 9 Yes Life time test Life time test report 2 2 4 No No
Chemical (e.g. corrosions,
H23 3 2 6 Yes Risk analysis Risk management report
degradation, contamination)
H24 3 2 6 Yes IEC 60601 Test EMC 60601-1 Test report 2 2 4 No No
H25 3 2 6 Yes Machine test Machine test report 2 2 4 No No
Lack of, or inadequate specification for,
H26 validated procedures for cleaning, 3 2 6 Yes Instruction for use Instruction for use 2 2 4 No No
disinfection and sterilization
Inadequate conduct of cleaning,
H27 3 2 6 Yes Instruction for use Instruction for use 2 2 4 No No
disinfection and sterilization
H28 No or inadequate information provided 3 2 6 Yes Instruction for use Instruction for use 2 2 4 No No
H29 Use error 3 2 6 Yes Instruction for use Instruction for use 2 2 4 No No
H30 confusing or missing instructions for use 3 2 6 Yes Instruction for use Instruction for use 2 2 4 No No
H31 misrepresentation of results 3 2 6 Yes Instruction for use Instruction for use 2 2 4 No No
H32 use by unskilled/untrained personnel 3 2 6 Yes Instruction for use Instruction for use 2 2 4 No No
H33 insufficient warning of side effects 3 2 6 Yes Instruction for use Instruction for use 2 2 4 No No
incompatibility with
H34 consumables/accessories/other medical 3 2 6 Yes Instruction for use Instruction for use 2 2 4 No No
devices
H35 slips, laps and mistakes 3 2 6 Yes Instruction for use Instruction for use 2 2 4 No No

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3.7 Completeness of risk evaluation (Step 10)
The risks from all identified hazards have been evaluated and decided to be
acceptable.
Identified Number of Risk Risk Evaluation Acceptable
Hazards Number control measures BAR ALARP IR Unacceptable
Energy --- A
Biological --- A
Environment --- A
Incorrect output of energy
and substances --- A
Use of the device --- A
User interface --- A
Functional failure,
maintenance and ageing --- A
Other generated hazards --- A

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4、Overall residual risk evaluation(Step11)

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5、Risk management report (Step 12)

My signature below signifies that I have read to approve the conclusion to this
risk analysis report.

Wang Yunliang Date :

Signature / Name

Xiang Youhua Date :

Signature / Name

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6、Production and Post production information (Step 13)

Manufacturer shall establish generic procedures to collect information from various
sources this information is written through the data collected until 2016-04-20.
Its raw data is kept in the Risk Management File.
6.1 Annual marketing record
Year SALES QUANTITY
2016 NA
Total NA

6.2 Customer complaints

Year Complaints
2016 0
Total 0

6.3 Incident
Year Incidents Reported
2016 0
Total 0

QA : Wang Xuemei Date : 2016-07-08

Signature / Name

QM : Wang Yunliang Date : 2016-07-08

Signature / Name

President : Xiang Youhua Date : 2016-07-08

Signature / Name

Wenzhou Bokang Instruments Co., Ltd. BK-RA-07