I.

Identification of Risks of a Medical Device: Surgical Gowns

Authors: Jeremie De Guzman, Sean Vergel De Dios, Matthew Cua, Laya De Guzman, Valline Go

The following risk table is modified from Annex C of PNS ISO 14971: 2007 (Philippine National
Standard, 2016). It is a guide that enables manufacturers and designers to identify risks across
multiple physical parameters of the gown PPE in the context of COVID. This enables designers to
remove potential risks and failures at the design stage and when it is being distributed in the
market for use.

Doing risk analysis using the ISO standard is required for any medical device risk classified from
B to D using the ASEAN medical device directive 2015 annex B. This table is not the complete
risk analysis but serves as the first step to identify all possible risks to the end users with a
device.

Applicable/
Questions to Elicit Possible Risks of the Relevant to Comments/ Questions to
Medical Device the Device? Consider
(Yes or No)
The medical device (gown) is for
the prevention of the user from
contact from hazards (e.g. bodily
fluids and liquids) that may
c.2.1 What is the intended use and how is cause workplace injuries and
the medical device to be used? Yes illnesses in conjunction with other
medical devices such as
respiratory protection devices,
hoods, apron etc.

2.1.1. What is the medical device's role

relative to
2.2.1.1. Diagnosis, prevention,
monitoring, treatment or alleviation of
disease,
2.2.1.2. Compensation for injury or
handicap or
2.2.1.3. Replacement or modification of
anatomy, or control of conception?
2.1.2. What are the indications for use
(e.g. patient population)?
2.1..3 does the medical device sustain or
support life?
2.1.4. Is special intervention necessary in
the case of failure of the medical device?
The medical device (gown) is
designed for the prevention of the
Yes wearer from contact with liquids
that may or may not be
dangerous/harmful.
No
No
Primarily this is to be used by
Healthcare frontliners including
Yes
but not limited to doctors, nurses,
allied health workers, etc.
No
Yes In case of failure of the device, it
is possible for the user to come
into contact with various liquids
that might cause workplace injury
or illnesses whether mild,
moderate, or severe in nature

c.2.2 is the medical device intended to be
implanted?
2.2.1. Factors that should be considered
include the location of implantation,
2.2.2. The characteristics of the patient
population
2.2.3. Age
2.2.4. Weight
2.2.5. Physical activity
2.2.6. The effect of ageing on implant
performance
2.2.7. The expected lifetime of the implant,
the reversibility of the implantation.
c.2.3 Is the medical device intended to be
in contact with the patient or other
persons?
Factors that should be considered include
the nature of the intended contact,
2.3.1. Surface contact
2.3.2. Invasive contact
2.3.3. Implantation and, for each, the
period and frequency of contact.
c.2.4 What materials or components are
utilized in the medical device or are used
with, or are in contact with the medical
device?
Factors that should be considered
include:
2.4.1. Compatibility with relevant
substances
2.4.2. Compatibility with tissues or body
fluids
Device failure requires
implementation of quarantine
protocol and mobilization of
possible ICU intervention in the
worst case scenario of
contamination with COVID19.
No
The medical device (gown) is an
apparel that can come into
Yes
contact with skin when worn
and/or handled.
The medical device will come into
contact with skin (user and
possible other people including
patients), Liquids including sweat,
Yes blood and medicine (user and
possible other people including
patients), as well as fabric
underneath the medical device
(gown) or the opposite.
The medical device may come
into contact with internal organs
Yes and contents of the body (Applies
only to surgical gowns during
certain procedures)
No
The medical device (gown) will
come into contact with a lot of
surfaces and liquids as well as
Yes
other medical devices such as
hoods, aprons, scrubs and many
more.
The medical device will come into
contact with items in the hospital
Yes environment (e.g. alcohol and
other disinfectants, medicine,
etc.)
Yes The medical device (gown)
should have no reaction to the
 wearer’s health when it comes
into contact with their skin and/or
bodily liquids including but not
limited to blood and sweat.

The contact might be prolonged

(upto 12 hours) under extreme
environments (20 degrees to 40
degrees)
The medical device (gown)
2.4.3. Whether characteristics relevant to should be able to repel liquids
safety are known Yes and relevant hazards coming
from the environment/workplace
and from the wearer.
The medical device (gown) might
2.4.4. Is the device manufactured utilizing have materials of animal origin
Yes
materials of animal origin and must be disclosed by the
manufacturer
c.2.5 Is energy delivered to or extracted
from the patient?
No
Factors that should be considered
include:
2.5.1. The type of energy transferred
2.5.2. Its control, quality, quantity, intensity
and duration
2.5.3. Whether energy levels are higher
than those currently used for similar
devices.
c.2.6 Are substances delivered to or
extracted from the patient?
No
Factors that should be considered
include:
2.6.1. Whether the substance is delivered
or extracted;
2.6.2. Whether it is a single substance or
range of substances
2.6.3. The maximum and minimum
transfer rates and control thereof.
c.2.7 Are biological materials processed
by the medical device for subsequent re-
use, transfusion or transplantation?
No
Factors that should be considered include
the type of process and substance(s)
processed
2.7.1. (Insert process or substance
processed; add rows as necessary)
c.2.8 Is the medical device supplied sterile Yes The medical device can be
or intended to be sterilized by the user, or supplied as non-sterilized but
are other microbiological controls cleaned (considered Non-
applicable? Surgical Gown) or sterilized
(Surgical and Isolation Gown).
Factors that should be considered include The status should be clearly

2.8.1. Whether the medical device is
intended for single use or re-use
packaging;
2.8.2. Shelf-life issues;
2.8.3. Limitation on the number of re-use
cycles
2.8.4. Method of product sterilization
2.8.5. The impact of other sterilization
methods not intended by the manufacturer
c.2.9 Is the medical device intended to be
routinely cleaned and disinfected by the
user?
2.9.1. Factors that should be considered
include the types of cleaning or
disinfecting agents to be used and any
limitations on the number of cleaning
cycles
2.9.2. The design of the medical device
can influence the effectiveness of routine
cleaning and disinfection
2.9.3. In addition, consideration should be
given to the effect of cleaning and
disinfecting agents on the safety or
performance of the device.
c.2.10 Is the medical device intended to
stipulated on the packaging also
with regards to reusability.
The medical device (gown) is
single use unless specified by the
Yes
manufacturer and follows the
manufacturer’s protocol for reuse.
Packaging should be appropriate
for keeping the medical device
(gown) sterile in standard storage
conditions (between 20 degrees
to 45 degrees, in a dry and no
Yes
direct sunlight environment)
There should be an expiry date
and manufacturing date indicated
in the label
The medical device (gown) can
be used for a number of times as
Yes defined by the manufacturer,
specifically following a reuse
protocol.
Defined by manufacturer on
reuse
(no need for pre-use sterilization
for medical devices (gowns) that
Yes
are stipulated to be sterilized
unless packaging has been
damaged then follow the
manufacturer’s instructions.)
Possible that the medical device
(gown) be re-used outside of
manufacturer’s specific
Yes instructions and can damage the
liquid protection of the gown as
well as ergonomics of the
medical device.
Medical device (gown) only for
Yes reuse as defined by manufacturer
if designed as reusable
Medical device (gown) only for
Yes
reuse as defined by manufacturer
Medical device (gown) only for
Yes
reuse as defined by manufacturer
Medical device (gown) only for
Yes
reuse as defined by manufacturer
No
modify the patient environment?

Factors that should be considered

include:
2.10.1. Temperature
2.10.2. Humidity
2.10.3. Atmospheric gas composition
2.10.4. Pressure
2.10.5. Light
c.2.11 Are measurements taken? No
2.11.1. Factors that should be considered
include the variables measured and the
accuracy and the precision of the
measurement results.
c.2.12 Is the medical device interpretative?
No
Factors that should be considered
include:
2.12.1. Whether conclusions are
presented by the medical device from
input or acquired data
2.12.2. The algorithms used
2.12.3. Confidence limits
2.12.4. Special attention should be given
to
unintended applications of the data or
algorithm.
This medical device (gown) will
be worn/used in conjunction with
c.2.13 Is the medical device intended for other PPEs such as respirators,
use in conjunction with other medical hoods, gloves, aprons and many
devices, medicines or other medical more.
technologies? Yes
The medical device (gown) will
Factors that should be considered be worn/used by a user who may
include: or may not use other medical
devices including but not limited
to surgical tools, ventilators etc.
This medical device (gown) will
be worn/used in conjunction with
other PPEs such as respirators,
2.13.1. Identifying any other medical
hoods, gloves, aprons and many
devices, medicines or other medical
more.
technologies that can be involved and the
Yes
potential problems associated with such
The medical device (gown) will
interactions, as well as patient compliance
be worn/used by a user who may
with the therapy.
or may not use other medical
devices including but not limited
to surgical tools, ventilators etc.
c.2.14 Are there unwanted outputs of
energy or substances?
No
Energy-related factors that should be
considered include:
2.14.1. Noise and vibration
 2.14.2. Heat
2.14.3. Radiation (including
ionizing, non-ionizing, and
ultraviolet/visible/infrared radiation)
2.14.4. Contact temperatures
2.14.5. Leakage currents
2.14.6. Electric or magnetic fields
2.14.7. Substance-related factors that
should be considered include substances
used in manufacturing
2.14.8. Cleaning or testing having
unwanted physiological effects if they
remain in the product
2.14.9. Other substance-related factors
that should be considered include
discharge of chemicals
2.14.10. Waste products
2.14.11. Body fluids
c.2.15 Is the medical device susceptible to
environmental influences?
Factors that should be considered include the
operational, transport and storage
environments. these include
2.15.1. Light
2.15.2. Temperature
2.15.3. Humidity
2.15.4. Vibrations
2.15.5. Spillage
The medical device (gown) will
Yes be exposed in various
environments.
The medical device (gown) might
be exposed to sunlight, especially
Yes
UV rays, that can cause the
material to break down.
The medical device (gown) might
be exposed to temperatures
between 20 degrees to 45
degrees Celsius for extended
periods of time (up to 12 hours).
Yes
This might cause the material to
break down and lose its liquid
protections. This might also
cause injury including rashes to
the wearer.
The medical device (gown) might
be exposed to high humidity for
extended periods of time (up to
12 hours). This might cause the
material to break down and lose
its liquid protection. This might
Yes also cause injury including rashes
to the wearer. Bacteria growth is
also a risk that can occur on the
surface of the medical device as
well as on the inside of the
medical device and on the skin of
the wearer.
No
The medical device (gowns)
Yes might be exposed liquids (which
include sweat, blood, bodily

2.15.6. Susceptibility to variations in power
and cooling supplies
2.15.7. Electromagnetic interference
c.2.16 Does the medical device influence
the environment?
Factors that should be considered
include:
2.16.1. The effects on power and cooling
supplies
2.16.2. Emission of toxic materials
2.16.3. The generation of electromagnetic
disturbance.
c.2.17 Are there essential consumables or
accessories associated with the medical
device?
2.17.1. Factors that should be considered
include specifications for such
consumables or accessories and any
restrictions placed upon users in their
selection of these.
c.2.18 Is maintenance or calibration
necessary?
Factors that should be considered
include:
2.18.1. Whether maintenance or
calibration are to be carried out by the
operator or user or by a specialist;
2.18.2. Are special substances or
equipment necessary for proper
maintenance or calibration?
c.2.19 Does the medical device contain
software?
Factors that should be considered
fluids, medicine, cleaning liquids,
hazardous fluids) spilling on the
gown
The medical device (gowns)
might be exposed in various
environments that are
temperature controlled such as
Yes
air conditioned rooms. The
materials might degrade in some
certain conditions reducing its
liquid protection capacity.
No
No
Yes
The medical (gown) device might
Yes have accessories but it will be
dependent on the manufacturer
The medical device (gown), has
to be worn correctly, maintained
(stored), reused correctly and
Yes must be checked before use if
there are any issues else the
primary purpose of protecting the
wearer from liquids.
The medical device (gown), has
to be worn correctly, maintained
(stored) correctly and must be
Yes checked before use if there are
any issues else the primary
purpose of protecting the wearer
from liquids.
The medical device (gown) is
only for reuse as per
manufacturer’s specifications and
Yes process. If not following proper
process as per manufacturer the
material might degrade and liquid
protection might be degraded.
No
include:
2.19.1. whether software is intended to be
installed, verified, modified or exchanged
by the operator or user or by a specialist.
c.2.20 Does the medical device have a
restricted shelf-life?
2.20.1. Factors that should be considered
include labelling or indicators and the
disposal of such medical devices when the
expiration date is reached.
c.2.21 Are there any delayed or long-term
use effects?
Factors that should be considered include
ergonomic and cumulative effects:
2.21.1. Pumps for saline that corrode over
time
2.21.2. Mechanical fatigue
2.21.3. Loosening of straps and
attachments
2.21.4. Vibration effects
2.21.5. Labels that wear or fall off
The medical device (gown) has a
shelf-life as determined by the
manufacturer. This should be
stated on the packaging by the
Yes manufacturer. Long term storage
might degrade the material and
cause ineffectiveness of the liquid
protection of the medical device
(gown).
Manufacturer must identify the
expiry date and manufacturing
date. The manufacturer must also
Yes identify indicators that might
cause the primary use of
protecting from liquids to fail due
to time.
Yes
No
The medical device (gown) may
have seams, straps or lining may
come loose over time and long
term usage.
Yes
The medical device (gown) may
have material may experience
reduced strength and reduced
water repellency with prolonged
use and repeated reuse
The medical device (gown) has
straps (or something similar) that
keeps it secured. The medical
device might come loose if not
securely tied if worn longer than
intended, used with mobility
Yes
outside of norm (eg riding
motorcycle) or in environments
outside of design. This might
cause the failure of the device it
is protection of the wearer from
liquids
No
Yes The medical device (gown) might
have labels that explain the
usage and/or provide
identification to the wearer. The
medical device’s labels might

2.21.6. Long term material degradation
c.2.22 To what mechanical forces will the
medical device be subjected?
2.22.1. Factors that should be considered
include whether the forces to which the
medical device will be subjected are under
the control of the user or controlled by
interaction with other persons
c.2.23 What determines the lifetime of the
medical device?
Factors that should be considered
include:
2.23.1. Ageing and battery depletion
c.2.24 Is the medical device intended for
single use?
2.24.1. Factors that should be considered
include: does the medical device self-
destruct after use? is it obvious that the
device has been used?
come loose if used with mobility
outside of norm (eg riding
motorcycle) or in environments
outside of design. This might
cause failure of aesthetic and
ergonomic functionalities
The medical device (gown) can
only be used once and reused x
number of times as determined
by the manufacturer if properly
sterilized. using the medical
Yes
device (gown) outside of
prescribed specifications will
result in the degradation of the
primary purpose of the medical
device which is liquid protection.
Forces include moving about in
the medical device (gown) but
may also include strenuous tasks
Yes
such as chest compressions, or
assisting patients (carrying,
lifting, moving, etc.)
The medical device (gown) once
worn by a human user creates
friction and mechanical stress on
joint locations such as armpits,
elbows, hips and cuffs that may
cause degradation of the material
Yes
in those areas causing cascading
issues in the reduction of the
capability of liquid protection.
Holes might appear in the
medical device where liquids
might get into.
The medical device (gowns) is
composed of textiles and its
lifetime (storage, use and reuse)
Yes
is dependent on the material
science and quality of the
production of the medical device.
No
The medical device (gowns) is a
single use device unless
Yes specifically mentioned by
manufacturer and only if reuse
process is properly followed
Yes Once the medical device is
unpacked from packaging it
should be considered “used” and
must be used immediately or
according to procedure and
guidelines set by the user’s
organization. There is a chance
of it being used if proper
procedure is not followed or

c.2.25 Is safe decommissioning or
disposal of the medical device necessary?
Factors that should be considered
include:
2.25.1. The waste products that are
generated during the disposal of the
medical device itself.
2.25.2. Does it contain toxic or hazardous
material?
2.25.3. Is the material recyclable?
c.2.26 Does installation or use of the
medical device require special training or
special skills?
2.26.1 Factors that should be considered
include the novelty of the medical device
and the likely skill and training of the
person installing the device.
wrong procedures are placed in.
The medical device (gowns) once
used is considered hazardous
Yes waste and has to be disposed of
as such else it may be hazardous
to the health of other people.
The medical device (gowns) once
used are considered toxic waste
as it may or have encountered
liquids that are hazardous or
infectious and must follow proper
disposal procedures or reuse
procedures set forth by the
Yes manufacturers. Failure to adhere
to proper decontamination and
sterilization for reuse might cause
risk and harm to other people.
Failure to adhere to proper
disposal of the medical device as
hazardous waste might cause
risk and harm to people
The medical device (gowns) once
used are considered toxic waste
as it may or have encountered
liquids that are hazardous or
infectious and must follow proper
disposal procedures or reuse
procedures set forth by the
Yes manufacturers. Failure to adhere
to proper decontamination and
sterilization for reuse might cause
risk and harm to other people.
Failure to adhere to proper
disposal of the medical device as
hazardous waste might cause
risk and harm to people
The material is of the medical
device can be recycled if adhered
Yes to proper decontamination and
sterilization for reuse to reduce
risk and harm to other people.
Simple and easy to follow
instructions on how to properly
don and doff the device should
be indicated on the labels
attached to the device. Links to
Yes
possible websites/videos are an
option. Manufacturers may also
send representatives to teach the
users how to properly use the
medical device (gowns).
Yes While not much skill is needed to
wear the device, the importance
of properly wearing and removing
the device is key in avoiding
workplace injury/illnesses due to

c.2.27 How will information for safe use be
provided?
Factors that should be considered
include:
2.27.1. Whether information will be
provided directly to the end user by the
manufacturer or will it involve the
participation of third parties such as
installers, care providers, health care
professionals or pharmacists
and whether this will have implications for
training;
2.27.2. Commissioning and handing over
to the end user and whether it is
likely/possible that installation can be
carried out by people without the
necessary skills;
2.27.3. Based on the expected life of the
device, whether re-training or re-
certification of operators or service
personnel would be required.
c.2.28 Will new manufacturing processes
need to be established or introduced?
2.28.1. Factors that should be considered
include new technology or a new scale of
production.
c.2.29 Is successful application of the
medical device critically dependent on
human factors such as the user interface?
c.2.29.1 Can the user interface design
features contribute to user error?
Factors that should be considered are
user interface design features that can
contribute to use error. Examples of
interface design features include:
2.29.1.1. Control and indicators
2.29.1.2. Symbols used
2.29.1.3. Ergonomic features
2.29.1.4. Physical design and layout
hazards.
Simple and easy to follow
instructions on how to properly
don and doff the device should
be indicated on the labels
attached to the device. Links to
Yes
possible websites/videos are an
option. Manufacturers may also
send representatives to teach the
users how to properly use the
medical device (gowns).
No
The medical device (gowns)
Yes should have clear instructions for
the use of the medical device/
No
There is a possibility of new
manufacturing processes be
developed, established and used
Yes
this is dependent on design
and/or materials used of
manufacturer
There is a possibility of new novel
materials and processes of these
novel materials being developed,
Yes
established and used dependent
on the design of the
manufacturer.
The medical device must be worn
properly and detailed instructions
Yes
must be properly conveyed to the
user by the manufacturer.
The packaging with instructions
Yes of the medical device should be
sufficient to avoid user error.
No
No
No
No

2.29.1.5. Hierarchy of operation
2.29.1.6. Menus for software driven
devices
2.29.1.7. Visibility of warnings
2.29.1.8. Audibility of alarms
2.29.1.9. Standardization of colour
coding. (See IEC 60601-1-6[25] for
additional guidance on usability and
IEC 60601-1-8[26] for guidance on
alarms.)
c.2.29.2 Is the medical device used in
an environment where distractions can
cause use error?
Factors that should be considered
include:
2.29.2.1. The consequence of use
error;
2.29.2.2. Whether the distractions are
commonplace
2.29.2.3. Whether the user can be
disturbed by an infrequent distraction.
c.2.29.3 Does the medical device have
connecting parts or accessories?
factors that should be considered include
the possibility of wrong connections
2.29.3.1. Similarity to other products’
connection
Indicated in the instructions
should include the step by step
Yes
process on how to don or doff the
medical device.
No
The medical device (gowns) must
have warning labels and
instruction labels on how they are
Yes
to be used. It must also contain
their intended use in order not to
use it for any other context.
No
No
The medical device (gown)
requires proper donning
according to the manufacturer. If
Yes improper donning is done due to
distractions then there is a
chance that the primary intended
of protection from liquids will fail.
Failure of proper donning and
use of the medical device will
Yes result in exposure of the wearer
to possible hazardous and
harmful liquids.
Distractions in properly wearing
and using the medical device are
common thus it is recommended
that the user follows the
Yes
instructions and procedures by
the manufacturer and follows
procedures set by the
organization of the user.
Improper lengths or sizes can
directly hamper or distract a user
Yes
or adversely affect job
performance.
The medical device may have
enclosures and belts that are
required to ensure that the
primary use of the medical device
Yes is met. If included in the gown
set, misused accessories such as
connectors, belts and tightening
components will likely cause
failure of protection from liquids.
Yes The medical device might have
similar connectors, belts and
tightening components with other
medical devices specifically
 PPEs and regular clothes that
might make it easier to use or
create misinterpretation of
instructions and use.
2.29.3.2. Connection force Yes
2.29.3.3. Feedback on connection
Yes
integrity
The medical device (gowns) have
tightening components that if
2.29.3.4 Over- and under-tightening Yes misused (including tightening and
over-tightening) will likely cause
failure of protection from liquids.
c.2.29.4 Does the medical device have a
control interface?
No
Factors that should be considered
include
2.29.4.1. Spacing
2.29.4.2. Coding
2.29.4.3. Grouping
2.29.4.4. Mapping
2.29.4.5. Modes of feedback
2.29.4.6. Blunders
2.29.4.7. Slips
2.29.4.8. Control differentiation
2.29.4.9. Visibility
2.29.4.10. Direction of activation or
change
2.29.4.11. Whether the controls are
continuous or discrete
2.29.4.12. The reversibility of settings or
actions.
The medical device (gown) may
c.2.29.5 Does the medical device
possibly have a display
display information?
depending on the manufacturer.
Yes
It may contain information
Factors that should be considered
relevant to the use, type, and
include:
handling of the device.
May need to have the picture or
2.29.5.1. Visibility in various
Yes an identifier for the heatlhcare
environments
worker and similar concepts
need to specify right side up/front
2.29.5.2. Orientation Yes
side/back etc.
2.29.5.3. The visual capabilities of the
No
user
2.29.5.4. Populations and perspectives No
2.29.5.5. Clarity of the presented
No
information
2.29.5.6. Units No
Gowns can be color coded esp
2.29.5.7. Colour coding Yes for COVID. For example agreeing
on risk colors or areas of activity.
2.29.5.8. Accessibility of critical
No
information
c.2.29.6 Is the medical device controlled No
by a menu?
Factors that should be considered
include
2.29.6.1. Complexity and number of
layers.
2.29.6.2. Awareness of state
2.29.6.3. Location of settings
2.29.6.4. Navigation method
2.29.6.5. Number of steps per action
2.29.6.6. Sequence clarity and
memorization problems
2.29.6.7. Importance of control function
relative to its accessibility and the
impact of deviating from specified
operating procedures.
c.2.29.7 will the medical device be used
by persons with special needs?
factors that should be considered include
the user
2.29.7.1. Their mental and physical
abilities, skill and training
2.29.7.2. Ergonomic aspects
2.29.7.3. The use environment
2.29.7.4. Installation requirements
2.29.7.5. And the patient's capability to
control or influence the use of the
medical device
2.29.7.6. Special attention should be
paid to users with special needs, such
as handicapped persons, the elderly
and children. Their special needs might
include assistance by another person to
enable the use of a medical device
2.29.7.7. Is the medical device intended
to be used by individuals with various
skill levels and cultural backgrounds?
c.2.29.8 Can the user interface be used
The medical device might be
possibly used and operated by
persons with disabilities and
Yes some operations and procedures
might need to be edited in order
to overcome users with specific
disabilities.
The medical devices (gown) may
be worn by people without mental
Yes faculties (even temporarily) to
correctly and properly wear the
medical device.
Possible users lacking of limbs
and legs and their disability
should not diminish the primary
Yes
purpose of the medical device
which is to protect the user from
liquids
No
No
The medical device (gowns)
user / wearer might not be able to
Yes tighten the gown and thus not
properly sealing the medical
device from liquids.
No
The medical device (gowns)
user / wearer might not be
properly trained there are risks in
Yes donning, tightening and removing
the gown and thus not properly
sealing the medical device from
liquids.
No
 to initiate user actions?

Factors that should be considered

include:
2.29.8.1. The possibility of initiating a
deliberate action for the user to enter a
controlled operation mode, which
enlarges the risks for the patient and
which creates awareness for the user or
this condition.
c.2.30 Does the medical device use an
alarm system?
No
Factors that should be considered are:
2.30.1. The risk of false alarms, missing
alarms, disconnected alarm systems,
unreliable remote alarm systems, and the
medical staff’s possibility of understanding
how the alarm system works. guidance for
alarm systems is given in IEC 60601-1-
8[26].
The medical device (gowns)
c.2.31 In what way(s) might the medical might be misused especially non-
device be deliberately misused? surgical medical devices (gowns)
Yes being used in surgical settings,
Factors that should be considered are: the risk here is that the user
might be exposed to harmful and
hazardous liquids.
2.31.1. incorrect use of connectors
No
2.31.2 disabling safety features or alarms No
The medical device might not
cleaned/sterilized as per
2.31.3 neglect of manufacturer's manufacturer’s standards and
Yes
recommended maintenance there might ben deliberate use
even when the device is visibly
damaged or improperly worn
c.2.32 Does the medical device hold data
No
critical to patient care?
2.32.1 factors that should be considered
include the consequence of the data being
modified or corrupted.
C.2.33 Is the medical device intended to
be mobile or portable?
No
Factors that should be considered are:
2.33.1. The necessary grips
2.33.2. Handles
2.33.3. Wheels
2.33.4. Brakes
2.33.5. Mechanical stability and durability.
The medical device primarily
C.2.34 Does the use of the medical device relies on the performance of
Yes
depend on essential performance? medical device textile materials in
repelling liquids.
 2.34.1. Factors that should be considered
are, for example, the characteristics of the
output of life-supporting devices or the
operation of an alarm.
No
(see IEC 60601-1[23] for a discussion of
essential performance of medical electrical
equipment and medical electrical
systems.)

References:
Ogrodnik, P. J. (2013). Medical device design: innovation from concept to market (1st ed.).
Amsterdam: Elsevier, Academic Press.
Philippine National Standard. (2016). Medical devices - application of risk management to medical
devices (PNS ISO Standard No. 14971:2007). Bureau of Philippine Standards; adapted from
International Organization of Standards.