EN ISO 20342-1:2022

SLOVENSKI STANDARD
01-oktober-2022
Nadomešča:
SIST EN ISO 20342-1:2019
Tehnični pripomočki za celovitost tkiv v ležečem položaju - 1. del: Splošne zahteve
(ISO 20342-1:2022)
Assistive products for tissue integrity when lying down - Part 1: General requirements
(ISO 20342-1:2022)
Hilfsmittel für die Gewebeintegrität im Liegen - Teil 1: Allgemeine Anforderungen (ISO
20342-1:2022)
Produits d'assistance pour l'intégrité des tissus en position allongée - Partie 1: Exigences
générales (ISO 20342-1:2022)
Ta slovenski standard je istoveten z: EN ISO 20342-1:2022
ICS:
11.180.01 Pripomočki za Aids for disabled and
onesposobljene in handicapped persons in
hendikepirane osebe na general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 20342-1
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2022
EUROPÄISCHE NORM
ICS 11.180.01 Supersedes EN ISO 20342-1:2019
English Version
Assistive products for tissue integrity when lying down -
Part 1: General requirements (ISO 20342-1:2022)
Produits d'assistance pour l'intégrité des tissus en Hilfsmittel für die Gewebeintegrität im Liegen - Teil 1:
position allongée - Partie 1: Exigences générales (ISO Allgemeine Anforderungen (ISO 20342-1:2022)
20342-1:2022)
This European Standard was approved by CEN on 26 June 2022.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20342-1:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 20342-1:2022) has been prepared by Technical Committee ISO/TC 173
"Assistive products" in collaboration with Technical Committee CEN/TC 293 “Assistive products and
accessibility” the secretariat of which is held by SIS.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by February 2023, and conflicting national standards
shall be withdrawn at the latest by February 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 20342-1:2019.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 20342-1:2022 has been approved by CEN as EN ISO 20342-1:2022 without any
modification.
INTERNATIONAL ISO
STANDARD 20342-1
Second edition
2022-07
Assistive products for tissue integrity
when lying down —
Part 1:
General requirements
Produits d'assistance pour l'intégrité des tissus en position
allongée —
Partie 1: Exigences générales
Reference number
ISO 20342-1:2022(E)
ISO 20342-1:2022(E)
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 20342-1:2022(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 3
4 General requirements and safety .7
4.1 General requirements . 7
4.2 Intended use . 8
4.2.1 General requirements . 8
4.2.2 Consideration regarding intended use . 8
4.2.3 Intended use statement . 8
4.3 APTI risk management . 9
4.4 APTI usability . 9
4.4.1 General . 9
4.4.2 Design requirements in relation to persons with cognitive impairment . 9
4.5 Design controls. 9
4.6 Clinical evaluation . 9
4.7 Foreseeable misuse . 9
4.8 Test conditions . 10
4.9 Lifting and carrying means . . 10
5 Safety requirements.10
5.1 Requirements for information supplied by the manufacturer . 10
5.1.1 General . 10
5.1.2 APTI traceability . 11
5.1.3 Education and training . 11
5.1.4 Pre-sale information . 11
5.1.5 User information .12
5.1.6 Service information and inspection . 13
5.1.7 Labelling . 13
5.1.8 Marking of user weight and maximum load .13
5.1.9 Packaging . 14
5.2 APTI that can be dismantled . . 14
5.2.1 General requirements . 14
5.2.2 Small parts . 14
5.2.3 Fasteners and connections . 14
5.3 Resistance to corrosion . 14
5.4 Noise and vibration . 14
5.5 Sound audible acoustic energy .15
5.6 Default indicators . 15
5.7 Feedback . 16
6 Flammability .16
6.1 General . 16
6.2 Flammability . 17
6.3 Moulded parts used as enclosures for electrical equipment . 17
7 Mechanical safety .17
7.1 Prevention of traps for the human body . . 17
7.2 Safety of moving and folding parts . 18
7.3 V-shaped openings . 19
7.4 Surfaces, corners, edges and protruding parts . 19
7.5 Folding and adjusting mechanisms . 19
7.6 Instability hazard. 20
7.7 Temperature of parts that come into contact with human skin . 20
iii
ISO 20342-1:2022(E)
7.8 Ergonomic principles . 21
7.9 Additional consideration . 21
8 Safety of electrical equipment . .21
8.1 General electrical requirements . 21
8.2 Electromagnetic compatibility.22
8.2.1 General .22
8.2.2 Emissions .22
8.2.3 Immunity . 22
8.2.4 Power frequency magnetic field immunity .22
8.3 Liquid ingress . 22
8.4 Interruption of power supply/supply mains to an APTI . 23
8.5 Hold to run activation .23
8.6 Emergency stop functions . 23
9 Biocompatibility .24
9.1 Biocompatibility and toxicity . 24
9.2 Animal tissue . 24
10 Contamination .24
10.1 Liquid ingress . 24
10.2 Cleaning and disinfection . 24
10.3 Cross infection and microbial contamination . 25
Annex A (informative) General information .26
Annex B (informative) Environmental and consumer related guidance .30
Annex C (informative) Periodic inspection .34
Bibliography .35
iv
ISO 20342-1:2022(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/
iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 173, Assistive products, in collaboration
with the European Committee for Standardization (CEN) Technical Committee CEN/TC 293, Assistive
products and accessibility, in accordance with the Agreement on technical cooperation between ISO and
CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 20342-1:2019), which has been technically
revised.
The main changes are as follows:
— the Scope was clarified;
— Clause 2 was updated;
— Clause 3 was updated;
— subclause 7.3 about V-shaped openings was amended;
— subclause 7.7 and Table 4 were amended (regarding surface temperature);
— the bibliography was updated.
A list of all parts in the ISO 20342 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
v
ISO 20342-1:2022(E)
Introduction
This document addresses Assistive Products for Tissue Integrity (APTI). As some devices can be used/
reused in more than one application environment, different requirements and test methods can apply
to the same APTI, depending on the application environment.
APTI play a very important role in the prevention and treatment of pressure injuries. Another important
role in the prevention and treatment of pressure injury is the clinical practice and the clinical evaluation.
[24]
Guidance can be found in the NPUAP/EPUAP/PPPIA Guidelines .
Surfaces applied on operating theatre tables can also impact in the process of patient management
and might need to be taken into consideration. It should be recognized however, patient stability and
specialist equipment used during an operation often create conflicting priorities to those of an APTI.
Using this document, clinicians and manufacturers should consider the impact of other items (including
additional APTI) used in conjunction with an APTI on tissue integrity and safety.
This document only covers general requirements to ensure safety of users.
vi
INTERNATIONAL STANDARD ISO 20342-1:2022(E)
Assistive products for tissue integrity when lying down —
Part 1:
General requirements
1 Scope
This document specifies general requirements and related test methods that are relevant to assistive
products for tissue integrity (APTI) in the lying position in different application environments such as
hospitals, home care and institutions. This document applies to the safety of APTI that are intended to
remain in situ during periods of lying, and to prevent and/or treat pressure injuries.
This document covers a range of different lying support surfaces intended to be used in combination
with the appropriate support platform (adjustable included) or as a whole integrated system.
This document does not apply to medical beds.
This document also covers assistive products primarily intended for tissue integrity for changing a
lying position and assistive products for maintaining a lying position.
This document does not apply to lying support surfaces used in combination with incubators or
operating/surgical tables.
It also covers safety and performance test methods to ensure protection against injuries to the user.
This document addresses the combination of a full body support surface and an adjustable mattress
support platform. It also covers safety and performance test methods to ensure protection against
injuries to the user.
This document specifies requirements and test methods for APTI within the following classifications of
ISO 9999:2022:
04 33 06 Assistive products for tissue integrity when lying down such as but not limited to
— mattresses and mattress overlays for pressure injury prevention, and
— mattress coverings for pressure injury prevention mattresses.
12 31 03 Assistive products for sliding and turning such as but not limited to the following:
Devices for changing position or direction of a person using sliding or turning techniques. The only
products included are those intended to be used in a lying position and remain in situ as part of the
lying support surface. They are the following:
— sliding products that glide one way and lock the other way;
— sheets and underlays in flexible materials with low friction;
— fabric sold by the metre, cut as required for repositioning use;
— powered turning product;
This excludes sliding boards unless the product is intended to be left in situ.
09 07 06 Positioning pillows, positioning cushions and positioning systems such as but not limited to
— leg positioners,
ISO 20342-1:2022(E)
— arm positioners, and
— multipurpose body positioners.
18 12 15 Bedding such as but not limited to
— draw sheets.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 554, Standard atmospheres for conditioning and/or testing — Specifications
ISO 3746, Acoustics — Determination of sound power levels and sound energy levels of noise sources using
sound pressure — Survey method using an enveloping measurement surface over a reflecting plane
ISO 9614-1, Acoustics — Determination of sound power levels of noise sources using sound intensity — Part
1: Measurement at discrete points
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 13732-1, Ergonomics of the thermal environment — Methods for the assessment of human responses to
contact with surfaces — Part 1: Hot surfaces
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer
— Part 1: General requirements
ISO 22442-1, Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk
management
IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, Medical electrical equipment — Part 1: General requirements
for basic safety and essential performance
IEC 60601-1-2, Medical electrical equipment — Part 1-2: General requirements for basic safety and essential
performance — Collateral standard: Electromagnetic compatibility — Requirements and tests
IEC 60601-1-6, Medical electrical equipment — Part 1-6: General requirements for basic safety and essential
performance — Collateral standard: Usability
IEC 60601-1-8, Medical electrical equipment — Part 1-8: General requirements for basic safety and
essential performance — Collateral standard: General requirements, tests and guidance for alarm systems
in medical electrical equipment and medical electrical systems
IEC 60601-1-11, Medical electrical equipment — Part 1-11: General requirements for basic safety and
essential performance — Collateral standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
IEC 60529, Degrees of protection provided by enclosures (IP Code)
IEC 60695-11-10, Fire hazard testing — Part 11-10: Test flames — 50 W horizontal and vertical flame test
methods
IEC 61000-3-2, Electromagnetic compatibility (EMC) — Part 3-2: Limits — Limits for harmonic current
emissions (equipment input current ≤16 A per phase)
ISO 20342-1:2022(E)
IEC 61000-3-3, Electromagnetic compatibility (EMC) — Part 3-3: Limits — Limitation of voltage changes,
voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤16
A per phase and not subject to conditional connection
IEC 61000-4-3, Electromagnetic compatibility (EMC) — Part 4-3: Testing and measurement techniques —
Radiated, radio-frequency, electromagnetic field immunity test
IEC 61000-4-8, Electromagnetic compatibility (EMC) — Part 4-8: Testing and measurement techniques —
Power frequency magnetic field immunity test
IEC 61672-1, Electroacoustics — Sound level meters — Part 1: Specifications
IEC 61672-2, Electroacoustics — Sound level meters — Part 2: Pattern evaluation tests
IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices
IEC 60601-2-35, Medical electrical equipment — Part 2-35: Particular requirements for the basic safety
and essential performance of heating devices using blankets, pads or mattresses and intended for heating
in medical use
EN 716-2:2017, Furniture — Children’s cots and folding cots for domestic use — Part 2: Test methods
EN 1041, Information supplied by the manufacturer of medical devices
CISPR 11, Industrial, scientific and medical (ISM) radio-frequency equipment — Electromagnetic
disturbance characteristics — Limits and methods of measurement
European Commission, MEDDEV 2.7/1 CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND
NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
application environment 4
care provided in a domestic area where the assistive product for tissue integrity (3.5) is used to alleviate
or compensate for an injury, disability or disease
Note 1 to entry: This excludes use in all other application environments (e.g. nursing homes, rehabilitation
and geriatric facilities) when an assistive product for tissue integrity (3.5) is purely designed for application
environment 4.
[SOURCE: IEC 60601-2-52:2009+AMD1: 2015: 201 .3 .204, modified — "assistive product for tissue
integrity" replaced "ME equipment".]
3.2
applied part
part of the assistive product for tissue integrity (3.5) that, in normal use, comes into physical contact
with the user of the assistive product for tissue integrity or a medical system to perform its function
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020: 3 .8, modified — "assistive product for tissue
integrity" replaced ME Equipment", "of the" replaced "for", "user" replaced "patient", and "necessary"
and notes not included.]
ISO 20342-1:2022(E)
3.3
assistant
person who is helping a user (3.30) of the assistive product for tissue integrity (3.5)
EXAMPLE The ways assistants help persons with a disability (3.11) can be reposition in bed, bed ingress and
egress, operating hoists and assisting with transferring in/out of seats.
Note 1 to entry: An assistant can be a health care professional or a non-professional, e.g. a relative.
3.4
assistive product
instrument, equipment or technical system intended by the manufacturer used for the prevention,
treatment or alleviation of or compensation for impairment (3.13)
3.5
assistive product for tissue integrity
APTI
surface intended to protect body tissue, designed to interface with the body when lying down (3.15) or
in adjusted position
3.6
bedding
items normally placed on a mattress (3.16)
EXAMPLE Mattress covers, underlays, sheets, blankets, quilts (duvets) and their covers, cushions, pillows,
bolsters and pillow cases.
3.7
body mass index
BMI
value derived from the mass (weight in kilograms) and height (in metres) of an individual, defined as
the body mass divided by the square of the body length, expressed in units of kg/m , calculated by the
following:
BMI = m/l
where
m is the mass in kg;
l is the length in m.
3.8
clinical evaluation
assessment and analysis of clinical data pertaining to a medical device (3.21) to verify the clinical safety
and performance of the device when used as intended by the manufacturer
Note 1 to entry: Can include a compilation of clinical data, any scientific literature and the results of any clinical
investigations (3.9), taking into account any relevant harmonized standards.
Note 2 to entry: Guidance for clinical data evaluation is given in MEDDEV 2.7/1.
[SOURCE: ISO 13485:2016:3.3, modified — Notes to entry added.]
3.9
clinical investigation
systematic investigation in one or more human subjects, undertaken to assess the clinical performance,
effectiveness, or safety of a medical device
[SOURCE: ISO 14155:2020:3.8, modified — Note 1 to entry was removed.]
ISO 20342-1:2022(E)
3.10
detachable part
part designed to be unfastened or disconnected without damage to the part or the whole
3.11
disability
impairments (3.13), activity limitations, and participation restrictions denoting the negative aspects of
the interaction between an individual (with a health condition) and that individual's contextual factors
(environmental and personal factors)
[SOURCE: ICF 2001, WHO]
3.12
expected service life
time specified by the manufacturer during which the assistive product for tissue integrity (3.5) is
expected to remain safe for use (i.e. maintain basic safety and claimed performance)
Note 1 to entry: Maintenance can be necessary during expected service life.
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020: 3 .28, modified — "assistive product for tissue
integrity" replaced "ME equipment or ME system", "may" replaced "can" and "claimed" replaced
"essential".]
3.13
impairment
problem in body function or structure, such as a significant deviation or loss
[SOURCE: ICF 2001, WHO]
3.14
intended use
use of a product, process or service in accordance with the specifications, instructions and information
provided by the manufacturer
Note 1 to entry: This information includes pre-sale information.
[SOURCE: ISO 14971: 2019:3,6, modified — "of" replaced "for which", note to entry modified.]
3.15
lying down
position when the user (3.30) is in prone, supine, semi-recumbent or lateral on a full body support
surface
3.16
mattress
full body support surface designed to be placed directly on the existing bed frame
[SOURCE: RESNA SS-1: 2014, Section 1]
3.17
mattress overlay
additional support surface designed to be placed directly on top of an existing support surface
[SOURCE: RESNA SS -1: 2014, modified — "mattress" changed to "support surface".]
ISO 20342-1:2022(E)
3.18
maximum load
safe working load
SWL
greatest permissible load specified by the manufacturer
Note 1 to entry: This load is related to safety of the product; e.g., strength and durability, and covers the mass of
the user (3.30), accessories, and other loads placed on the assistive product for tissue integrity (3.5).
3.19
maximum user weight
greatest allowable user weight for the intended use of the assistive product for tissue integrity (3.5)
3.20
medical bed
device for which the intended use (3.14) is sleeping/resting, which contains a mattress support platform
and intended to assist in diagnosis, monitoring, prevention, treatment, alleviation of disease, or
compensation for an injury or handicap
[SOURCE: IEC 60601-2-52: 2009+AMD1: 2015: 201 .3 .212, modified — Notes are not included.]
3.21
medical device
instrument, apparatus, appliance, material, or other article, including software, whether used alone or
in combination, intended by the manufacturer to be used for human beings solely or principally for the
purpose of
— diagnosis, prevention, monitoring, treatment, or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or handicap,
— investigation, replacement, or modification of the anatomy or of a physiological process, and
— control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological,
immunological, or metabolic means, but which can be assisted in its function by such means.
Note 1 to entry: Devices are different from drugs and their biological evaluation requires a different approach.
Note 2 to entry: Use of “medical device” includes dental devices.
3.22
minimum user weight
lowest allowable user weight for the intended use of the assistive product for tissue integrity (3.5)
3.23
normal use
use of a product, process, or service in accordance with the specifications, instructions, and information
provided by the manufacturer, not only intended for medical use, but also, for example, maintenance,
service and transport
Note 1 to entry: Normal use is not to be confused with intended use (3.14). While both include the concept of use as
intended by the manufacturer, intended use (3.14) focuses on the medical purpose while normal use incorporates
not only the medical purposes, but also maintenance, service, transport, etc.
[SOURCE: ISO 17966: 2016:3.19, modified — "etc." deleted and "and" and note to entry added.]
ISO 20342-1:2022(E)
3.24
operator
person managing the assistive product for tissue integrity (3.5)
Note 1 to entry: The operator can be a number of roles depending on the application environment; for example,
the user (3.29), the assistant (3.2) or the service personnel.
3.25
pressure injury
pressure ulcer
localized damage to the skin and/or underlying soft tissue, often over a bony prominence
Note 1 to entry: The injury can present as intact skin or as an open ulcer and can be painful. The injury occurs
as a result of intense and/or prolonged pressure or pressure in combination with shear. The tolerance of soft
tissue for pressure and shear can also be affected by microclimate, nutrition, perfusion, co-morbidities and the
condition of the soft tissue.
3.26
risk management
systematic application of management policies, procedures and practices to the tasks of analysing,
evaluating, controlling and monitoring risk
3.27
single fault condition
condition in which a single means for reducing a risk is defective or a single abnormal condition is
present
[S OU RC E: I EC 6 06 01-1:20 05+A M D1: 2012+ A M D2: 2020 : 3 .116]
3.28
technical documentation
manufacturer’s data that shows that an assistive product (3.4) conforms to specified requirements
Note 1 to entry: For the purposes of this document, such requirements include requirements specified in this
document and/or any regulatory requirements.
3.29
usability
characteristic of the user interface that establishes effectiveness, efficiency, ease of user learning and
user satisfaction
[SOURCE: ISO 14708-1:2014:3.37]
3.30
user
person for whom the assistive product for tissue integrity (3.5) is intended
Note 1 to entry: The user can also be the operator (3.24).
4 General requirements and safety
4.1 General requirements
Further guidance around medical device development, manufacturing and management can be found
in ISO 13485.
An APTI is a medical device and like any other medical devices, it shall be designed, manufactured and
promoted for the appropriate use. Many application environments, types of caregivers and people sizes,
ISO 20342-1:2022(E)
shapes and capabilities exist. These need to be considered during the development, manufacturing and
promotion of an APTI.
NOTE An example of the methodology for development, manufacturing and promotion of an APTI is given in
Clause A.1.
4.2 Intended use
4.2.1 General requirements
Manufacturers shall develop an intended use statement for their APTI. This should include the
application environment, the appropriate patient population (based on patient risk), and general
medical claims (such as claims to reduce the risk of pressure injuries).
The intended use should be given proper consideration throughout the development of an APTI and
considered during risk evaluation.
4.2.2 Consideration regarding intended use
Defining the intended use of an APTI will help with identifying boundaries, thereby guiding users
through the selection and usage of an APTI, and developers through the development cycle. The
objective is not to limit the use of an APTI, but to make sure the context in which the APTI is supposed
to be used is well defined and understood.
4.2.3 Intended use statement
4.2.3.1 Claims
To define better the intended use, it is key to identify what the APTI will do from a clinical standpoint.
These are called claims. These help to position the clinical value of the APTI.
Ultimately, claims related to intended use statements shall be substantiated and supported by evidence;
either a specific test or a clinical evaluation showing the claimed outcome is provided by the APTI.
4.2.3.2 APTI description
Once claims are defined, the next step is to provide a description of the support surface. This description
will enhance the understanding of the physical characteristics of the APTI.
EXAMPLE The manufacturer could define the overall dimension of the APTI, which would help in the
selection process as it relates to the pairing of an APTI to a bed and/or medical bed.
4.2.3.3 Users and application environments
In addition to the manufacturers claims and the APTI description, the manufacturer shall also define
the APTI users and the application environment(s) in which the APTI can be use
...