SIST EN ISO 20342-1:2019/oprA1:2021
(Amendment)Assistive products for tissue integrity when lying down - Part 1: General requirements - Amendment 1 (ISO 20342-1:2019/DAM 1:2021)
Assistive products for tissue integrity when lying down - Part 1: General requirements - Amendment 1 (ISO 20342-1:2019/DAM 1:2021)
Unterstützende Produkte zur Gewebeintegrität im Liegen - Teil 1: Allgemeine Festlegungen (ISO 20342-1:2019/DAM 1:2021)
No scope available
Produits d'assistance pour l'intégrité des tissus en position allongée - Partie 1: Exigences générales - Amendement 1 (ISO 20342-1:2019/DAM 1:2021)
Tehnični pripomočki za celovitost tkiv v ležečem položaju - 1. del: Splošne zahteve - Dopolnilo 1 (ISO 20342-1:2019/DAM 1:2021)
General Information
- Status
- Not Published
- Public Enquiry End Date
- 05-Sep-2021
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 98 - Abandoned project (Adopted Project)
- Start Date
- 18-Jul-2025
- Due Date
- 23-Jul-2025
- Completion Date
- 18-Jul-2025
Relations
- Effective Date
- 07-Apr-2021
Overview
EN ISO 20342-1:2019/prA1 (ISO 20342-1:2019/DAM 1:2021) is an amendment to the international standard for assistive products for tissue integrity when lying down - Part 1: General requirements. The amendment updates scope, safety and performance test requirements, usability expectations, and normative references to strengthen protection against injury and improve usability for people who use lying support surfaces.
Key topics and technical requirements
- Scope refinement
- Applies to a range of lying support surfaces used either with an appropriate support platform (including adjustable platforms) or as integrated systems.
- Does not apply to medical beds, incubators, or operating/surgical tables.
- Safety and performance testing
- Amendment explicitly includes safety and performance test methods to ensure user protection from injuries.
- Usability and human factors
- Manufacturers are required to address usability using IEC 62366 or IEC 60601-1-6 where applicable (usability engineering for medical devices).
- Risk management and clinical investigation
- Adds ISO 14971 (risk management for medical devices) as a normative reference.
- Redefines clinical investigation in line with ISO 14155:2020 to assess device clinical performance, effectiveness or safety.
- Mechanical safety
- V-shaped openings: openings shall be greater than 60° to reduce entrapment risk; openings under 75° require manufacturer risk analysis per ISO 14971.
- Surfaces, corners, edges: requirements reference EN 1888-1 and EN 1888-2 where applicable.
- Temperature limits
- Surface-temperature guidance updated; for non-heating applied parts, IEC 60601-1 ergonomic temperature limits apply. Surface temperature shall not exceed 41 °C for contacts longer than 10 minutes, with higher short‑duration limits defined. If higher temperatures are clinically necessary, justification must be documented in the device Risk Management File.
- Information and instructions
- References added for manufacturer information: ISO 20417 and IEC 82079-1 (preparation of instructions for use).
Practical applications and users
This amendment is essential for:
- Manufacturers and designers of lying support surfaces and integrated assistive systems (mattresses, overlays, cushions).
- Regulatory and compliance teams preparing technical files and risk management documentation.
- Test laboratories developing and performing safety and performance tests.
- Procurement and clinical engineers evaluating devices for healthcare settings and long‑term care.
- Usability and human‑factors specialists working on device labeling and user instructions.
Related standards (high relevance)
- ISO 14971 - Risk management for medical devices
- IEC 62366 / IEC 60601-1-6 - Usability engineering for medical devices
- ISO 14155 - Clinical investigation of medical devices
- ISO 20417, IEC 82079-1 - Manufacturer information / instructions for use
- EN 1888-1 / EN 1888-2 - Requirements referenced for surfaces and edges
Keywords: ISO 20342-1 amendment, assistive products, tissue integrity, lying support surfaces, risk management, usability engineering, temperature limits, V-shaped openings.
Frequently Asked Questions
SIST EN ISO 20342-1:2019/oprA1:2021 is a draft published by the Slovenian Institute for Standardization (SIST). Its full title is "Assistive products for tissue integrity when lying down - Part 1: General requirements - Amendment 1 (ISO 20342-1:2019/DAM 1:2021)". This standard covers: No scope available
No scope available
SIST EN ISO 20342-1:2019/oprA1:2021 is classified under the following ICS (International Classification for Standards) categories: 11.180.01 - Aids for disabled and handicapped persons in general. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 20342-1:2019/oprA1:2021 has the following relationships with other standards: It is inter standard links to SIST EN ISO 20342-1:2019. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN ISO 20342-1:2019/oprA1:2021 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2021
Tehnični pripomočki za celovitost tkiv v ležečem položaju - 1. del: Splošne zahteve
- Dopolnilo 1 (ISO 20342-1:2019/DAM 1:2021)
Assistive products for tissue integrity when lying down - Part 1: General requirements -
Amendment 1 (ISO 20342-1:2019/DAM 1:2021)
Unterstützende Produkte zur Gewebeintegrität im Liegen - Teil 1: Allgemeine
Festlegungen (ISO 20342-1:2019/DAM 1:2021)
Produits d'assistance pour l'intégrité des tissus en position allongée - Partie 1: Exigences
générales - Amendement 1 (ISO 20342-1:2019/DAM 1:2021)
Ta slovenski standard je istoveten z: EN ISO 20342-1:2019/prA1
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.
DRAFT AMENDMENT
ISO 20342-1:2019/DAM 1
ISO/TC 173 Secretariat: SIS
Voting begins on: Voting terminates on:
2021-06-15 2021-09-07
Assistive products for tissue integrity when lying down —
Part 1:
General requirements
AMENDMENT 1
Produits d'assistance pour l'intégrité des tissus en position allongée —
Partie 1: Exigences générales
AMENDEMENT 1
ICS: 11.180.01
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
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STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO 20342-1:2019/DAM 1:2021(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2021
ISO 20342-1:2019/DAM 1:2021(E)
© ISO 2021
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ISO 20342-1:2019/DAM 1:2021(E)
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This document was prepared by Technical Committee ISO/TC 173, Assistive products for tissue integrity.
A list of all parts in the ISO 20342 series can be found on the ISO website.
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ISO 20342-1:2019/DAM 1:2021(E)
Assistive products for tissue integrity when lying down —
Part 1:
General
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