prEN ISO 21762
(Main)Medical devices utilizing non-viable human materials - Risk management (ISO/DIS 21762:2025)
Medical devices utilizing non-viable human materials - Risk management (ISO/DIS 21762:2025)
This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of human origin. The materials are non-viable or have been rendered non-viable. The document specifies, in junction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. This document is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing human tissues or derivatives such as:
a) contamination by bacteria, moulds or yeasts;
b) contamination by viruses;
c) contamination by agents causing Transmissible Spongiform Encephalopathies (TSE);
d) material responsible for undesired pyrogenic, immunological or toxicological reactions.
For parasites and other unclassified pathogenic entities, similar principles can apply.
This document does not stipulate levels of acceptability, because they are determined by a multiplicity of factors.
This document does not specify a quality management system for the control of all stages of production of medical devices.
Menschliche Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten eingesetzt werden - Risikomanagement (ISO/DIS 21762:2025)
Dispositifs médicaux utilisant des matériaux humains non viables - Gestion des risques (ISO/DIS 21762:2025)
Medicinski pripomočki, ki uporabljajo nežive človeške materiale - Obvladovanje tveganj (ISO/DIS 21762:2025)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2025
Medicinski pripomočki, ki uporabljajo nežive človeške materiale - Obvladovanje
tveganj (ISO/DIS 21762:2025)
Medical devices utilizing non-viable human materials - Risk management (ISO/DIS
21762:2025)
Menschliche Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten
eingesetzt werden - Risikomanagement (ISO/DIS 21762:2025)
Dispositifs médicaux utilisant des matériaux humains non viables - Gestion des risques
(ISO/DIS 21762:2025)
Ta slovenski standard je istoveten z: prEN ISO 21762
ICS:
11.040.99 Druga medicinska oprema Other medical equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
International
Standard
ISO/DIS 21762
ISO/TC 194
Medical devices utilizing non-
Secretariat: DIN
viable human materials - Risk
Voting begins on:
management
2025-09-16
ICS: 11.040.99
Voting terminates on:
2025-12-09
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document has not been edited by the ISO Central Secretariat.
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Reference number
ISO/DIS 21762:2025(en)
DRAFT
ISO/DIS 21762:2025(en)
International
Standard
ISO/DIS 21762
ISO/TC 194
Medical devices utilizing non-
Secretariat: DIN
viable human materials - Risk
Voting begins on:
management
ICS: 11.040.99
Voting terminates on:
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document has not been edited by the ISO Central Secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
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WHICH REFERENCE MAY BE MADE IN
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Published in Switzerland Reference number
ISO/DIS 21762:2025(en)
ii
ISO/DIS 21762:2025(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements for risk management system . 3
4.1 Risk management process .3
4.2 Management responsibilities .4
4.3 Competence of personnel .4
4.4 Risk management plan .4
4.5 Risk management file .4
5 Risk analysis . 4
5.1 Risk analysis process .4
5.2 Intended use and reasonably foreseeable misuse .4
5.3 Identification of characteristics related to safety .5
5.4 Identification of hazards and hazardous situations .6
5.5 Risk Estimation .6
6 Risk evaluation . 6
7 Risk control . 6
7.1 Risk control option analysis .6
7.2 Implementation of risk control measures .6
7.2.1 General .6
7.2.2 Risk control for viruses and TSE agents and other transmissible agents .6
7.2.3 Risk control of other hazards .7
7.3 Residual risk evaluation .7
7.3.1 General .7
7.3.2 Risks for TSE agents and other transmissible agents .7
7.4 Benefit-Risk analysis .7
7.5 Risks arising from risk control measures .7
7.6 Completeness of risk control .8
8 Evaluation of overall residual risk acceptability . 8
8.1 General .8
8.2 Documentation .8
9 Risk management review . 8
10 Production and post-production activities . 8
Annex A (informative) Guidance on the application of this document . 9
Annex B (informative) Graphical representation of part of the risk management process for
medical devices utilizing human material . 10
Annex C (informative) Information relevant to the management of TSE risk and other
transmissible agents.11
Bibliography . 14
iii
ISO/DIS 21762:2025(en)
Foreword
ISO (the International Organization for Standardization) and IEC (the International Electrotechnical
Commission) form the specialized system for worldwide standardization. National bodies that are
members of ISO or IEC participate in the development of International Standards through technical
committees established by the respective organization to deal with particular fields of technical activity.
ISO and IEC technical committees collaborate in fields of mutual interest. Other international organizations,
governmental and non-governmental, in liaison with ISO and IEC, also take part in the work.
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 document 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 and IEC 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) or the IEC list of patent declarations
received (see http://patents.iec.ch).
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 194 Biological and clinical evaluation of medical
devices, in collaboration with the European Committee for Standardization (CEN) Technical Committee
CEN/TC 206, Biocompatibility of medical and dental materials and devices, in accordance with the Agreement
on technical cooperation between ISO and CEN (Vienna Agreement).
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.
iv
ISO/DIS 21762:2025(en)
Introduction
Certain medical devices utilize materials of human origin.
Human tissues and their derivatives are used in the design and manufacture of medical devices to provide
performance characteristics that have been chosen for advantages over options which are lower risk from a
transmissib
...
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