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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STANDARDS MAY ON OCCASION HAVE TO
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RECIPIENTS OF THIS DRAFT ARE INVITED
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NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
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
transmissible agent perspective. The range and quantities of materials of human origin in medical devices
vary. These materials can comprise a major part of the device e.g. demineralised or mineral sintered bones,
heart valves, acellular cornea, placenta and amniotic membranes, dermis, tendons).
ISO 14971 is a general standard which specifies a process for a manufacturer by identifying hazards and
hazardous situations associated with medical devices, including in vitro medical devices, to estimate and
evaluate the risks associated with those hazards, to control these risks and to monitor the effectiveness of
the control throughout the life cycle. This document provides additional requirements and guidance for the
evaluation of medical devices manufactured utilizing human tissues or derivatives which are non-viable or
rendered non-viable.
This document is intended to cover medical devices including active implantable medical devices such as
implantable infusion pumps.
This document does not apply to in vitro diagnostic devices.
This document can only be used in combination with ISO 14971 and is not a “stand-alone” standard.
NOTE Compliance to this document is shown by fulfilling its specified requirements. The guidance given in the
notes and the informative annexes is not normative and is not provided as a checklist for auditors.
v
DRAFT International Standard ISO/DIS 21762:2025(en)
Medical devices utilizing non-viable human materials - Risk
management
1 Scope
This document applies to medical devices other than in vitro diagnostic medical devices manufactured
utilizing human materials which are non-viable or have been rendered non-viable. The document specifies,
in conjunction 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 determining the acceptability
of residual risks, taking into account the risk profile and expected benefit as compared to available
alternatives, in line with ISO 14971. This document is intended to provide requirements and guidance on
risk management related to the hazards typical of medical devices manufactured utilizing human materials
such as:
a) contamination by bacteria, moulds, yeasts or parasites;
b) contamination by viruses;
c) contamination by agents causing transmissible spongiform encephalopathies (TSEs) and other
transmissible agents;
d) material responsible for undesired pyrogenic, immunological or toxicological reactions.
This document does not stipulate levels of acceptability which, because they are determined by a multiplicity
of factors, cannot be set down in such an international standard.
This document does not specify a quality management system for the control of all stages of production of
medical devices.
NOTE 1 It is not a requirement of this document to have a full quality management system during manufacture.
However, attention is drawn to international standards for quality management systems (see ISO 13485) that control
all stages of production or reprocessing of medical devices.
NOTE 2 For guidance on the application of this document, see Annex A.
This document does not address requirements for consent to donation of human materials.
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 14971:2019, Medical devices — Application of risk management to medical devices
ISO 22442-3, Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination
and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14971 and the following apply.
ISO/DIS 21762:2025(en)
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
human
Homo sapiens
3.2
animal
vertebrate or invertebrate [including amphibian, arthropod (e.g. crustacean), bird, coral, fish, reptile,
mollusc and mammal] excluding humans (Homo sapiens)
3.3
cell
smallest organized unit of any living form which is capable of independent existence and of replacement of
its own substance in a suitable environment
[SOURCE: ISO 22442-1:2020, 3.2]
3.4
derivative
substance obtained from processed human material
EXAMPLE Collagen, human serum albumin, thrombin, urokinase.
Note 1 to entry: Some materials included in this definition may be considered to be derivatives in some jurisdictions
but not in others.
3.5
human material
cells, tissues or exudates obtained from a human (3.1) donor which have been rendered non viable
Note 1 to entry: Human DNA extracted for genetic purposes is excluded.
3.6
exudate
substance that is made by the human body that are not tissues or cells
EXAMPLE Hair, urine, bile, milk.
3.7
elimination
removal
process by which the number of transmissible agents is reduced
[SOURCE: ISO 22442-1:2020 3.4]
Note 1 to entry: The effectiveness of the process for the elimination of viruses and TSE and other transmissible agents
should be expressed mathematically in terms of a reduction factor (see clause C.2 and ISO 22442-3:2007, Annex F).
Note 2 to entry: Elimination aims to prevent infection or pathogenic reaction caused by transmissible agents.
3.8
inactivation
process by which the ability to cause infection or pathogenic reaction by a transmissible agent is reduced
Note 1 to entry: The effectiveness of the process for inactivation of viruses and TSE and other transmissible agents
should be expressed mathematically in terms of a reduction factor (see ISO 22442-3:2007, Annex F).
Note 2 to entry: Inactivation aims to prevent infection by, and replication of, transmissible agents.
ISO/DIS 21762:2025(en)
3.9
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material
or other similar or related article, intended by the manufacturer to be used, alone or in combination, for
human beings, for one or more of the specific medical purpose(s) of
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
— investigation, replacement, modification, or support of the anatomy or of a physiological process,
— supporting or sustaining life,
— control of conception,
— disinfection of a medical device,
— providing information by means of in vitro examination of specimens derived from the human body,
and which does not achieve its primary intended action by pharmacological, immunological or metabolic
means, in or on the human body, but which can be assisted in its function by such means
Note 1 to entry: Products which could be considered to be medical devices in some jurisdictions but not in others
include:
— disinfection substances;
— aids for persons with disabilities;
— devices incorporating animal (3.2) and/or human (3.1) tissues;
— devices for in vitro fertilization or assisted reproduction technologies.
[SOURCE: ISO/IEC Guide 63:2019, 3.7]
3.10
non-viable
having no potential for metabolism or multiplication
3.11
supplier agreement
binding contract between two or more parties that assigns responsibilities for technical requirements
3.12
tissue
organization of cells (3.3) and/or extra-cellular constituents
Note 1 to entry: Some materials included in this definition may be considered to be tissues in some jurisdictions but
not in others.
3.13
transmissible agents
bacteria, mould, yeast, parasites, viruses, TSE agents and unclassified pathogenic entities
4 General requirements for risk management system
4.1 Risk management process
The requirements of ISO 14971 apply. Compliance with these requirements shall be verified by inspection of
the appropriate documents, e.g. the risk management file.
ISO/DIS 21762:2025(en)
The manufacturer shall document the rationale for the use of human material (including the choice of
tissues).
4.2 Management responsibilities
The organization responsible for manufacturing the medical device, shall specify, in a supplier agreement,
the principles to be applied, in line with this document, for the sourcing of human material, including:
— Technical specifications;
— Donor screening and assessment;
— Clinical assessment and disease status;
— Informed consent;
— Ethical conduct;
— Anonymisation and traceability;
— Certification of origin;
— Audit of sourcing procedures.
The organization responsible for sourcing human material shall conduct and document sourcing in line with
the terms and conditions of the supplier agreement and maintain and document traceability of the human
material to the donor.
NOTE National or regional regulations can apply.
A process shall be established to verify and document the provenance of human material to provide evidence
of ethical and regulatory compliance.
4.3 Competence of personnel
ISO 14971:2019, 4.3 applies.
4.4 Risk management plan
ISO 14971:2019, 4.4 applies.
4.5 Risk management file
ISO 14971:2019, 4.5 applies.
5 Risk analysis
5.1 Risk analysis process
ISO 14971:2019, 5.1 applies.
5.2 Intended use and reasonably foreseeable misuse
ISO 14971:2019, 5.2 applies.
ISO/DIS 21762:2025(en)
5.3 Identification of characteristics related to safety
5.3.1.1 Contact with the patient or other person
The following factors shall be addressed, if applicable:
a) the quantity of human material considering the lifetime of the device and cumulative effect i.e. the
number of devices which could be used in a single procedure and over the lifetime of the patient;
b) the contact surface area;
c) the type(s) of human material coming into contact with body tissues or fluids;
d) the type
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