ISO/FDIS 10993-1

Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process

This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the nature and duration of their contact with the body; — the evaluation of existing relevant data from all sources; — the identification of gaps in the available data set on the basis of a risk analysis; — the identification of additional data sets necessary to analyse the biological safety of the medical device; — the assessment of the biological safety of the medical device. This document applies to evaluation of materials and medical devices that are expected to have direct or indirect contact with: — the patient's body during intended use; — the user's body, if the medical device is intended for protection (e.g., surgical gloves, masks and others). This document is applicable to biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices. This document also gives guidelines for the assessment of biological hazards arising from: — risks, such as changes to the medical device over time, as a part of the overall biological safety assessment; — breakage of a medical device or medical device component which exposes body tissue to new or novel materials. Other parts of ISO 10993 cover specific aspects of biological assessments and related tests. Device-specific or product standards address mechanical testing. This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents and other pathogens.

Évaluation biologique des dispositifs médicaux — Partie 1: Exigences et principes généraux pour l’évaluation de la sécurité biologique au sein d’un processus de gestion des risques

Le présent document spécifie: — les principes généraux sur lesquels repose l'évaluation biologique des dispositifs médicaux dans un processus de gestion du risque; — la classification générale des dispositifs médicaux, fondée sur la nature et la durée de leur contact avec le corps humain; — l'évaluation de toutes les données pertinentes existantes; — l'identification de lacunes dans les ensembles de données disponibles sur la base d'une analyse de risque; — l'identification d'ensembles de données supplémentaires nécessaires à l'analyse de la sécurité biologique du dispositif médical; — l'évaluation de la sécurité biologique du dispositif médical. Le présent document s'applique à l'évaluation de matériaux et dispositifs médicaux qui sont destinés à entrer en contact direct ou indirect avec: — le corps du patient pendant leur utilisation prévue; — le corps de l'utilisateur si le dispositif médical est destiné à la protection (par exemple gants chirurgicaux, masques et autres). Le présent document est applicable à l'évaluation biologique de tous types de dispositifs médicaux, y compris les dispositifs médicaux actifs, non actifs, implantables et non implantables. Le présent document donne également des lignes directrices pour l'évaluation des dangers biologiques provenant de: — risques tels que des modifications du dispositif médical au fil du temps, dans le cadre de l'évaluation de sécurité biologique générale; — rupture d'un dispositif médical ou d'un composant de dispositif médical qui expose des tissus de l'organisme à des matériaux nouveaux. Les autres parties de l'ISO 10993 couvrent des aspects spécifiques des évaluations biologiques et des essais associés. Des normes de produits ou spécifiques aux dispositifs traitent des essais mécaniques. Le présent document exclut les dangers relatifs aux bactéries, moisissures, levures, virus, agents de l'encéphalopathie spongiforme transmissible (EST) et autres agents pathogènes.

General Information

• Status: Not Published
• ICS: 11.100 - Laboratory medicine
• ICS: 11.100.20 - Biological evaluation of medical devices
• Technical Committee: ISO/TC 194 - Biological and clinical evaluation of medical devices
• Drafting Committee: ISO/TC 194 - Biological and clinical evaluation of medical devices
• Current Stage: 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
• Start Date: 22-May-2025
• Completion Date: 22-May-2025

Relations

• Revises: ISO 10993-1:2018 - Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
• Effective Date: 06-Jun-2022

Standards Content (Sample)

FINAL DRAFT
International
Standard
ISO/TC 194
Biological evaluation of medical
Secretariat: DIN
devices —
Voting begins on:
2025-05-22
Part 1:
Requirements and general
Voting terminates on:
2025-07-17
principles for the evaluation of
biological safety within a risk
management process
Évaluation biologique des dispositifs médicaux —
Partie 1: Exigences et principes généraux pour l’évaluation de la
sécurité biologique au sein d’un processus de gestion des risques
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 SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
FINAL DRAFT
International
Standard
ISO/TC 194
Biological evaluation of medical
Secretariat: DIN
devices —
Voting begins on:
Part 1:
Requirements and general
Voting terminates on:
principles for the evaluation of
biological safety within a risk
management process
Évaluation biologique des dispositifs médicaux —
Partie 1: Exigences et principes généraux pour l’évaluation de la
sécurité biologique au sein d’un processus de gestion des risques
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 SUPPOR TING DOCUMENTATION.
© ISO 2025
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ii
Contents Page
Foreword .v
Introduction .vii
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 General principles . 8
4.1 Biological evaluation within the ISO 14971 risk management framework .8
4.2 Biological evaluation process .10
4.3 Medical device life cycle .11
4.4 Animal welfare . 12
5 Biological evaluation plan .12
6 Biological risk analysis .13
6.1 General approach . 13
6.2 Identification of characteristics related to biological safety .14
6.3 Identification of biological hazards, biologically hazardous situations and potential
biological harms .14
6.4 Categorization of medical device and determination of scope of evaluation .16
6.4.1 General .16
6.4.2 Exposure duration categories .16
6.4.3 Calculation of exposure duration for categorization of medical devices .17
6.4.4 Body contact and biological effects for consideration .17
6.5 Biological effects for evaluation .21
6.5.1 Overall approach .21
6.5.2 Cytotoxicity .21
6.5.3 Sensitization . 22
6.5.4 Irritation . 22
6.5.5 Systemic toxicity . 22
6.5.6 Local effects after tissue contact . 23
6.5.7 Genotoxicity . 23
6.5.8 Carcinogenicity . 23
6.5.9 Haemocompatibility .24
6.5.10 Other biological effects .24
6.5.11 Other factors to be considered . 25
6.6 Gap analysis . 28
6.6.1 General . 28
6.6.2 Medical devices evaluated using previous versions of this document . 28
6.7 Biological equivalence . 28
6.8 Testing . 30
6.8.1 General principles . 30
6.8.2 Biological, physical and chemical testing .31
6.8.3 Degradation testing .32
6.8.4 Toxicokinetic studies .32
6.9 Biological risk estimation . 33
7 Biological risk evaluation.33
8 Biological risk control .34
9 Biological evaluation report . .34
10 Production and post-production activities .34
Annex A (informative) Material selection and characterization to support the biological
evaluation of a medical device .36
Annex B (informative) Rationale for key changes in the biological effects listed in Tables 1 to 4 .39

iii
Annex ZA (informative) Relationship between this European Standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered . 41
Bibliography .46

iv
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 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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
...

ISO/TC 194/WG 1
Secretariat: DIN
Date: 2025-01-1203-14
Biological evaluation of medical devices —
—
Part 1:
Requirements and general principles for the evaluation of biological
safety within a risk management process
Évaluation biologique des dispositifs médicaux —
Partie 1: Exigences et principes généraux pour l’évaluation de la sécurité biologique au sein d’un processus de
gestion des risques
FDIS stage
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
EmailE-mail: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
Contents
Foreword . iv
Introduction . vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 3
4 General principles . 9
4.1 Biological evaluation within the ISO 14971 risk management framework . 9
4.2 Biological evaluation process . 12
4.3 Medical device life cycle . 14
4.4 Animal welfare . 15
5 Biological evaluation plan . 16
6 Biological risk analysis . 16
6.1 General approach . 16
6.2 Identification of characteristics related to biological safety . 17
6.3 Identification of biological hazards, biologically hazardous situations and potential
biological harms . 18
6.4 Categorization of medical device and determination of scope of evaluation . 19
6.5 Biological effects for evaluation . 25
6.6 Gap analysis . 33
6.7 Biological equivalence . 33
6.8 Testing . 36
6.9 Biological risk estimation . 39
7 Biological risk evaluation . 39
8 Biological risk control . 40
9 Biological evaluation report . 40
10 Production and post-production activities . 41
Annex A (informative) Material selection and characterization to support the biological
evaluation of a medical device . 43
Annex B (informative) Rationale for key changes in the biological effects listed in Tables 1 to 446
Annex ZA (informative) Relationship between this European Standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered . 48
Bibliography . 54
iii
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 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity, or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s)
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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, BiocompatibilityBiological and clinical evaluation of medical and dental materials and devices, in
accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This sixth edition cancels and replaces the fifth edition (ISO 10993-1:2018), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— — The standardthis document has been completely reorganised and the title was changed to alignhas
been aligned with the risk management framework described in ISO 14971.;
— — additional content has been added to provide more guidance and clarification of calculation of
exposure duration.;
— — additional content has been added to provide more guidance on characterisationcharacterization of
the device and identification of biological hazards.;
— — the identification of biological effects (previously referred to as biological endpointsend points) has
been modified.;
— — the term “externally communicating” has been replaced in the normative text by language which
reflects the specific tissue contact of device components.;
— — the term “effects after implantation” has been changed to “local effects after tissue contact” as some
non-implanted devices also will need this type of assessment.;
iv
— Annex A— Annex A has been revised to move much of the content to the normative text. The remaining
text in Annex A is now confined to provision ofonly provide guidance on materials
characterisation.characterization, the rest of its former content has been incorporated into the main text;
— Annex B— New Annex B explains has been added to explain the rationale for the changes to biological
effects listed in Table 1 to Table 4Table 1-Table 4.
A list of all parts in the ISO 10993 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
Introduction
The primary aim of this document is to provide guidance and requirements for the biological evaluation of a
medical device within a risk management process to protect humans from biological risks arising from the use
of medical devices and the materials from which they are made. Biological risk evaluation compares the
estimated biological risk against given risk criteria to determine the acceptability of the biological risk as part
of the overall risk management.
Biological evaluation is primarily concerned with medical device biological safety, through consideration of
risks associated with biological hazards. Nonetheless, some activities undertaken in the course of biological
evaluation in addition to assessments of long-term safety can also generate information on device
performance, for example the use of functional implant models to assess long-term responses such as tissue
ingrowth. Biological evaluation, as described in this document, is synonymous with biocompatibility
evaluation.
Biological evaluation is conducted on the finished medical device as it is intended to be used. The principles
and methods described can also be useful in the evaluation of candidate materials or prototype devices during
a medical device development process, and data obtained from such evaluations can be of value in the
assessment of the finished medical device.
Medical device design is wide-ranging, and, at one extreme, a medical device consists only of a single material,
which can exist in more than one physical form, while at the other extreme, is a complex article consisting of
numerous components made from multiple materials. Biological safety cannot be considered in isolation from
the overall medical device design and can require the balancing of conflicting requirements. For example, the
choice of the best material with respect to its biological safety can result in a less functional medical device.
The evaluation of biological safety is conducted in the context of the specific intended use of a particular
medical device. Materials can be safe in one medical device and not in another. It is impossible to make
generalisedgeneralized conclusions about the safety of a particular material for all medical applications.
Biological responses that are regarded as adverse, caused by a material in one application, mightare not
benecessarily regarded as adverse in a different situation.
Physical and chemical information supports the overall biological evaluation and can be used to inform testing
needs if any. When biological testing is required, such testing is based upon in vitro, ex vivo, or in vivo models.
The interpretation of the results of biological tests requires caution because the inherent variability in
biological responses between species and individuals means that the biological response observed in animal
or cell culture models can differ from those observed in clinical use. Differences in response to the same
material among individuals means that some individuals can have adverse reactions, even to well-established
materials. Thus, biological evaluation is an exercise in risk management. When applied in the evaluation of
candidate materials or prototype devices during a medical device development process, it allows the informed
and timely consideration of risk control measures such as use of alternative materials, manufacturing
processes or designs.
The biological evaluation processes described in this document draw on all available sources of information
relevant to biological safety of the medical device, including post-market information. This allows a
comprehensive review of the medical device, the identification of biological hazards and the biological harms
which can arise and estimation of the associated risks. This comprehensive approach allows the identification
of any gaps in the existing data set and the consequent need for conduct of supplementary assessments (e.g.,.
chemical analysis and hazard identification;, biological testing to refine a biological risk estimate).
This document is supported by a wide range of test methods and other guidance published in other documents
in the ISO 10993 series as well as other standards.
...

PROJET FINAL
Norme
internationale
ISO/TC 194
Évaluation biologique des
Secrétariat: DIN
dispositifs médicaux —
Début de vote:
2025-05-22
Partie 1:
Exigences et principes généraux
Vote clos le:
2025-07-17
pour l’évaluation de la sécurité
biologique au sein d’un processus
de gestion des risques
Biological evaluation of medical devices —
Part 1: Requirements and general principles for the evaluation of
biological safety within a risk management process
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
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Numéro de référence
PROJET FINAL
Norme
internationale
ISO/TC 194
Évaluation biologique des
Secrétariat: DIN
dispositifs médicaux —
Début de vote:
Partie 1: 2025-05-22
Exigences et principes généraux
Vote clos le:
2025-07-17
pour l’évaluation de la sécurité
biologique au sein d’un processus
de gestion des risques
Biological evaluation of medical devices —
Part 1: Requirements and general principles for the evaluation of
biological safety within a risk management process
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
DOCUMENT PROTÉGÉ PAR COPYRIGHT
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
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AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
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publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
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SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
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Publié en Suisse Numéro de référence
ii
Sommaire Page
Avant-propos .v
Introduction .vii
1 Domaine d’application . 1
2 Références normatives . 2
3 Termes et définitions . 3
4 Principes généraux . 8
4.1 Évaluation biologique dans le cadre de gestion des risques selon l’ISO 14971 .8
4.2 Processus d’évaluation biologique .11
4.3 Cycle de vie du dispositif médical . 12
4.4 Bien-être des animaux . 13
5 Plan d’évaluation biologique . 14
6 Analyse des risques biologiques . 14
6.1 Approche générale.14
6.2 Identification des caractéristiques liées à la sécurité biologique . 15
6.3 Identification des dangers biologiques, des situations biologiquement dangereuses et
des dommages biologiques potentiels .16
6.4 Catégorisation du dispositif médical et détermination de la portée de l’évaluation .17
6.4.1 Généralités .17
6.4.2 Catégories de durée d’exposition .18
6.4.3 Calcul de la durée d’exposition pour la catégorisation des dispositifs médicaux .18
6.4.4 Contact avec le corps et effets biologiques à prendre en compte .19
6.5 Effets biologiques pour évaluation . 23
6.5.1 Approche générale . 23
6.5.2 Cytotoxicité . 23
6.5.3 Sensibilisation . . .24
6.5.4 Irritation .24
6.5.5 Toxicité systémique .24
6.5.6 Effets locaux après contact avec les tissus . 25
6.5.7 Génotoxicité . 25
6.5.8 Cancérogénicité . 26
6.5.9 Hémocompatibilité . 26
6.5.10 Autres effets biologiques.27
6.5.11 Autres facteurs à considérer . . 28
6.6 Analyse des lacunes . 30
6.6.1 Généralités . 30
6.6.2 Dispositifs médicaux évalués à l’aide des versions précédentes du présent
document .31
6.7 Équivalence biologique .31
6.8 Essais . 33
6.8.1 Principes généraux . 33
6.8.2 Essais biologiques, physiques et chimiques . 34
6.8.3 Essais de dégradation . 35
6.8.4 Études toxicocinétiques . 36
6.9 Estimation des risques biologiques . 36
7 Évaluation des risques biologiques .36
8 Maîtrise des risques biologiques .37
9 Rapport d’évaluation biologique .37
10 Activités de production et de postproduction .38
Annexe A (informative) Choix et caractérisation des matériaux en appui de l’évaluation
biologique d’un dispositif médical . .40

iii
Annexe B (informative) Justification des principaux changements dans les effets biologiques
énumérés dans les Tableaux 1 à 4 .43
Annexe ZA (informative) Relation entre la présente Norme européenne et les exigences générales
en matière de sécurité et de performances concernées du Règlement (UE) 2017/745 .45
Bibliographie .50

iv
Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes nationaux
de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est en général
confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude a le droit de
faire partie du comité technique créé à cet effet. Les organisations internationales, gouvernementales
et non gouvernementales, en liaison avec l’ISO participent également aux travaux. L’ISO collabore
étroitement avec la Commission électrotechnique internationale (IEC) en ce qui concerne la normalisation
électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents
critères d’approbation requis pour les différents types de documents ISO. Le présent document
a été rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2
(voir www.iso.org/directives).
L’ISO attire l’attention sur le fait que la mise en application du présent document peut entraîner l’utilisation
d’un ou de plusieurs brevets. L’ISO ne prend pas position quant à la preuve, à la validité et à l’applicabilité de
tout droit de brevet revendiqué à cet égard. À la date de publication du présent document, l’ISO n’avait pas
reçu notification qu’un ou plusieurs brevets pouvaient être nécessaires à sa mise en application. Toutefois,
il
...