oSIST prEN ISO 10993-3:2025

SLOVENSKI STANDARD
01-junij-2025
Biološko ovrednotenje medicinskih pripomočkov - 3. del: Ovrednotenje genske
toksičnosti, kancerogenosti, toksičnosti za razmnoževanje in toksičnosti za razvoj
(ISO/DIS 10993-3:2025)
Biological evaluation of medical devices - Part 3: Evaluation of genotoxicity,
carcinogenicity, reproductive toxicity, and developmental toxicity (ISO/DIS 10993-3:2025)
Biologische Beurteilung von Medizinprodukten - Teil 3: Bewertung der Genotoxizität,
Karzinogenität, Reproduktionstoxizität und Entwicklungstoxizität (ISO/DIS 10993-3:2025)
Évaluation biologique des dispositifs médicaux - Partie 3: Évaluation de la génotoxicité,
de la cancérogénicité, de la toxicité sur la reproduction et le développement (ISO/DIS
10993-3:2025)
Ta slovenski standard je istoveten z: prEN ISO 10993-3
ICS:
11.100.20 Biološko ovrednotenje Biological evaluation of
medicinskih pripomočkov medical devices
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 10993-3
ISO/TC 194
Biological evaluation of medical
Secretariat: DIN
devices —
Voting begins on:
Part 3: 2025-04-04
Evaluation of genotoxicity,
Voting terminates on:
2025-06-27
carcinogenicity, reproductive
toxicity, and developmental toxicity
ICS: 11.100.20
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Reference number
ISO/DIS 10993-3:2025(en)
DRAFT
ISO/DIS 10993-3:2025(en)
International
Standard
ISO/DIS 10993-3
ISO/TC 194
Biological evaluation of medical
Secretariat: DIN
devices —
Voting begins on:
Part 3:
Evaluation of genotoxicity,
Voting terminates on:
carcinogenicity, reproductive
toxicity, and developmental toxicity
ICS: 11.100.20
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 is circulated as received from the committee 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
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Published in Switzerland Reference number
ISO/DIS 10993-3:2025(en)
ii
ISO/DIS 10993-3:2025(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Assessment strategies . . 3
4.1 General .3
4.2 Other considerations .3
5 Genotoxicity assessment . 3
5.1 General .3
5.2 Testing strategy .4
5.2.1 General .4
5.2.2 Test battery .4
5.2.3 In vivo genotoxicity testing .5
5.2.4 Follow-up evaluation .5
5.3 Test sample preparation .5
6 Carcinogenicity Assessments . 6
6.1 General .6
6.2 Evaluation strategy .6
6.2.1 General .6
6.2.2 Genotoxic carcinogens .6
6.2.3 Non-genotoxic carcinogens .7
7 Evaluation of reproductive and developmental toxicity . 7
7.1 General .7
7.2 Evaluation methods .8
8 Test report . 9
Annex A (informative) Test sample preparation procedure for genotoxicity testing .10
Annex B (normative) Tests for genotoxicity .16
Annex C (informative) Carcinogenicity Tests in animals .26
Annex D (informative) Genotoxicity assessment of nanomaterials .29
Annex E (informative) Recipe for S9 mix .30
Annex F (informative) Endocrine Disruptors .31
Annex G (informative) Evaluation of reproductive and developmental toxicity .32
Annex ZA (informative) Relationship between this European standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered .36
Bibliography .40

iii
ISO/DIS 10993-3:2025(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. In the field of
information technology, ISO and IEC have established a joint technical committee, ISO/IEC JTC 1.
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 on 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 the following URL:
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).
This fourth edition of ISO 10993-3 cancels and replaces the third edition (ISO 10993-3:2014), which has
been technically revised.
The main changes compared to the previous edition are as follows:
— Deletion of the Annex on Cellular Transformation;
— Restructure of Annex A on Guidance on selecting an appropriate test sample preparation procedure for
genotoxicity testing;
— Addition of Annex C on in vivo carcinogenicity assays that includes the Annex on solid state carcinogenesis;
— Addition of Annex D on Genotoxicity Assessment of Nanomaterials;
— Expanded Annex B on genotoxicity test methods;
— Addition of Annex E on Recipe for S9 mix;
— Addition of Annex G on the evaluation of reproductive and developmental toxicity;
— Update of normative references and bibliography.
A list of all parts in the ISO 10993 series can be found on the ISO website.
Any
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