prEN ISO 10993-7

SLOVENSKI STANDARD
01-september-2024
Biološko ovrednotenje medicinskih pripomočkov - 7. del: Ostanki po sterilizaciji z
etilenoksidom (ISO/DIS 10993-7:2024)
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
(ISO/DIS 10993-7:2024)
Biologische Beurteilung von Medizinprodukten - Teil 7: Ethylenoxid-
Sterilisationsrückstände (ISO/DIS 10993-7:2024)
Évaluation biologique des dispositifs médicaux - Partie 7: Résidus de stérilisation à
l'oxyde d'éthylène (ISO/DIS 10993-7:2024)
Ta slovenski standard je istoveten z: prEN ISO 10993-7
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 10993-7
ISO/TC 194
Biological evaluation of medical
Secretariat: DIN
devices —
Voting begins on:
Part 7: 2024-06-17
Ethylene oxide sterilization
Voting terminates on:
2024-09-09
residuals
Évaluation biologique des dispositifs médicaux —
Partie 7: Résidus de stérilisation à l'oxyde d'éthylène
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
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This document is circulated as received from the committee secretariat.
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Reference number
ISO/DIS 10993-7:2024(en)
DRAFT
ISO/DIS 10993-7:2024(en)
International
Standard
ISO/DIS 10993-7
ISO/TC 194
Biological evaluation of medical
Secretariat: DIN
devices —
Voting begins on:
Part 7:
Ethylene oxide sterilization
Voting terminates on:
residuals
Évaluation biologique des dispositifs médicaux —
Partie 7: Résidus de stérilisation à l'oxyde d'éthylène
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 2024
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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NATIONAL REGULATIONS.
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TO SUBMIT, WITH THEIR COMMENTS,
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Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 10993-7:2024(en)
ii
ISO/DIS 10993-7:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 5
4.1 General .5
4.2 Categorization of devices .6
4.3 Allowable limits .6
4.3.1 General .6
4.3.2 Limited contact devices .7
4.3.3 Prolonged contact devices .8
4.3.4 Long-term contact devices .8
4.3.5 Special situations .9
4.3.6 Tolerable contact level .10
4.4 Determination of EO and ECH residuals .11
4.4.1 Procedure .11
4.4.2 Test method validation .11
4.4.3 Product sampling .11
4.4.4 Product extraction .11
4.4.5 Multi-device Systems . 12
5 Product release .12
5.1 General . 12
5.2 Batch release of products . . 12
5.3 Release of products at defined minimum aeration time . 12
5.4 Procedure for product release using residual dissipation curves . 13
6 Adoption of products into established aeration family . 14
7 Requalification. 14
Annex A (informative) Guidance for the application of this document for the determination of
EO and ECH residuals in medical devices .15
Annex B (informative) Factors influencing product residuals .25
Annex C (informative) Rationale for the provisions of this document .28
Annex D (informative) Establishment of allowable limits for EO .33
Annex E (informative) Establishment of allowable limits for ECH .50
Annex F (informative) Ethylene Glycol .60
Annex G (normative) Evaluation of gas chromatograms .64
Annex H (informative) Gas chromatographic determination for EO and ECH .68
Annex I (informative) Preparation of EO and ECH standards .72
Annex J (informative) Ethylene oxide and ethylene chlorohydrin residual measuring methods . 76
Annex K (informative) Examples of product release methods .84
Annex ZA (informative) Relationship between this European Standard the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be covered .102
Bibliography .105

iii
ISO/DIS 10993-7:2024(en)
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 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 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.
This third edition cancels and replaces the second edition (ISO 10993-7:2008, ISO 10993-7:2008/Cor 1:2009
and ISO 10993-7:2008/Amd 1:2019), which has been technically revised. This edition shall be implemented
within 3 years of publication.
The main changes compared to the previous edition are as follows:
— manufacturer to define allowable limits and extraction conditions, based on the patient population and
the duration of use;
— allow for the use of a risk assessment to establish allowable limits;
— provide additional guidance
...