SIST EN ISO 10993-7:2009/A1:2022

SLOVENSKI STANDARD
01-marec-2022
Biološko ovrednotenje medicinskih pripomočkov - 7. del: Ostanki po sterilizaciji z
etilenoksidom - Dopolnilo A1: Uporaba dovoljenih mejnih vrednosti za
novorojenčke in dojenčke (ISO 10993-7:2008/Amd 1:2019)
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals -
Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-
7:2008/Amd 1:2019)
Biologische Beurteilung von Medizinprodukten - Teil 7: Ethylenoxid-
Sterilisationsrückstände - Änderung 1 (ISO 10993-7:2008/Amd 1:2019)
Évaluation biologique des dispositifs médicaux - Partie 7: Résidus de stérilisation à
l'oxyde d'éthylène - Amendement 1 (ISO 10993-7:2008/Amd 1:2019)
Ta slovenski standard je istoveten z: EN ISO 10993-7:2008/A1:2022
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.

EN ISO 10993-7:2008/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2022
EUROPÄISCHE NORM
ICS 11.100.20
English Version
Biological evaluation of medical devices - Part 7: Ethylene
oxide sterilization residuals - Amendment 1: Applicability
of allowable limits for neonates and infants (ISO 10993-
7:2008/Amd 1:2019)
Évaluation biologique des dispositifs médicaux - Partie Biologische Beurteilung von Medizinprodukten - Teil 7:
7: Résidus de stérilisation à l'oxyde d'éthylène - Ethylenoxid-Sterilisationsrückstände - Änderung 1
Amendement 1 (ISO 10993-7:2008/Amd 1:2019) (ISO 10993-7:2008/Amd 1:2019)
This amendment A1 modifies the European Standard EN ISO 10993-7:2008; it was approved by CEN on 5 November 2019.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-7:2008/A1:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 10993-7:2008/A1:2022) has been prepared by Technical Committee ISO/TC
194 "Biological and clinical evaluation of medical devices" in collaboration with Technical Committee
CEN/TC 206 “Biological and clinical evaluation of medical devices” the secretariat of which is held by
DIN.
This Amendment to the European Standard EN ISO 10993-7:2008 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by July 2022, and
conflicting national standards shall be withdrawn at the latest by July 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 10993-7:2008/Amd 1:2019 has been approved by CEN as EN ISO 10993-
7:2008/A1:2022 without any modification.

INTERNATIONAL ISO
STANDARD 10993-7
Second edition
2008-10-15
AMENDMENT 1
2019-12
Biological evaluation of medical
devices —
Part 7:
Ethylene oxide sterilization residuals
AMENDMENT 1: Applicability of
allowable limits for neonates and infants
Reference number
ISO 10993-7:2008/Amd.1:2019(E)
©
ISO 2019
ISO 10993-7:2008/Amd.1:2019(E)

© ISO 2019
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Published in Switzerland
ii © ISO 2019 – All rights reserved

ISO 10993-7:2008/Amd.1:2019(E)

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.
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.
SIST EN ISO 10993
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