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EN ISO 10993-7:2008/A1:2022

(Amendment)

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)

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)

2021-12-09- JO-  the EN was submitted to FV wiith the link to the legislation (90/385/EEC, 93/42/EEC)
however since these legilsations have been repealed, the link has been removed and the EN is to proceed to publication

Biologische Beurteilung von Medizinprodukten - Teil 7: Ethylenoxid Sterilisationsrückstände - Änderung 1: Anwendbarkeit zulässiger Grenzwerte für Neugeborene und Kleinkinder (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)

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)

General Information

Status
Published
Publication Date
11-Jan-2022
Withdrawal Date
30-Jul-2022
ICS
11.100.20 - Biological evaluation of medical devices
Technical Committee
CEN/TC 206 - Biocompatibility of medical and dental materials and devices
Drafting Committee
CEN/TC 206 - Biocompatibility of medical and dental materials and devices
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
12-Jan-2022
Completion Date
12-Jan-2022
Directive
90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
Ref Project
SIST EN ISO 10993-7:2009/A1:2022 - 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)

Relations

Amends
EN ISO 10993-7:2008 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
Effective Date
14-Dec-2016

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EN ISO 10993-7:2009/A1:2022EN ISO 10993-7:2009/A1:2022
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EN ISO 10993-7:2009/A1:2022
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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-7:2009/A1:2022
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
SIST EN ISO 10993-7:2009/A1:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

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


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.

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SIST EN ISO 10993-7:2009/A1:2022
EN ISO 10993-7:2008/A1:2022 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 10993-7:2009/A1:2022
EN ISO 10993-7:2008/A1:2022 (E)
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
...

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