EN ISO 10993-7:2008

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

ISO 10993-7:2008 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released. Additional background, including guidance and a flowchart showing how the standard is applied are also included in informative annexes.
EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by ISO 10993-7:2008.

Biologische Beurteilung von Medizinprodukten - Teil 7: Ethylenoxid- Sterilisationsrückstände (ISO 10993-7:2008)

Dieser Teil von ISO 10993 legt die zulässigen Grenzwerte für den Restgehalt von Ethylenoxid (EO) und Ethylenchlorhydrin (Rest-ECH) in einzelnen mit EO sterilisierten Medizinprodukten, die Verfahren für die Messung von EO und ECH sowie die Verfahren für die Bestimmung der Übereinstimmung fest, damit die Produkte freigegeben werden dürfen. Weitere Hintergrundinformationen, eine Anleitung und ein Flussdiagramm, auf dem dargestellt ist, wie dieses Dokument angewendet wird, sind ebenfalls in den informativen Anhängen enthalten.
EO sterilisierte Produkte, die nicht mit Patienten in Berührung kommen (z. B. In vitro-Diagnostika), fallen nicht in den Anwendungsbereich von diesem Teil der ISO 10993.
ANMERKUNG   Dieser Teil von ISO 10993 spezifiziert keine Grenzwerte für Ethylenglykol (EG).

Évaluation biologique des dispositifs médicaux - Partie 7: Résidus de stérilisation à l'oxyde d'éthylène (ISO 10993-7:2008)

L'ISO 10993-7:2007 spécifie les limites admissibles des résidus d'oxyde d'éthylène (OE) et de chlorhydrate d'éthylène (ECH) pour des dispositifs médicaux individuels stérilisés à l'oxyde d'éthylène, les modes opératoires pour le mesurage de l'oxyde d'éthylène et du chlorhydrate d'éthylène et les méthodes de mesure en vue de déterminer leur conformité et de procéder à leur libération. Une documentation supplémentaire, y compris des directives et un diagramme de flux sont également inclus dans les annexes informatives.

Biološko ovrednotenje medicinskih pripomočkov - 7. del: Ostanki po sterilizaciji z etilenoksidom (ISO 10993-7:2008)

Ta del ISO 10993 določa dopustne meje za ostanke etilenoksida (EO) in etilen klorohidrina (ECH) na posameznem medicinskem pripomočku, steriliziranem z etilenoksidom; postopke za merjenje EO in ECH; in metode za ugotavljanje skladnosti, da se pripomočki lahko sprostijo. Dodatne informacije in vodilo ter prikaz delovnih postopkov, ki razlagajo uporabo standarda, so vključeni v informativne dodatke. Ta standard ne zajema pripomočkov, steriliziranih z etilenoksidom, ki niso v stiku z bolnikom (npr. diagnostičnih preskusnih sistemov in vitro).

General Information

• Status: Published
• Publication Date: 14-Oct-2008
• Withdrawal Date: 14-Oct-2011
• 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: 15-Oct-2008
• Completion Date: 15-Oct-2008
• 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
• Directive: 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 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

Relations

• Replaces: EN ISO 10993-7:1995 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:1995)
• Effective Date: 22-Dec-2008
• Amended By: EN ISO 10993-7:2008/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)
• Effective Date: 14-Dec-2016
• Corrected By: EN ISO 10993-7:2008/AC:2009 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009)
• Effective Date: 22-Aug-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-7:2009
01-januar-2009
1DGRPHãþD
SIST EN ISO 10993-7:2000
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO2VWDQNLSRVWHULOL]DFLML]
HWLOHQRNVLGRP,62
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
(ISO 10993-7:2008)
Biologische Beurteilung von Medizinprodukten - Teil 7: Ethylenoxid-
Sterilisationsrückstände (ISO 10993-7:2008)
Evaluation biologique des dispositifs médicaux - Partie 7: Résidus de stérilisation a
l'oxyde d'éthylene (ISO 10993-7:2008)
Ta slovenski standard je istoveten z: EN ISO 10993-7:2008
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
SIST EN ISO 10993-7:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10993-7:2009

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SIST EN ISO 10993-7:2009
EUROPEAN STANDARD
EN ISO 10993-7
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2008
ICS 11.100.20 Supersedes EN ISO 10993-7:1995
English Version
Biological evaluation of medical devices - Part 7: Ethylene oxide
sterilization residuals (ISO 10993-7:2008)
Évaluation biologique des dispositifs médicaux - Partie 7: Biologische Beurteilung von Medizinprodukten - Teil 7:
Résidus de stérilisation à l'oxyde d'éthylène (ISO 10993- Ethylenoxid- Sterilisationsrückstände (ISO 10993-7:2008)
7:2008)
This European Standard was approved by CEN on 23 September 2008.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-7:2008: E
worldwide for CEN national Members.

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SIST EN ISO 10993-7:2009
EN ISO 10993-7:2008 (E)
Contents Page
Foreword.3
Annex ZA (informative) Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC Medical devices .4
Annex ZB (informative) Relationship between this International Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices .5

2

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SIST EN ISO 10993-7:2009
EN ISO 10993-7:2008 (E)
Foreword
This document (EN ISO 10993-7:2008) has been prepared by Technical Committee ISO/TC 194 "Biological
evaluation of medical devices" in collaboration with Technical Committee CEN/TC 206 “Biological evaluation
of medical devices” the secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by April 2009, and conflicting national standards shall be withdrawn at the
latest by October 2011.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10993-7:1995.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EC Directives.
For relationship with EC Directives, see informative Annexes ZA and ZB, which are an integral part of this
document.
NOTE : The Essential Requirements of the Medical Devices Directives require that risks be reduced or
eliminated as far as possible and, specifically, that risks posed by residues be minimized and ris
...