EN ISO 10993-7:2008

SLOVENSKI STANDARD
01-januar-2009
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SIST EN ISO 10993-7:2000
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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

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 risks
posed by substances leaking from a device be reduced to a minimum. It is inherent in these Essential
Requirements that, within the maximum limits specified by this standard, exposure to a genotoxic
carcinogen should be reduced to levels as low as reasonably practicable, taking account of the
generally acknowledged state of the art, the technological level existing at the time of design and
technical and economic considerations compatible with a high level of health and safety.
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, 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 the United Kingdom.
Endorsement notice
The text of ISO 10993-7:2008 has been approved by CEN as a EN ISO 10993-7:2008 without any
modification.
Annex ZA
(informative)
Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC Medical devices
This International Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.

Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA confers, within the limits of the scope of this standard, a presumption of conformity
with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

Table ZA — Correspondence between this International Standard and Directive 93/42/EEC on medical
devices
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying remarks/Note
International Standard Directive 93/42/EEC
4, 5 Annex I, 7.2 and 7.5 For presumption of conformity, the
standard needs to be interpreted as
explained in the European Foreword.

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this International standard.

Annex ZB
(informative)
Relationship between this International Standard and the Essential
Requirements of EU Directive 90/385/EEC
on Active Implantable Medical Devices

This International Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 90/385/EEC on active implantable medical devices.

Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZB confers, within the limits of the scope of this standard, a presumption of conformity
with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

Table ZB — Correspondence between this International Standard and Directive 90/385/EEC on active
implantable medical devices
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying remarks/Note
International Standard Directive 90/385/EEC
4, 5 Annex I, 9 For presumption of conformity, the
standard needs to be interpreted as
explained in the European Foreword.

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this International standard.

INTERNATIONAL ISO
STANDARD 10993-7
Second edition
2008-10-15
Biological evaluation of medical
devices —
Part 7:
Ethylene oxide sterilization residuals
Évaluation biologique des dispositifs médicaux —
Partie 7: Résidus de stérilisation à l'oxyde d'éthylène

Reference number
ISO 10993-7:2008(E)
©
ISO 2008
ISO 10993-7:2008(E)
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ISO 10993-7:2008(E)
Contents Page
Foreword. iv
Introduction . vi
1 Scope .1
2 Normative references .1
3 Terms and definitions .1
4 Requirements.2
4.1 General.2
4.2 Categorization of devices .2
4.3 Allowable limits.3
4.4 Determination of EO and ECH residuals .5
5 Product release.10
5.1 General.10
5.2 Release of products without dissipation curve data .10
5.3 Procedure for product release using residue dissipation curves .10
Annex A (normative) Evaluation of gas chromatograms.12
Annex B (informative) Gas chromatographic determination for EO and ECH.15
Annex C (informative) Flowchart and guidance for the application of this part of ISO 10993 series
of standards to the determination of EO and ECH residuals in medical devices.19
Annex D (informative) Factors influencing product residual.26
Annex E (informative) Extraction conditions for determination of residual EO .28
Annex F (informative) Rationale for the provisions of this part of ISO 10993 .29
Annex G (informative) Establishment of allowable limits for EO .33
Annex H (informative) Establishment of allowable limits for ECH.50
Annex I (informative) Establishment of allowable limits for EG.59
Annex J (informative) Preparation of EO and ECH standards.63
Annex K (informative) Ethylene oxide residue measuring methods .67
Bibliography .
...