EN ISO 10993-12:2012

SLOVENSKI STANDARD
01-oktober-2012
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SIST EN ISO 10993-12:2009
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Biological evaluation of medical devices - Part 12: Sample preparation and reference
materials (ISO 10993-12:2012)
Biologische Beurteilung von Medizinprodukten - Teil 12: Probenvorbereitung und
Referenzmaterialien (ISO 10993-12:2012)
Évaluation biologique des dispositifs médicaux - Partie 12: Préparation des échantillons
et matériaux de référence (ISO 10993-12:2012)
Ta slovenski standard je istoveten z: EN ISO 10993-12:2012
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 10993-12
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2012
ICS 11.100.20 Supersedes EN ISO 10993-12:2009
English Version
Biological evaluation of medical devices - Part 12: Sample
preparation and reference materials (ISO 10993-12:2012)
Évaluation biologique des dispositifs médicaux - Partie 12: Biologische Beurteilung von Medizinprodukten - Teil 12:
Préparation des échantillons et matériaux de référence Probenvorbereitung und Referenzmaterialien (ISO 10993-
(ISO 10993-12:2012) 12:2012)
This European Standard was approved by CEN on 30 June 2012.

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-CENELEC 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-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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-12:2012: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices .4
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on active implantable medical devices .5

Foreword
This document (EN ISO 10993-12:2012) 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 January 2013, and conflicting national standards shall be withdrawn at
the latest by January 2013.
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 10993-12:2009.
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 EU Directives.
For relationship with EU Directives, see informative Annex ZA and ZB, which are an integral parts of this
document.
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, Former Yugoslav Republic of Macedonia, 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 10993-12:2012 has been approved by CEN as a EN ISO 10993-12:2012 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices
This European 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 Union 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.1 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.1 — Correspondence between this European Standard
and Directive 93/42/EEC on medical devices
Clauses of this Essential Requirements (ERs) Qualifying remarks/Notes
European Standard of Directive 93/42/EEC
This standard provides a means of preparing
samples to assess conformity with this part of
this ER in conjunction with other relevant parts
4, 5, 6, 7, 8, 9, 10, 11 7.2 first sentence only
of EN ISO 10993 for the design and
manufacture of medical devices. Packaging is
not covered.
This standard provides a means of preparing
samples of medical devices to assess
4, 5, 6, 7, 8, 9, 10 , 11 7.5 first paragraph only conformity with this part of this ER in
conjunction with other relevant parts of EN ISO
10993.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
Annex ZB
(informative)
Relationship between this European Standard
and the Essential Requirements of EU Directive 90/385/EEC
on active implantable medical devices
This European 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 Union 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.1 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.1 — Correspondence between this European Standard
and Directive 90/385/EEC on active implantable medical devices
Clauses of this Essential Requirements (ERs) Qualifying remarks/Notes
European Standard of Directive 90/385/EEC
This standard provides a means of preparing
samples of medical devices to assess
4, 5, 6, 7, 8, 9, 10, 11 9 (first and second indents only) conformity with these parts of this ER in
conjunction with other relevant parts of EN ISO
10993.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.

INTERNATIONAL ISO
STANDARD 10993-12
Fourth edition
2012-07-01
Biological evaluation of medical devices —
Part 12:
Sample preparation and reference materials
Évaluation biologique des dispositifs médicaux —
Partie 12: Préparation des échantillons et matériaux de référence
Reference number
ISO 10993-12:2012(E)
©
ISO 2012
ISO 10993-12:2012(E)
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
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Published in Switzerland
ii © ISO 2012 – All rights reserved

ISO 10993-12:2012(E)
Contents Page
Foreword .iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 3
5 Reference materials (RMs) . 4
5.1 General . 4
5.2 Certification of RMs for biological safety testing . 4
6 Use of RMs as experimental controls . 4
7 Test sample selection . 5
8 Test sample and RM preparation . 5
9 Selection of representative portions from a device . 5
10 Preparation of extracts of samples . 6
10.1 General . 6
10.2 Containers for extraction . 6
10.3 Extraction conditions and methods . 6
10.4 Extraction conditions for hazard identification and risk estimation in the exaggerated-use
condition (points to consider in relation to Annex D) . 9
11 Records . 9
Annex A (informative) Experimental controls .10
Annex B (informative) General principles on, and practices of, test sample preparation and
sample selection .12
Annex C (informative) Principles of test sample extraction.14
Annex D (informative) Exhaustive extraction of polymeric materials for biological evaluation .17
Bibliography .19
ISO 10993-12:2012(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
...