EN ISO 10993-12:2004

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2002)

UAP instead of VA/ISO (CC/020416)

Biologische Beurteilung von Medizinprodukten - Teil 12: Probenvorbereitung und Referenzmaterialien (ISO 10993-12:2002)

Der vorliegende Teil der ISO 10993 legt Anforderungen fest und gibt Anleitungen zu Verfahren, die bei der Probenvorbereitung und bei der Auswahl von Referenzmaterialien für die biologische Prüfung von Medizinprodukten nach einem oder mehreren Teilen der ISO 10993 zu befolgen sind.
Dieser Teil der ISO 10993 bezieht sich insbesondere auf die:
-   Auswahl der Prüfmaterialien;
-   Auswahl repräsentativer Teile eines Medizinproduktes;
-   Probenvorbereitung;
-   Kontrollen der Prüfmethoden;
-   Auswahl und Anforderungen an die Referenzmaterialien und;
-   Herstellung der Extrakte.
Die Anwendbarkeit dieses Teils der ISO 10993 auf resorbierbare Materialien, Materialien, die in situ polymerisieren, auf Materialien aus dem Bereich des Tissue-Engineerings und auf Materialien mit Bestandteilen tierischen Ursprungs sollte sorgfältig überprüft werden.

Evaluation biologique des dispositifs médicaux - Partie 12: Préparation des échantillons et matériaux de référence (ISO 10993-12:2002)

Biološko ovrednotenje medicinskih pripomočkov - 12. del: Priprava vzorcev in referenčni materiali (ISO 10993-12:2002)

General Information

• Status: Withdrawn
• Publication Date: 09-Nov-2004
• Withdrawal Date: 14-Nov-2007
• ICS: 11.100 - Laboratory medicine
• 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: 9960 - Withdrawal effective - Withdrawal
• Start Date: 15-Nov-2007
• Completion Date: 15-Nov-2007
• 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 10993-12:2005 - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2002)

Relations

• Replaces: EN ISO 10993-12:1996 - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:1996)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 10993-12:2007 - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2005
1DGRPHãþD
SIST EN ISO 10993-12:2000
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO3ULSUDYDY]RUFHYLQ
UHIHUHQþQLPDWHULDOL,62
Biological evaluation of medical devices - Part 12: Sample preparation and reference
materials (ISO 10993-12:2002)
Biologische Beurteilung von Medizinprodukten - Teil 12: Probenvorbereitung und
Referenzmaterialien (ISO 10993-12:2002)
Evaluation biologique des dispositifs médicaux - Partie 12: Préparation des échantillons
et matériaux de référence (ISO 10993-12:2002)
Ta slovenski standard je istoveten z: EN ISO 10993-12:2004
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
November 2004
ICS 11.100 Supersedes EN ISO 10993-12:1996
English version
Biological evaluation of medical devices - Part 12: Sample
preparation and reference materials (ISO 10993-12:2002)
Evaluation 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 10993-12:2002) 12:2002)
This European Standard was approved by CEN on 27 October 2004.

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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-12:2004: E
worldwide for CEN national Members.

Foreword
The text of the International Standard from Technical Committee ISO/TC 194 "Biological
evaluation of medical devices” of the International Organization for Standardization (ISO) has
been taken over as a European Standard by Technical Committee CEN/TC 206 “Biocompatibility
of medical and dental materials and 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 May 2005, and conflicting national standards
shall be withdrawn at the latest by May 2005.

This document supersedes EN ISO 10993-12:1996.

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
Directive(s).
For relationship with EU Directive(s), see informative Annex ZB, which is an integral part 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, Cyprus,
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

Endorsement notice
The text of ISO 10993-12:2002 has been approved by CEN as a European Standard, EN ISO
10993-12:2004, without any modifications.

NOTE Normative references to International Standards are listed in annex ZA (normative).

Annex ZA
(normative)
Normative references to international publications with their
relevant European publications

This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of
any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).

NOTE Where an International Publication has been modified by common modifications, indicated by (mod.),
the relevant EN/HD applies.
Publication Year Title EN Year

ISO 14971 2000 Medical devices – Application of risk EN ISO 14971 2000
management to medical devices
Annex ZB
(Informative)
Clauses of this International Standard addressing essential
requirements or other provisions of EU Directives
This European standard 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 93/42/EEC of 14 June 1993 concerning medical devices.

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

The following clauses of this standard are likely to support requirements of UE Directive
93/42/EEC of 14 June 1993 concerning medical devices

Compliance with the clauses of this standard provides one means of conforming with the specific
essential requirements of the Directive concerned and associated EFTA regulations.

Table ZB.1 — Correspondence between this European Standard and EU Directives
Clauses/subclauses of this Essential requirements Qualifying remarks/Notes
International Standard (ERs) of Directive 93/42/EEC

4, 5, 6, 7, 8, 9, 10, 11 7.1, 7.2, 7.3, 7.5 EN ISO 10993-12 'Biological
evaluation of medical devices –
Part 12: Sample preparation
and reference materials' should
be used in conjunction with th
tests indicated in EN ISO
10993-1 'Biological evaluation
of medical devices – Part 1:
Evaluation and testing'.
INTERNATIONAL ISO
STANDARD 10993-12
Second edition
2002-12-15
Corrected version
2003-06-01
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 10993-12:2002(E)
©
ISO 2002
ISO 10993-12:2002(E)
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ISO 10993-12:2002(E)
Contents Page
Foreword. iv
Introduction . vi
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 1
4 Experimental controls . 3
5 Reference materials . 3
5.1 General. 3
5.2 Certification of RMs for biological safety testing .4
6 Use of RMs as experimental controls . 4
7 Test material selection . 4
8 Test sample and RM preparation . 4
9 Selection of representative portions from a device . 5
10 Preparation of extracts of samples . 5
10.1 General. 5
10.2 Containers for extraction . 5
10.3 Extraction conditions and methods. 6
10.4 Extraction conditions for hazard identification and risk estimation in exaggerated-use
condition . 8
11 Records. 8
Annex A (informative) Experimental controls. 9
Annex B (informative) General principles and practices of test material preparation and sample
selection. 11
Annex C (informative) Principles of test material extraction . 13
Bibliography . 15

ISO 10993-12:2002(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 10993-12 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices.
This second edition cancels and replaces the first edition (ISO 10993-12:1996), which has been technically
revised.
ISO 10993 consists of the following parts, under the general title Biological evaluation of medical devices:
 Part 1: Evaluation and testing
 Part 2: Animal welfare requirements
 Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
 Part 4: Selection of tests for interactions with blood
 Part 5: Tests for in vitro cytotoxicity
 Part 6: Tests for local effects after implantation
 Part 7: Ethylene oxide sterilization residuals
 Part 8: Selection and qualification of reference materials for biological tests
 Part 9:
...