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• Status: Withdrawn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
SIST EN ISO 10993-12:2005
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
SIST EN ISO 10993-12:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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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.

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EN ISO 10993-12:2004 (E)

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).

2

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EN ISO 10993-12:2004 (E)
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 t
...