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EN ISO 10993-12:2007

(Main)

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)

2005-08-12  Will be re-submitted to a parallel DIS/CEN enquiry (followed by //FDIS/FV) for publication as complete revision.
2005-02-03  40.20 different than ISO, de-synchronization due to misleading notification from ISO/CS.
2004-11-08  Creation by NT further to ISO/CS request as docs ready to be processed to // Enq ISO lead (NT/041108).

Biologische Beurteilung von Medizinprodukten - Teil 12: Proben-vorbereitung und Referenzmaterialien (ISO 10993-12:2007)

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-Reihe zu befolgen sind.
Dieser Teil der ISO 10993 bezieht sich insbesondere auf die:
   Auswahl der Prüfmuster,
   Auswahl repräsentativer Teile eines Medizinproduktes,
   Probenvorbereitung,
   Kontrollen der Prüfmethoden,
   Auswahl und Anforderungen an die Referenzmaterialien und
   Herstellung der Extrakte.
Dieser Teil der ISO 10993 ist nicht anwendbar auf Materialien oder Produkte, die lebende Zellen enthalten.

Évaluation biologique des dispositifs médicaux - Partie 12: Préparation des échantillons et matériaux de référence (ISO 10993-12:2007)

Biološko ovrednotenje medicinskih pripomočkov - 12. del: Priprava vzorcev in referenčni materiali (ISO 10993-12:2007)

General Information

Status
Withdrawn
Publication Date
14-Nov-2007
Withdrawal Date
28-Apr-2009
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
9960 - Withdrawal effective - Withdrawal
Start Date
29-Apr-2009
Completion Date
29-Apr-2009
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
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 10993-12:2008 - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)

Relations

Replaces
EN ISO 10993-12:2004 - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2002)
Effective Date
22-Dec-2008
Replaced By
EN ISO 10993-12:2009 - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)
Effective Date
06-May-2009

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)Evaluation biologique des dispositifs médicaux - Partie 12: Préparation des échantillons et des matériaux de référence (ISO 10993-12:2007)Biologische Beurteilung von Medizinprodukten - Teil 12: Proben-vorbereitung und Referenzmaterialien (ISO 10993-12:2007)Ta slovenski standard je istoveten z:EN ISO 10993-12:2007SIST EN ISO 10993-12:2008en11.100.20ICS:SIST EN ISO 10993-12:20051DGRPHãþDSLOVENSKI
STANDARDSIST EN ISO 10993-12:200801-april-2008







EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 10993-12November 2007ICS 11.100.20Supersedes EN ISO 10993-12:2004
English VersionBiological evaluation of medical devices - Part 12: Samplepreparation and reference materials (ISO 10993-12:2007)Évaluation biologique des dispositifs médicaux - Partie 12:Préparation des échantillons et matériaux de référence(ISO 10993-12:2007)Biologische Beurteilung von Medizinprodukten - Teil 12:Proben-vorbereitung und Referenzmaterialien (ISO 10993-12:2007)This European Standard was approved by CEN on 30 September 2007.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards 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 translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial 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 STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2007 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 10993-12:2007: E



EN ISO 10993-12:2007 (E) 2 Contents Page Foreword.3



EN ISO 10993-12:2007 (E) 3 Foreword This document (EN ISO 10993-12:2007) 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 May 2008, and conflicting national standards shall be withdrawn at the latest by May 2008. This document supersedes EN ISO 10993-12:2004. 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 Directive(s). For relationship with EC Directive(s), see informative Annex ZA, 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, 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 10993-12:2007 has been approved by CEN as a EN ISO 10993-12:2007 without any modification.



EN ISO 10993-12:2007 (E) 4 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directives 93/42/EEC on medical devices and 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 Directives 93/42/EEC on medical devices and 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 ZA.1 confers, within t
...

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