prEN ISO 10993-5

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999)

20090130 - WI abandoned due to duplication under WI 00206035

Biologische Beurteilung von Medizinprodukten - Teil 5: Prüfungen auf Zytotoxizität: In vitro-Methoden (ISO 10993-5:1999)

Évaluation biologique des dispositifs médicaux - Partie 5 : Essais concernant la cytotoxicité in vitro (ISO 10993-5:1999)

Biološko ovrednotenje medicinskih pripomočkov - 5. del: Preskusi za ugotavljanje citotoksičnosti in vitro (ISO 10993-5:1999)

General Information

• Status: Not Published
• Publication Date: 28-Jun-2009
• Withdrawal Date: 28-Dec-2009
• ICS: 11.100 - Laboratory medicine
• 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
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• 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: kSIST prEN ISO 10993-5:2009 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999)

Relations

• Revises: EN ISO 10993-5:1999 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999)
• Effective Date: 18-Jan-2023

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biologische Beurteilung von Medizinprodukten - Teil 5: Prüfungen auf Zytotoxizität: In vitro-Methoden (ISO 10993-5:1999)Évaluation biologique des dispositifs médicaux - Partie 5 : Essais concernant la cytotoxicité in vitro (ISO 10993-5:1999)Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999)11.100.20Biological evaluation of medical devicesICS:Ta slovenski standard je istoveten z:prEN ISO 10993-5kSIST prEN ISO 10993-5:2009en01-marec-2009kSIST prEN ISO 10993-5:2009SLOVENSKI
STANDARD



kSIST prEN ISO 10993-5:2009



EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMFINAL DRAFTprEN ISO 10993-5November 2008ICS 11.100.20Will supersede EN ISO 10993-5:1999
English VersionBiological evaluation of medical devices - Part 5: Tests for invitro cytotoxicity (ISO 10993-5:1999)Évaluation biologique des dispositifs médicaux - Partie 5:Essais concernant la cytotoxicité in vitro (ISO 10993-5:1999)Biologische Beurteilung von Medizinprodukten - Teil 5:Prüfungen auf Zytotoxizität: In vitro-Methoden (ISO 10993-5:1999)This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the TechnicalCommittee CEN/TC 206.If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations whichstipulate the conditions for giving this European Standard the status of a national standard without any alteration.This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other languagemade by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has thesame 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.Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice andshall not be referred to as a European Standard.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2008 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. prEN ISO 10993-5:2008: EkSIST prEN ISO 10993-5:2009



prEN ISO 10993-5:2008 (E) 2 Contents Page Foreword .3Annex ZA (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 93/42/EEC on Medical Devices .4Annex ZB (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 90/385/EEC on Active Implantable Medical Devices .5 kSIST prEN ISO 10993-5:2009



prEN ISO 10993-5:2008 (E) 3 Foreword The text of ISO 10993-5:1999 has been prepared by Technical Committee ISO/TC 194 “Biological evaluation of medical devices” of the International Organization for Standardization (ISO) and has been taken over as prEN ISO 10993-5:2008 by Technical Committee CEN/TC 206 “Biological evaluation of medical devices” the secretariat of which is held by NEN. This document is currently submitted to the Unique Acceptance Procedure. This document will supersede EN ISO 10993-5:1999. 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 93/42/EEC on Medical Devices and 90/385/EEC on Active Implantable Medical Devices. For relationship with EU Directives, see informative Annex ZA and ZB, which is an integral part of this document. Endorsement notice The text of ISO 10993-5:1999 has been approved by CEN as a prEN ISO 10993-5:2008 without any modification. kSIST prEN ISO 10993-5:2009



prEN ISO 10993-5:2008 (E) 4 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 Communities under that Directive and has been implemented as a national standard in at least one Member State, compliance
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