EN ISO 10993-11:2009

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

ISO 10993-11:2006 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.

Biologische Beurteilung von Medizinprodukten - Teil 11: Prüfungen auf systemische Toxizität (ISO 10993-11:2006)

Dieser Teil von ISO 10993 legt Anforderungen an Verfahren fest und gibt eine Anleitung, die bei der Beurteilung des Potenzials von Materialien für Medizinprodukte zur Auslösung nachteiliger systemischer Re-aktionen zu befolgen sind.

Évaluation biologique des dispositifs médicaux - Partie 11: Essais de toxicité systémique (ISO 10993-11:2006)

L'ISO 10993-11:2006 spécifie des exigences et fournit des directives quant aux modes opératoires à suivre pour évaluer la possibilité de réactions systémiques défavorables de la part de matériaux de dispositifs médicaux.

Biološko ovrednotenje medicinskih pripomočkov - 11. del: Preskusi sistemske toksičnosti (ISO 10993-11:2006)

General Information

• Status: Withdrawn
• Publication Date: 28-Apr-2009
• Withdrawal Date: 29-May-2018
• 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
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 30-May-2018
• 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: SIST EN ISO 10993-11:2009 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

Relations

• Replaces: EN ISO 10993-11:2006 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 10993-11:2018 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
• Effective Date: 06-Jun-2018

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biologische Beurteilung von Medizinprodukten - Teil 11: Prüfungen auf systemische Toxizität (ISO 10993-11:2006)Évaluation biologique des dispositifs médicaux - Partie 11 : Essais de toxicité systémique (ISO 10993-11:2006)Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)11.100.20Biological evaluation of medical devicesICS:Ta slovenski standard je istoveten z:EN ISO 10993-11:2009SIST EN ISO 10993-11:2009en01-julij-2009SIST EN ISO 10993-11:2009SLOVENSKI
STANDARDSIST EN ISO 10993-11:20061DGRPHãþD



SIST EN ISO 10993-11:2009



EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 10993-11April 2009ICS 11.100.20Supersedes EN ISO 10993-11:2006
English VersionBiological evaluation of medical devices - Part 11: Tests forsystemic toxicity (ISO 10993-11:2006)Évaluation biologique des dispositifs médicaux - Partie 11:Essais de toxicité systémique (ISO 10993-11:2006)Biologische Beurteilung von Medizinprodukten - Teil 11:Prüfungen auf systemische Toxizität (ISO 10993-11:2006)This European Standard was approved by CEN on 12 April 2009.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:
Avenue Marnix 17,
B-1000 Brussels© 2009 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 10993-11:2009: ESIST EN ISO 10993-11:2009



EN ISO 10993-11:2009 (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 . Error! Bookmark not defined.Annex ZB (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 90/385/EEC on Active Implantable Medical Devices .5 SIST EN ISO 10993-11:2009



EN ISO 10993-11:2009 (E) 3 Foreword The text of ISO 10993-11:2006 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 EN ISO 10993-11:2009 by 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 October 2009, and conflicting national standards shall be withdrawn at the latest by March 2010. 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 10993-11:2006. 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 are 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, 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 10993-11:2006 has been approved by CEN as a EN ISO 10993-11:2009 without any modification. SIST EN ISO 10993-11:2009



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