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CEN

EN ISO 10993-6:2009

(Main)

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

ISO 10993-6:2007 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices.
ISO 10993-6:2007 applies to materials that are:
solid and non-biodegradable;
degradable and/or resorbable;
non-solid, such as porous materials, liquids, pastes and particulates.
ISO 10993-6:2007 may also be applied to medical devices that are intended to be used topically in clinical indications where the surface or lining may have been breached, in order to evaluate local tissue responses.
This part of ISO 10993 does not deal with systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. However, the long-term implantation studies intended for evaluation of local biological effects may provide insight into some of these properties. Systemic toxicity studies conducted by implantation may satisfy the requirements of ISO 10993-6:2007.

Biologische Beurteilung von Medizinprodukten - Teil 6: Prüfung auf lokale Effekte nach Implantation (ISO 10993-6:2007)

Évaluation biologique des dispositifs médicaux - Partie 6: Essais concernant les effets locaux après implantation (ISO 10993-6:2007)

L'ISO 10993-6:2007 spécifie les méthodes d'essai pour l'évaluation des effets locaux après une implantation de biomatériaux destinés à être utilisés dans des dispositifs médicaux.
L'ISO 10993-6:2007 s'applique aux matériaux qui sont solides et non biodégradables, dégradables et/ou résorbables et non solides, comme les matériaux poreux, liquides, pâteux et particulaires.
L'ISO 10993-6:2007 ne traite pas de la toxicité systémique, de la cancérogénicité, de la tératogénicité ou de la mutagénicité. Les études d'implantation de longue durée destinées à l'évaluation des effets biologiques locaux peuvent cependant apporter certaines informations sur certaines de ces propriétés. Des études de toxicité systémique effectuées par implantation peuvent répondre aux exigences de l'ISO 10993-6:2007.

Biološko ovrednotenje medicinskih pripomočkov - 6. del: Preskusi, povezani z lokalnimi učinki po implantaciji (ISO 10993-6:2007)

General Information

Status
Withdrawn
Publication Date
19-May-2009
Withdrawal Date
13-Dec-2016
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
14-Dec-2016
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
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 10993-6:2009 - Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

Relations

Replaces
EN ISO 10993-6:2007 - Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)
Effective Date
30-May-2009
Replaced By
EN ISO 10993-6:2016 - Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
Effective Date
14-Mar-2012

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-6:2009
01-september-2009
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO3UHVNXVLSRYH]DQL]
ORNDOQLPLXþLQNLSRLPSODQWDFLML ,62
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
(ISO 10993-6:2007)
Biologische Beurteilung von Medizinprodukten - Teil 6: Prüfungen auf lokale Effekte nach
Implantationen (ISO 10993-6:2007)
Évaluation biologique des dispositifs médicaux - Partie 6: Essais concernant les effets
locaux après implantation (ISO 10993-6:2007)
Ta slovenski standard je istoveten z: EN ISO 10993-6:2009
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
SIST EN ISO 10993-6:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10993-6:2009

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SIST EN ISO 10993-6:2009
EUROPEAN STANDARD
EN ISO 10993-6
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.100.20 Supersedes EN ISO 10993-6:2007
English Version
Biological evaluation of medical devices - Part 6: Tests for local
effects after implantation (ISO 10993-6:2007)
Évaluation biologique des dispositifs médicaux - Partie 6: Biologische Beurteilung von Medizinprodukten - Teil 6:
Essais concernant les effets locaux après implantation Prüfungen auf lokale Effekte nach Implantationen (ISO
(ISO 10993-6:2007) 10993-6:2007)
This European Standard was approved by CEN on 28 April 2009.
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 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 translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same 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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-6:2009: E
worldwide for CEN national Members.

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SIST EN ISO 10993-6:2009
EN ISO 10993-6:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices .4
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices .5

2

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SIST EN ISO 10993-6:2009
EN ISO 10993-6:2009 (E)
Foreword
The text of ISO 10993-6:2007 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 10993-6:2009 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 November 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 10993-6:2007.
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.
According to the CEN/CENELEC
...

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