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EN ISO 10993-6:2007

(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)

This part of ISO 10993 specifies test methods for the assessment of the local effects of an implant material on living tissue, at both the macroscopic and microscopic level.  The test specimen is implanted into a site and tissue appropriate for evaluation of the biological safety of the material. The implant is not intended to be subjected to mechanical or functional loading. The local effects are evaluated by a comparison of the tissue response caused by a test specimen to that caused by materials used in medical devices whose clinical acceptability has been established.  The test methods for local effects after implantation are used to assess subchronic effects (short-term, up to 12 weeks), or chronic effects (long-term, longer than 12 weeks).

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

Dieser Teil von ISO 10993 legt Prüfverfahren fest zur Beurteilung der lokalen Effekte nach der Implantation von Biomaterialien, die zur Verwendung in Medizinprodukten vorgesehen sind.
Dieser Teil von ISO 10993 gilt für Werkstoffe, die
   fest und nicht biologisch abbaufähig;
   abbaufähig und/oder resorbierbar; und
   nicht im festen Zustand sind, wie poröse Werkstoffe, sowie Flüssigkeiten, Pasten und suspendierte Partikel.
Der Prüfkörper wird in eine Stelle und Tierart implantiert, die geeignet ist, die biologische Sicherheit des Werkstoffes zu beurteilen. Diese Implantationsprüfungen sind nicht dazu vorgesehen, die Leistung des Prüfkörpers im Sinne der mechanischen oder funktionellen Belastbarkeit zu ermitteln. Dieser Teil von ISO 10993 kann auch für Medizinprodukte gelten, die dazu vorgesehen sind, bei klinischen Indikationen lokal angewendet zu werden, bei denen die Oberfläche oder Auskleidung einer Körperhöhle geöffnet worden sein kann, um die Reaktionen des lokalen Gewebes zu beurteilen.
Die lokalen Effekte werden durch einen Vergleich der durch einen Prüfkörper hervorgerufenen Gewebsreaktion mit der durch in Medizinprodukten verwendete Kontrollwerkstoffe hervorgerufenen Gewebsreaktion beurteilt, deren klinische Vertretbarkeit und deren Merkmale der Bioverträglichkeit festgestellt worden sind. Das Ziel der Prüfverfahren ist die Charakterisierung der Vorgeschichte und des Verlaufs der Gewebsreaktion nach Implantation eines Medizinproduktes bzw. Biomaterials, einschließlich der endgültigen Aufnahme oder der Resorption bzw. des Abbaus des Werkstoffs. Insbesondere bei abbaufähigen bzw. resorbierbaren Werkstoffen sollten die Abbaumerkmale des Werkstoffs und die sich daraus ergebende Gewebsreaktion ermittelt werden.
Dieser Teil von ISO 10993 behandelt nicht die systemische Toxizität, die Karzinogenität, die Teratogenität oder die Mutagenität.

Évaluation biologique des dispositifs médicaux - Partie 6: Essais concernant les effets locaux après implantation (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
14-Apr-2007
Withdrawal Date
19-May-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
20-May-2009
Completion Date
20-May-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 10993-6:2007 - Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

Relations

Replaces
EN 30993-6:1994 - Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:1994)
Effective Date
22-Dec-2008
Replaced By
EN ISO 10993-6:2009 - Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)
Effective Date
30-May-2009

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-6:2007
01-september-2007
1DGRPHãþD
SIST EN 30993-6:2000
%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 apres implantation (ISO 10993-6:2007)
Ta slovenski standard je istoveten z: EN ISO 10993-6:2007
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
SIST EN ISO 10993-6:2007 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

EUROPEAN STANDARD
EN ISO 10993-6
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2007
ICS 11.100.20 Supersedes EN 30993-6:1994
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 13 March 2007.
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: rue de Stassart, 36  B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-6:2007: E
worldwide for CEN national Members.

---------------------- Page: 2 ----------------------

EN ISO 10993-6:2007 (E)







Foreword


This document (EN ISO 10993-6:2007) has been prepared by Technical Committee ISO/TC 194
"Biological evaluation of medical devices" in collaboration with 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 October 2007, and conflicting national standards shall
be withdrawn at the latest by October 2007.

This document supersedes EN 30993-6:1994.

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 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 United Kingdom.


Endorsement notice

The text of ISO 10993-6:2007 has been approved by CEN as EN ISO 10993-6:2007 without any
modifications.

2

---------------------- Page: 3 ----------------------

EN ISO 10993-6:2007 (E)


Annex ZA

(informative)

Clauses of this International Standard addressing essential requirements
or other provisions of EU Directives 90/385/EEC for Active Implantable
Medical Devices and 93/42/EEC for Medical Devices


This International Standard 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 90/385/EEC for Active Implantable Medical Devices and
...

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