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CEN

EN ISO 10993-16:2010

(Main)

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)

ISO 10993-16:2010 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.

Biologische Beurteilung von Medizinprodukten - Teil 16: Entwurf und Auslegung toxikokinetischer Untersuchungen hinsichtlich Abbauprodukten und herauslösbaren Bestandteilen (ISO 10993-16:2010)

Dieser Teil von ISO 10993 beschreibt Prinzipien dafür, wie toxikokinetische Untersuchungen, die bei Medizinprodukten von Bedeutung sind, entworfen und durchgeführt werden sollten. Anhang A beschreibt die Überlegungen zur Durchführung toxikokinetischer Untersuchungen zur biologischen Beurteilung von Medizinprodukten.

Évaluation biologique des dispositifs médicaux - Partie 16: Conception des études toxicocinétiques des produits de dégradation et des substances relargables (ISO 10993-16:2010)

L'ISO 10993-16:2010 énonce les principes de conception et de mise en œuvre des études toxicocinétiques relatives aux dispositifs médicaux. L'Annexe A décrit les considérations relatives à l'inclusion d'études toxicocinétiques dans l'évaluation biologique des dispositifs médicaux.

Biološko ovrednotenje medicinskih pripomočkov - 16. del: Načrt toksikokinetičnih raziskav razgradnih produktov in izlužnin (ISO 10993-16:2010)

Ta del ISO 10993 podaja načela o načrtu in izvedbi toksikokinetičnih raziskav, pomembnih za medicinske pripomočke. Dodatek A opisuje premisleke o vključitvi toksikokinetičnih raziskav v biološko ovrednotenje medicinskih pripomočkov.

General Information

Status
Withdrawn
Publication Date
14-Feb-2010
Withdrawal Date
05-Dec-2017
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
06-Dec-2017
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/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
M/095 - In vitro diagnostic (prog.)
Ref Project
SIST EN ISO 10993-16:2010 - Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)

Relations

Replaces
EN ISO 10993-16:2009 - Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)
Effective Date
04-Jul-2009
Replaced By
EN ISO 10993-16:2017 - Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
Effective Date
08-Jun-2015

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-16:2010
01-junij-2010
1DGRPHãþD
SIST EN ISO 10993-16:2009
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO1DþUWWRNVLNRNLQHWLþQLK
UD]LVNDYUD]JUDGQLKSURGXNWRYLQL]OXåQLQ ,62
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for
degradation products and leachables (ISO 10993-16:2010)
Biologische Beurteilung von Medizinprodukten - Teil 16: Entwurf und Auslegung
toxikokinetischer Untersuchungen hinsichtlich Abbauprodukten und Extrakten (ISO
10993-16:2010)
Évaluation biologique des dispositifs médicaux - Partie 16: Conception des études
toxicocinétiques des produits de dégradation et des substances relargables (ISO 10993-
16:2010)
Ta slovenski standard je istoveten z: EN ISO 10993-16:2010
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
SIST EN ISO 10993-16:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10993-16:2010

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SIST EN ISO 10993-16:2010


EUROPEAN STANDARD
EN ISO 10993-16

NORME EUROPÉENNE

EUROPÄISCHE NORM
February 2010
ICS 11.100.20 Supersedes EN ISO 10993-16:2009
English Version
Biological evaluation of medical devices - Part 16: Toxicokinetic
study design for degradation products and leachables (ISO
10993-16:2010)
Évaluation biologique des dispositifs médicaux - Partie 16: Biologische Beurteilung von Medizinprodukten - Teil 16:
Conception des études toxicocinétiques des produits de Entwurf und Auslegung toxikenitischer Untersuchungen
dégradation et des substances relargables (ISO 10993- hinsichtlich Abbauprodukten und herauslösbaren
16:2010) Bestandteilen (ISO 10993-16:2010)
This European Standard was approved by CEN on 20 January 2010.

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, Croatia, 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
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-16:2010: E
worldwide for CEN national Members.

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

SIST EN ISO 10993-16:2010
EN ISO 10993-16:2010 (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 10993-16:2010
EN ISO 10993-16:2010 (E)
Foreword
This document (EN ISO 10993-16:2010) has been prepared by Technical Committee ISO/TC 194 "Biological
evaluation of medical devices" in collaboration 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 August 2010, and conflicting national standards shall be withdrawn at
the latest by August 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 10993-16:2009.
This document has been prepared under a mandate given to CEN by the European Commission and the
European F
...

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This document specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices. It is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or that of the medical devices themselves.
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