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EN ISO 10993-16:2017

(Main)

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

ISO 10993-16:2017 provides principles on designing and performing toxicokinetic studies relevant to medical devices. 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 Substanzen (ISO 10993-16:2017)

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 10993-16:2017)

ISO 10993-16:2017 énonce les principes de conception et de mise en ?uvre 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 10993-16:2017)

Ta dokument določa načela za načrtovanje in izvajanje toksikokinetičnih študij, ki se nanašajo na medicinske pripomočke. Dodatek A podaja razloge za vključitev toksikokinetičnih študij pri biološkem vrednotenju medicinskih pripomočkov.

General Information

Status
Published
Publication Date
05-Dec-2017
Withdrawal Date
29-Jun-2018
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
6060 - Definitive text made available (DAV) - Publishing
Start Date
06-Dec-2017
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 10993-16:2018 - Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

Relations

Replaces
EN ISO 10993-16:2010 - Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)
Effective Date
08-Jun-2015

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ISO 10993 - Biological Evaluation of Medical Devices Package
ISO 10993 - Biological Evaluation of Medical Devices Package
20 documents

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-16:2018
01-februar-2018
1DGRPHãþD
SIST EN ISO 10993-16:2010
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO1DþUWWRNVLNRNLQHWLþQLK
UD]LVNDYUD]JUDGQLKSURGXNWRYLQL]OXåQLQ ,62
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for
degradation products and leachables (ISO 10993-16:2017)
Biologische Beurteilung von Medizinprodukten - Teil 16: Entwurf und Auslegung
toxikokinetischer Untersuchungen hinsichtlich Abbauprodukten und herauslösbaren
Substanzen (ISO 10993-16:2017)
Évaluation biologique des dispositifs médicaux - Partie 16: Conception des études
toxicocinétiques des produits de dégradation et des substances relargables (ISO 10993-
16:2017)
Ta slovenski standard je istoveten z: EN ISO 10993-16:2017
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
SIST EN ISO 10993-16:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10993-16:2018

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SIST EN ISO 10993-16:2018


EN ISO 10993-16
EUROPEAN STANDARD

NORME EUROPÉENNE

December 2017
EUROPÄISCHE NORM
ICS 11.100.20 Supersedes EN ISO 10993-16:2010
English Version

Biological evaluation of medical devices - Part 16:
Toxicokinetic study design for degradation products and
leachables (ISO 10993-16:2017)
Évaluation biologique des dispositifs médicaux - Partie Biologische Beurteilung von Medizinprodukten - Teil
16: Conception des études toxicocinétiques des 16: Entwurf und Auslegung toxikokinetischer
produits de dégradation et des substances relargables Untersuchungen hinsichtlich Abbauprodukten und
(ISO 10993-16:2017) herauslösbaren Substanzen (ISO 10993-16:2017)
This European Standard was approved by CEN on 9 August 2017.

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-CENELEC 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-CENELEC 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-16:2017 E
worldwide for CEN national Members.

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SIST EN ISO 10993-16:2018
EN ISO 10993-16:2017 (E)
Contents Page
European foreword . 3
Annex ZA (informative)  Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 5
Annex ZB (informative)  Relationship between this European Standard and the essential
requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered . 7

2

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SIST EN ISO 10993-16:2018
EN ISO 10993-16:2017 (E)
European foreword
The text of ISO 10993-16:2017 has been prepared by Technical Committee ISO/TC 194 "Biological and
clinical evaluation of medical devices" of the International Organization for Standardization (ISO) and
has been taken over as EN ISO 110993-16:2017 by Technical Committee CEN/TC 206 “Biological and
clinical evaluation of medical devices” the secretariat of which is held by DIN.
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 June 2018, and conflicting national standards shall be
withdrawn at the latest by June 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible 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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