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NF EN ISO 10993-18 : 2009

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
Withdrawn date

11-09-2021

Published date

01-12-2013

Avant-propos
Introduction
1 Domaine d'application
2 Références normatives
3 Termes et définitions
4 Symboles et termes abrégés
5 Principes généraux
6 Mode opératoire de caractérisation
7 Paramètres et méthodes de caractérisation chimique
8 Rapport relatif aux données recueillies
Annexe A (normative) - Diagramme résumant les étapes de
         génération des données de caractérisation
         chimique à utiliser pour l'évaluation toxicologique
         des risques
Annexe B (informative) - Sources d'information pour la
         caractérisation chimique
Annexe C (informative) - Principes pour juger de
         l'équivalence toxicologique
Bibliographie

Specifies a framework for the identification of a material and the identification and quantification of its chemical constituents. The chemical characterization information generated can be used for a range of important applications.

DevelopmentNote
Indice de classement: S99-501-18. PR NF EN ISO 10993-18 April 2003. (04/2003) PR NF EN ISO 10993-18 February 2009. (02/2009)
DocumentType
Standard
PublisherName
Association Francaise de Normalisation
Status
Withdrawn
SupersededBy

2007/47/EC : 2007 COR 1 2015 DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 SEPTEMBER 2007 AMENDING COUNCIL DIRECTIVE 1990/385/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES, COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 1998/8/EC CONCERNING THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET(TEXT WITH EEA RELEVANCE)
ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 14971:2007 Medical devices Application of risk management to medical devices

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