NF EN ISO 10993-18 : 2009

Withdrawn

View Superseded by

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

Withdrawn date

09-11-2021

Published date

12-01-2013

Publisher

Association Francaise de Normalisation

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Status	Withdrawn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	NF EN ISO 10993-18:2020

Standards	Relationship
ISO 10993-18:2005	Identical
UNI EN ISO 10993-18 : 2009	Identical
NBN EN ISO 10993-18 : 2009	Identical
SN EN ISO 10993-18 : 2009	Identical
ONORM EN ISO 10993-18 : 2009	Identical
BS EN ISO 10993-18:2009	Identical
UNE-EN ISO 10993-18:2009	Identical
NS EN ISO 10993-18 : 2009	Identical
DIN EN ISO 10993-18:2009-08	Identical
EN ISO 10993-18:2009	Identical
I.S. EN ISO 10993-18:2009	Identical
NEN EN ISO 10993-18 : 2009	Identical
DIN EN ISO 10993-18 E : 2009	Identical

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