Skip to content
Please enter a keyword to search

  • NF EN ISO 10993-18 : 2009

    View superseded by
    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
    View superseded by

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

    Available format(s): 

    Withdrawn date:  09-11-2021

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Association Francaise de Normalisation

    Sorry this product is not available in your region.

    Add To Cart

    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Development Note 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)
    Document Type Standard
    Publisher Association Francaise de Normalisation
    Status Withdrawn
    Superseded By

    Standards Referencing This Book - (Show below) - (Hide below)

    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
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective