• NF EN ISO 8871-2 : 2005 AMD 1 2014

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    ELECTROMETRIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION

    Available format(s): 

    Withdrawn date:  01-10-2021

    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 Essais
    4 Préparation des échantillons pour essais
    5 Réactifs et appareillage
    Annexe A (informative) Identification de l'élastomère par
                           pyrolyse IR
    Annexe B (informative) Détermination de la déformation
                           rémanente après compression
    Annexe C (informative) Gonflement dans l'huile
    Annexe D (informative) Développement d'une empreinte digitale
                           par chromatographie en phase gazeuse
    Annexe E (informative) Détermination des substances volatiles
                           par chromatographie en phase gazeuse
                           selon la méthode de l'espace de tête
    Annexe F (informative) Détermination de l'humidité résiduelle
    Annexe G (informative) Détermination d'une empreinte digitale
                           par thermogravimétrie
    Bibliographie

    Abstract - (Show below) - (Hide below)

    Provides evaluation procedures applicable to elastomeric parts used for drug containers and medical devices in order to guarantee the product identity between the samples evaluated in the (suitability test) acceptance process and the current supplies.

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

    Development Note Indice de classement: S93-102-2. (04/2005) Supersedes NF EN ISO 8871. (11/2006)
    Document Type Standard
    Publisher Association Francaise de Normalisation
    Status Withdrawn
    Superseded By

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

    NF ISO 247 : 2007 RUBBER - DETERMINATION OF ASH
    NF EN ISO 8871-1 : 2005 ELECTROMETRIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 1: EXTRACTABLES IN AQUEOUS AUTOCLAVATES
    NF ISO 2781 : 2008 AMD 1 2010 RUBBER, VULCANIZED OR THERMOPLASTIC - DETERMINATION OF DENSITY
    ISO 48:2010 Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD)
    • 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