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  • UNE-EN ISO 10993-12:2013

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)

    Available format(s):  Hardcopy, PDF

    Superseded date:  16-02-2022

    Language(s):  Spanish, Castilian, English

    Published date:  27-02-2013

    Publisher:  Asociacion Espanola de Normalizacion

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    Abstract - (Show below) - (Hide below)

    Descrive requisiti e dà guida sulle procedure Essere seguito nella preparazione dei campioni e nella selezione Di materiali di riferimento per verifica di dispositivo medica in biologico Sistemi in conformità con uno e più parti dell'ISO 10993 Serie.

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    Committee CTN 111
    Document Type Standard
    Publisher Asociacion Espanola de Normalizacion
    Status Superseded
    Superseded By
    Supersedes

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

    ISO 10993-3:2014 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
    ISO Guide 33:2015 Reference materials Good practice in using reference materials
    ISO Guide 35:2017 Reference materials Guidance for characterization and assessment of homogeneity and stability
    ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
    ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
    ISO Guide 30:2015 Reference materials Selected terms and definitions
    CFR 40(PTS700-789) : JUL 2016 PROTECTION OF ENVIRONMENT - ENVIRONMENTAL PROTECTION AGENCY
    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
    ISO Guide 31:2015 Reference materials — Contents of certificates, labels and accompanying documentation
    NFS 90 701 : 1988 MEDICO-SURGICAL EQUIPMENT - BIOCOMPATIBILITY OF MATERIALS AND MEDICAL DEVICES
    ISO Guide 34:2009 General requirements for the competence of reference material producers
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