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  • ISO 19001:2013

    Current The latest, up-to-date edition.

    In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  French, English

    Published date:  07-03-2013

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 19001:2013 specifies requirements for information supplied by the manufacturer with reagents used in staining in biology. It applies to producers, suppliers and vendors of dyes, stains, chromogenic reagents and other reagents used for staining in histology and cytology including bacteriology, haematology, histochemistry, as performed in medical laboratories, both routine and research bacteriology. The requirements for information supplied by the manufacturer specified in ISO 19001:2013 are a prerequisite for achieving comparable and reproducible results in all fields of staining in biology.

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

    Committee ISO/TC 212
    Development Note Supersedes ISO/DIS 19001. (03/2013)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    PD ISO/TS 17518:2015 Medical laboratories. Reagents for staining biological material. Guidance for users
    CSA ISO 14971 : 2007 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    ISO/TS 17518:2015 Medical laboratories — Reagents for staining biological material — Guidance for users
    AAMI ISO 14971 : 2007 : INC : ERR 1 : 2007 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    UNE-EN ISO 21572:2013 Foodstuffs - Molecular biomarker analysis - Protein-based methods (ISO 21572:2013)
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    CEI UNI EN ISO 14971 : 2013 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    I.S. EN ISO 14971:2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01)
    DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
    UNE-ISO 28004:2014 Security management systems for the supply chain. Guidelines for the implementation of ISO 28000
    BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
    DIN EN ISO 21572 E : 2013 FOODSTUFFS - MOLECULAR BIOMARKER ANALYSIS - PROTEIN-BASED METHODS (ISO 21572:2013)
    I.S. EN ISO 21572:2013 FOODSTUFFS - MOLECULAR BIOMARKER ANALYSIS - PROTEIN-BASED METHODS (ISO 21572:2013)
    10/30143797 DC : 0 BS ISO/IEC 24760-1 - INFROMATION TECHNOLOGY - SECURITY TECHNIQUES - A FRAMEWORK FOR IDENTITY MANAGEMENT - PART 1: TERMINOLOGY AND CONCEPTS
    UNI CEI EN ISO 14971 : 2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    AAMI ISO 14971 : 2007 : R2010 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    BS EN ISO 21572:2013 Foodstuffs. Molecular biomarker analysis. Protein-based methods
    UNI EN ISO 21572 : 2013 FOODSTUFFS - MOLECULAR BIOMARKER ANALYSIS - PROTEIN-BASED METHODS
    ISO 21572:2013 Foodstuffs Molecular biomarker analysis Protein-based methods
    DIN EN ISO 21572:2013-06 FOODSTUFFS - MOLECULAR BIOMARKER ANALYSIS - PROTEIN-BASED METHODS (ISO 21572:2013)
    EN ISO 21572:2013 Foodstuffs - Molecular biomarker analysis - Protein-based methods (ISO 21572:2013)
    CSA ISO 14971 : 2007 : R2017 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    CSA ISO 14971 : 2007 : R2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES

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

    ISO 80000-9:2009 Quantities and units Part 9: Physical chemistry and molecular physics
    ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
    ISO 80000-1:2009 Quantities and units — Part 1: General
    ISO 18113-2:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
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