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  • BS EN ISO 11608-1:2015

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Needle-based injection systems for medical use. Requirements and test methods Needle-based injection systems

    Available format(s):  Hardcopy, PDF

    Superseded date:  24-06-2022

    Language(s):  English

    Published date:  31-01-2015

    Publisher:  British Standards Institution

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

    Committee CH/84
    Development Note Supersedes 97/563387 DC (03/2005) Supersedes 10/30208977 DC. (04/2012)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    ISO 11608-4:2006 Pen-injectors for medical use Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
    ISO 14253-1:2017 Geometrical product specifications (GPS) Inspection by measurement of workpieces and measuring equipment Part 1: Decision rules for verifying conformity or nonconformity with specifications
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medicaldevices
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    ISO 16269-6:2014 Statistical interpretation of data Part 6: Determination of statistical tolerance intervals
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    IEC 61000-4-2:2008 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
    IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 9001:2015 Quality management systems - Requirements
    ISO 9000:2015 Quality management systems Fundamentals and vocabulary
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    IEC 60601-1-9:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
    ISO/IEC Guide 98-3:2008 Uncertainty of measurement Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
    IEC 60068-2-30:2005 Environmental testing - Part 2-30: Tests - Test Db: Damp heat, cyclic (12 h + 12 h cycle)
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