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  • 10/30213842 DC : 0

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BS EN ISO 11608-5 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-10-2012

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    5 Test methods
    6 Test report
    7 Information to be supplied by the manufacturer
    Annex A (informative) - Rationale for requirements
    Annex ZA (informative) - Relationship between this
             International Standard and the Essential
             Requirements of EU Directive 93/42/EEC
    Bibliography

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

    Comment Closes On
    Committee CH/84
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

    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 8537:2016 Sterile single-use syringes, with or without needle, for insulin
    ISO/IEC Guide 98:1993 Guide to the expression of uncertainty in measurement (GUM)
    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
    ISO 11608-1:2014 Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    ISO 11608-2:2012 Needle-based injection systems for medical use Requirements and test methods Part 2: Needles
    ISO 16269-6:2014 Statistical interpretation of data — Part 6: Determination of statistical tolerance intervals
    ISO 11608-3:2012 Needle-based injection systems for medical use Requirements and test methods Part 3: Finished containers
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    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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