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  • DIN EN ISO 11608-5:2013-01

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012)

    Available format(s):  Hardcopy, PDF

    Superseded date:  01-05-2023

    Language(s):  German, English

    Published date:  01-01-2013

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    National foreword
    National Annex NA (informative) - Bibliography
    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
    Bibliography
    Annex ZA (informative) - Relationship between this European
             Standard and the Essential Requirements
             of EC Directive 93/42/EEC on medical devices

    Abstract - (Show below) - (Hide below)

    Defines requirements and test methods for the automated functions of needle-based injection systems with automated functions (NIS-AUTO), for the administration of medicinal products in humans.

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

    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Superseded By

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

    DIN ISO 11040-4:2007-10 PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)
    DIN EN ISO 11608-7:2015-08 (Draft) NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 7: ACCESSIBILITY FOR PERSONS WITH VISUAL IMPAIRMENT (ISO 11608-7:2016)

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

    DIN EN ISO 13485:2016-08 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
    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
    DIN EN ISO 14253-1:2013-12 GEOMETRICAL PRODUCT SPECIFICATIONS (GPS) - INSPECTION BY MEASUREMENT OF WORKPIECES AND MEASURING EQUIPMENT - PART 1: DECISION RULES FOR PROVING CONFORMITY OR NONCONFORMITY WITH SPECIFICATIONS (ISO 14253-1:2013)
    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
    DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
    DIN EN ISO 23908:2013-10 SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - SHARPS PROTECTION FEATURES FOR SINGLE-USE HYPODERMIC NEEDLES, INTRODUCERS FOR CATHETERS AND NEEDLES USED FOR BLOOD SAMPLING (ISO 23908:2011)
    DIN EN 60068-2-30:2006-06 ENVIRONMENTAL TESTING - PART 2-30: TESTS - TEST DB: DAMP HEAT, CYCLIC (12 H + 12 H CYCLE)
    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 11608-3:2012 Needle-based injection systems for medical use Requirements and test methods Part 3: Finished containers
    DIN ISO 16269-6:2009-10 STATISTICAL INTERPRETATION OF DATA - PART 6: DETERMINATION OF STATISTICAL TOLERANCE INTERVALS
    DIN EN ISO 9000:2015-11 QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY (ISO 9000:2015)
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO 23908:2011 Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    DIN EN ISO 8537:2008-10 STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN (ISO 8537:2016)
    ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
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