• SN EN ISO 21649 : 2010

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS

    Available format(s): 

    Superseded date:  08-03-2023

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Swiss Standards

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Symbols and abbreviated terms
    5 Requirements
      5.1 General requirements
      5.2 Noise requirements
      5.3 Dose specification requirements
      5.4 Uncertainty of measurements and conformance with
          specifications
      5.5 Performance profile requirements
      5.6 Test requirements
    6 Test methods
      6.1 General
      6.2 Test procedures
      6.3 Test conditions
      6.4 Test evaluations
    7 Test report
    8 Information supplied by the manufacturer
      8.1 General
      8.2 Marking
      8.3 Instructions for use
    Annex A (informative) Two-sided tolerance limit factors (k)
    Annex B (informative) Examples of accuracy limit calculations
             and random settings
    Annex C (informative) Correspondence between ISO/IEC
             standards and EN standards
    Annex ZA (informative) Relationship between this
             International Standard and the Essential
             Requirements of EU Directive 93/42/EEC
    Bibliography

    Abstract - (Show below) - (Hide below)

    Applies to safety and performance and testing requirements for single-use and multiple-use needle-free injection systems intended for human use in clinics and other medical settings and for personal use by patients.

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    Document Type Standard
    Publisher Swiss Standards
    Status Superseded
    Superseded By
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