• UNE-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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 (ISO 21649:2006)

    Available format(s):  Hardcopy, PDF

    Superseded date:  04-10-2023

    Language(s):  Spanish, Castilian, English

    Published date:  27-01-2010

    Publisher:  Asociacion Espanola de Normalizacion

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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.

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

    Committee CTN 111
    Document Type Standard
    Publisher Asociacion Espanola de Normalizacion
    Status Superseded
    Superseded By
    Supersedes
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