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EN ISO 7864:2016

Current

Current

The latest, up-to-date edition.

Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)

Published date

31-08-2016

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Summarise this standard

European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Packaging
6 Information supplied by the manufacturer
Annex A (normative) - Method for preparation
        of extracts
Annex B (informative) - Fragmentation test for
        medical needles
Annex C (informative) - Determination of flow
        rate through the needle
Annex D (informative) - Test method for measuring
        the penetration force and drag force for needles
Annex E (informative) - Needle bonding strength
        test method
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential Requirements
         of EU Directive 93/42/EEC [OJ L 169] aimed to be
         covered

ISO 7864:2016 specifies requirements for sterile hypodermic needles for single use of designated metric sizes 0,18 mm to 1,2 mm.It does not apply to those devices that are covered by their own standard such as dental needles and pen needles.

Committee
CEN/TC 205
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current

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