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BS EN ISO 7864 : 2016

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BS EN ISO 7864 : 2016

STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS (ISO 7864:2016)

British Standards Institution

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Table of Contents

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

Abstract

Defines requirements for sterile hypodermic needles for single use of designated metric sizes 0,18 mm to 1,2 mm.

General Product Information

Document Type Standard
Status Current
Publisher British Standards Institution
Committee CH/84
Supersedes
  • BS 5081-2(1993) : 1993 AMD 9104
  • BS 5081-2(1987) : 1987
  • 91/53632 DC : JUN 91
  • 14/30296389 DC : 0