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BS EN 868-2 : 2017

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BS EN 868-2 : 2017

PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS

British Standards Institution

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Table of Contents

European foreword <br>Introduction <br>1 Scope <br>2 Normative references <br>3 Terms and definitions <br>4 Requirements <br>5 Information to be supplied by the manufacturer <br>Annex A (informative) - Details of significant technical <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;changes between this European Standard and the <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;previous edition <br>Annex B (informative) - Method for the determination <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;of drape <br>Annex C (normative) - Method for the determination <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;of water repellency <br>Annex D (normative) - Method for the determination <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;of pore size <br>Annex E (informative) - Repeatability and reproducibility <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;of test methods <br>Bibliography

Abstract

Defines test methods and values for materials for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.

General Product Information

Document Type Standard
Status Current
Publisher British Standards Institution
Committee CH/198
Supersedes
  • 15/30325855 DC : 0
  • 07/30166924 DC : DRAFT AUG 2007
  • BS 6254(1989) : 1989
  • 92/58622 DC : DEC 92
  • BS 6255(1989) : 1989