Name: 02/560165 DC : DRAFT JAN 2002 - BS EN 556-2 - STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES
Brand: British Standards Institution

BS EN 556-2 - STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES

Published date

11-23-2012

Publisher

British Standards Institution

Superseded date

01-14-2004

Superseded by

BS EN 556-2:2015

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Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
  3.1 Aseptic processing
  3.2 Bioburden
  3.3 Media Fills
  3.4 Medical device
  3.5 Sterility
  3.6 Sterile
  3.7 Terminally-sterilized
  3.8 Test for sterility
4 Requirements
Annex ZA (informative) Clauses of this European Standard
         addressing essential requirements or other
         provisions of EU Directives
Bibliography

BS EN 556-2

Committee	CH/67/-/1
DocumentType	Draft
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS EN 556-2:2015

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02/560165 DC : DRAFT JAN 2002

BS EN 556-2 - STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED &#39;STERILE&#39; - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES

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BS EN 556-2 - STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES