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02/560165 DC : DRAFT JAN 2002

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

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

Superseded date

14-01-2004

Superseded by

BS EN 556-2:2015

Published date

23-11-2012

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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Superseded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

EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
EN ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
EN ISO 13488 : 2000 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
EN 1441 : 1997 MEDICAL DEVICES - RISK ANALYSIS
EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
EN ISO 9002:1994/AC:1997 QUALITY SYSTEMS - SPECIFICATION FOR PRODUCTION AND INSTALLATION
EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
ISO 9001:2015 Quality management systems — Requirements
EN 980:2008 Symbols for use in the labelling of medical devices
EN ISO 14160:2011 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011)
EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT

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