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Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View superseded by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

Available format(s):

Superseded date: 14-01-2004

Language(s):

Published date: 23-11-2012

Publisher: British Standards Institution

Table of Contents - (Show below) - (Hide below)

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

Abstract - (Show below) - (Hide below)

BS EN 556-2

General Product Information - (Show below) - (Hide below)

Comment Closes On
Committee	CH/67/-/1
Document Type	Draft
ISBN
Pages
Published
Publisher	British Standards Institution
Status	Superseded
Superseded By	BS EN 556-2:2015

Standards Referencing This Book - (Show below) - (Hide below)

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

Categories associated with this Standard - (Show below) - (Hide below)

Sub-Categories associated with this Standard - (Show below) - (Hide below)

Sorry this product is not available in your region.

Add To Cart