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03/108542 DC : DRAFT MAY 2003

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BS EN ISO 11140-1 - STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
Superseded date

22-02-2006

Published date

23-11-2012

BS EN ISO 11140-1

Committee
LBI/35/3
DocumentType
Draft
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

Standards Relationship
PREN ISO 11140-1 : DRAFT 2012 Identical

ISO 11140-2:1998 Sterilization of health care products Chemical indicators Part 2: Test equipment and methods
EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
EN 45014 : 1998 GENERAL CRITERIA FOR SUPPLIER'S DECLARATION OF CONFORMITY
ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
PREN 14180 : DRAFT 2012 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
ISO 9001:2015 Quality management systems — Requirements
ISO 11607:2003 Packaging for terminally sterilized medical devices
ISO 11137:1995 Sterilization of health care products Requirements for validation and routine control Radiation sterilization
EN 28601 : 1992 DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES
EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
EN 45001 : 1989 GENERAL CRITERIA FOR THE OPERATION OF TESTING LABORATORIES

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