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BS EN 550:1994

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Sterilization of medical devices. Validation and routine control of ethylene oxide sterilization
Available format(s)

Hardcopy , PDF

Superseded date

06-29-2007

Language(s)

English

Published date

10-15-1994

Publisher

British Standards Institution

Cooperating organizations
National foreword
Foreword
Introduction
1. Scope
2. Normative references
3. Definitions
4. General
5. Validation
6. Process control and monitoring
7. Product release from sterilization
Annexes
A. (normative) Method for calculating D-values using
     microbiological performance qualification method B
B. (informative) Guidance on the application of EN 550
C. (informative) Bibliography
National annex NA (informative) Committees responsible
National annex NB (informative) Cross-references

Provides requirements and guidance

Committee
CH/198
DevelopmentNote
Reviewed and confirmed by BSI, March, 2005. (03/2005) Supersedes 91/57776 DC. (09/2005)
DocumentType
Standard
Pages
30
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
NBN EN 550 : 1995 Identical
NS EN 550 : 1ED 1994 Identical
NF EN 550 : 1994 Identical
UNI EN 550 : 1996 Identical
SN EN 550 : 1995 Identical
NEN EN 550 : 1994 Identical
EN 550 : 1994 Identical
I.S. EN 550:1994 Identical
UNE-EN 550:1995 Identical
DIN EN 550:1994-11 Identical

BS EN 866-1:1997 Biological systems for testing sterilizers and sterilization processes General requirements
BS EN 554:1994 Sterilization of medical devices. Validation and routine control of sterilization by moist heat

EN 724 : 1994 GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR NON-ACTIVE MEDICAL DEVICES
EN 1174-1 : 1996 STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - REQUIREMENTS
BS EN 46002:1997 Specification for application of EN ISO 9002 to the manufacture of medical devices
BS 5750-1(1974) : LATEST QUALITY SYSTEMS - SPECIFICATION FOR DESIGN DEVELOPMENT PRODUCTION INSTALLATION AND SERVICING
BS 5750-0.1(1987) : 1987 QUALITY SYSTEMS - PRINCIPAL CONCEPTS AND APPLICATIONS - GUIDE TO SELECTION AND USE
EN 30993-6 : 1994 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
BS 5750-0.2(1987) : 1987 QUALITY SYSTEMS - PRINCIPAL CONCEPTS AND APPLICATIONS - GUIDE TO QUALITY MANAGEMENT AND QUALITY SYSTEM ELEMENTS
BS 5750-2(1974) : LATEST QUALITY SYSTEMS - SPECIFICATION FOR PRODUCTION AND INSTALLATION
BS EN 554:1994 Sterilization of medical devices. Validation and routine control of sterilization by moist heat
EN 50103 : 1995 GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR THE ACTIVE (INCLUDING ACTIVE IMPLANTABLE) MEDICAL DEVICE INDUSTRY
EN 866-2:1997/AC:1998 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - PARTICULAR SYSTEMS FOR USE IN ETHYLENE OXIDE STERILIZERS
BS EN 556:1995 Sterilization of medical devices. Requirements for terminally-sterilized devices to be labelled \'Sterile\'
BS EN 46001:1997 Specification for application of EN ISO 9001 to the manufacture of medical devices

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PDF - English
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