BS EN 550:1994
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Sterilization of medical devices. Validation and routine control of ethylene oxide sterilization
Hardcopy , PDF
29-06-2007
English
15-10-1994
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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Superseded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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