BS EN 554:1994
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 sterilization by moist heat
Hardcopy , PDF
29-09-2006
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. (informative) Guidance on the application of EN 554
B. (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 91/57780 DC (09/2005)
|
| DocumentType |
Standard
|
| Pages |
22
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| I.S. EN 554:1994 | Identical |
| NF EN 554 : 1994 | Identical |
| UNI EN 554 : 1996 | Identical |
| NBN EN 554 : 1995 | Identical |
| SN EN 554 : 1995 | Identical |
| UNE-EN 554:1995 | Identical |
| NS EN 554 : 1994 | Identical |
| EN 554 : 1994 | Identical |
| NEN EN 554 : 1994 | Identical |
| DIN EN 554:1994-11 | Identical |
| BS EN 866-1:1997 | Biological systems for testing sterilizers and sterilization processes General requirements |
| BS EN 550:1994 | Sterilization of medical devices. Validation and routine control of ethylene oxide sterilization |
| EN 285:2015 | Sterilization - Steam sterilizers - Large sterilizers |
| EN 868-5:2009 | Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods |
| EN 868-4:2017 | Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods |
| EN 868-1 : 1997 | PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS |
| 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 |
| EN 868-2:2017 | Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods |
| BS 5750-1(1974) : LATEST | QUALITY SYSTEMS - SPECIFICATION FOR DESIGN DEVELOPMENT PRODUCTION INSTALLATION AND SERVICING |
| BS EN 550:1994 | Sterilization of medical devices. Validation and routine control of ethylene oxide sterilization |
| BS 5750-0.1(1987) : 1987 | QUALITY SYSTEMS - PRINCIPAL CONCEPTS AND APPLICATIONS - GUIDE TO SELECTION AND USE |
| EN 868-3:2017 | Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods |
| BS 5750-0.2(1987) : 1987 | QUALITY SYSTEMS - PRINCIPAL CONCEPTS AND APPLICATIONS - GUIDE TO QUALITY MANAGEMENT AND QUALITY SYSTEM ELEMENTS |
| ISO 3746:2010 | Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane |
| EN 866-1 : 1997 | BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - GENERAL REQUIREMENTS |
| BS 5750-2(1974) : LATEST | QUALITY SYSTEMS - SPECIFICATION FOR PRODUCTION AND INSTALLATION |
| EN 867-1 : 1997 | NON-BIOLOGICAL SYSTEMS FOR USE IN STERILIZERS - GENERAL REQUIREMENTS |
| ISO 11134:1994 | Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization |
| 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 |
| IEC 61010-1:2010+AMD1:2016 CSV | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
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