16/30302485 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN ISO 11737-1 - STERILIZATION OF HEALTH CARE PRODUCTS - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCT
Hardcopy , PDF
English
21-02-2018
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system elements
5 Selection of product
6 Methods of determination and microbial
characterization of bioburden
7 Validation of method for determining
bioburden
8 Routine determination of bioburden and
interpretation of data
9 Maintenance of the method of determination
of bioburden
Annex A (informative) - Guidance on determination
of a population of microorganisms on product
Annex B (informative) - Guidance on methods of
determination of bioburden
Annex C (informative) - Validation of bioburden
recovery efficiency
Annex D (informative) - Typical assignment of responsibilities
Annex ZA (informative) - Relationship between this
European Standard and the Essential Requirements of
EU Directive 90/385/EEC on active implantable medical
devices
Annex ZB (informative) - Relationship between this European
Standard and the Essential Requirements of EU Directive
93/42/EEC on medical devices
Annex ZC (informative) - Relationship between this European
Standard and the Essential Requirements of EU Directive
98/79/EC on in vitro diagnostic medical devices
Bibliography
BS EN ISO 11737-1.
| Committee |
CH/198
|
| DocumentType |
Draft
|
| Pages |
70
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
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