04/30048584 DC : DRAFT MAY 2004
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
BS EN ISO 11137-2 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
Superseded date
29-06-2007
Superseded by
Published date
23-11-2012
Publisher
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BS EN ISO 11137-2
| Committee |
CH/198
|
| DocumentType |
Draft
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| ISO 11137-1:2006 | Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 11737-2:2009 | Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| ISO 11737-1:2006 | Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| AAMI TIR27 : 1ED 2001 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION STERILIZATION - SUBSTANTIATION OF 25 KGY AS A STERILIZATION DOSE - METHOD VD MAX |
| AAMI ST32 : 1991 | GUIDELINE FOR GAMMA RADIATION STERILIZATION |
| ISO 11137-3:2017 | Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control |
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