BS PD ISO/TS 13004 : 2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - SUBSTANTIATION OF SELECTED STERILIZATION DOSE: METHOD VD[MAX][SD]
Hardcopy , PDF
English
01-01-2013
31-07-2014
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Definition and maintenance of product families
for sterilization dose substantiation and
sterilization dose auditing
5 Selection and testing of product for substantiating
and auditing a selected sterilization dose
6 Method VD[max][SD] - Substantiation of a selected
sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5,
or 35 kGy
7 Maintaining process effectiveness
8 Tables of values for SIP equal to 1,0 VD[max][SD],
SIP dose reduction factor and augmentation dose
corresponding to applicable values of average
bioburden for selected sterilization doses of
17,5, 20, 22,5, 27,5, 30, 32,5 and 35 kGy
9 Worked examples
Bibliography
Explains a method for substantiating a selected sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5 or 35 kGy that achieves a sterility assurance level (SAL) of 10[-6] or less for radiation sterilization of health care products.
| Committee |
CH/198
|
| DevelopmentNote |
Renumbered and superseded by BS PD CEN ISO/TS 13004. (07/2014)
|
| DocumentType |
Standard
|
| Pages |
68
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ISO/TS 13004:2013 | Identical |
| 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 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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