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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - SUBSTANTIATION OF SELECTED STERILIZATION DOSE: METHOD VD[MAX][SD]
Hardcopy , PDF
07-31-2014
English
01-01-2013
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
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