CEN ISO/TS 13004:2014
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO/TS 13004:2013)
28-06-2023
28-05-2014
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
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