ISO/TS 13004:2013
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
Hardcopy , PDF
English
06-05-2013
09-04-2025
ISO/TS 13004:2013 describes 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. ISO/TS 13004:2013 also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.
| Committee |
ISO/TC 198
|
| DocumentType |
Technical Specification
|
| Pages |
57
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| ONORM ONR CEN ISO/TS 13004 : 2014 | Identical |
| NEN NPR ISO/TS 13004 : 2013 | Identical |
| S.R. CEN ISO/TS 13004:2014 | Identical |
| PD CEN ISO/TS 13004:2014 | Identical |
| CEN ISO/TS 13004:2014 | Identical |
| DIN CEN ISO/TS 13004;DIN SPEC 13223:2014-10 | Identical |
| BS PD ISO/TS 13004 : 2013 | Identical |
| ANSI/AAMI/ISO TIR13004:2013(R2016) | Identical |
| AAMI ISO TIR 13004 :2013 | Identical |
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