ISO/TS 13004:2013
Withdrawn
View Superseded by
Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
Hardcopy , PDF
English
05-06-2013
04-09-2025
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Withdrawn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 |
A newer version of this standard is available.
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
Users cannot be edited or removed once added to your Multi user PDF.