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Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
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 |
CEN/TC 204
|
| DocumentType |
Technical Specification
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Withdrawn
|
| Standards | Relationship |
| ONORM ONR CEN ISO/TS 13004 : 2014 | Identical |
| PD CEN ISO/TS 13004:2014 | Identical |
| DIN CEN ISO/TS 13004;DIN SPEC 13223:2014-10 | Identical |
| UNI CEN ISO/TS 13004 : 2014 | Identical |
| ISO/TS 13004:2013 | Identical |
| S.R. CEN ISO/TS 13004:2014 | 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 |
| ISO 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
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