AAMI TIR13004:2013 (R2016) PDF Download
Standard EN Sample
Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose: Method VDmaxSD
Also Known As: ANSI/AAMI/ISO TIR13004:2013 (R2016)
SKU136124264
Published by
Association for the Advancement of Medical Instrumentation
AAMI
Publication Date2013-10-04
Pages CountPages85
Full Description
This Technical Specification 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. This Technical Specification also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.
Details
| Language(s) | English |
| File Size | 2.0 MB |
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