Name:
ISO/TS 13004:2013 PDF
Published Date:
04/30/2013
Status:
[ Withdrawn ]
Publisher:
International Organization for Standardization (Technical Standard)
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.
| File Size : | 1 file , 860 KB |
| Note : | This product is unavailable in Russia, Ukraine, Belarus |
| Published : | 04/30/2013 |
| Same As : | ISO/TS 13004:2013 |