BS EN ISO 11737-2:2009 specifies the general criteria for tests of sterility on medical devices that have
been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine
sterilization processing. These tests are intended to be performed when defining, validating or maintaining a
sterilization process.
BS EN ISO 11737-2:2009 is not applicable to:
a) sterility testing for routine release of product that has been subjected to a sterilization process;
b) performing a test for sterility (see 3.12);
NOTE 1 The performance of a) or b) is not a requirement of ISO 11135-1, ISO 11137-1, ISO 14160, ISO 14937 or
ISO 17665-1.
c) culturing of biological indicators or inoculated products.
NOTE 2 Guidance on culturing biological indicators is included in ISO 14161[8].
Cross References:ISO 10012
ISO 11737-1:2006
ISO 13485:2003
ISO/IEC 17025:2005
ISO 11135-1
ISO/TS 11135-2
ISO 11137-1
ISO 11137-2
ISO 11138-2
ISO/TS 11139:2006
ISO 14160
ISO 14161
ISO 14644-1
ISO 14644-4
ISO 14644-7
ISO 14937
ISO 17665-1
ISO 20857
ISO 9000:2005
ISO 9001:2008
ISO 90003
90/385/EEC
93/42/EEC
98/79/EC
All current amendments available at time of purchase are included with the purchase of this document. | File Size : | 1
file
, 850 KB |
| ISBN(s) : | 9780580578526 |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 28 |
| Product Code(s) : | 30157770, 30157770, 30157770 |
| Published : | 03/31/2010 |
| Same As : | BS EN ISO 11737-2:2009 |
