BS EN ISO 11737-1:2006 specifies requirements and provides guidance for the enumeration and microbial
characterization of the population of viable microorganisms on or in a medical device, component, raw material or package.
NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of the bioburden data.
BS EN ISO 11737-1:2006 does not specify requirements for the enumeration or identification of viral or protozoan contaminants.
NOTE 2 Furthermore, the requirements specified in BS EN ISO 11737-1:2006 are not intended to address the removal and detection of the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
BS EN ISO 11737-1:2006 does not specify requirements for the microbiological monitoring of the environment in which medical devices are manufactured.
Cross References:ISO 10012
ISO 13485:2003
ISO/IEC 17025:2005
ISO/TR 7871:1997
ISO 8258:1991
ISO 9000:2005
ISO 17665-1
ISO 11137-1
ISO 11137-2
ISO 11137-3
ISO 11138-2
ISO/TS 11139:2006
ISO 11737-2
ISO 14160:1998
ISO 14937:2000
ISO 90003:2004
ISO 9001:2000
ASTM D4855:1997
90/385/EEC
93/42/EEC
98/79/EC
| File Size : | 1
file
, 1.4 MB |
| ISBN(s) : | 9780580751974, 0580481654 |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 46 |
| Product Code(s) : | 30245504, 30245504, 30245504 |
| Published : | 06/30/2011 |
| Same As : | BS EN ISO 11737-1:2006 |
