BS EN ISO 11137-2:2007 PDF

BS EN ISO 11137-2:2007 specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10-6. This part of ISO 11137 also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose.

BS EN ISO 11137-2:2007 defines product families for dose establishment and dose auditing.

Cross References:
ISO 11137-1:2006
ISO 11737-1
ISO 11737-2
ISO 13485
ISO 11137:1995
ISO 11137-3:2006
ISO/TS 11139:2006
AAMI RS:1984
AAMI TIR27:2001
ANSI/AAMI ST32:1991
ISO 14971
90/385/EEC
93/42/EEC
98/79/EC


Replaces BS EN 552:1994 which remains current.

File Size :	1 file , 910 KB
ISBN(s) :	9780580675010, 9780580532863
Note :	This product is unavailable in Ukraine, Russia, Belarus
Number of Pages :	72
Product Code(s) :	30202032, 30202032, 30202032
Published :	10/31/2009
Same As :	BS EN ISO 11137-2:2007