BS EN ISO 11137-2:2007

Sterilization of health care products. Radiation-Establishing the sterilization dose

standard by British Standard / European Standard / International Organization for Standardization , 10/31/2009

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ISO 11137-2:2006

April 2006
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
- Historical Version

Full Description

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.

Product Details

Published:: 10/31/2009
ISBN(s):: 9780580675010, 9780580532863
Number of Pages:: 72
File Size:: 1 file , 910 KB
Same As:: ISO 11137-2:2006
Product Code(s):: 30202032, 30202032, 30202032
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BS EN ISO 11137-2:2007

Sterilization of health care products. Radiation-Establishing the sterilization dose

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ISO 11137-2:2006

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Document History

BS EN ISO 11137-2:2015+A1:2023

BS EN ISO 11137-2:2015

BS EN ISO 11137-2:2013

BS EN ISO 11137-2:2012