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BS EN ISO 11137-2:2015

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

standard by British Standard / European Standard / International Organization for Standardization , 06/30/2015

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Identical Versions Available

ISO 11137-2:2013

June 2013
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
- This is the most recent version of this document.

Full Description

BS EN ISO 11137-2:2015 specifies methods for 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 sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.

This part of ISO 11137 defines product families for sterilization dose establishment and sterilization dose audit.

Cross References:
ISO 11137-1:2006
ISO 11737-1
ISO 11737-2
90/385/EEC
93/42/EEC
98/79/EC
ISO 11137:1995
ISO 11137-3:2006
ISO/TS 11139:2006
ISO 13485
ISO 14971
AAMI RS:1984
AAMI TIR 27:2001
ANSI/AAMI ST32:1991
NHB 5340.1A:1968

All current amendments available at time of purchase are included with the purchase of this document.

Product Details

Published:: 06/30/2015
ISBN(s):: 9780580907593
Number of Pages:: 84
File Size:: 1 file , 1.7 MB
Same As:: ISO 11137-2:2013
Product Code(s):: 30326234, 30326234, 30326234
Note:: This product is unavailable in Ukraine, Russia, Belarus

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