1502606

CAN/CSA Z11137-2-07 (R2012)

Sterilization of Health Care Products - Radiation - Part 2: Establishing the Sterilization Dose (Adopted ISO 11137-2:2006, first edition, 2006-04-15; corrected version, 2006-08-01)

standard by Canadian Standards Association / National Standard of Canada , 03/01/2007

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Full Description

This part of ISO 11137 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.

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

 

Product Details

Edition:
1st
Published:
03/01/2007
ISBN(s):
15554364485
Number of Pages:
78
File Size:
1 file , 1.8 MB
Product Code(s):
2418372, 2418372
Note:
This product is unavailable in Russia, Ukraine, Belarus
 

Document History

  1. CAN/CSA-ISO 11137-2:16 (R2021)


    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (Adopted ISO 11137-2:2013, third edition, 2013-06-01)

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  2. CAN/CSA Z11137-2-07 (R2012)

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    Sterilization of Health Care Products - Radiation - Part 2: Establishing the Sterilization Dose (Adopted ISO 11137-2:2006, first edition, 2006-04-15; corrected version, 2006-08-01)

    • Historical Version