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)

Publisher:
Canadian Standards Association / National Standard of Canada

Document status:

Active

Format:

Electronic (PDF)

Delivery time:

10 minutes

Delivery time (for Russian version):

200 business days

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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.

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

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

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)

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