Codes & Standards - Purchase
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)
SKU: 2418372
Published by CSA Group
Publication Year 2007
Reaffirmed in 2012
78 pages
Withdrawn
Product Details
Preface
This is the first edition of CAN/CSA-Z11137-2, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11137-2 (first edition, 2006-04-15; corrected version, 2006-08-01).
Scope
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.
This is the first edition of CAN/CSA-Z11137-2, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11137-2 (first edition, 2006-04-15; corrected version, 2006-08-01).
Scope
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.