Name: 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)
Brand: Canadian Standards Association
SKU: CSA ISO 11137-2:16 (R2021)
Price: 280.00 USD
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CSA ISO 11137-2:16 (R2021)

Current Reaffirmation

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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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)

Scope

This part of ISO 11137 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.

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)

Scope

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