CSA ISO 11137-2:16 (R2021)

Name: CSA ISO 11137-2:16 (R2021)
Brand: CSA Group
SKU: CSA2424755
Price: 209.00 USD
Availability: InStock

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

Standard Details

CSA Preface This is the second edition of CAN/CSA-ISO 11137-2, 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 (third edition, 2013-06-01). It supersedes the previous edition published in 2007 as CAN/CSA-Z11137-2 (adopted ISO 11137-2:2006). For brevity, this Standard will be referred to as "CAN/CSA-ISO 11137-2" throughout. This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group. 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.

General Information

Status : ACTIVE

Standard Type: Main

Document No: CSA ISO 11137-2:16 (R2021)

Document Year: 2016

Pages: 91

Adopted: Yes

Section Volume:
Health Care Technology Health Care Technology

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CSA ISO 11137-2:16 (R2021)

CSA ISO 11137-2:16 (R2021)

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