🔥🔥 Don’t Miss Out on Our End of Autumn Sale. If you have any questions, feel free to click the bottom right corner to contact our customer service..

Concat us[email protected]
Shopping Cart

No products in the cart.

🔍
CAN/CSA-ISO 11137-2:16 (R2021):2016 Edition

CAN/CSA-ISO 11137-2:16 (R2021):2016 Edition

$53.95

Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose

Published By Publication Date Number of Pages
CSA 2016-07-01 91
PDF Format Searchable Printable Preview Now
Guaranteed Safe Checkout
Categories: ,

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

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.

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.

Related products

CAN/CSA-ISO 11137-2:16 (R2021)
$53.95