CAN/CSA Z11137-1-07 (R2021) ✓ Most Recent

1502605

Sterilization of Health Care Products - Radiation - Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices (Adopted ISO 11137-1:2006, First Edition, 2006-04-15)

standard by Canadian Standards Association / National Standard of Canada , 03/01/2007

Amendments Available

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Full Description

This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. NOTE Although the scope of this part of ISO 11137 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment. See more

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Amendments, rulings, supplements, and errata

  1. CAN/CSA Z11137-1-07/A2:22


    Amendment 2:2022 to Sterilization of Health Care Products - Radiation - Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices (Adopted ISO 11137-1:2006, First Edition, 2006-04-15)

  2. CAN/CSA Z11137-1A-07 (R2021)


    Amendment 1:2016 to Sterilization of Health Care Products - Radiation - Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices (Adopted ISO 11137-1:2006, First Edition, 2006-04-15)

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Product Details

Edition:

1st

Published:

03/01/2007

ISBN(s):

1554364493

Number of Pages:

56

File Size:

1 file

Product Code(s):

2418370, 2418371, 2418370

Note:

This product is restricted and cannot be purchased in the following countries Russia, Ukraine, Belarus