A2:2019 to Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices

Publisher:
Association for the Advancement of Medical Instrumentation/International Org. for Standardization

Document status:

Active

Format:

Electronic (PDF)

Delivery time:

10 minutes

Delivery time (for Russian version):

200 business days

SKU:

4.3.4 Add the following sentence to the end of the clause: Detailed guidance on dosimetry and associated measurement uncertainty is given in ISO 11137-3. 11.2 Replace the second sentence with the following: The procedure(s) shall define the requirements (see 9.4.3 or 9.4.4 as appropriate) for designating a sterilization process as conforming.

ANSI :	ANSI Approved
File Size :	1 file , 260 KB
ISBN(s) :	9781570207174
Note :	This product is unavailable in Ukraine, Russia, Belarus
Number of Pages :	11
Published :	05/01/2019

AAMI/ISO 11137-1:2006/(R)2015 A2:2019 PDF

A2:2019 to Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices

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