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

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

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

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

Published Date:
05/01/2019

Status:
Active

Description:

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:
Choose Document Language:
$36.6
Need Help?
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

History

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