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AAMI/ISO 13408-1:2008/(R)2017 & A1:2013/(R)2017

Aseptic processing of health care products--Part 1: General requirements

standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization , 09/23/2008

📝 Amendments Available

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About This Item

 

Full Description

Includes amendment.

Specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of the manufacturing process for aseptically processed health care products.
 

Product Details

Published:
09/23/2008
ISBN(s):
1570203261
ANSI:
ANSI Approved
Number of Pages:
63
File Size:
1 file , 990 KB
Same As:
AAMI/ISO 13408-1:2008/(R)2017 & A1:2013/(R)2017
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Amendments, rulings, supplements, and errata

  1. AAMI/ISO 13408-1:2008/(R)2011/A1:2013


    Aseptic processing of health care products--Part 1: General requirements, Amendment 1