AAMI AAMI 13408-1:2008 (R2017)+A1:2013 (R2017)

AAMI 13408-1:2008 (R2017)+A1:2013 (R2017) PDF Download

Standard EN Sample
AAMI 13408-1:2008 (R2017)+A1:2013 (R2017) Sample

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

Also Known As: ANSI/AAMI/ISO 13408-1:2008 (R2017)+A1:2013 (R2017)

SKU135917676 Published by Association for the Advancement of Medical Instrumentation AAMI Publication Date2008-09-23 Pages CountPages79

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.
Details
Language(s)English
ISBN1570203261
File Size1.3 MB
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