ANSI/AAMI/ISO 13408-6:2005/(R)2013 & A1:2013
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ANSI/AAMI/ISO 13408-6:2005/(R)2013 & A1:2013

Aseptic processing of health care products—Part 6: Isolator systems (Includes Amendment 1)

Summary

This document specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products. The document focuses on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials. The included amendment updates references, modifies a number of definitions and informative notes, introduces new requirements, and updates the Bibliography. Annex 3

Technical characteristics

Publisher Association for the Advancement of Medical Instrumentation (AAMI)
Publication Date 01/01/2005
Confirmation Date 01/01/2013
Page Count 0
Themes Sterilization—Industrial
EAN ---
ISBN ---
Weight (in grams) ---
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