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

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Aseptic processing of health care products - Part 6: Isolator systems

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

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Full Description

AAMI/ISO 13408-6 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. See more

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Amendments, rulings, supplements, and errata

  1. AAMI/ISO 13408-6:2005/A1:2013


    Aseptic processing of health care products - Part 6: Isolator systems, Amendment 1

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Product Details

Published:

09/23/2008

ISBN(s):

1570203318

ANSI:

ANSI Approved

Number of Pages:

32