1600805 Preview

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

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

📝 Amendments Available

View all product details

Most Recent

Track It

Language:
    • Available Formats
    •  
    • Availability
    • Priced From ( in USD )
    • Printed Edition
    • Ships in 1-2 business days
    • $149.00
    • Add to Cart

Customers Who Bought This Also Bought

 

About This Item

 

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.
 

Product Details

Published:
09/23/2008
ISBN(s):
1570203318
ANSI:
ANSI Approved
Number of Pages:
32
File Size:
1 file , 180 KB
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

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