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AAMI/ISO 13408-7:2012/(R)2018

Aseptic processing of health care products - Part 7: Alternative processes for atypical medical devices and combination products

standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization , 09/27/2012

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Full Description

AAMI/ISO 13408-7 specifies the requirements for, and offers guidance on, processes, programmes and procedures for procurement, development, validation, routine control of the manufacturing process and transport for aseptically processed cell based medical products (CBMP), especially tissue engineering products (TEP's) whose biological properties have to be kept intact to maintain their efficacy as a medical device and / or medicinal product.
 

Product Details

Published:
09/27/2012
ISBN(s):
9781570204555
ANSI:
ANSI Approved
Number of Pages:
36
File Size:
1 file , 970 KB
Same As:
ISO 13408-7:2012
Note:
This product is unavailable in Ukraine, Russia, Belarus