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

Publisher:
Association for the Advancement of Medical Instrumentation/International Org. for Standardization

Document status:

Active

Format:

Electronic (PDF)

Delivery time:

10 minutes

Delivery time (for Russian version):

200 business days

SKU:

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.

ANSI :	ANSI Approved
File Size :	1 file , 970 KB
ISBN(s) :	9781570204555
Note :	This product is unavailable in Ukraine, Russia, Belarus
Number of Pages :	36
Published :	09/27/2012
Same As :	AAMI/ISO 13408-7:2012/(R)2018

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

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

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