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

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

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

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

PUBLISH DATE 2012
AAMI ANSI/AAMI/ISO 13408-7:2012/(R)2018
This document specifies the requirements for, and offers guidance on, processes, programs 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 (TEPs) whose biological properties have to be kept intact to maintain their efficacy as a medical device and/or medicinal product.
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