ANSI/AAMI/ISO 13408-7:2012/(R)2018
Active , Confirmed Standard
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ANSI/AAMI/ISO 13408-7:2012/(R)2018

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

Summary

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. Annex 3

Technical characteristics

Publisher Association for the Advancement of Medical Instrumentation (AAMI)
Publication Date 01/01/2012
Confirmation Date 01/01/2018
Page Count 0
Themes Sterilization—Industrial
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ISBN ---
Weight (in grams) ---
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