ANSI AAMI ISO 13022-2012

Category: Technical


Posted on 2020-09-14, by banz.

Description

Medical Products Containing Viable Human Cells - Application Of Risk Management And Requirements For Processing Practices
Specifies requirements and guidance for processing practices and managing risk associated with viable cellular components of products regulated as medicinal products, biologics, medical devices and active implantable medical devices, or combinations thereof. It covers viable human materials of autologous as well as allogeneic human origin, obtained from living or deceased donors.

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ANSI AAMI ISO 13022-2012

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