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ANSI/AAMI/ISO 13022:2012

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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Association for the Advancement of Medical Instrumentation [aami]

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