ANSI/AAMI/ISO 13022:2012
Active Standard
Most Recent

ANSI/AAMI/ISO 13022:2012

Medical products containing viable human cells—Application of risk management and requirements for processing practices

Summary

Specifies a procedure to identify the hazards and hazardous situations and to manage the risk associated with viable cellular component(s) of products regulated as medicinal products, biologics, medical devices and active implantable medical devices or combinations thereof. Covers viable human materials of autologous as well as allogeneic human origin. Annex 3

Technical characteristics

Publisher Association for the Advancement of Medical Instrumentation (AAMI)
Publication Date 01/01/2012
Page Count 0
Themes Biological Evaluation
EAN ---
ISBN ---
Weight (in grams) ---
No products.

Previous versions

Contact us