ANSI/AAMI/ISO 13022:2012
Medical products containing viable human cells.Application of risk management and requirements for processing practices
- Standard No.
- ANSI/AAMI/ISO 13022:2012
- Release Date
- 2012
- Published By
- US-AAMI
- Latest
- ANSI/AAMI/ISO 13022:2012
- Scope
- 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, biologies, medical devices and active implantable medical devices or combinations thereof. Covers viable human materials of autologous as well as allogeneic human origin.
ANSI/AAMI/ISO 13022:2012 history
- 2012 ANSI/AAMI/ISO 13022:2012 Medical products containing viable human cells.Application of risk management and requirements for processing practices
