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AAMI/ISO 13022:2012
Medical products containing viable human cells -- Application of risk management and requirements for processing practicesMore info
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.
| Author | ANSI/AAMI/ISO |
|---|---|
| Editor | AAMI |
| Document type | Standard |
| Format | File |
| Confirmation date | 2012-06-18 |
| ICS | 11.100.20 : Biological evaluation of medical devices |
| Cross references | ISO 13022 (2012-04), IDT |
| Year | 2012 |
| Document history | |
| Country | USA |
| Keyword | ANSI 13022;13022;ANSI/AAMI/ISO 13022-2012 |