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AAMI/ISO 13408-7:2012
Aseptic processing of health care products - Part 7: Alternative processes for atypical medical devices and combination productsMore info
Specifies requirements and provides guidance on alternative approaches to process simulations for the qualification of the aseptic processing of atypical medical devices and combination products that cannot be terminally sterilized and where the process simulation approach according to AAMI/ISO 13408-1 cannot be applied.
| Author | ANSI/AAMI/ISO |
|---|---|
| Editor | AAMI |
| Document type | Standard |
| Format | File |
| Confirmation date | 2012-07-26 |
| ICS | 11.080.01 : Sterilization and disinfection in general |
| Cross references | ISO 13408-7 (2012-08), IDT |
| Year | 2012 |
| Document history | |
| Country | USA |
| Keyword | ANSI 13408;ANSI/AAMI/ISO 13408;13408;ANSI/AAMI/ISO 13408-7-2012 |