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AAMI/ISO 13408-1:2008 (R2011)
Aseptic processing of health care products - Part 1: General requirementsMore info
Specifies the general requirements for, and offers guidance on processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically processed health care products.
| Author | ANSI/AAMI/ISO |
|---|---|
| Editor | AAMI |
| Document type | Standard |
| Format | File |
| Confirmation date | 2011-12-14 |
| ICS | 11.080.01 : Sterilization and disinfection in general 11.120.01 : Pharmaceutics in general |
| Cross references | ISO 13408-1 (1998-08), IDT |
| Modified by | ANSI/AAMI/ISO 13408-1/A1 (2013) |
| Year | 2008 |
| Document history | |
| Country | USA |
| Keyword | ANSI 13408;ANSI/AAMI/ISO 13408;13408;ANSI/AAMI/ISO 13408-1-2008 (R2011) |