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AAMI/ISO 13408-5:2012 (R2015)
Aseptic processing of health care products - Part 5: Sterilization in placeMore info
Specifies the general requirements for sterilization in place (SIP) applied to product contact surfaces of the equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control. This document applies to processes where sterilizing agents are delivered to the internal surfaces of the equipment that can come in contact with the product.
| Author | ANSI/AAMI/ISO |
|---|---|
| Editor | AAMI |
| Document type | Standard |
| Format | File |
| Confirmation date | 2015-08-03 |
| ICS | 11.080.01 : Sterilization and disinfection in general |
| Replace | ANSI/AAMI/ISO 13408-5 (2006) |
| Year | 2012 |
| Document history | ANSI/AAMI/ISO 13408-5 (2012) |
| Country | USA |
| Keyword | ANSI 13408;ANSI/AAMI/ISO 13408;13408;ANSI/AAMI/ISO 13408-5-2012 (R2015) |