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AAMI/ISO 11607-2 AMD 1:2014 (R2016)
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processesMore info
This standard specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized and maintain sterility to the point of use. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
| Author | ANSI/AAMI/ISO |
|---|---|
| Editor | AAMI |
| Document type | Standard |
| Format | File |
| Confirmation date | 2016-02-11 |
| ICS | 11.080.30 : Sterilized packaging |
| Cross references | ISO 11607-2 AMD 1 (2014-07), IDT |
| Modify | ANSI/AAMI/ISO 11607-2 (2006) |
| Year | 2014 |
| Document history | |
| Country | USA |
| Keyword | ANSI 11607;ANSI/AAMI/ISO 11607;ANSI/AAMI/ISO 11607-2;11607;ANSI/AAMI/ISO 11607-2-2006,A1-2014 (R2015) |