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Specifies requirements for the development, validation and routine control of an industrial dry heat sterilization process for medical devices. Dry heat sterilization processes covered by this standard include but are not limited to forced air cycles and convection cycles. Although this standard primarily addresses dry heat sterilization, it also covers depyrogenation processes. The standard excludes processes that utilize infrared or microwaves as the heating medium.
Author | ANSI/AAMI/ISO |
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Editor | AAMI |
Document type | Standard |
Format | File |
Confirmation date | 2015-12-07 |
ICS | 11.080.01 : Sterilization and disinfection in general |
Replace | ANSI/AAMI ST 63 (2002) |
Cross references | ISO 20857 (2010-08), IDT |
Year | 2010 |
Document history | ANSI/AAMI/ISO 20857 (2010) |
Country | USA |
Keyword | ANSI 20857;20857;ANSI/AAMI/ISO 20857-2010 (R2015) |