ANSI/AAMI/ISO 11737-2:2009
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

Standard No.

ANSI/AAMI/ISO 11737-2:2009

Release Date

2009

Published By

American National Standards Institute （ANSI)

Status

Be replaced

Replace By

ANSI/AAMI/ISO 11737-2:2019

Latest

ANSI/AAMI/ISO 11737-2:2019

Scope

Specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent that is a fraction of the specified sterilization process. These tests are intended to be performed when defining, validating or maintaining a sterilization process.

ANSI/AAMI/ISO 11737-2:2009 history

• 1970 ANSI/AAMI/ISO 11737-2:2019 Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
• 2009 ANSI/AAMI/ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process