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
ISO 11737-2:2009 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.
| Get this standard | Prices exclude GST | |
|---|---|---|
| PDF ( Single user document) |
$118.26 NZD
|
|
| HardCopy |
$152.17 NZD
|
|
| Networkable PDF |
Price varies
|
Scope
Normative references
Terms and definitions
Quality management system elements
Documentation
Management responsibility
Product realization
Measurement, analysis and improvement
Selection of product
General
Sample item portion (SIP)
Packaging of product and sample item portions
Methods for performing tests of sterility
Assessment of method for performing tests of sterility
Maintenance of the method for performing tests of sterility
Previous versions
Keep me up-to-date
Sign up to receive updates when there are changes to this standard
Related Information
Similar Standards
-
AS/NZS ISO 11137.1:2006
Sterilization of health care products - Radiation - Requirements for development, validation and routine control of a sterilization process for medical devices
-
AS/NZS ISO 11137.3:2006
Sterilization of health care products - Radiation - Guidance on dosimetric aspects
-
BS EN 12322:1999
In vitro diagnostic medical devices. Culture media for microbiology. Performance criteria for culture media
-
BS EN 1659:1997
In vitro diagnostic systems. Culture media for microbiology. Terms and definitions
Scope
Normative references
Terms and definitions
Quality management system elements
Documentation
Management responsibility
Product realization
Measurement, analysis and improvement
Selection of product
General
Sample item portion (SIP)
Packaging of product and sample item portions
Methods for performing tests of sterility
Assessment of method for performing tests of sterility
Maintenance of the method for performing tests of sterility