DSF/PREN ISO 11737-2
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO/DIS 11737-2:2007)
inactive
| Organization: | DS |
| Status: | inactive |
| Page Count: | 27 |
| ICS Code (Medical microbiology): | 07.100.10 |
| ICS Code (Sterilization and disinfection in general): | 11.080.01 |
scope:
1.1 This part of ISO 11737 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.
1.2 This part of ISO 11737 is not applicable to:
a) sterility testing for routine release of product that has been subjected to a sterilization process;
b) performance of a test for sterility (3.11); or
NOTE The performance of a) or b) above is not a requirement of ISO 11135-1, 11137-1, 14160, 14937 or 17665-1.
c) culturing of biological indicators, or inoculated products.
NOTE Guidance on culturing biological indicators is included in ISO 14161.
Document History
May 18, 2020
Sterilization of health care products – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
1.1 This document specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been reduced relative to that...
November 30, 2009
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
1.1 This part of ISO 11737 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...
April 27, 2000
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process (ISO 11737-2:1998)
This part of ISO 11737 specifies the general criteria for tests of sterility on medical devices which have been exposed to a treatment with the sterilizing agent that is a fraction of the specified...
Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO/FDIS 11737-2:2019)
1.1 This document 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...
Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO/DIS 11737-2:2018)
1.1 This document 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...
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO/FDIS 11737-2:2009)
1.1 This part of ISO 11737 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...
DSF/PREN ISO 11737-2
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO/DIS 11737-2:2007)
1.1 This part of ISO 11737 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...