ISO - 11737-3
Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing
active, Most Current
| Organization: | ISO |
| Publication Date: | 1 June 2023 |
| Status: | active |
| Page Count: | 70 |
| ICS Code (Medical microbiology): | 07.100.10 |
| ICS Code (Sterilization and disinfection in general): | 11.080.01 |
scope:
Inclusions
This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in health care products, components or raw materials using bacterial endotoxins test (BET) methods, using amebocyte lysate reagents.
Exclusions
This document is not applicable to the evaluation of pyrogens other than bacterial endotoxins. Other endotoxin detection methodologies are not included.
This document does not address setting specific endotoxin limit specifications.
Document History
11737-3
June 1, 2023
Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing
Inclusions
This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in health care products, components or raw materials using bacterial endotoxins...
July 1, 2004
Sterilization of medical devices Microbiological methods Part 3: Guidance on evaluation and interpretation of bioburden data
This part of ISO 11737 provides guidance on evaluating and interpreting the data generated during routine monitoring of the microbiological quality of medical devices.
This part of ISO 11737 is not...