DSF/ISO/DIS 11737-3
Sterilization of health care products – Microbiological methods – Part 3: Bacterial endotoxin testing
inactive
| Organization: | DS |
| Status: | inactive |
| Page Count: | 68 |
| ICS Code (Medical microbiology): | 07.100.10 |
| ICS Code (Sterilization and disinfection in general): | 11.080.01 |
scope:
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 amoebocyte lysate reagents. NOTE - See Annex A for guidance on Clauses 1 to 10.
Document History
June 28, 2023
Sterilization of health care products – Microbiological methods – Part 3: Bacterial endotoxin testing
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)...
September 17, 2004
Sterilization of medical devices - Microbiological methods - Part 3: Guidance on the evaluation and interpretation of bioburden data
The standard provides guidance on evaluation and interpreting the data generated during routine monitoring of the microbiological quality of medical devices.
DSF/ISO/DIS 11737-3
Sterilization of health care products – Microbiological methods – Part 3: Bacterial endotoxin testing
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)...