ISO-11737-3 › Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing

ISO-11737-3 - 1ST EDITION - CURRENT -- See the following: ISO-11737-1
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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. This document is not applicable to the evaluation of pyrogens other than bacterial endotoxins. Other endotoxin detection methodologies are not included (see B.12). This document does not address setting specific endotoxin limit specifications.

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07.100.10 (Medical microbiology Laboratory medicine, see 11.100)

11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)

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Document Number

ISO 11737-3:2023

Revision Level

1ST EDITION

Status

Current

Publication Date

June 1, 2023

Committee Number

ISO/TC 198