Draft Details

Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing (New Standard)
Designation:CSA ISO 11737-3
Source:CSA
Review start date:Apr 24, 2026
Review end date:Jun 23, 2026
Contact email:robin.chevalier(at)csagroup.org
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Draft Scope/Description:

1 Scope

1.1 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.

1.2 Exclusions

1.2.1 This document is not applicable to the evaluation of pyrogens other than bacterial endotoxins. Other endotoxin detection methodologies are not included (see B.12).

1.2.2 This document does not address setting specific endotoxin limit specifications.

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