ISO 11737-3:2023
Current
The latest, up-to-date edition.
Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing
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English, French
26-06-2023
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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.
| Committee |
ISO/TC 198
|
| DocumentType |
Standard
|
| Pages |
62
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Standards | Relationship |
| DS/ISO 11737-3:2023 | Identical |
| NF ISO 11737-3:2023 | Identical |
| SS-ISO 11737-3:2024 | Identical |
| NS-EN ISO 13408-1:2024 | Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023) |
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