Reference number
ISO 11737-3:2023
International Standard
ISO 11737-3:2023
Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing
Edition 1
2023-06
Preview
ISO 11737-3:2023
76249
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Publicado (Edición 1, 2023)

ISO 11737-3:2023

ISO 11737-3:2023
76249
Idioma
Formato
CHF 194
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Resumen

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.

Informaciones generales

  •  : Publicado
     : 2023-06
    : Norma Internacional publicada [60.60]
  •  : 1
     : 62
  • ISO/TC 198
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