Standard

ISO 11737-3:2023

Attuale

Le modifiche e le versioni esistenti o nuove devono essere acquistate separatamente.

Lingua
Servizi

Astratto

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.

Specifiche dei prodotti

  • Standard da ISO
  • Pubblicato:
  • Edizione: 1
  • Tipo di documento: IS
  • Pagine
  • Publisher ISO
  • Distributor ISO
  • ICS 07.100.10
  • ICS 11.080.01
  • International TC ISO/TC 198