Standard

ISO 11737-3:2023

Jun 2023 Historical draft

Note: This standard has a new edition: ISO 11737-3:2023

Corrigendums and amendments are bought separately.

Language English

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Abstract

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.

Document information

Standard from ISO
Published: 26 June 2023
Expires: 27 March 2022
Edition: 1
Version: 1
Document type: IS
ISBN:

ICS 07.100.10
ICS 11.080.01
ISO TC ISO/TC 198

ISO 11737-3:2023

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ISO 11737-3:2023

ISO 11737-3:2023

ISO 11737-3:2023

ISO 11737-3:2004

ISO 11737-3:2004

ISO 11737-3:2004

Abstract

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Extended editions Extended editions (0)

Version history Related corrigendum and amendments (0)

Version history History (6)

ISO 11737-3:2023

ISO 11737-3:2023

ISO 11737-3:2023

ISO 11737-3:2004

ISO 11737-3:2004

ISO 11737-3:2004

Abstract

Document information