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prEN ISO 11737-3

Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing (ISO 11737-3:2023)

Draft New
Comment end date 2026-03-17
Export comments

Project stage codes

1. Decision on WI Proposal
2. Projektas
3. Viešoji apklausa
From 2026-01-16 till 2026-03-17
4. Closure of enquiry
5. Submission to Formal Vote

Organisation

CEN Europos standartizacijos komitetas

ICS

07.100.10 - Medical microbiology

Technical Committee

TK 32 Health

ForeignTC'S

CEN/TC 204

Number of comments

0

Comment start date

2026-01-16

Scope

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