40.60 Close of voting Apr 2, 2026
CEN
CEN/TC 204 Sterilization of medical devices
European Norm
07.100.10 Medical microbiology | 11.080.01 Sterilization and disinfection in general
Draft
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.
Legislation related to this standard
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
IN_DEVELOPMENT
prEN ISO 11737-3
40.60
Close of voting
Apr 2, 2026
