60.55 Ratification completed (DOR) Nov 11, 2024
CEN
CEN/TC 102 Sterilizers and associated equipment for processing of medical devices
European Norm
11.080.10 Sterilizing equipment
This document specifies requirements for washer-disinfectors (WD) that are intended to be used for emptying, flushing, washing and thermal disinfection of non-critical devices in the form of human waste containers by one operating cycle.
This document is intended to be used in conjunction with the general requirements specified in ISO 15883-1:2024, except for those specified in 4.1.1, and with the requirements of ISO 15883-5:2021, except for those specified in 4.1.2.
Legislation related to this standard
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
PUBLISHED
EN ISO 15883-3:2009
IN_DEVELOPMENT
FprEN ISO 15883-3
60.55
Ratification completed (DOR)
Nov 11, 2024