20.60 Close of comment period Jul 24, 2024
CEN
CEN/TC 102 Sterilizers and associated equipment for processing of medical devices
European Norm
This document specifies requirements for electrically heated steam boilers manufactured from stainless steel specifically dedicated for generating steam for sterilizers and disinfectors.
This document covers only steam boilers that are heated by immersion heaters and which have a maximum allowable pressure (PS) of not greater than 6 bar, a maximum volume (V) of 1 000 litres and a product of PS ∙ V not greater than 3 000 bar ∙ l.
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
Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment
PUBLISHED
EN 14222:2021
IN_DEVELOPMENT
EN 14222:2021/prA1
20.60
Close of comment period
Jul 24, 2024
