60.60 Standard published Apr 22, 2026
CEN
CEN/TC 205 Non-active medical devices
European Norm
11.200 Birth control. Mechanical contraceptives
This document specifies requirements and test methods for male condoms made from natural rubber latex.
This document does not specify requirements related to any medicinal substances applied to or delivered by the condom.
NOTE The safety and effectiveness of any medicinal substance are assessed according to national and regional regulations.
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
WITHDRAWN
EN ISO 4074:2015
PUBLISHED
EN ISO 4074:2026
60.60
Standard published
Apr 22, 2026