Published
ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.
NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.
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
HarmonizedRegulation (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
Harmonized
                WITHDRAWN
                                    SRPS CEN ISO/TS 11135-2:2011
                            
                WITHDRAWN
                                    SRPS EN ISO 11135-1:2008
                            
                WITHDRAWN
                                    SRPS ISO 11135:1998
                            
                    PUBLISHED
                    SRPS EN ISO 11135:2015
                    60.60
                                        Standard published
                    Jun 22, 2015