60.60 Standard published Apr 2, 2025
CEN
CEN/TC 102 Sterilizers and associated equipment for processing of medical devices
European Norm
11.080.10 Sterilizing equipment
Published
1.1 This document specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only.
These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities.
1.2 This document specifies minimum requirements:
- for the performance and design of sterilizers intended to deliver an LTSF process capable of sterilizing medical devices;
- for the equipment and controls of these sterilizers which are needed for operation, control and monitoring of the sterilization processes, and which can be used for validation of the sterilization process.
1.3 This document specifies further test equipment and test procedures used to verify conformance of the equipment design and performance specified by this document.
1.4 This document does not specify requirements and tests for decontamination systems for use in rooms, enclosures, or environmental spaces.
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
Harmonised Standard / Cited in the Official Journal
WITHDRAWN
EN 14180:2014
PUBLISHED
EN 14180:2025
60.60
Standard published
Apr 2, 2025
