99.60 Withdrawal effective Jul 15, 2009
CEN
CEN/TC 102 Sterilizers and associated equipment for processing of medical devices
European Norm
11.080.10 Sterilizing equipment
This European Standard 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.
This European Standard specifies minimum requirements:
- for the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices;
- for the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.
Legislation related to this standard
Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
WITHDRAWN
EN 14180:2003+A1:2009
99.60
Withdrawal effective
Jul 15, 2009