RO
SR EN 14180+A2:2009
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
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.
Status :
Withdrawn
Approval date : 12/15/2009
Publish date : 12/17/2009
Withdrawal date : 10/31/2014
Number of pages : 58
ICS : 11.080.10 Sterilizing equipment
Technical Committee : 377 - Medical devices
- Replaces SR EN 14180+A1:2009
- Normative reference SR EN 867-5:2002
- Normative reference SR EN ISO 228-1:2003
- Normative reference SR EN 60751:2002
- Normative reference SR EN ISO 11138-1:2007
- Normative reference SR EN ISO 3746:2009
- Normative reference SR EN ISO 11138-5:2007
- Normative reference SR EN 868-5:2009
- Normative reference SR EN 60584-2:2003
- Normative reference SR EN 61326-1:2006
- Normative reference SR EN 61010-2-040:2006
- Normative reference SR EN 61010-1:2002
- Replaced by SR EN 14180:2014