BAS EN 14180:2005

Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing


General Information
Status: Withdrawn
No. of pages: 54
Language: English
Edition: 1.
Adoption method: Endorsment
Publication date: 21.12.2005
Directive:
93/42/EEC, Medical devices
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Abstract
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: ¾ 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.

Lifecycle
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Original document and degree of correspondence
  • EN 14180:2003, identical

Relation to BAS standards