EN 14180:2003

Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing EN 14180:2003

Publication date:   Jan 22, 2004

General information

99.60 Withdrawal effective   May 13, 2009

CEN

CEN/TC 102 Sterilizers and associated equipment for processing of medical devices

European Norm

11.080.10   Sterilizing equipment

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Scope

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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

NOW

WITHDRAWN
EN 14180:2003
99.60 Withdrawal effective
May 13, 2009

CORRIGENDA / AMENDMENTS

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EN 14180:2003/prA1

ABANDON
EN 14180:2003/prA2