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Norm

ÖNORM EN 285

Issue date: 2016 04 01

Sterilization - Steam sterilizers - Large sterilizers

This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices an...
Withdrawn: 2022 03 01
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 104 Pages
Language:
German | English
Currently valid:
This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this European Standard are selected to represent the majority of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizers for medical devices. However, specific loads (e.g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads. This European Standard applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l. Large steam sterilizers can also be used during the commercial production of medical devices. This European Standard does not specify requirements for large steam sterilizers intended to use, contain or be exposed to flammable substances or substances which could cause combustion. This European Standard does not specify requirements for equipment intended to process biological waste or human tissues. This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer.
ÖNORM EN 285
2022 03 01
Sterilization - Steam sterilizers - Large sterilizers
Norm
ÖNORM EN 285
2016 04 01
Sterilization - Steam sterilizers - Large sterilizers
Norm
ÖNORM EN 285
2009 09 15
Sterilization - Steam sterilizers - Large sterilizers
Norm
ÖNORM EN 285
2008 06 01
Sterilization - Steam sterilizers - Large sterilizers
Norm
ÖNORM EN 285
2006 07 01
Sterilization - Steam sterilizers - Large sterilizers
Norm
ÖNORM EN 285/AC
1998 10 01
Sterilization - Steam sterilizers - Large sterilizers (Corrigendum)
Norm
ÖNORM EN 285/AC1
1997 06 01
Sterilization - Steam sterilizers - Large sterilizers (Corrigendum)
Norm
ÖNORM EN 285
1997 02 01
Sterilization - Steam sterilizers - Large sterilizers
Norm
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Norm
ÖNORM EN 285
Issue date : 2022 03 01
Sterilization - Steam sterilizers - Large sterilizers