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Norm
ÖNORM EN ISO 9919
Issue date: 2009 09 01
Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005)
This International Standard specifies particular requirements for the basic safety and essential performance of pulse oximeter equipment intended for use on humans. This ...
Withdrawn: 2012 03 01
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 95 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
ICS
This International Standard specifies particular requirements for the basic safety and essential performance of pulse oximeter equipment intended for use on humans. This includes any part necessary for normal use, e.g. the pulse oximeter monitor, pulse oximeter probe, probe cable extender.
These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders, that has been reprocessed.
The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate on patients in healthcare institutions as well as on patients in home care.
ÖNORM EN ISO 80601-2-61
2019 07 15
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential per...
Norm
ÖVE/ÖNORM EN ISO 80601-2-61
2012 03 01
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential per...
Norm
ÖVE/ÖNORM EN ISO 80601-2-61
2012 03 01
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential per...
Norm
ÖNORM EN ISO 9919
2009 09 01
Medical electrical equipment - Particular requirements for the basic safety and essential performanc...
Norm
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ÖNORM EN ISO 9919
2005 10 01
Medical electrical equipment - Particular requirements for the basic safety and essential performanc...
Norm
Norm
Issue date :
2005 03 15
Medical electrical equipment — Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
Norm
Issue date :
2003 02 26
Clinical investigation of medical devices for human subjects — Part 1: General requirements
Norm
Issue date :
2003 05 16
Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
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Issue date :
2000 12 21
Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
Norm
Issue date :
2000 04 13
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied
Norm
Issue date :
2002 08 15
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Amendment 1
Norm
Issue date :
2004 01 28
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Amendment 2
Norm
Issue date :
2012 03 01
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2011) (english version)
Norm
Issue date :
2012 03 01
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2011) (german version)