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Norm
ÖNORM EN ISO 80601-2-55
Issue date: 2018 12 15
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018)
IEC 60601-1:2005+Amd 1:2012, Clause 1 applies, except as follows:
IEC 60601-1:2005+Amd 1:2012, 1.1 is replaced by:
This document specifies particular requirements for t...
Valid
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 74 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
IEC 60601-1:2005+Amd 1:2012, Clause 1 applies, except as follows:
IEC 60601-1:2005+Amd 1:2012, 1.1 is replaced by:
This document specifies particular requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE of a RESPIRATORY GAS MONITOR (RGM), hereafter referred to as ME EQUIPMENT, intended for CONTINUOUS OPERATION for use with a PATIENT.
This document specifies requirements for
— anaesthetic gas monitoring,
— carbon dioxide monitoring, and
— oxygen monitoring.
This document is not applicable to an RGM intended for use with flammable anaesthetic agents.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005+Amd 1:2012, 7.2.13 and 8.4.1.
ÖNORM EN ISO 80601-2-55
2018 12 15
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential...
Norm
↖
ÖVE/ÖNORM EN ISO 80601-2-55
2012 04 01
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential...
Norm
ÖVE/ÖNORM EN ISO 80601-2-55
2012 04 01
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential...
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2009 09 15
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2006 04 01
Medical electrical equipment - Particular requirements for the basic safety and essential performanc...
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ÖNORM EN ISO 21647
2005 07 01
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ÖNORM EN 12598
1999 07 01
Oxygen monitors for patient breathing mixtures - Particular requirements
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ÖNORM EN ISO 11196
1998 02 01
Anaesthetic gas monitors (ISO 11196:1995 including Technical Corrigendum 1:1997)
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Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors