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Norm
ÖNORM EN ISO 21647
Issue date: 2006 04 01
Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004) (consolidated version)
This International Standard specifies particular requirements for the basic safety and essential performance of
respiratory gas monitors (RGM) (as defined in 3.15) inten...
Withdrawn: 2010 01 01
Publisher:
Austrian Standards International
Format:
Digital | 52 Pages
Language:
German
| English
Currently valid:
Optionally co-design standards:
ICS
This International Standard specifies particular requirements for the basic safety and essential performance of
respiratory gas monitors (RGM) (as defined in 3.15) intended for continuous operation for use with humans.
This International Standard specifies requirements for
aa) anaesthetic gas monitoring,
bb) carbon dioxide monitoring,
cc) oxygen monitoring.
This International Standard is not applicable to monitors intended for use with flammable anaesthetic agents.
The requirements of this International Standard which replace or modify the requirements of
IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the
corresponding general requirements.
Environmental aspects are addressed in Annex CC.
NOTE Additional aspects of environmental impact are addressed in ISO 14971.
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2018 12 15
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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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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
ÖNORM EN ISO 21647
2009 09 15
Medical electrical equipment - Particular requirements for the basic safety and essential performanc...
Norm
ÖNORM EN ISO 21647
2006 04 01
Medical electrical equipment - Particular requirements for the basic safety and essential performanc...
Norm
↖
ÖNORM EN ISO 21647
2005 07 01
Medical electrical equipment - Particular requirements for the basic safety and essential performanc...
Norm
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 - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004, including Cor 1:2005)
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Issue date :
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Medical electrical equipment — Particular requirements for the basic safety and essential performance of respiratory gas monitors
