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DSF/prEN ISO 21647

Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004, including Cor 1:2005)

pending
Organization: DS
Status: pending
Page Count: 57
ICS Code (Anaesthetic, respiratory and reanimation equipment): 11.040.10
scope:

IEC 60601-1:1998, Clause 1, applies, except as follows. Amendment (add at the end of 1.1): 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.

Document History

June 3, 2009
Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors
This International Standard is a Particular Standard based on IEC 60601-1:1998, including Amendments 1 (1991) and 2 (1995, hereafter referred to as the General Standard. The General Standard is the...
April 19, 2006
Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors
This standard specifies particular requirements for the basic safety and essential performance of respiratory gas monitors intended for continuous operation for use with humans.
February 2, 2005
Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors
This standard specifies particular requirements for the basic safety and essential performance of respiratory gas monitors intended for continuous operation for use with humans.
DSF/prEN ISO 21647
Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004, including Cor 1:2005)
IEC 60601-1:1998, Clause 1, applies, except as follows. Amendment (add at the end of 1.1): This International Standard specifies particular requirements for the basic safety and essential performance...
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