SS-EN-ISO-21647 › Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004 incl. Cor 1:2005)
Show Complete Document History
The following bibliographic material is provided to assist you with your purchasing decision:
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.
To find similar documents by classification:
Medical devices. Revised Machinery Directive
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
SS-EN ISO 21647:2009
April 27, 2009
EN ISO 21647:2009(IDT); ISO 21647:2004(IDT); ISO 21647:2004/Cor 1:2005(IDT)