ISO 21647:2004 PDF

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.

ISO 21647:2004 Referenced Document

IEC 60068-2-32:1975 Basic environmental testing procedures. Part 2 : Tests. Test Ed: Free fall
IEC 60079-4 Electrical apparatus for explosive gas atmospheres - Part 4: Method of test for ignition temperature; Amendment 1
IEC 60601-1-2:2001 Medical electrical equipment - Part 1-2: General requirements for safety; Collateral standard: Electromagnetic compatibility; Requirements and tests
IEC 60601-1-8:2003 Medical electrical equipment - Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 60601-1:1988 Medical electrical equipment; part 1: general requirements for safety
ISO 15223:2000 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied
ISO 594-2 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
ISO 7000 Graphical symbols for use on equipment — Index and synopsis*， 2019-07-12 Update

2005 ISO 21647:2004/cor 1:2005 Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors; Technical Corrigendum 1
2004 ISO 21647:2004 Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors