Particular requirements for the basic safety and essential performance of respiratory gas monitors
(ISO 21647:2004, including Cor 1:2005); German version EN ISO 21647:2009 Class/Status:
VDE Art. No.: 0750148
This Standard specifies particular requirements for the basic safety and essential performance of respiratory gas monitors intended for continuous use for humans. At present, this Standard specifies requirements for anaesthetic agent monitors, carbon dioxide monitors and oxygen monitors. Monitors intended for use with flammable anaesthetics are outside the scope of this International Standard. In this amended standard the new version of informative Annex ZA was added according the changes in the medical device directive.
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