EN ISO 8185:1997

Humidifiers for medical use - General requirements for humidification systems (ISO 8185:1997)

Publication date:   Mar 19, 2004

Scope

Clause 1 of IEC 60601-1:1988 applies with the following amendment: ISO 8185 is one of a series of International Standards based on lEC 60601-1; in IEC 60601-1 (the "General Standard"), this type of International Standard is referred to as a "Particular Standardt. As stated in 1.3 of IEC 60601-1:1988, the requirements of this International Standard take precedence over those of IEC 60601-1. Humidifiers may be gas-powered, electrically powered, or both. However, this International Standard has been prepared as a Particular Standard based on IEC 60601-1, which gives general requirements for all aspects of safety, not only electrical safety, and many of the requirements are therefore applicable to humidifiers not powered by electricity. Where this International Standard specifies that a clause of IEC 60601-1 applies, it means that the clause applies only if the requirement is relevant to the humidifier system under consideration. This International Standard includes requirements for the safety and performance of humidifiers, as defined in 1.3.107, suitable for inclusion in breathing systems. This International Standard also includes some requirements for delivery tubes, including heated delivery tubes (heated-wire delivery tubes), and devices intended to control these heated delivery tubes, heated delivery tube controllers. This International Standard is not applicable to heat and moisture exchangers (HMEs). This International Standard is not applicable to devices commonly referred to as "room humidifiers" and humidifiers used in heating, ventilation and air conditioning systems, and humidifiers incorporated into infant incubators. This International Standard is not applicable to nebulizers used for the delivery of drugs to patients.

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