Anestetické a respirační přístroje

Komise : CEN/TC 215 (Respiratory and anaesthetic equipment)
Původce: CEN
K připomínkám do: 18.05.2018
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IEC 60601-1:2005+A1:2012, 1.1 is replaced by:

This International Standard applies to the basic safety and essential performance of medical supply units, hereafter also referred to as me equipment.

This International Standard applies to medical supply units manufactured within a factory or assembled on site, including cabinetry and other enclosures, which incorporate patient care services.

NOTE 1       A party that assembles on site various components intended for patient care services into an enclosure is considered the manufacturer of the medical supply unit.

Hazards inherent in the intended function of me equipment or me systems within the scope of this International Standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of IEC 60601-1:2005+A1:2012 (see 201.1.4).

NOTE 2       See also IEC 60601-1:2005+A1:2012, 4.2.

Komise : CEN/TC 215 (Respiratory and anaesthetic equipment)
Původce: CEN
K připomínkám do: 18.05.2018
Zobraz více Zobraz méně
 

Clause 1 of ISO 18190:2016 applies.

In addition:

This International, device-specific, Standard specifies requirements for laryngoscopes with non-flexible blades and handles, with internal battery-operated power sources, used for illuminating the larynx during intubation. It also specifies critical dimensions for those handles and blades with interchangeable hook‐on fittings.

It is not applicable to:

flexible laryngoscopes;

laryngoscopes designed for surgery;

laryngoscopes powered from mains electricity supply;

laryngoscopes connected by light‐transmitting cables to external light sources;

or

video laryngoscopes designed to work with an external, integral or attached video systém.