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ANS/ISO7767-97
Oxygen Monitors for Monitoring Patient Breathing Mixtures-Safety Requirements (NOTICE: This standard has been withdrawn and replaced by ANSI/ISO 21647. Contact ASTM International (www.astm.org) for the latest information.)
42 стр.
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ICS:
11.040.10 Anaesthetic,. Including medical gas installations / Наркозные, дыхательные и реанимационные аппараты
Тематика:
Medical Services
Описание
Область применения

ISO 7767 was adopted as ANS/ISO 7767-97 with deviations.

IS0 7767 is one of a series of International Standards based onIEC 601-I (the "General Standard"). This type of InternationalStandard is referred to as a "Particular Standard". As stated in1.3 of IEC 601-1:1988, the requirements of this InternationalStandard take precedence over those of IEC 601-I.

The scope given in clause 1 of IEC 601-I:1988 applies exceptthat 1.1 shall be replaced by the following:

This International Standard specifies safety requirements foroxygen monitors, as defined in clause 1.3.14, intended for use indetermining the oxygen level in gas mixtures. Both diverting andnon-diverting oxygen monitors are covered.

The field of application includes, but is not limited to:

a) anaesthetic machines and breathing systems;
b)W ventilators;
c) infant incubators;
d) oxygen concentrators.

Devices that do not "measure and indicate" are not intended tobe covered by this International Standard. For instance, a devicethat has no function other than to signal an alarm at a specificoxygen level would not be considered to be an oxygen monitor foruse in direct patient monitoring applications.

The phrase "in a gaseous mixture" implies that devices that measureor monitor oxygen in a liquid phase (for example, blood gasanalyzer or indwelling catheters) are not covered by thisInternational Standard.

Oxygen monitors intended for use in laboratory researchapplications are outside the scope of this InternationalStandard.