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Standard [WITHDRAWN] 2012-01

DIN EN ISO 80601-2-61:2012-01;VDE 0750-2-61:2012-01

VDE 0750-2-61:2012-01

Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2011); German version EN ISO 80601-2-61:2011

German title
Medizinische elektrische Geräte - Teil 2-61: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Pulsoximetriegeräten (ISO 80601-2-61:2011); Deutsche Fassung EN ISO 80601-2-61:2011
Publication date
2012-01
Original language
German

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Publication date
2012-01
Original language
German

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Overview

This part of the standard series describes the safety requirements for pulse oximeter equipment intended for use on humans. The approximation of arterial oxygen haemoglobin saturation and pulse rate using pulse oximetry is common practice in many areas of medicine. This product standard from the standards of the series DIN EN 606060-1 (VDE 0750-1) describes the safety requirements for pulse oximeter equipment and accessories, such as monitor, probe and cable extender. The informative part provides the following, amongst others: - a literature survey relevant to the determination of the maximum safe temperature of the interface between a pulse oximeters probe and the patient's tissue; - a discussion of the formulae used to evaluate the SPO2 accuracy of pulse oximeter equipment measurements, and the names that are assigned to those formulae; - guidance on when in vitro blood calibration of pulse oximeters equipment is needed; - a guideline for a controlled desaturation study for the calibration of pulse oximeters equipment; - a tutorial introduction to several kinds of testers used in pulse oximetry; - a description of concepts of pulse oximeters equipment response time. The responsible committee is Subcommittee UK 812.1 "Diagnostik" ("Diagnostics") of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE.

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