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关于ISO 80601-2-61 -2011之简介及性能分析
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Introduction
The approximation of arterial haemoglobin saturation and pulse rate using pulse oximetry is common practice
in many areas of medicine. This standard covers BASIC SAFETY and ESSENTIAL PERFORMANCE requirements
achievable within the limits of existing technology.
Annex AA contains a rationale for some of the requirements. It is included to provide additional insight into the
reasoning of the committee that led to a requirement and identifying the HAZARDS that the requirement
addresses.
Annex BB is a literature survey relevant to the determination of the maximum safe temperature of the interface
between a PULSE OXIMETER PROBE and a PATIENT‘S tissue.
Annex CC discusses both the formulae used to evaluate the SpO2 ACCURACY of PULSE OXIMETER EQUIPMENT
measurements， and the names that are assigned to those formulae.
Annex DD presents guidance on when in vitro blood calibration of PULSE OXIMETER EQUIPMENT is needed.
Annex EE presents a guideline for a CONTROLLED DESATURATION STUDY for the calibration of PULSE OXIMETER
EQUIPMENT.
Annex FF is a tutorial introduction to several kinds of testers used in pulse oximetry.
Annex GG describes concepts of PULSE OXIMETER EQUIPMENT response time.
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