标准编号：ISO 80601-2-85:2021
中文名称：医用电气设备 第2-85部分：脑组织血氧计设备的基本安全性和基本性能的特殊要求
英文名称：Medical electrical equipment — Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment
发布日期：2021-03
标准范围
This document applies to basic safety and essential performance of cerebral tissue oximeter equipment, that employs light at multiple wavelengths to derive a quantitative measure of oxygen saturation of haemoglobin within the volume of tissue sampled under the probe attached to the head. The cerebral tissue oximeter equipment can be based on continuous light, frequency domain or time domain technologies. This document applies to ME equipment used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. Additional standards may apply to ME equipment for those environments of use.
NOTE 1 Cerebral tissue oximeters are sometimes referred to as near infrared spectroscopy equipment in medical literature.
Not included within the scope of this document are:
-- invasive tissue or vascular oximeters;
-- oximeters that require a blood sample from the patient;
-- equipment measuring dissolved oxygen;
-- ME equipment, or part thereof, that measures path-length-dependent haemoglobin change. The requirements for functional near-infrared spectroscopy equipment are found in ISO 80601-2-71 ;
-- ME equipment, or part thereof, that measures arterial saturation based on pulsatile changes in tissue optical properties (SpO2 ). The requirements for pulse oximeter equipment are found in ISO 80601-2-61 ;
-- ME equipment, or any part thereof, that claims to monitor tissue in parts of the body other than the head.
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