英语翻译50.101.2.3 Characteristics of the clinical study populationThe summary of the clinical study report used to access SpO2 accuracy shall state whether the test subjects were sick or healthy and shall describe their skin colour,age and gende

英语翻译50.101.2.3 Characteristics of the clinical study populationThe summary of the clinical study report used to access SpO2 accuracy shall state whether the test subjects were sick or healthy and shall describe their skin colour,age and gende
英语翻译
50.101.2.3 Characteristics of the clinical study population
The summary of the clinical study report used to access SpO2 accuracy shall state whether the test subjects were sick or healthy and shall describe their skin colour,age and gender.This information shall be disclosed in the accompanying documents.
50.102 Accuracy under conditions of motion
If a manufacturer claims that the pulse oximeter equipment is accurate during motion,accuracy specifications during motion shall be disclosed in the instructions for use.
A summary of the test methods used to establish the accuracy claims during motion shall be disclosed in the technical description.
Check the compliance by inspection of the instructions for use and technical description.
50.103 Accuracy under conditions of low perfusion
If a manufacturer claims that the pulse oximeter equlpment is accurate under conditions of low perfusion,accuracy specifications under these conditions shall be disclosed in the instructions for use.
A summary of the test methods used to establish the accuracy claims under conditions of low perfusion shall be disclosed in the technical description.
Check the compliance by inspection of the instructions for use and technical description.
50.104 Pulse rate accuracy
Pulse rate accuracy shall be stated sa the root-mean-square(rms)difference between paired pulse rate data recorded with the pulse oximeter equipment and with a reference method.Pulse rate accruacy shall be stated either over the full claimed range of the pulse oximeter equipment or as separate pulse rate accuracy specifications over segments of that range.The reference method for the computation of pulse rate accuracy may be,for example,an electronic pulse simulator,ECG heart rate,palpated pulse,thoracic auscultations or a second pulse oximeter equipment which has been qualified by comparison to one of these references.
Check the compliance by inspection.

英语翻译50.101.2.3 Characteristics of the clinical study populationThe summary of the clinical study report used to access SpO2 accuracy shall state whether the test subjects were sick or healthy and shall describe their skin colour,age and gende
50.101.2.3特点的临床研究人口
综述的临床研究报告,用来存取血氧饱和度的准确性,应说明是否试验受试者生病或健康,并应描述他们的肤色,年龄和gender.this资料应予以披露,在所附的文件.
50.102精度的条件下,议案
如果一个制造商声称,脉冲oximeter设备是准确的期间议案,准确性规格期间的议案,应予以披露,在使用指示.
总结了测试方法可用来建立的准确性,索赔期间的议案,应予以披露,在技术说明.
检查遵守检查的指示,为使用和技术说明.
50.103精度的条件下,低灌注
如果一个制造商声称,脉冲oximeter equlpment是准确的条件下,低灌注,准确性规格,在这种情况下,应予以披露,在使用指示.
总结了测试方法可用来建立的准确性,索赔的条件下,低灌注,应予以披露,在技术说明.
检查遵守检查的指示,为使用和技术说明.
50.104脉冲率的准确性
脉冲率的准确性,应说明该公司的均方根（均方根）的区别成对脉冲率记录的数据与脉冲oximeter设备和具有参考method.pulse率精度应说明要么超过充分声称,一系列的脉冲oximeter设备或作为单独的脉冲率的准确性,规格,超过部分即range.the参考方法计算脉冲率的准确性可能,例如,一个电子脉冲模拟器,心电图,心率,脉搏palpated ,胸auscultations或第二个脉冲oximeter设备已合格的比较,其中的参考.
检查遵守检查.