英语翻译50.101.2 Determination of SpO2 accuracy50.101.2.1 *Date collectionThe claims of SpO2 accuracy shall be supported by clinical study measurements taken over the full range,±3%,of SaO2 values for which SpO2 accuracy is claimed.The clinical

英语翻译50.101.2 Determination of SpO2 accuracy50.101.2.1 *Date collectionThe claims of SpO2 accuracy shall be supported by clinical study measurements taken over the full range,±3%,of SaO2 values for which SpO2 accuracy is claimed.The clinical
英语翻译
50.101.2 Determination of SpO2 accuracy
50.101.2.1 *Date collection
The claims of SpO2 accuracy shall be supported by clinical study measurements taken over the full range,±3%,of SaO2 values for which SpO2 accuracy is claimed.The clinical study shall comply with the requirements of ISO 14155-1 and ISO 14155-2.
Data points should be recorded with comparable density ove the full range claimed.
NOTE See also Annex EE.
Conditions which adversely affect the SpO2 accuracy need nto be stated as part of the SpO2 accuracy specification,but shall be disclosed in the accompanying.documents,as required by 6.8.2 aa)3.
A summary of the test methods used to establish the SpO2 accuracy claims shall be disclosed in the technical description.
Functional testers or patient simulators shall ont be used to validate the SpO2 accuracy of pulse oximeter equipment.
50.101.2.2*Date analysls
For each range specified,SpO2 accuracy of the pulse oximeter equipment shall be stated in terms of the root-mean-square (rms) difference between measured values (SpO2i)and reference Values (SRi),as given by the following formula :
n
Arms=∑(SpO2i-SRi)2
i=1
n
NOTE 1 The concepts of bias and precision as given in reference[3] and ambiguity as given in reference[54] also have value in representing the accuracy of medical equipment .The decision to require the form of SpO2 accuracy stated above (which has been traditional in pulse oximetry,although under the misnomer “standard deviation ”) is based on the belief that it will be more widely understood by the general community of clinical operators and on the recognition that in some cases it represents the overall SpO2 accuracy of pulse oximeter equipment better than do bias and precision.
NOTE 2 Attention is also drawn to VIM[64]and the GUM (Guide to the Expression of Uncertainty in Measurement )[65] as well as the document of ISO/TC 69,Applications of statistical methods,for determination of accuracy and precision .
The standard reference for the SpO2 accuracy as read by pulse oximeter equipment shall be traceable to SaO2 values obtained from CO-oximeter analysis of simultaneously drawn arterial blood.The CO-oximeter should have a SaO2 accuracy of 1％ (1 standard deviation )or better over the range for which the manufacturer makes SpO2 accuracy claims.Quality assurance procedures for verifying CO-oximeter accuracy that are required in laboratories reporting clinical data should be utilized.
EXAMPLE Available procedures are available for example from NCCLS[5]and the College of American Pathologists [18].
NOTE 3 It is not appropriate to use SaO2 values calculated from measurements made by blood gas analysers that actually measure PaO2 (arterial oxygen pressure) rather than SaO2.
NOTE 4 See also Annex EE.

英语翻译50.101.2 Determination of SpO2 accuracy50.101.2.1 *Date collectionThe claims of SpO2 accuracy shall be supported by clinical study measurements taken over the full range,±3%,of SaO2 values for which SpO2 accuracy is claimed.The clinical
50.101.2测定血氧饱和度的准确性
50.101.2.1 *日期收集
索赔的血氧饱和度的准确性,应予以支持的临床研究测量接管了全套,± 3 ％ ,血氧饱和度值,其中血氧饱和度的准确性是claimed.the的临床研究应遵守的要求,国际标准化组织14155-1和ISO 14155-2 .
数据点都应加以记录,具有可比性的密度奥雅纳全套声称.注意：也见附件电子工程专辑.
条件产生不利影响的血氧饱和度的准确性,不必说明,作为部分的血氧饱和度的准确性,规范,但应尽快加以披露,在accompanying.documents所要求的那样,6.8.2机管局） 3 .
总结了测试方法用于建立血氧饱和度的准确性,索赔应予以披露,在技术说明.
功能测试或病人模拟器应的ONT被用来验证血氧饱和度的准确性,脉冲oximeter设备.
50.101.2.2 *数据分析
为每个指定的范围内,血氧饱和度的准确性,脉搏oximeter设备应在条款规定的均方根（均方根）的区别实测值（ spo2i ）和参考值（斯里兰卡） ,给予下列公式：
n
Arms=∑(SpO2i-SRi)2
i=1
n
注1的概念,偏见和精确给出了参考[ 3 ]和含糊之处,给出了参考[ 54 ]也有价值的代表的准确性,医疗设备.该决定规定的形式,血氧饱和度的准确性以上（已在传统的脉搏血氧仪,虽然下用词不当“标准偏差” ）的基础上,相信这将得到更广泛的理解,一般社区的临床营办商及关于承认在某些情况下,它代表了整体的血氧饱和度的准确性,脉冲oximeter设备总比做的偏见和精度.
注2还提请注意在Vim [ 64 ]和胶（指南,以表达测量不确定度） [ 65 ] ,以及为文件的ISO /技术合作69 ,应用统计方法,测定准确度和精密度.
标准的参考依据血氧饱和度的准确性为已读脉冲oximeter设备应可追溯至血氧饱和度值所得的合作,oximeter分析,同时得出的动脉血压.的合作,oximeter应该有一个,血氧饱和度的准确性,1 ％ （ 1标准偏差）或更好的超过范围为制造商,使血氧饱和度的准确性claims.quality保证程序,核实合作,oximeter的准确性,是需要在实验室报告的临床资料,应利用.
例如可用的程序,供,例如从nccls [ 5 ]和美国病理学院[ 18 ] .
注3是不恰当的使用血氧饱和度的计算值从测量所作出的血气分析仪,其实措施,动脉血氧分压（动脉血氧分压的压力） ,而不是血氧饱和度.
注4见附件电子工程专辑.