翻译：血氧仪器临床测试英文标准991950 Accuracy of operating dataIEC 60601-1:1988,Clause 50 applies,except as follows.Addition: *SpO2 accuracy of pulse oximeter equipment50.101.1 *SpecificationThe SpO2 accuracy of pulse oximeter eq

翻译：血氧仪器临床测试英文标准991950 Accuracy of operating dataIEC 60601-1:1988,Clause 50 applies,except as follows.Addition: *SpO2 accuracy of pulse oximeter equipment50.101.1 *SpecificationThe SpO2 accuracy of pulse oximeter eq
翻译：血氧仪器临床测试英文标准9919
50 Accuracy of operating data
IEC 60601-1:1988,Clause 50 applies,except as follows.
Addition:
*SpO2 accuracy of pulse oximeter equipment
50.101.1 *Specification
The SpO2 accuracy of pulse oximeter equipment shall be a root-mean-square difference of less than or equal to 4,0% SpO2 over the range of 70%to 100%SaO2.
The declared ranges of SpO2 and SpO2 accruacy over those ranges shall be disclosed in the instructions for use. The SpO2 accuracy shall be stated over the range 70%to 100%(see 50.101.2.1). SpO2 accuracy information shall be accompanied by a note reminding the reader that,because pulse oximeter equipment measurements are statistically distributed,only about two-thirds of pulse oximeter equipment measurements can be expected to fall within±Arms of the value measured by a CO-oximeter .When a pulse oximeter montitor is suitable for use with a variety of pulse oxlmeter probes, SpO2 accuracy information shall be made available for each type of pulse oximeter probe .Additional SpO2 accuracy specifications over other ranges may also be provided.
If SpO2 accuracy claims in a range below 65% SpO2 are made, SpO2 accuracy shall be stated in an additional range over a span of saturation not to exceed 20% SpO2.
EXAMPLE 1 A specified SpO2 accuracy range of 60%to 80% SpO2.
EXAMPLE 2 A specified SpO2 accuracy range of 60%to 70% SpO2..
Check the compliance by following the requirements of 50.101.2 and inspection of the accompanying documents.

翻译：血氧仪器临床测试英文标准991950 Accuracy of operating dataIEC 60601-1:1988,Clause 50 applies,except as follows.Addition: *SpO2 accuracy of pulse oximeter equipment50.101.1 *SpecificationThe SpO2 accuracy of pulse oximeter eq
50的准确性,营运数据
的IEC 60601-1:1988 ,第50条适用,除如下.
此外：
*血氧饱和度的准确性,脉冲oximeter设备
50.101.1 *规格
该血氧饱和度的准确性,脉冲oximeter设备应一的均方根差异小于或等于4,0 ％ ,血氧饱和度超过范围的70 ％至100 ％ ,血氧饱和度.
申报的范围,血氧饱和度和血氧饱和度精度超过这些范围,应予以披露,在使用指示.该血氧饱和度的准确性,应予以载明的范围超过70 ％至100 ％ （见50.101.2.1 ） .血氧饱和度的准确性,资料应附有一份说明,提醒读者,由于脉冲oximeter设备测量统计分布,只有约三分之二的脉冲oximeter设备测量可以预料,属于±武器的价值来衡量一个合作, oximeter当一个脉冲oximeter montitor适合用在各种脉冲oxlmeter探头,血氧饱和度信息的准确性,应提供每类脉冲oximeter探针.额外的血氧饱和度的准确性,规格超过其他范围也可提供.
如果血氧饱和度的准确性,要求在一个范围内低于65 ％ ,血氧饱和度是,血氧饱和度的准确性,应在一额外的范围跨度饱和度不超过20 ％ ,血氧饱和度.
例如一指定的血氧饱和度的精度范围内的60 ％至80 ％ ,血氧饱和度.
示例2指定的血氧饱和度的精度范围内的60 ％至70 ％ ,血氧饱和度..
检查遵守下列规定50.101.2和检查所附的文件.