UC知道翻译：血氧仪器临床测试英文标准9919
来源：百度知道 编辑：UC知道 时间：2024/05/29 23:46:53
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
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
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。