1 范围 ··························································································…… (1)
2 术语和定义 ·················································································…… (1)
2.1 血氧饱和度 ··············································································…… (1)
2.2 Sa02·······················································································…… (1)
2.3 Sp氏 ·······················································································…… (1)
2.4 脉搏血氧计 ··············································································…… (1)
2.5 脉搏血氧模拟器 ········································································…… (1)
2.6 脉搏血氧计的校准 ·····································································…… (1)
2.7 S,OZ测量误差 ···········································································…… (1)
3 概述 ··························································································…… (1)
4 计量特性 ····················································································…… (2)
4.1 S102‘’““·················································································…… (2)
4.2 脉搏 ·······················································································…… (2)
5 校准条件 ····················································································…… (2)
5.1环境条件 ·················································································…… (2)
5.2 标准设备 ·················································································…… (2)
6校准项目和校准方法 ·····································································……(2)
6.1 Sr02的测量范围和测量误差 ·························································…… (2)
6.2 脉搏测量范围和测量误差 ····························································…… (2)
7 校准结果表达 ··············································································…… (3)
8 复校时间间隔 ··············································································…… (3)
附录A 脉搏血氧计血氧饱和度校准的不确定度·······································…… (4)
附录B 校准证书内容········································································…… (5)
脉搏血氧计试行校准规范
范 围
本规范适用于脉搏血氧计的校准,同时也适用于多参数监护仪中脉搏血氧参数的校
准
2 术语和 定义
2.1 血氧饱和度
指动脉血氧与血红蛋白结合的程度,是单位血红蛋白含氧百分数。
2.2 Sg0z
表示由血气分析法测得的动脉血氧饱和度。用来确定SP仇的测量误差。
2.3 S102
表示由脉搏血氧计测得的动脉血氧饱和度。
2.4 脉搏血氧计
采用分光光度测定法,测量人体内动脉血氧饱和度的一种光电测量仪器。
2.5 脉搏血氧模拟器
视为一个虚拟的患者食指,通过模拟相应的R曲线,所复现的血氧饱和度 (约定)
真值,可对脉搏血氧计的性能进行校准。
校准所使用的脉搏血氧模拟器,需经试验证明能正确模拟 R曲线,并真实地复现
血氧饱和度 (约定)真值。
2.6 脉搏血氧计的校准
在规定的条件下,为确定脉搏血氧计所测量的血氧饱和度与脉搏血氧模拟器所复现
的血氧饱和度 (约定)真值之间关系的一组操作。
2.7 SPO,测量误差
利用脉搏血氧计测量的血氧饱和度值与脉搏血氧模拟器所复现的血氧饱和度 (约
定)真值计算总体标准差,以反映脉搏血氧计的血氧饱和度测量误差。
……