GB/T 19702-2005 体外诊断医疗器械生物源性样品中量的测量 参考测量程序的说明

ICS11.040

C30

中华人民共和国国家标准

GB/T19702-2005/ISO15193:2002

体外诊断医疗器械

生物源性样品中量的测量

参考测量程序的说明

Invitrodiagnosticmedicaldevices-

Measurementofquantitiesinsamplesofbiologicalorigin-

Presentationofreferencemeasurementprocedures

(ISO15193:2002,IDT)

2005-03-23发布2005-12-01实施

中华人民共和国国家质量监督检验检疫总局发布

中国国家标准化管理委员会

GB/T19702-2005/ISO15193:2002

目次

前言·············。································································································……工

引言·········································································································，·······……n

1范围······························································，·········································，······……1

2规范性引用文件·······························································································……1

3术语和定义··········、···························，·······························································……1

4参考测量程序的说明························································································…·…2

4.1书面参考测量程序的要素························，··················································…·…“2

4.2警告和安全性注意事项·······，·····································，，···········，·········，···············一·3

4.3弓}b···········································································································…‘…4

4.4范围，··，····，··，，，，····，，·，··········，，，···，，，，······，，····，，，，，二4

4.5术语·····，························，，··················，··················，，····································……4

4.6测量原理和方法············。································，···············································……4

4.7核查表·······················、··············································································……4

4.8试剂·······································································，··············，·················，····一·5

4.9仪器············································································································……6

4.1。采样和样品··································································································……6

4.11测量系统和分析部分的准备································，·······，··································…·…7

4.12测量系统的操作························································，····································……7

4.13数据处理·······································································································一·8

4.14分析可靠性·····，································、···························································，··…8

4.15特殊事项········。····························，····························································……10

4.1G通过实验室间的研究进行验证························、··························，····················……10

4.17报告·························································、···············································……17

4.18质量保证···················································，······，·····························，，··········，·…11

4.19参考文献···································································································……11

4.2。发布和修订日期·······················，·······························································……n

附录A(资料性附录)除量以外的参数的参考程序·······································，··，···········……12

附录B(资料性附录)参考文献·····························································，···············……13

表1参考测量程序说明中的要素·····································，··········，·······…·…““”、·“’““””3

GB/T19702-2005/ISO15193:2002

月明吕

本标准等同采用ISO15193:2002((体外诊断医疗器械—生物源性样品中量的测量—参考测量

程序的说明》。

本标准等同翻译ISO15193:2002,

为便于使用，本标准做了下列编辑性修改:

—本“国际标准”一词改为“本标准”;

—用小数点.“”代替作为小数点的逗号“，”;

—将“大写字母或粗体字”改为“黑体字，’:

—删除国际标准的前言。

本标准的附录A和附录B为资料性附录。

本标准由国家食品药品监督管理局提出。

本标准由全国医用临床检验实验室和体外诊断系统标准化技术委员会归口。

本标准起草单位:北京市医疗器械检验所。

本标准主要起草人:胡冬梅、毕春雷、章兆园、丛玉隆、郭健。

GB/T19702-2005/1S015193:2002

引言

在科学、技术和常规服务工作中，为了获得有用且可靠的测量结果，必须有参考测量系统做支持，以

使其具有可比性并且可溯源至最高计量学水平的测量标准。在这样一个计量系统中，分析用参考测量

程序起到了很重要的作用，因为它们可以用于:

—评价测量系统的操作特性一包括测量仪荔、辅助设备和试剂;

—证明用于测量同一量的不同常规测量程序的功能互换性;

—为参考物质赋值，然后再用其对常规测量程序进行校准和控制;

—检测患者样品中影响分析的量。

尤其对于临床实验室测量来说，把具有充分可比性、可以重现并且准确的结果报告给临床医生和患

者，对于急性和连续性患者护理是非常重要的。

某些情况下，当一个参考测量程序与:

—在标准、技术要求或技术法规等规定的;

—应由供应商明确表述数值的;

—产品或过程的性能有直接关系的。

技术要求有关时，该参考测量程序应以书面标准的形式给出。

ISO/IEC指南15中对制定此类标准的益处进行了描述。

GB/T19702-2005/ISO15193:2002

体外诊断医疗器械

生物源性样品中量的测量

参考测量程序的说明

范围

本标准规定了起草参考测量程序的要求。

注:本标准旨在达到这样的目的:一个有经验的实验室工作者，按照符合本标准的一个书面的测量程序操作，可获得

测量不确定度不超出规定范围的结果。

本标准适用于在实验医学各个学科分支中，需要进行参考测量程序文件制作的所有个人、机构或研

究所。

2规范性引用文件

下列标准中的条款通过本标准的引用而成为本标准的条款。凡是注日期的引用文件，其随后所有

的修改单(不包括堪误的内容)或修订版均不适用于本标准，然而，鼓励根据本标准目的达成协议的各方

研究是否可使用这些文件的最新版本。凡是不注日期的引用文件，其最新版本适用于本标准

GB6682分析实验室用水规格和试验方法

ISO6353-2化学分析试剂—第2部分:规范—第1系列

ISO6353-3化学分析试剂—第3部分:规范—第2系列

ISO/IEC指南—第2部分:1992国际标准的制定方法

国际计量学基础和通用术语词汇(VIM)，第2版，日内瓦:ISO,1993""'

测量不确定度表达指南，第1版，日内瓦:ISO,1993"

术语和定义

计量学基础和通用术语国际词汇((3.1和3.2引自VIM)以及“测量不确定度表达指南”中的以及下

列术语和定义适用于本标准

3.1

原始样品primarysample

从一个系统中最初取出的一或几个部分采集物，旨在提供该系统的信息或作为对该系统状态进行

判定的基础。

注:在某些情况下，所提供的信息可以应用于一个更大的系统或一