定义并描述被测对象特性的标准化方法,用于统一测量结果。包含确定测量量的参考方法,以及评估其他测量程序准确度的校准方法。
| 标准号 & 类别 | 标准名称 | 发布 |
|---|---|---|
| BS EN 12286:1999(2001) 规范 |
体外诊断医疗美利体育官网首页网址.生物有机体试样数量测量.参考测量过程说明 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures
分析样品 |
1999-01-01 英国标准学会 |
| BS EN 14136:2004 规范 |
Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
|
2004-05-26 英国标准学会 |
| BS EN ISO 15193:2009 规范 |
体外诊断医疗器械.生物源样品的数量测量.基准测量规程的内容和表示要求 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures
分析样品 |
2009-05-31 英国标准学会 |
| BS EN ISO 15193:2009(2016) 规范 |
体外诊断医疗器械 生物来源样品中数量的测量 参考测量程序的内容和表示的要求 In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for content and presentation of reference measurement procedures
|
2016-01-01 英国标准学会 |
| BS EN ISO 15195:2019 规范 |
Laboratory medicine. Requirements for the competence of calibration laboratories using reference measurement procedures
不确定度 |
2019-02-28 英国标准学会 |
| BS IEC 61935-1-2:2018 试验标准 |
平衡和同轴信息技术布线测试规范 ISO/IEC 11801 中规定的已安装平衡布线 使用现场测试仪器测量电阻不平衡的附加要求 Specification for the testing of balanced and coaxial information technology cabling - Installed balanced cabling as specified in ISO/IEC 11801. Additional requirements for measurement of resistance unbalance with field test instrumentation
电阻不平衡 |
2018-12-31 英国标准学会 |
| CLSI C45-A-2004 指南标准 |
Approved Guidelines for Measuring Free Thyroid Hormone
|
2004 临床与实验室标准协会 |
| DIN EN 14136:2004 规范 |
Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures; German version EN 14136:2004
体外诊断 |
2004-08 德国标准化学会 |
| DIN EN 14136:2004-08 规范 |
Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures; German version EN 14136:2004
体外诊断 |
2004-08 德国标准化学会 |
| DIN EN ISO 15193:2009 规范 |
体外诊断医疗美利体育官网首页网址.生物源样品中数量的测量.参考测量程序的内容和表示要求(ISO 15193:2009),DIN EN ISO 15193:2009-10的英文版本 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009); English version of DIN EN ISO 15193:2009-10
分析物 |
2009-10 德国标准化学会 |
| DIN EN ISO 15193:2009-10 规范 |
体外诊断医疗器械 生物来源样品中数量的测量 参考测量程序的内容和表示的要求 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009); German version EN ISO 15193:2009
分析物 |
2009-10 德国标准化学会 |
| DIN EN ISO 15195 E:2018-05 规范标准 |
Competence requirements for calibration laboratories using reference measurement procedures in laboratory medicine (draft)
计量可追溯性 |
2018-05 德国标准化学会 |
| DIN EN ISO 15195:2004 规范 |
Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195:2003); German version EN ISO 15195:2003
参考材料 |
2004-01 德国标准化学会 |
| DIN EN ISO 15195:2019 试验 |
实验室医学 使用参考测量程序的校准实验室能力要求(ISO 15195:2018) Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)
校准实验室 |
2019-07-01 德国标准化学会 |
| DIN EN ISO 15195:2019-07 规范 |
Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018); German version EN ISO 15195:2019
校准实验室 计量溯源性 |
2019-07 德国标准化学会 |
| EN ISO 15195:2003 规范 |
实验室医学.基准测量实验室要求 ISO 15195-2003 Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195:2003)
参考材料 |
2003 欧洲标准化委员会 |
| GB/T 19702-2021 规范 |
体外诊断医疗器械 生物源性样品中量的测量 参考测量程序的表述和内容的要求 In vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Requirements for content and presentation of reference measurement procedures
|
2021-03-09 国家市场监督管理总局 |
| GB/T 21919-2022 |
Laboratory medicine—Requirements for the competence of calibration laboratories using reference measurement procedures
|
2022-10-14 国家市场监督管理总局 |
| GOST ISO 17511-2011 规范 |
体外诊断医疗装置.生物样品的定量测量.校准仪和控制材料赋值的计量溯源性 In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values assigned to calibrators and control materials
校准品 计量溯源性 |
2011 俄罗斯标准局 |
| GOST R ISO 15193-2007 规范 |
用于体外诊断的医疗产品 生物来源样品中数量的测量 参考测量技术的描述 In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Presentation of reference measurements procedures
|
2008-05-30 俄罗斯标准局 |
| GOST R ISO 15195-2006 规范 |
Laboratory medicine. Requirements for reference measurement laboratories
标准物质 |
2006 俄罗斯标准局 |
| IEC 61935-1:2019 试验 |
平衡和同轴信息技术电缆的试验规范.第1部分:ISO/IEC 11801-1规定的安装平衡电缆及相关标准 Specification for the testing of balanced and coaxial information technology cabling - Part 1: Installed balanced cabling as specified in ISO/IEC 11801-1 and related standards
|
2019-09-26 国际电工委员会 |
| ISO 15193:2009 规范 |
体外诊断医疗器械.生物有机体试样的数量测量.内容要求和基准测量过程介绍 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures
分析样品 |
2009-05 国际标准化组织 |
| ISO 15195:2003 规范 |
Laboratory medicine - Requirements for reference measurement laboratories
参考材料 |
2003-10 国际标准化组织 |
| ISO 15195:2018 规范 |
Laboratory medicine — Requirements for the competence of calibration laboratories using reference measurement procedures
|
2018-12-20 国际标准化组织 |
| ISO 17511:2003 规范 |
体外诊断医疗装置.生物试样的定量测量.校准仪和控制材料赋值的计量溯源性 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
校准品 计量溯源性 |
2003-08 国际标准化组织 |
| ISO 17511:2020 规范 |
体外诊断医疗器械.校准品 真实性控制材料和人体样品值的计量溯源性要求 In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
校准器 |
2020-04-24 国际标准化组织 |
| LST EN ISO 15193:2009 规范 |
体外诊断医疗器械 生物来源样品中量的测定 参考测量程序内容和格式的要求 (ISO 15193:2009) In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)
|
2009-08-31 立陶宛标准局 |
| LST EN ISO 15195:2019 规范 |
检验医学 应用基本测量程序校准实验室能力要求(ISO 15195:2018) Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)
校准实验室 |
2019-04-30 立陶宛标准局 |
| SS-EN 14136:2004 规范 |
使用外部质量评估方案对体外诊断美利体育登录入口官网程序的性能进行评估 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
体外诊断医疗器械 |
2004-09-06 瑞典标准研究所 |
| SS-EN ISO 15193:2009 规范 |
体外诊断医疗美利体育官网首页网址 生物源样品中量的测量 参考测量程序的内容和呈现要求(ISO 15193:2009) In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)
分析物 测量对象 |
2009 瑞典标准研究所 |
| SS-EN ISO 15195:2019 规范标准 |
医学实验室 使用参考测量程序的校准实验室能力要求(ISO 15195:2018) Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)
校准实验室 |
2019-02-18 瑞典标准研究所 |
| SS-EN ISO 18153:2004 规范 |
体外诊断医疗美利体育官网首页网址 生物样本中量的测量 用于校准物质和控制材料分配给酶催化浓度的价值的计量溯源(ISO 18153:2003) In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)
校准品 |
2004 瑞典标准研究所 |
| UNE-EN 14136:2004 规范 |
Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
体外诊断医疗器械 |
2004-12-10 西班牙标准化协会 |
| UNE-EN ISO 15195:2004 规范 |
检验医学 参考测量实验室的要求(ISO 15195:2003) Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195:2003)
溯源性 |
2004-05-07 西班牙标准化协会 |
| UNE-EN ISO 15195:2019 规范标准 |
Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)
校准实验室 |
2019-10-23 西班牙标准化协会 |
| UNE-EN ISO 17511:2004 规范 |
体外诊断医疗美利体育官网首页网址 生物样品中数量的测量 分配给校准器和控制材料的值的计量溯源性(ISO 17511:2003) In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)
校准品 计量溯源性 |
2004-04-07 西班牙标准化协会 |
| VDE 0819-935-1-2010 试验 |
平衡和同轴信息技术布线测试规范 第1部分:按照标准系列 EN 50173(IEC 61935-1:2009 修订版)规定的安装平衡布线 Specification for the testing of balanced and coaxial information technology cabling - Part 1: Installed balanced cabling as specified in the standards series EN 50173 (IEC 61935-1:2009@ modified); German version EN 61935-1:2009
|
2010-07-01 德国电气,电子和信息技术协会 |
| WS/T 617-2018 试验 |
Aspartate aminotransferase catalytic activity concentration reference measurement procedure
分析溶液 |
2018-08-20 行业标准-卫生 |
| WST 362:2011 试验标准 |
Serum cholesterol reference measurement procedure spectrophotometry (obsolete)
|
2011-12-14 国家卫生健康委员会 |
| YY/T 1195-2011 试验 |
Reference measurement procedure of total protein in serum
|
2011-12-31 行业标准-医药 |
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