现行

UNE-EN 12286-1999

IN VITRO DIAGNOSTIC MEDICAL DEVICES. MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN. PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES.
体外诊断医疗设备 生物来源样品中数量的测量 介绍参考测量程序

1999-03-08

现行

UNE-EN 12287-2000

In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Description of reference materials.
体外诊断医疗设备 生物来源样品中数量的测量 参考资料说明

2000-03-31

现行

KS P ISO 15193(2019 Confirm)

체외진단용 의료기기 — 생물 유래 시료의 정량 측정 — 기준측정 절차의 내용 및 표시 요구사항
体外诊断医疗器械 - 生物来源样本中的量的测量 - 内容的要求和参考测量程序的介绍

2014-12-12

现行

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
体外诊断医疗器械——生物来源样品数量的测量——参考测量程序的内容和表示要求

2009-04-28

现行

BS EN 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
体外诊断医疗设备 生物来源样品中数量的测量 参考测量程序的内容和表示要求

2016-01-31

现行

GB/T 19702-2021

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

现行

KS P ISO 17511(2016 Confirm)

체외진단 의료기기－생물 유래 시료의 정량 측정－보정 및 대조물질에 부여된 값의 측정학적 소급성
体外诊断医疗器械生物样品数量的测量校准品和对照品数值的计量溯源性

2010-12-17

现行

GB/T 21415-2008

体外诊断医疗器械 生物样品中量的测量 校准品和控制物质赋值的计量学溯源性
In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials

2008-01-22

现行

BS EN ISO 15194-2009

In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for certified reference materials and the content of supporting documentation
体外诊断医疗设备 生物来源样品中数量的测量 认证标准物质的要求和支持文件的内容

2016-01-31

现行

ISO 15194-2009

In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for certified reference materials and the content of supporting documentation
体外诊断医疗器械——生物来源样品数量的测量——认证标准物质的要求和支持文件的内容

2009-04-28

现行

GOST R ISO 15194-2013

Изделия медицинские для диагностики in vitro. Измерение величин в пробах биологического происхождения. Требования к аттестованным стандартным образцам и содержанию сопроводительной документации
体外诊断医疗器械 测量生物来源样品中的数量 认证参考材料的要求和支持文件的内容

现行

GB/T 19703-2020

体外诊断医疗器械 生物源性样品中量的测量 有证参考物质及支持文件内容的要求
In vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Requirements for certified reference materials and the content of supporting documentation

2020-11-19

现行

DIN EN ISO 15193

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)
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要求（ISO 15193-2009）；德文版EN ISO 15193:2009

2009-10-01

现行

UNE-EN 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)
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要求（ISO 15193-2009）

2009-11-25

现行

BS 06/30154803 DC

EN ISO 15193. In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for content and presentation of reference measurement procedures
EN ISO 15193 体外诊断医疗设备 生物来源样品中数量的测量 参考测量程序的内容和表示要求

2006-08-16

现行

KS P ISO 18153(2021 Confirm)

체외진단 의료기기－생물 유래 시료의 정량 측정－보정 및 대조물질에 부여된 효소 촉매 농도 값의 측정학적 소급성
体外诊断医疗器械——生物样品数量的测量——校准品和对照品酶催化浓度值的计量溯源性

2010-12-17

现行

KS P ISO 18153(2016 Confirm)

체외진단 의료기기－생물 유래 시료의 정량 측정－보정 및 대조물질에 부여된 효소 촉매 농도 값의 측정학적 소급성
体外诊断医疗器械生物样品量的测量校准品和对照品酶催化浓度值的计量溯源性

2010-12-17

现行

YY/T 0638-2008

体外诊断医疗器械　生物样品中量的测量　校准品和控制物质中酶催化浓度赋值的计量学溯源性
In vitro diagnostic medical devices—Measurement of quantities in biological samples—Metrological traceability of assigned values for catalytic concentration of enzymes in calibrators and control materials

2008-04-25

现行

ISO 18153-2003

In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials
体外诊断医疗器械——生物样品中数量的测量——指定校准器和控制材料的酶催化浓度值的计量溯源性

2003-08-25

现行

DIN EN ISO 17511

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)
体外诊断医疗器械.生物样品中数量的测量.校准器和控制材料赋值的计量溯源性（ISO 17511-2003）；德文版EN ISO 17511:2003

2003-11-01