IVD

欧盟为消除各成员国间的贸易壁垒，逐步建立成为一个统一的大市场，以确保人员、服务、资金和产品（如医疗器械）的自由流通。在医疗器械领域，欧盟委员会制定了三个欧盟指令，以替代原来各成员的认可体系，使有关这类产品投放市场的规定协调一致。

医疗器械领域 三个欧盟指令

这三个指令分别是：

• Medical devices Directive - MDD Directive 93/42/EEC
• In vitro diagnostic medical devices - IVD Directive 98/79/EC
• Active implantable medical devices - AIMD Directive 90/385/EEC 适用于心脏起搏器，可植入的胰岛素泵等有源植入性医疗器械。

IVD Directive 98/79/EC

Directive 98/79/EC - IVD - In vitro diagnostic medical devices - 体外诊断医疗器械

体外诊断，即IVD(In Vitro Diagnosis)，是指在人体之外，通过对人体样本(血液、体液、组织等)进行检测而获取临床诊断信息，进而判断疾病或机体功能的产品和服务。体外诊断产品主要由诊断设备（仪器）和诊断试剂构成。根据我国国家药品监督管理局（NMPA）的《医疗器械分类目录》标准，体外诊断设备属于临床检验分析仪器类。

IVD体外诊断医疗器械产品分类

体外诊断仪器

• 按诊断方法分：临床化学分析仪器、免疫化学分析仪器、血液分析仪器、微生物分析仪器。
• 按搭配试剂分：开放式系统、封闭式系统。

体外诊断试剂

• 按检验原理分：生化诊断试剂、免疫诊断试剂、分子诊断试剂、微生物诊断试剂、尿液诊断试剂、凝血类诊断试剂、血液学和流式细胞诊断试剂。

IVD体外诊断主要测试标准

电磁兼容

• EN 61326-1 / GB 18268-1
• 测量，控制和实验室用电气设备。电磁兼容性要求。第1部分：一般要求
• Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 1: General requirements
• EN 61326-2-6:2006 / GBT 18268.26-2010
• 测量，控制和实验室用电气设备 - EMC要求 - 第2-6部分：特殊要求 - 体外诊断（IVD）医疗设备
• 测量控制和实验室用的电设备 电磁兼容性要求 第26部分：特殊要求 体外诊断 IVD 医疗设备
• Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment

安规

• GB 4793.1-2007(IEC 61010-2:2001) 测量、控制和实验室用电气设备的安全要求 第1部分：通用要求
• GB 4793.9-2013(IEC 61010-2-081:2009) 测量、控制和实验室用电气设备的安全要求 第9部分：实验室用分析和其他目的自动和半自动设备的特殊要求
• YY 0648-2008(IEC 61010-2-101:2002) 测量、控制和试验室用电气设备的安全要求

环境

• GB/T 14710-2009 医用电器环境要求及试验方法

IVD体外诊断主要测试项目

分析性能指标

• 精密度
• 准度
• 线性范围
• 可报告范围
• 检出限和灵敏度
• 分析干扰

电气安全

• 防电击
• 防机械危险
• 防机械冲击和撞击
• 防止火焰蔓延
• 设备的温度限值和耐热
• 防液体危险
• 防辐射以及防声和超声压力
• 对释放的气体和物质的防护
• 元器件
• 连锁装置
• 测量电路
• …………

电磁兼容性

• 电快速瞬变脉冲群试验
• 浪涌试验
• 静电试验
• 射频传导试验
• 电压跌落和短时中断试验
• 射频电磁场辐射抗扰度试验
• 工频磁场辐射抗扰度试验
• 谐波试验
• 闪烁试验
• 端子骚扰电压试验
• 辐射发射试验
• …………

根据联盟协调立法公布的协调标准参考文献

• EN 556-1:2001/AC:2006 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices

• EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated STERILE" - Part 2: Requirements for aseptically processed medical devices

• EN ISO 11137-1:2015 (new) Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)

• EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013) Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)

• EN 12322:1999 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media

• EN ISO 13408-1:2015 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

• EN ISO 13408-2:2011 Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)

• EN ISO 13408-3:2011 Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)

• EN ISO 13408-4:2011 Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

• EN ISO 13408-5:2011 Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

• EN ISO 13408-6:2011 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

• EN ISO 13408-7:2015 Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)

• EN ISO 13485:2016 (new) Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

• EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing

• EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices

• EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents

• EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects

• EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

• EN 14254:2004 In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans

• EN 14820:2004 Single-use containers for human venous blood specimen collection

• EN ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)

• EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

• 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)

• 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 (ISO 15194:2009)

• EN ISO 15197:2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)

• EN ISO 15223-1:2016 (new) Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2016-12-15)

• EN 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)

• EN ISO 18113-1:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)

• EN ISO 18113-2:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)

• EN ISO 18113-3:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)

• EN ISO 18113-4:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)

• EN ISO 18113-5:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)

• EN 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)

• EN ISO 20776-1:2006 Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2006)

• EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

• EN 61010-2-101:2002 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

• IEC 61010-2-101:2002 (Modified)

• EN 61326-2-6:2006 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment

• EN 62304:2006/AC:2008 Medical device software - Software life-cycle processes

• EN 62366:2008Medical devices - Application of usability engineering to medical devices

Refter to www.emc.wiki/thread-4070-1-1.html

标准更迭

IVD指令Directive 98/79/EC将于在2020年5月26日将被，MDR指令REGULATION (EU) 2017/745替代

MDR指令

REGULATION (EU) 2017/745

MDR指令详细请跳转MDR，查看更多。