IVD-体外诊断医疗器械

IVD - In vitro diagnostic medical devices-Directive 98/79/EC - 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。
  

主要测试标准

• 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
  

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

根据联盟协调立法公布的协调标准参考文献

ESO (1)	Reference and title of the standard (and reference document)	First publication OJ	Reference of superseded standard	Date of cessation of presumption of conformity of superseded standard Note 1
CEN	EN 556-1:2001Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices	31/07/2002	EN 556:1994 + A1:1998 Note 2.1	30/04/2002
	EN 556-1:2001/AC:2006	15/11/2006
CEN	EN 556-2:2015Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices	13/05/2016	EN 556-2:2003 Note 2.1	30/06/2016
CEN	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)	This is the first publication
CEN	EN ISO 11137-2:2015Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)	13/05/2016	EN ISO 11137-2:2013 Note 2.1	30/06/2016
CEN	EN ISO 11737-2:2009Sterilization 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)	07/07/2010
CEN	EN 12322:1999In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media	09/10/1999
	EN 12322:1999/A1:2001	31/07/2002	Note 3	30/04/2002
CEN	EN ISO 13408-1:2015Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)	13/05/2016	EN ISO 13408-1:2011 Note 2.1	30/06/2016
CEN	EN ISO 13408-2:2011Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)	19/08/2011
CEN	EN ISO 13408-3:2011Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)	19/08/2011
CEN	EN ISO 13408-4:2011Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)	19/08/2011
CEN	EN ISO 13408-5:2011Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)	19/08/2011
CEN	EN ISO 13408-6:2011Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)	19/08/2011
CEN	EN ISO 13408-7:2015Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)	13/05/2016
CEN	EN ISO 13485:2016 (new)Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)	This is the first publication	EN ISO 13485:2012 Note 2.1	31/03/2019
	EN ISO 13485:2016/AC:2016 (new)	This is the first publication
CEN	EN 13532:2002General requirements for in vitro diagnostic medical devices for self-testing	17/12/2002
CEN	EN 13612:2002Performance evaluation of in vitro diagnostic medical devices	17/12/2002
	EN 13612:2002/AC:2002	02/12/2009
CEN	EN 13641:2002Elimination or reduction of risk of infection related to in vitro diagnostic reagents	17/12/2002
CEN	EN 13975:2003Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects	21/11/2003
CEN	EN 14136:2004Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures	15/11/2006
CEN	EN 14254:2004In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans	28/04/2005
CEN	EN 14820:2004Single-use containers for human venous blood specimen collection	28/04/2005
CEN	EN ISO 14937:2009Sterilization 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)	07/07/2010	EN ISO 14937:2000 Note 2.1	30/04/2010
CEN	EN ISO 14971:2012Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)	30/08/2012	EN ISO 14971:2009 Note 2.1	30/08/2012
CEN	EN ISO 15193:2009In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)	07/07/2010
CEN	EN ISO 15194:2009In 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)	07/07/2010
CEN	EN ISO 15197:2015In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)	13/05/2016	EN ISO 15197:2013 Note 2.1	31/07/2016
For blood glucose test strips and control solutions, the date of cessation of presumption of conformity of the superseded standard shall be 30/06/2017.
CEN	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)	This is the first publication	EN 980:2008 Note 2.1	31/12/2017
CEN	EN ISO 17511:2003In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)	28/04/2005
CEN	EN ISO 18113-1:2011In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)	27/04/2012	EN ISO 18113-1:2009 Note 2.1	30/04/2012
CEN	EN ISO 18113-2:2011In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)	27/04/2012	EN ISO 18113-2:2009 Note 2.1	30/04/2012
CEN	EN ISO 18113-3:2011In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)	27/04/2012	EN ISO 18113-3:2009 Note 2.1	30/04/2012
CEN	EN ISO 18113-4:2011In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)	27/04/2012	EN ISO 18113-4:2009 Note 2.1	30/04/2012
CEN	EN ISO 18113-5:2011In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)	27/04/2012	EN ISO 18113-5:2009 Note 2.1	30/04/2012
CEN	EN ISO 18153:2003In 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)	21/11/2003
CEN	EN ISO 20776-1:2006Clinical 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)	09/08/2007
CEN	EN ISO 23640:2015In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)	13/05/2016	EN 13640:2002 Note 2.1	30/06/2017
Cenelec	EN 61010-2-101:2002Safety 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)	17/12/2002
Cenelec	EN 61326-2-6:2006Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment IEC 61326-2-6:2005	27/11/2008
Cenelec	EN 62304:2006Medical device software - Software life-cycle processes IEC 62304:2006	27/11/2008
	EN 62304:2006/AC:2008	18/01/2011
Cenelec	EN 62366:2008Medical devices - Application of usability engineering to medical devices IEC 62366:2007	27/11/2008

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