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体外诊断医疗器械指令的协调标准

发布日期: 2017-05-18 来源:tbtguide 字号: [ 大中小 ]

与体外诊断医疗器械指令有关的协调标准约40余项(官网链接)，详细的协调标准清单见下表：

标准组织	协调性标准	发布时间	被替代标准	被替代标准终止日期
CEN	EN 556-1:2001 Sterilization 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	30/04/2002
CEN	EN 556-2:2003 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices	09/08/2007
CEN	EN ISO 11137-2:2012 (new) Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012)
CEN	EN ISO 11737-2:2009 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)	07/07/2010
CEN	EN 12322:1999 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media	09/10/1999
CEN	EN 12322:1999/A1:2001	31/07/2002		30/04/2002
CEN	EN ISO 13408-1:2011 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008)	19/08/2011
CEN	EN ISO 13408-2:2011 Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)	19/08/2011
CEN	EN ISO 13408-3:2011 Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)	19/08/2011
CEN	EN ISO 13408-4:2011 Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)	19/08/2011
CEN	EN ISO 13408-5:2011 Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)	19/08/2011
CEN	EN ISO 13408-6:2011 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)	19/08/2011
CEN	EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)	30/08/2012	EN ISO 13485:2003	31/08/2012
CEN	EN ISO 13485:2012/AC:2012	30/08/2012
CEN	EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing	17/12/2002
CEN	EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices	17/12/2002
CEN	EN 13640:2002 Stability testing of in vitro diagnostic reagents	17/12/2002
CEN	EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents	17/12/2002
CEN	EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects	21/11/2003
CEN	EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures	15/11/2006
CEN	EN 14254:2004 In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans	28/04/2005
CEN	EN 14820:2004 Single-use containers for human venous blood specimen collection	28/04/2005
CEN	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)	07/07/2010	EN ISO 14937:2000	30/04/2010
CEN	EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)	30/08/2012	EN ISO 14971:2009	30/08/2012
CEN	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)	07/07/2010
CEN	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)	07/07/2010
CEN	EN ISO 15197:2003 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003)	28/04/2005
CEN	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)	28/04/2005
CEN	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)	27/04/2012	EN ISO 18113-1:2009	30/04/2012
CEN	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)	27/04/2012	EN ISO 18113-2:2009	30/04/2012
CEN	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	27/04/2012	EN ISO 18113-3:2009	30/04/2012
CEN	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)	27/04/2012	EN ISO 18113-4:2009	30/04/2012
CEN	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)	27/04/2012	EN ISO 18113-5:2009	30/04/2012
CEN	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)	21/11/2003
Cenelec	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)	09/08/2007
Cenelec	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)	17/12/2002
Cenelec	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 IEC 61326-2-6:2005	27/11/2008
Cenelec	EN 62304:2006 Medical device software - Software life-cycle processes IEC 62304:2006	27/11/2008
Cenelec	EN 62366:2008 Medical devices - Application of usability engineering to medical devices IEC 62366:2007	27/11/2008