List of European Harmonized Standards For Directive 98/79/EC for In vitro diagnostic medical devices (with links to the Official English Language Edition of each)

Standard:Title:
EN 556-1 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
EN 556-2 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
EN 980 Symbols for use in the labelling of medical devices
EN ISO 11737-2 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 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
EN ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
EN 13532 General requirements for in vitro diagnostic medical devices for self-testing
EN 13612 Performance evaluation of in vitro diagnostic medical devices
EN 13640 Stability testing of in vitro diagnostic reagents
EN 13641 Elimination or reduction of risk of infection related to in vitro diagnostic reagents
EN 13975 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
EN 14136 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
EN 14254 In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans
EN 14820 Single-use containers for human venous blood specimen collection
EN ISO 14937 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 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
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)
EN ISO 15194 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 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003)
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)
EN ISO 18113-1 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 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 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 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 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 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 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 61010-2-101 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 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
EN 62304 Medical device software - Software life-cycle processes IEC 62304:2006
EN 62366 Medical devices - Application of usability engineering to medical devices IEC 62366:2007