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Spec:
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Title:
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EN 556-1
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Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
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EN 556-2
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Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
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EN 980
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Symbols for use in the labelling of medical devices
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EN ISO 11737-2
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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)
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EN 12322
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In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
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EN ISO 13485
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Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
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EN 13532
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General requirements for in vitro diagnostic medical devices for self-testing
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EN 13612
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Performance evaluation of in vitro diagnostic medical devices
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EN 13640
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Stability testing of in vitro diagnostic reagents
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EN 13641
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Elimination or reduction of risk of infection related to in vitro diagnostic reagents
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EN 13975
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Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
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EN 14136
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Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
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EN 14254
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In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans
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EN 14820
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Single-use containers for human venous blood specimen collection
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EN ISO 14937
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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)
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EN ISO 14971
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Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
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EN ISO 15193
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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)
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EN ISO 15194
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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)
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EN ISO 15197
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In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003)
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EN ISO 17511
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In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)
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EN ISO 18113-1
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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
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EN ISO 18113-2
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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
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EN ISO 18113-3
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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
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EN ISO 18113-4
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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
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EN ISO 18113-5
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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
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EN ISO 18153
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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)
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EN ISO 20776-1
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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)
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EN 61010-2-101
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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)
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EN 61326-2-6
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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
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EN 62304
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Medical device software - Software life-cycle processes IEC 62304:2006
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EN 62366
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Medical devices - Application of usability engineering to medical devices IEC 62366:2007
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