IVDD协调标准清单（医疗器械CE认证资料）

</script>Standard   Titles
EN 375: 2001  Information supplied by the manufacturer with in vitro diagnostic reagents for professional use
EN 376: 2002  Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing
EN 591: 2001  Instructions for use in vitro diagnostic instruments for professional use
EN 592: 2002  Instructions for use for in vitro diagnostic instruments for self-testing
EN 928: 1995   In vitro diagnostic systems – Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices
EN 980: 1996/ A2:2001  Graphical symbols for use in the labelling of medical devices
EN 1658: 1996   Requirements for marking of in vitro diagnostic instruments
EN 12286: 1998/ A1:2000  In vitro diagnostic medical devices – Measurement of quantities in samples of biological origin – Presentation of reference measurement procedures
EN 12287: 1999   In vitro diagnostic medical devices – Measurement of quantities in samples of biological origin – Description of reference materials
EN 12322: 1999/ A1:2001  In vitro diagnostic medical devices – Culture media for microbiology – Performance criteria for culture media
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 13640: 2002  Stability testing 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 ISO 14971:  Medical devices – Application of risk management to medical devices (ISO 14971:2000)
2000
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 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
  Reference document: IEC 61010-2-101:2002 (Modified)</ul>
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