IVDD协调标准清单（医疗器械CE认证资料）

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)