IVDD协调标准清单

snr19256724

IVDD协调标准清单（医疗器械CE认证资料）

www.6sq.net  品质论坛 t'N}1D"w^
• EN 375: 2001        Information supplied by the manufacturer with in vitro diagnostic reagents for professional useH
• 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-testingbbs.6sq.net www.6sq.net  品质论坛  mS
  RlQz
• 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 www.6sq.net  品质论坛 5{(K
  fG-VUa!B[H4D+w
• 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 www.6sq.net  品质论坛 hS3^:{E8w-A/@
• EN 13612: 2002        Performance evaluation of in vitro diagnostic medical devices
• EN 13640: 2002        Stability testing of in vitro diagnostic medical devices-质量-SPC ,six sigma,TS16949,MSA,FMEA www.6sq.net  品质论坛  V2[]A2od,L3J
  EN 13641: 2002        Elimination or reduction of risk of infection related to in vitro diagnostic reagents www.6sq.net  品质论坛 U1NsTVqk
  EN 13975:2003        Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects www.6sq.net  品质论坛 +MqB#s%p6Li|Y
  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)bbs.6sq.net www.6sq.net  品质论坛 (i
  l"rg#tW"\b2j.m
• 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)