2上海2018年会final文稿2 - 副本.pptxVIP

第一点修改 -修改了题目和范围- ISO 17511：2018（美国修改稿） IN VITRO DIAGNOSTIC MEDICAL DEVICES —REQUIREMENTS FOR ESTABLISHING METROLOGICAL TRACEABILITY OF VALUES ASSIGNED TO CALIBRATORS, TRUENESS CONTROL MATERIALS AND HUMAN SAMPLES;2018版 1范圍 ALL IVD MDS THAT PROVIDE MEASUREMENT RESULTS IN THE FORM OF NUMERIC VALUES, I.E. RATIONAL (RATIO) AND/OR DIFFERENTIAL (INTERVAL) SCALES, AND COUNTING SCALES IVD MDS WHERE THE MEASUREMENT RESULT IS REPORTED AS A QUALITATIVE VALUE ESTABLISHED WITH A RATIO OF TWO MEASUREMENTS (I.E. THE SIGNAL FROM A SPECIMEN BEING TESTED AND THE SIGNAL FROM A RM WITH A SPECIFIED CONCE