GOST ISO 17593-2011 Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy《临床实验室测试和体外医.pdf

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1、 IN VITRO in vitro (ISO 17593:2007, IDT) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)ISO 175932011, 1.092 . 1.22009 . , - . , , -, 1 - ()2 3 , (- 402011 29 2011 .) : ( 3166) 00497 ( 3166) 00497 BYKZKGRUTJUZ 4 13 2011 . 1383- ISO 175932011 1 2013 .5 ISO 17593:2007 Clin

2、ical laboratorytesting and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oralanticoagulant therapy ( in vitro. - in vitro -).C (IDT). 175932009. - 6 ( ) - . , - . C, 2013 -, II ISO 1759320111 .12 13 24 64.1 . 64.2 74.3 .74.4 .74.5 74.6 .84.7 85 , 95.1 .95.

3、2 in vitro .95.3 in vitro - 105.4 .115.5 .116 126.1 126.2 126.3 .126.4 .126.5 126.6 .126.7 , .126.8 .126.9 126.10 , 136.11 .136.12 .146.13 147 147.1 147.2 148 158.1 .158.2 .158.3 .158.4 16III ISO 1759320118.5 .208.6 .269 279.1 .279.2 .279.3 .279.4 .279.5 .289.6 289.7 29 A () 30 B () 31 C () .34 D ()

4、 in vitro .35 E () in vitro - 38 F () in vitro .3946 () .48IV ISO 175932011 in vitro, , . . - in vitro - , , ,.- , , , . - , , . -, . , - , - , - , . , 68, 69. , , (, ), -. -, ( - ), , , - () . , , , . , , , ., - , , - , . , in vitro (,IEC 61010, ISO 13485, ISO 14971 ISO 18113), , . , .V ISO 1759320

5、11 IN VITRO in vitro Clinical laboratory testing and in vitro medical devices.Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy1 in vitro - , , - . , K - (). (, , ), .* :- in vitro , K, ;- , - - .2 :ISO 13485:2003 Medical devices Quality management systems R

6、equirements for regulatorypurposes ( . . -)ISO 14971:2000 Medical devices. Application of risk management to medical devices ( -. )ISO 15198:2004 Clinical laboratory medicine In vitro diagnostic medical devices Validation of userquality control procedures by the manufacturer ( . - in vitro. , - )* 1

7、 11 102- .1 ISO 175932011 20130101ISO 17511:2003 In vitro diagnostic medical devices Measurement of quantities in biologicalsamples Metrologicaltraceabilityofvaluesassignedtocalibratorsandcontrolmaterials(- in vitro.-,)ISO 18113-1 In vitro diagnostic medical devices Information supplied by the manuf

8、acturer(labelling) Part 1: Terms, definitions and general requirements ( - in vitro. , ().1.,)ISO 18113-4 In vitro diagnostic medical devices Information supplied by the manufacturer(labelling) Part4:Invitrodiagnosticreagentsforself-testing( in vitro. , (-).4.in vitro )ISO 18113-5 In vitro diagnosti

9、c medical devices Information supplied by the manufacturer(labelling) Part 5: In vitro diagnostic instruments for self-testing ( - in vitro. , ().5. in vitro)IEC 61000-4-2Electromagneticcompatibility(EMC) Part4:Testingandmeasurementtechniques Section 2: Electrostatic discharge immunity test ( . 4. .

10、2.)IEC 61000-4-3Electromagneticcompatibility(EMC) Part4:Testingandmeasurementtechniques Section 3: Radiated, radio-frequency, electromagnetic field immunity test ( -.4-3.-)IEC 61010-1:2001Safetyrequirementsforelectricalequipmentformeasurement,control,andlaboratoryuse. Part 1. General requirements (

11、,.1.)IEC 61010-2-101:2002 Safety requirements for electrical equipment for measurement, control andlaboratoryuse.Part2-101.Particularrequirementsforinvitrodiagnostic(IVD)medicalequipment(,-.2-101.in vitro(IVD)IEC 61326 Electrical equipment for measurement, control and laboratory use. EMC requirements( , . )EN 13532:2002Generalrequirementsforinvitrodiagnosticmedicaldevicesforself-testing(- in vitro)EN 13612 Performance evaluation of in vitro diagnostic medical devices (