GOST R ISO 12866-2011 State system for ensuring the uniformity of measurements Ophthalmic perimeters Technical requirements and test methods《确保测量一致性的国家系统 眼科器械 视野计 技术要求和试验方法》.pdf

1、 128662011 ISO 12866:1999Ophthalmic instruments Perimeters(IDT) 27 2002 . 184- , 1.02004 . 1 - - ( ) , 42 296 3 13 2011 . 1074-4 128661999 . (ISO 12866:1999 Ophthalmic instruments Perimeters). - 1.52004 ( 3.5). - , 5 , - . () . , , 2013 , - - II 1286620111 .12 13 14 .34.1 .34.2 .34.3 .44.4 45 55.1 5

2、5.2 55.3 55.4 55.5 65.6 65.7 .66 67 .6 () .7 B () , .8 () .910III 128662011 State system for ensuring the uniformity of measurements. Ophthalmic perimeters.Technical requirements and test methods 201305011 15004 , - - . - . 15004 .2 : 601-1:1988 . 1. (IEC 601-1:1988 Medical electrical equipment Part

3、 1: General requirements for safety) 60601-1:2005 . 1. - (IEC 60601-1:2005 Medical electrical equipment Part 1: Generalrequirements for basic safety and essential performance) 60601-1-1:2000 . 1-1. -. (IEC 60601-1-1:2000Medical electrical equipment Part 1-1: General requirements for safety Collatera

4、l standard: safetyrequirements for medical electrical systems) 15004-1 . . 1. , (ISO 15004-1:2006 Ophthalmic instruments Fundamental requirements and test methods Part 1:General requirements applicable to all ophthalmic instruments)3 :3.1 :, .3.1.1 : , .3.1.2 : , - .1 128662011 3.1.3 : , 30 - .3.1.4

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6、 log10Lmax/c68 LT. (4) LS c68 L c68 LT.2 1286620113.11 : , , .3.12 : , - .3.13 : , .3.14 : , , - .3.15 c70: .4 4.1 . , , . , 15004-1. , 4.24.4 . 5.4.2 4.2.1 , , , 1. 1 LB +25 % 20 % 5.1 c68 L/LB +25 % 20 % 5.1, 5.2 -c177 0,5 , - 10 ;c177 1,0 , - 10 c18430 ;c177 2,0 , - 30 -5.3 +20 % 15 % , - 5.4 c17

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