1、 1 (ISO 15004-1:2006, MOD) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)31590.12012(ISO 15004-1:2006), 1.092 . 1.22009 . , - . , , -, 1 - ()2 (-)3 , (- 24 2012 . 41) : ( 3166) 00497 ( 3166) 00497 AZBYKGMDRUUZ -4 1 2012 . 655- 31590.12012 (ISO 15004-1:2006) 1 2015 .5 IS
2、O 15004-1:2006 Ophthalmic instruments Fundamental requirements and test methods Part 1: Generalrequirements applicable to all ophthalmic instruments ( . . 1. , - ) . , , - / , , . (en). (MOD). 535182009 ( 15004-1:2006)6 -, - . () . , - - C, 2013 -, II 31590.120121 12 13 24 .24.1 .24.2 24.3 24.4 .24.
3、5 24.6 34.7 34.8 .34.9 35 .35.1 35.2 35.3 46 .46.1 46.2 46.3 .47 47.1 57.2 57.3 .57.4 .68 68.1 .68.2 .6 A () - , .7 .8III 31590.12012 1 Ophthalmic instruments. Part 1. General requirements applicable to all ophthalmic instruments and test methods 201501011 -( ), . , - . , , , -,.2 : ISO 149712011 .
4、30324.095 ( 601-188) . 1. - 315082012 . . IEC 60601-1-12011 . 1-1. . IEC 60601-1-62011 . 1-6. . . - - - , 1 , . (), - () . , , - , , .1 31590.12012(ISO 15004-1:2006) 3 -:3.1 (ophthalmic instrument): , - .3.2 (non-invasive ophthalmic instrument): - , .3.3 (active ophthalmic instrument): - , / . , , ,
5、 .3.4 (manufacturer): - , .4 4.1 4.1.1 , 30324.0 IEC 60601-1-1, - , .4.1.2 , , - . - , .4.1.3 - ISO 14971, :- ;- ( ).4.1.4 31508.4.2 4.2.1 , , , , , , .4.3 4.3.1 , - .4.4 4.4.1 , - , .4.4.2 - IEC 60601-1-1 - IEC 60601-1-6.4.5 4.5.1 , - , , , -, , .2 31590.120124.5.2 , , . 7.1 , - .4.6 4.6.1 , / , /
6、- / .4.7 4.7.1 - .4.8 4.8.1 , /, , 30324.0 ( 42.142.3, Xb).4.9 4.9.1 - .5 5.1 5.1.1 - 1. 1 , 10 35 , % 30 90 , 800 1060 ( )10 6 ) . , 5.1, 5.2 5.3, 7.3 .5.2 5.2.1 2. - - 1. 2 , 10 +55 , % 10 95 , 700 10605.2.2 2 - . -3 31590.12012, 8.1 , 1. 31590.1 . , _ _ . 1 . , .5.3 5.3.1 -, 3. 3 , 40 +70 , % 10 95 , 500 1060 , 10 500 : 0,5 30 6 10 6 5.3.2 , .5.3.3 - - 1.6 6.1 6.1.1 30324.0 IEC60601-1-6.7.4.6.2 6.2.1 4, 21 30324.0 .6.3 6.3.1 , .
