GOST R ISO 19980-2013 State system for ensuring the uniformity of measurements Ophthalmic instruments Corneal topographers《确保测量一致性的国家系统 眼科器械 角膜外形素描系统》.pdf

1、 19980-2013 ISO 19980:2005 Ophthalmic instruments - Corneal topographers (IDT) 2014 199802013 II 1 - - ( ) , 4 2 - , 206 - 3 06 2013 . 1023- 4 19980:2005 - . (ISO 19980:2005 Ophthalmic instruments - Corneal to-pographers). - , - 5 1.02012 ( 8). - , . (-) . - , - (gost.ru). , 2014 , - 199802013 III 1

2、9980:2005 . ( , ISO) - ( ). , , . , , , -. , , - . - , (IEC) . , - /, 2. , , . 75 % , . , - . - . 19980 7 / 172 . 199802013 IV 19980-2013 . - 19980:2005 . () -. 19980-2013 19980:2005. 199802013 1 Ophthalmic instruments. Corneal topographers 20140701 1 , , - . - , - , - . , , . , , - , . - , ( ), - .

3、 , , - , . 2 , - . -. , . . : 60601-1:1988 . 1. - (IEC 60601-1:1988, Medical electrical equipment Part 1: General requirements for safety) 3 -: 3.1 (corneal apex): , . 3.2 (corneal eccentricity); e: e (. 3.9) - , . - , (. 1 A). 199802013 2 1 pa Eb e p 1 1 0,0 1,0 1,0 1 p 0 0 1 1). 2 E = e2. (4) 3 e

4、, . 4 , . 3.10 (elevation): , 3.10.1 (axial elevation): , - , CT 3.10.2 (normal elevation): , - . 3.10.3 (reference normal elevation): , - . 3.11 (keratometric constant): , 337,5 - , - 1, . 3.12 (keratometric dioptres), - 1: , - 337,5. 3.13 (meridional plane): , - . 3.14 (normal) 3.14.1 (surface nor

5、mal): , - . 3.14.2 (meridional normal): , - - . 3.15 p (p-value): , , , - (. 1), : 12222axbz; (5) 22bap ; (6) E = 1 p, (7) a, b , + - ; - - . 3.16 (Placido ring target): , - , , . 199802013 6 3.17 (radius of curvature): , . - (). 3.17.1 (axial radius of curvature), (sagittal radius of curvature); ra

6、: , P, ( 2), )(sin xxra , (8) x - , ; (x) - x. 3.17.2 (meridional radius of curvature), (tangential radius of curvature); rm: mmKr1 (. 2). (9) 3.18 (surface) 3.18.1 (aspheric surface), (non-spherical surface): , , , , - 3.18.2 (atoric surface): , - , , -, , . - . 3.18.3 (oblate surface): , . 3.18.4

7、(prolate surface): , . 3.18.5 (reference surface): , - - , . - , , - , , - . 3.18.6 (toric surface): , , . - . 3.19 (toricity): -. 3.20 (transverse plane): , - , . 4 4.1 8 -, , 3,75 . 8 . 4.2 4.1 - , 0,5 . 4.3 - 199802013 7 5.1 5.3, - 5.4. 4.4 - B. 5 () () 5.1 5.1.1 (), 5.2 , 5.3 -, 5.4. - . 5.1.2 , , , . in vivo (. D). 5.2 5.2.1 , . . - , . 5.2.2 , , . - . . 5.2.3 , . , , . . , . . 5.2.4