1、 60601-2-41 2014 2-41 () IEC 60601-2-41:2009 Medical electrical equipment Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis (IDT) 2015 60601-2-41201 4 II 1 ( ) , 4 2 411 , 3 - 04 2014 . 500- 4 60601-2-41:2009 . 2-41.
2、 - () (IEC 60601-2-41:2009 Medical electrical equipment Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis). - - , - 5 1.02012 ( 8). ( 1 ) , -. () - . , (gost.ru) , 2015 -, - 60601-2-41201 4 III 201.1 , 1 201.2 2 201.
3、3 3 201.4 .8 201.5 .8 201.6 8 201.7 , .9 201.8 9 201.9 , .10 201.10 .13 201.11 13 201.12 14 201.13 .28 201.14 (PEMC) 28 201.15 28 201.16 .28 201.17 .28 () .29 () 31 .33 .34 60601-2-41201 4 IV - () . 60601-1:2005 - . 1. - (IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements fo
4、r basic safety and essential performance), . - . (*), , , - . 60601-2-41201 4 1 2-41 () Medical electrical equipment. Part 2-41. Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis 201506 01 201.1 , 1 1, : 201.1.1* : , - () , . :
5、 - ; - , 60601-2-18; - , , 9680; - 60598-2-1 60598-2-4; - , ; - , - , , - ; - , ; - 60598-2-22. . 4.2 . 201.1.2 : - () , 201.3.203. 201.1.4 : 1 60601-1:2005 . 1. (IEC 60601-1:2005, Medical electrical equipment Part 1: Gen-eral requirements for basic safety and essential performance) ( ). 60601-2-412
6、01 4 2 60601 , -, , . - . 60601-1 . - . 201 (, 201.1 1 ) - 20, () () - (, 202.4 4 - 60601-1-2, 203.4 4 60601-1-3 .). : - , - ; - , ; - , - . , , , -, 201.101. , - 3.1 3.139, - 201.3.201. , BB ., ), bb) . , , , - , 20, () () - , 202 60601-1-2, 203 60601-1-3 . , , . - , ; , . 201.2 2 , : : 60417 , (IE
7、C 60417, Graphical symbols for use on equipment) 60598-2-9 . 2. . 9. - () (IEC 60598-2-9, Luminaires Part 2: Particular requirements. Sec-tion Nine: Photo and film luminaires (non-professional) 11664-1 . 1. (ISO 11664-1, Colorimetry Part 1: CIE standard colorimetric observers) 13.3 (CIE 13.3, Method
8、 of Measuring and Specifying Colour Rendering Properties of Light Sources) 15 (CIE 15, Colorimetry) 69 . , - (CIE 69, Methods of characterizing illuminance meters and luminance meters: Performance, characteristics and specifications) 60601-2-41201 4 3 201.3 60601-1, : . 201.3.63 (MEDICAL ELECTRICAL
9、EQUIPMENT) : 201.101 - . 60601-2-41201 44 201.101 60601-2-41201 4 5 : 201.3.101 Ec (CENTRAL ILLUMINANCE cE ): 1000 ( , , 1000 ) - - . 201.3.102 (DEPTH OF ILLUMINATION): 1000 ( , , 1000 ) , 20 % (cE ). 201.3.103* (FAIL SAFE): - -. 201.3.104 ; (LIGHT FIELD CENTRE; LFC): ( ). . 201.3.105 d10(LIGHT FIEL
10、D DIAMETER 10d ): -, ( ), - 10 % cE . 201.3.106 () (LUMINAIRE FOR DIAGNOSIS): -, . . . 201.101. 201.3.107 (MAJOR SURGICAL LUMINAIRE): - , , -. - , . . 201.101. 201.3.108 ( -) MINOR SURGICAL LUMINAIRE (TREATMENT LUMINAIRE): -, , - . - , . . 201.101. 201.3.109 (SHADOW DILUTION): . 201.3.110 (DETACHABLE HANDLE): , - , . , . 201.3.111 (SURGICAL LUMINAIRE): , - ,
