1、 , () INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (ISC) 30324.0.4 2002 ( 60601-1-4:1996) 1 4. (IEC 60601-1-4:1996, MOD) 2015 30324.0.4 2002 II , 1.092 . 1.22009 . , . , , , 1 - (-) 2 (-) 3 , (- 06 2002 . 22-2002) : ( 3166) 00497 ( 3166) 00497 AM BY KZ KG MD - RU TJ UA 4 29 -
2、2012 . 1313- 30324.0.42002 ( 60601-1-4:1996) - 1 2015 . 5 IEC 60601-1-4:1996 Medical electrical equipment Part 1: General requirements for safety 4. Collateral standard: Programmable electrical medical systems ( . 1. - . 4. . -) 52.204.3.1.6 52.208.2. C (MOD). 50267.0.499 ( 60601-1-496) 6 30324.0.4
3、2002 III - , . () - - . , , 2015 -, - 30324.0.4 2002 IV . 1 1 1 1.201 . 1 1.202 . 1 1.203 . 2 2 . 2 2.201 . 2 2.202 3 6 , 3 6.8 . 3 . ; 4 52 4 52.201 4 52.202 5 52.203 . 5 52.204 5 52.205 7 52.206 7 52.207 . 7 52.208 . 7 52.209 8 52.210 8 52.211 8 52.212 . 8 () 9 () 10 () 12 DDD () .17 () / 20 FFF (
4、) 21 30324.0.4 2002 V IEC 60601-1-4:1996 Medical electrical equipment Part 1: General requirements for safety 4. Collateral standard: Programmable electrical medical systems ( . 1. - . 4. ), 62 -. 30324.0 - . 1. ( -). : - (, ); - , (, ). , . , -, 201, , . . , , . - . , , , . -, , - / . -, . - . . ,
5、- , (). , , , , - . : - ; - ; - , ; 30324.0.4 2002 ( 60601-1-4:1996) 1 1 4. Medical electrical equipment. Part 1. General requirements for safety. 4. Safety requirements for programmable medical electrical systems 2015 01 01 . 1 1.201 , () (). , : 2.2.15 30324.0 2.203 IEC 60601-1-1, - , . . 1.202 -
6、() , . : a) , b) ; c) ; : d) , e) , f) , , g) , h) , j) ; : k) , 30324.0.4 2002 2 l) , m) , n) , ) . 1.203 1.203.1 30324.0 - 30324.0 . 30324.0 : - 30324.0; - ( 30324.0.4); - - . 1.203.2 - . 1.203.3 : 30324.095 ( 601-188) . 1. - IEC 60601-1-12011 . 1. . ISO 90012011 . ISO 9000-3:1991 Quality manageme
7、nt and quality assurance standards Part 3: Guidelines for the application of ISO 9001 to the development, supply and maintenance of software ( - . 3. ISO 9001 , ) IEC 60788:1984 Medical radiology Terminology ( . ) 2 2.201 - 30324.0, IEC 60601-1-1, IEC 60788, 2.201.12.201.15. AAA. 2.201.1 , () - ( ). 2.201.2 . . 2.201.3 , . . 2.201.4 () -, (). 2.201.5 () , . 30324.0.4 2002 3 2.201.6 , - . 2.201.7 , . 2.201.8 , . 2.201.9 , . -. 2.201.10 . 2.201.11 , , , . 2.201.12 , - -. 2.201.13 . 2.201.14 ( ) . 2.201.15 ( ) - , . 2.202 : ; , ; ; , - , , , , ; , - ( ) -, , ,