GOST R IEC 62083-2013 Medical electrical equipment Requirements for the safety of radiotherapy treatment planning systems《医疗电气设备 放射治疗计划系统的安全要求》.pdf

1、 620832013 IEC 62083:2009 Medical electrical equipment Requirements for the safety of radiotherapy treat-ment planning systems (IDT) 2014 620832013 II 1 - ( ) , 4 2 411 , 3 08 2013 . 1484-. 4 62083:2009 . (IEC 62083:2009 Medical electrical equipment Requirements for the safety of radiotherapy treatm

2、ent planning systems). - , - 5 1.02012 ( 8). ( 1 ) , -. () - . , (gost.ru) , 2014 , - 620832013 III () , , - . , . , - , , . - . , - , . , - , . . , , . , - . , - . , , 60601-1. , - , 60601-1. , - , - , - , . . A . , , - 62304 (. 14). 61217 , , . 61217 . 62366 (. 16). 620832013 1 Medical electrical

3、equipment. Requirements for the safety of radiotherapy treatment planning systems 20150101 1 , (): - ; - , ; - ; - . . - , - . 2. . . - ( ) 60601-1 . 1. (IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance) 60601-1-2 . 1-2. - . . . (

4、IEC 60601-1-2, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility Requirements and tests) 60601-2-1:2009 . 2-1. 1 50 (IEC 60601-2-1:2009, Medical electrical equipment. Part 2-1. Particular requirem

5、ents for the basic safety and essential per-formance of electron accelerators in the range 1 MeV to 50 MeV) 60601-2-11:1997 . 2. - (IEC 60601211:1997, Medical electri-cal equipment Part 2: Particular requirements for the safety of gamma beam therapy equipment) / 60788:2004 . (IEC/TR60788:2004 Medica

6、l electrical equipment Glossary of defined terms) 60950-1 . . 1. (IEC 60950-1, Information technology equipment Safety Part 1: General require-ments) 61000-4-1 (). 4-1. -. . 61000-4 (IEC 61000-4-1, Electromagnetic compatibility (EMC) Part 4-1: Testing and measurement techniques Overview of IEC 61000

7、-4 series) 620832013 2 61000-4-2 (). 4-2. -. (IEC 61000-4-2, Electromagnetic compatibility (EMC) Part 4-2: Testing and measurement techniques Electrostatic discharge immunity test) 61000-4-3 (). 4-3. -. (IEC 61000-4-3, Electromagnetic compatibility (EMC) Part 4-3 : Testing and measurement techniques

8、 Radi-ated, radio-frequency, electromagnetic field immunity test) 61000-4-4 (). 4-4. -. / (IEC 61000-4-4, Electromagnetic compatibility (EMC) Part 4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test) 61217 . , (IEC 61217, Radiotherapy equipment Coordinates, moveme

9、nts and scales) 62304 . - (IEC 62304, Medical device software Software life cycle processes) 62366:2007 . - (IEC 62366:2007, Medical devices Application of usability engineering to medical devices) - , 1 , - , , . -, , - (). -, , , , , . , , , , - . 3 , 3.1 . , , . 3.1.1 : 3.1.2 : , , - , . 3.1.3 : , , . 3.1.4 : 3.1.5 : , - 3.1.6 : , , , . ( ) , - , ( ). 620832013 3 3.1.7 : 3.1.8 : , - - . , . - . 3.1.9 : 3.2 : 4 4.1 62304 , , . . , - , . - , - . - -. . 4.2 - () , (. 10.2). - . -