GOST 31582-2012 Implantable electrodes for cardiac pacemakers Technical requirements and test methods《心脏起搏器的可移植电极 技术要求和试验方法》.pdf

《GOST 31582-2012 Implantable electrodes for cardiac pacemakers Technical requirements and test methods《心脏起搏器的可移植电极 技术要求和试验方法》.pdf》由会员分享，可在线阅读，更多相关《GOST 31582-2012 Implantable electrodes for cardiac pacemakers Technical requirements and test methods《心脏起搏器的可移植电极 技术要求和试验方法》.pdf（12页珍藏版）》请在麦多课文档分享上搜索。

1、 (ISO 14708-2:2005, NEQ) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)315822012, 1.092 . 1.22009 . , - . , , -, 1 - ()2 (-)3 , ( 24 2012 . 41) : ( 3166) 00497 ( 3166) 00497 AZBYKZKGMDRUTJUZ -4 1 2012 . 680- 315822012 - 1 2015 .5 ISO 14708-2:2005 Implants forsurgery Act

2、ive implantable medical devices Part 2: Cardiac pacemakers ( . . 2. ). (NEQ). 539192010.6 -, - . () . , - - C, 2014 -, II 3158220121 .12 13 14 25 25.1 .25.2 .25.3 25.4 .45.5 45.6 .46 , , , 66.1 66.2 66.3 66.4 6III 315822012 Implantable electrodes for cardiac pacemakers.Technical requirements and tes

3、t methods1 , () . - 30324.0.2 : ISO 10993-12011 . . 1. 146302002* . - 30324.095 ( 601-188) . 1. - 312122003 . - - , 1 , - . - (), () . , , , , .3 , 30324.0, 31212 , - *, - :* 146302011 . .* 5841-32010 IS-1 . 113182010 DF-1 . - .1 315822012 201501013.1 : , - .3.2 : .3.3 : , - .3.4 :, .3.5 , Rc: , , .

4、3.6 , Zp: , . - /.4 4.1 30324.0 14630.4.2 -, , - *, IS-1 DF-1.4.3 , 5.2, .4.4 , 5.3, .4.5 , 5.4, 2 .4.6 5.5.4.7 5.6.4.8 .4.9 , - ISO 10993-1.5 5.1 NaCl 0,9 / c177 10 % (37 c177 2) C. , - , 1 .5.2 . . 5 %.5.3 5.3.1 , , , 1.(d)50, 0,8- ; 1,2 d. , , 10 %. 15 , 10 %. .* 5841-32010 IS-1 . 113182010 DF-1

5、. - .2 315822012 50 , (F)33c177 5 % , -, 1. (R)10c177 2%.5.3.2 , , 10 . 50 , (F)33c177 5 % , 2. (R)10 c177 2%.5.3.3 (65 c177 5)1,(4 c177 0,1)(0,5 c177 0,05). (Zp), , - (. 1 2) Zp=10()VVdtVdtTT12020c45c242c242, T .3 315822012 1 2 5.4 -, , 1 . 50200 . - (100 c177 5) , 15 - . . 1 - . 2 , , .5.5 - , 5 20 %, -1. , , - 5.3, , 5 %, 5.4 2 .5.6 5.6.1 - ( 3) 110 % -. , (6 c177 0,1) .4 315822012 3 , - c113= 905 . , - . c113 = 905 2 47000 . , . - . , , 5.2, , 5.4 2 , - .5.6.2 ( 4), , , , 0,5 . ; - , , , , - *, IS-1 DF-1, .* 5841-32010 IS-1 . 113182010 DF-1 . - .5 315822012 4 , -c177 45 c177 2(4).