GOST R ISO 14708-1-2012 Implants for surgery Active implantable medical devices Part 1 General requirements for safety marking and information to be provided by the manufacturer《外科.pdf

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1、2014 1 , , ISO 14708-1:2000 Implants for surgery Active implantable medical devices Part 1: General requirements for safety, marking and information to be provided by the manufacturer (IDT) 14708-12012 14708-12012II1 - . . . ( . . . ) , 42 3 - 30 2012 . 265-4 14708-1:2000 . . 1. -, , (ISO 14708-1:20

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3、5 , 816 , .817 , .918 , 919 , .920 , 1021 , , 1122 , 1123 1224 , - 1325 , - 1326 , - 1427 .1428 14 A () / 14283 .17 B () , A 29 () .30 () .35 36 14708-12012 1 201401011 - . - , 14708. - , . , , - . , - , (-, ). (. 3.3).2 . . - ( ). 8601:1998 . . (ISO 8601:1998, Data elements and interchange formats

4、Information inter-change Representation of dates and times) 11607:1997 , (ISO 11607:1997, Packaging for terminally sterilized medical devices) 14155:1996 (ISO 14155:1996, Clinical inves-tigation of medical devices) 15223:2000 . , - (ISO 15223:2000, Medical devices Symbols to be used with medical dev

5、ices labels, labeling and information to be supplied) 60068-2-14:1986 . 2. . - N: (IEC 60068-2-14:1986, Environmental testing Part 2: Tests N: Change of temperature) 1 , , Implants for surgery. Active implantable medical devices. Part 1. General requirements for safety, marking and information to be

6、 provided by the manufacturer 14708-120122 60068-2-32:1990 . 2. . - d: ( 1) IEC 60068-2-32:1990, Environmental testing Part 2: Tests Ed: Free fall (Procedure 1) 60068-2-47:1999 . 2-47. -. , , - (IEC 60068-2-47:1999, Environmental testing Part 2-47: Test meth-ods Mounting of components, equipment and

7、 other articles for vibration, impact and similar dynamic tests) 60068-2-64:1993 . 2. . - Fh: ( ) IEC 60068-2-64:1993, Environmental testing Part 2: Tests methods Test Fh: Vibration, broad-band random (digital control) and guidance) 60601-1:1988 . 1. -. 1:1991 2:1995 (IEC 60601-1-1:1988, Medical ele

8、ctrical equipment Part 1: General requirements for safety. Amendment 1:1991 and Amendment 2:1995) 60601-1-1:1992 . 1. -. 1. . (IEC 60601-1-1:1992, Medical electrical equipment Part 1: General requirements for safety 1. Collateral standard: Safety requirements for medical electrical systems) 60601-1-

9、2:1993 . 1. -. 2. . . (IEC 60601-1-2:1993, Medical electrical equipment Part 1: General requirements for safety 2. Collateral stan-dard: Electromagnetic compatibility Requirements and tests) 60601-1-4:1996 . 1. -. 4. . (IEC 60601-1-4:1996, Medical electrical equipment Part 1: General requirements fo

10、r safety 4. Collateral stan-dard: Programmable electrical medical systems) 60601-2-27:1994 . 2. - (IEC 60601-2-27:1994, Medical elec-trical equipment Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment) 61000-4-2:1995 . 4. . 2. . - (IEC 61000-4-2:1995, Electro

11、magnetic compatibility (EMC) Part 4: Testing and measurement techniques Section 2: Electrostatic discharge immunity test. Basic EMC Publication)3 :3.1 : -, , - :- , , , - ;- , ;- , , , - , .3.2 : , - , , .3.3 : , - - , -, . , , 14708-120123 , , , , - . , -, .3.4 : , - ( - ). .3.5 : , - , . .3.6 : , -, .3.7 : , .3.8 : , - . , , .3.9 : , .3.10 : , , , .3.11 : , , - , .3.12 : , , - , - .3.13 : , - -, , .3.14 : .3.15 : .3.16 : , , , .3.17