GOST R ISO 16054-2013 Implants for surgery Minimum data sets for surgical implants《外科植入物 外科植入物的最小数据集》.pdf

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1、 16054 2013 ISO 16054:2000 Implants for surgery Minimum data sets for surgical implants (IDT) 160542013 II 1 - . . ( . . ) , 4 2 3 07 2013 . 82- 4 16054:2000 . (ISO 16054:2000 Implants for surgery Minimum data sets for surgical implants). , . 5 1.02012 ( 8). ( 1 ) , . () . , (gost.ru) , 2014 , 16054

2、2013 III 16054 16054 . , 150 . , . , , , , . . , 13485. , , , . , . 160542013 1 Implants for surgery. Minimum data sets for surgical implants 20150101 1 , , . , , . , . , , . 30 , , . , , , , , . , , . - , , . 2 . . ( ). 13485 . . ISO 9001 (ISO 13485, Quality systems Medical devices Particular requi

3、rements for the application of ISO 9001) 8402 . (ISO 8402, Quality managementand quality assurance Vocabulary) 3 13485, 8402, : 3.1 (implantable medical device): , , , , 30 . 160542013 2 - 13485 , , . , , 13485 , . 3.2 (implant event): , : , , 30 , . 3.3 (explant event): , . 3.4 (medical facility):

4、, () . 1 - (. 8402) . 2 - , , , . 4 1.1 ( ) , , , , . : () ; . 1.2 , ) d), : a) ; b) ; c) , , , ; d) (), , , , . , , , , , , . . , . 1.3 , ) j). , ) j), . 160542013 3 , , , , : a) / ;b) / ;c) , ;d) , ;e) ;f) , , , ; g) , , , , ; h) ( ); i) , , ;j) ( ) . . , . , . . , , . 160542013 4 () , , , , , . , . NP 15418, EAN/UPC FACT ; NP 15420 . . EAN/UPC; NP 15417 . . 128; (Health Industry Bar Code, HIBC); HL7. ; HL7; , ISO/IEC JTC 1/SC 31; EN 800, . . 39. 160542013 5 () .1 13485:2003 IDT 13485 - 2004 . . 8402 - * * . . . : - IDT .