KS P ISO 16054-2009 Implants for surgery－Minimum data sets for surgical implants《外科植入物 外科植入物的最小数据组》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 16054 KS P ISO 16054:2009 2009 12 21 http:/www.kats.go.krKS P ISO 16054:2009 : ( ) ( ) () () ( ) : (http:/www.standard.go.kr) ： ：2004 11 22 ：2009 12 21 2009-0834 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 16054:2009 i 2000 1 ISO 16

2、054, Implants for surgery Minimum data sets for surgical implants . , . , . . KS P ISO 13485 . 3 . . KS P ISO 16054:2009 Implants for surgery Minimum data sets for surgical implants 1 , . . . , 30 . . . , . . 2 . . ( ) . KS P ISO 13485, ISO 8402, Quality management and quality assurance Vocabulary 3

3、 KS P ISO 13485 ISO 8402(3.1 ) . KS P ISO 16054:2009 2 3.1 (implantable medical device) . 30 , KS P ISO 13485 . KS P ISO 13485 . 3.2 (implant event) , 30 , 3.3 (explant event) 3.4 1 (ISO 8402 ) . 2 . 4 (data set) 4.1 (general) , . . 4.2 (supplier data) a)d) . a) b) KS P ISO 16054:2009 3 c) d) , , ,

4、, . . . . . 4.3 a)j) . a)j) . , , . a) b) c) d) e) f) g) , h) 1 i) j) ( ) . . . 3 . . KS P ISO 16054:2009 4 A ( ) 3 . . NP 15418, EAN/UPC Application Identifiers and FACT Data identifiers NP 15420, Bar coding Symbology Specification EAN/UPC NP 15417, Bar coding Symbology Specification Code 128 The H

5、ealth Industry Bar Code (HIBC) supplier labelling standard HL7： Application Protocol for Electronic Data Exchange in Healthcare Environments HL7s Implementation Support Guide Appropriate standards under development by ISO/IEC JTC 1/SC 31 EN 800, Bar Coding Symbology Specification Code 39 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P ISO 16054:2009 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Implants for surgeryMinimum data sets for surgical implants ICS 11.040.40 Korean Agency for Technology and Standards http:/www.kats.go.kr