GOST R ISO 11238-2014 Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated information on su.pdf

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1、 112382014 . ISO 11238:2012Health informatics Identification of medicinal products Data elements and structures for the unique identificationand exchange of regulated information on substances(IDT) 1 - ( ) - , 42 468 ISO C 2153 17 2014 . 1618-4 11238:2012 - . . (ISO 11238:2012 Health informatics Ide

2、ntification of medicinal products Data elements and structuresfor unique identification and exchange of regulated information on substances)5 1.02012 ( 8). ( 1 ) , -.() - . , - (www.gost.ru) , 2015 , - - II 1123820141 .12 , 12.1 12.2 .73 .73.1 73.2 , 83.3 , 93.4 .103.5 113.6 123.7 24 () 3235III 1123

3、82014 . , . :ISO 11615, Health informatics Identification of medicinal products Data elements and structuresfor the unique identification and exchange of regulated medicinal product information ( -. . - );ISO 11616, Health informatics Identification of medicinal products Data elements and structures

4、for the unique identification and exchange of regulated pharmaceutical product information (. . - );ISO 11238, Health informatics Identification of medicinal products Data elements and structuresfor the unique identification and exchange of regulated information on substances ( -. . - );ISO 11239, H

5、ealth informatics Identification of medicinal products Data elements and structuresfor the unique identification and exchange of regulated information on pharmaceutical dose forms, units ofpresentation, routes of administration and packaging ( . - . - , , );ISO 11240, Health informatics Identificati

6、on of medicinal products Data elements and structuresfor the unique identification and exchange of units of measurement ( . - . ). (IDMP Identification ofMedicinal Products) , , , . , - . IDMP :- , , - (United States Food and Drug Administration);- , Pharma Company A Health Canada;- , , University X

7、 ;- , , - (MHRA UK Medicines and Health Care ProductsRegulatory Agency) (NHS National Health Service);- , , (PMDA Pharmaceutical and Medical Device Agency) . IDMP . - . , IDMP, , . , , , , . -IV 112382014 , , - . HL7 (Common Product Model), - . , , - , - HL7 (HL7 substances implementation guide) HL7

8、 . , - , . , - , , . , - , . - , ., , . - . - ( , ), . - , , , - . , . , - , , . -, . - , -, , . - , , , , -, , , , , , . , - , . - -, . , , , . , , , - , -, . , , - , . , .V 112382014 . Health informatics. Identification of medicinal products.Data elements and structures for the unique identification and exchange of regulated information on substances 201510011 , - , - , , . .2 , 2.1 .2.1.1 (activemarker):-, , - . , - .2.1.2 (analytical data): , , . , , .2.1.3 (chemical bond): , .2.1.4 (chemical substance): , , . , - , .2.1.5 (chiral substance): , .2.1.6 (component):

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