GOST R ISO 15225-2014 Medical devices Quality management Medical device nomenclature data structure《医疗器械 质量管理 医疗器械命名数据结构》.pdf

1、 152252014 . ISO 15225:2010Medical devices Quality management Medical device nomenclature data structure(IDT) 1 - - , 42 436 - 3 22 2014 . 1161-4 15225:2010 -. . (ISO15225:2010Medicaldevices Qualitymanagement Medicaldevicenomenclaturedatastructure). - , 5 1.02012 ( 8). ( 1 ) , -.() - . , - (gost.ru)

2、 , 2015 , - - II 1522520141 .12 13 14 .34.1 .34.2 .34.3 34.4 44.5 44.6 , .45 .55.1 .55.2 55.3 65.4 66 66.1 .66.2 .76.3 .76.4 86.5 .8 () .10 () - .12 () 14 D () .15 () .1617III 152252014 15225 210 . - , , . , , , . ( 15225:2000), . 15225:2000/Amd.1:2004. - , . , :- 3 , , , , , (GMDN), GMDN, , ;- 13,

3、14 15; -;- D, ., , , (GMDN).IV 152252014 . Medical devices. Quality management.Medical devices nomenclature data structure 201509011 , , , , , - . -, , , - . , .2 -:/ 8859-1:1998 . 8- - . 1. 1 (ISO/IEC 8859-1:1998 Informationtechnology 8 bit single-byte coded graphic character sets Part 1: Latin alp

4、habet No. 1)3 : , ( , , , .), - . .3.1 (base concept): - GMDN. GMDN3.2 (character): , , ./ 8859-1:1998, 4.33.3 (code): (, - ) -, / .3.4 (collective term): , , , .1 152252014 -, , :- ;- ;- ;- ;- ;- , ;- (. . ).3.5 (concept): , . 1087-1:2000, 3.2.13.6 (definition): - .3.7 (device category): .3.8 , (de

5、vice intended for clinicalinvestigation): , - / .3.9 , (device intended for performanceevaluation): , .3.10 (device type): . .3.11 (file): , ./ 2382-1:1993, 01.08.063.12 ()foreignkey(relation): , ./ 2382-17:1999, 17.04.153.13 (generic devicegroup): , / .3.14 (Global Medical Device Nomenclature,GMDN)

6、: , , , , . -, , , , - , .3.15 GMDN (GMDN agency): , -, , -, .3.16 (identifier): , , , , . 2382-4:1999, 04.09.023.17 (multiple-linked synonym): () () - , . GMDN3.18 (name): . . 1087-1:2000, 3.4.2.3.19 (nomenclature): , , . 1087-1:2000, 3.5.32 1522520143.20 (preferred term): , - , .3.21 (primary key)

7、: , ./ 2382-17:1999, 17.03.113.22 (product specifier): , , . GMDN3.23 (relational structure): , - ./ 2382-17:1999, 17.04.033.24 (secondary key): , , ; ./ 2382-17:1999, 17.03.123.25 (synonym): - .3.26 (template specifier): , , - , , , .3.27 (template term): , .3.28 (term): . . 1087-1:2000, 3.4.3.4 4.1 . , , . - . :a) (. 4.2);b) (. 4.3);c) (. 4.4);d) (. 4.5).4.2 , - , . , . , , .4.3 :a) , , , , , , . ;b) , , ;c) , , ;d) , - . .3 1522520144.4 , - . - . (, -/, /) . , - , :a) (. 5.2.3);b) (. 5.2.4);c) (. 5.2.5);d) (. 5.2.6).