医療機器等のための UDI対応バーコード表示ガイド

1 UDI . 2017 6 2 .. The Distribution Systems Research Institute (DSRI).. 1 2017 3 . 2 2017 6 GS1 5-1 GS1.. GS1 . 7.. 2013 9 FDA . UDI Unique Device Identification . 2014 9 GUDID(Global Unique Device Identification Database) 2017 5 . 2020 5 UDI .. 1999 . GS1-128 .. GS GS1 . UDI . GS1 .. GS1-128 GS1 . GS1 .. 1.. 1. 2. GS1 .. 2. 3. GS1 .. 2. GTIN Global Trade Item Number .. 2. GTIN-13 .. 3. GTIN-14 .. 4. GTIN .. 6. GTIN .. 6. GTIN .. 8.. 9. 10. (1)GTIN 01 .. 10. (2) 17 .. 11. (3) 10 .. 12. (4) 21 .. 12. AI .. 13. (1) 11 .. 13. (2) 20 .. 14. (3) 422 .. 14. (4) 8012 .. 14. (5) 90 .. 14. (6) 91 99 .. 15. 4.. 16.. 16. GS1-128 .. 16. GS1 GS1 DataMatrix .. 16.. 17. 5.. 18.. 18. GS1-128 .. 19. GS1-128 .. 20.. 20. 6.. 23.. 23.. 23. 7.. 24.. 24.. 24. GS1 GS1 .. 26. GS1 .. 27.. 28.. 39.

2 1.. GS . GS1-128 GS1 .. GS1 . GS1 .. FDA UDI .. GS1 .. GS1 . GS1 . UDI .. 1. 2. GS1 . GS1 110 . GS1 . GS1 .. GS1 GS1 GS1 General Specifications . GTIN GS1 GTIN . GS1 Healthcare GTIN Allocation Rules . GS1 GS1 GS1 GTIN .. GS1-128 GS1-128 GS1-128 .. 3. GS1 . GS1 . GS . (GS1 Identification key) 2016 11 GS . GS1 .. GS1 GTIN Global Trade Item Number . GTIN . GTIN Global Trade Item Number . GTIN GS1 . GS1 .. GTIN . GS1 GS1. Japan GS1 GS1 GTIN . GTIN . " . GTIN 8 12 13 14 . GTIN-8 GTIN-12 GTIN-13 GTIN-14 . 2. GTIN . GTIN . GTIN-13 GTIN-14 .. GTIN . JAN Japanese Article Number . GTIN-13 EAN European Article Number . (Universal Product Code) GTIN-12 . GTIN-13 GTIN-14 . GTIN-12 GTIN-8 GTIN-12 GTIN-8.. GTIN-13. GTIN-13 13 . GTIN-13 .. 1 . GTIN-13 .. GTIN-13 GS1 . GS1 GTIN GS1 . GS1 Company Prefix GS1.

3 2 45 49 9 7 . GS1 . GS1 9 3 GS1 7 . 5 GTIN .. 000 00000 . 001 00001 . 3.. 12 10 . GTIN-13 .. GTIN-14. GTIN-14 GTIN-13 . 14 GS1 . GS1 . GTIN-13 .. 1 . 1 8 1 8 . 1 2 .. GS1 GTIN-14 GTIN-13 . GTIN-14 GTIN-13 . GTIN-13 . 13 . 4. GTIN-14 . GTIN-13 GTIN-14 . GTIN-13 12 . 13 . 13 14 .. GTIN-14 GTIN-13 GTIN-13 GTIN-14 GS1 .. 5. GTIN . GTIN . 1 . GTIN-13 .. GTIN .. GTIN GTIN-13 GTIN-1 .. GTIN GTIN-13 .. GTIN GTIN . GTIN GS1 .. GTIN . GTIN-14 1 8 . GTIN-13 GS1-128 GS1 . 0 14 .. GTIN .. GTIN . 6. GTIN . GS1 GTIN-13 . POS . POS GTIN-13 . GTIN-13 .. GTIN-13 GTIN . GTIN-13 GTIN-13 GTIN-14 . GS1 . GTIN-14 . GTIN . GTIN-13 GTIN-14 . GTIN-13 GTIN-13. 4912345123459 4912345123459.. GTIN-13 GTIN-14. 4912345234568 14912345123456. POS GTIN-13 . POS . GTIN-13 POS JAN . GTIN-14 JAN POS GS1-128.

4 GTIN-13 JAN GS1-128 POS . JAN GS1-128 .. JAN GS1-128 .. 7. GTIN .. AED.. 2008 .. FDA UDI .. GTIN 1 1 1 . GTIN . GTIN .. GTIN GTIN . GTIN GTIN-13 . GTIN-13 GTIN-14 GTIN .. GTIN .. GTIN .. Unit of Use . Unit of Use .. GTIN FDA UDI GTIN .. 8.. GTIN . GS -128 GS1 . Application Identifier: AI AI . 2 4 . GS AI 120 3 28 . AI . UDI GS1 AI . AI / . 01 (GTIN) 01+N14 14 . 10 10+ 20 . 11 YYMMDD 11+N6 . 17 YYMMDD 17+N6 . 21 21+ 20 . N 0 9 . X 2 0 9 .. GS1 4 . AI . AI GTIN .. AI .. AI .. AI AI . AI .. AI 11 AI .. 9. AI. GTIN . UDI .. (1)GTIN 01 . GTIN AI 01 GS1-128 GS GTIN . 14 . 14 GTIN -8 -12 GTIN-13 . GTIN 0 . 14 . 14 GTIN . GTIN-8 GTIN-12 . ( 0 1 ) 0 0 0 0 0 0 4 9 9 6 8 7 9 8 ( 0 1 ) 0 0 6 1 4 1 4 1 3 2 1 6 8 1. GTIN-13 GTIN-14 . ( 0 1 ) 0 4 9 1 2 3 4 5 0 0 0 0 1 9. N 0 9 . 10. (2) 17.

5 17 . 2 . 2 00 2020 8 200800 . FDA UDI . ( 2020 8 31 200831).. A I .. 17 N1 N2 N3 N4 N5 N6. N 0 9 .. 2020 8 31 .. 2020 8 .. 11. (3) 10 . AI 10 . 20 . 2 .. A I . 10 X1 X20. 2 P. 27 .. (01)14912345000016(17)200831(10)AB123. ( 0 1 ) 1 4 9 1 2 3 4 5 0 0 0 0 1 6 (1 7 ) 2 4 1 2 3 1 ( 1 0 ) 1 2 3 4 5 6 7 8 9 0 1 2 3 4 5 6 7 8 9 0. (4) 21 . 21 . 20 2 .. A I . 21 X1 X20. 2 .. (01)14912345000016(17)200831(21)12345678 90. 12. AI. AI 01 GTIN AI(17) AI 10 . AI 21 . AI FDA UDI. UDI-PI(Production Identifier PI( )) . AI 11 .. AI . AI 01 AI 17 AI 10 AI(21) AI .. (1) 11 . 11 . 2 . FDA UDI UDI-PI .. A I .. 11 N1 N2 N3 N4 N5 N6. N 0 9 .. (01)14912345000016(17)201231(11)161231(1 0)AB123(21)123. 13. (2) 20 . GTIN .. A I . 20 N1 N2. N 0 9 . (3) 422 . ISO 3166 3 . 3 4 .. A I . 422 N1 N2 N3. N 0 9.

6 (4) 8012 .. A I . 8012 X1 X20. 2 . (5) 90 .. A I . 90 X1 X30. 2 . 14. (6) 91 99 .. A I . 91~99 X1 X30. 2 . AI 30 . AI 30 .. AI 30 * . AI 30 . AI 30 .. AI(30) . GS1 30 GS1-128 . 0 .. 15. 4.. UDI GS1-128 GS1 2 .. GS1-128 . GS1-128 ISO/IEC 15417 JIS X0504 Code 128 . GS1 . ( 0 1 ) 0 4 9 1 2 3 4 5 0 0 0 0 1 9 ( 1 7 ) 2 0 1 0 3 0 ( 1 0 ) 1 2 3. GS1 GS1 DataMatrix . GS1 ISO/IEC 16022 JIS X0512 . GS1 . GS1-128 .. (01)04912345000019 (01)04912345000019. (17)201030(10)123 (17)201030(10)123. GS1-128 . GS1 . GS1 . GS1 . GS1-128 . GS1 . 16. AI GS1 FNC1. GS1-128 GS1 AI GS1 GS1. FNC1 . GS1-128 FNC1 . GS1 GS1 GS1 .. FNC1 GS1 .. FNC1 2 . GS1 .. FNC1 ( ) . ( . ) .. HRI: Human Readable Interpretation .. GTIN AI .. AI AI .. (01)04912345000019 (01)049123. (17)201030(10)123 45000019(17)201030(10)123.

7 (01)04912345000019. (17)201030(10)123. (17)201030(10)123 (01)04912345000019. (01)04912345000019 (01)04912345000019. (17)201030(10)123 (17)201030(10)123. (01)04912345000019. (17)201030(10)123. 17. 5.. GS1 . 5-1 .. GS1 . GS1 system symbol specification table . 5-1 . X . mm ( ) mm ( ) .. GS1- 128 10X 10X ( ") ( ") ( ") ( "). GS1 X . 1X, 4 (ECC 200) ( ") ( ") ( ") . GS1 GS1 system symbol specification table 6 . / / nm ABCDF . C 7 . mil 1mil= 06 6 x .. GS1 128 . GS1 X. 5-1 GS1-128 GS1 .. GS1-128 X GS1 X ( ) .. 18.. X . X . (01)04912345000019. (01)04912345000019(17)201030(10)123 (17)201030(10)123. X . (01)04912345000019. ( 0 1 ) 0 4 9 1 2 3 4 5 0 0 0 0 1 9 ( 1 7 ) 2 0 1 0 3 0 ( 1 0 ) 1 2 3 (17)201030(10)123. GS1-128 . GS1-128 . 1 AI . FNC1 48 FNC1 .. GS1 10X . 100mm 100 . 100.

8 5-1 .. 2 . 2 .. 19.. ( )108 . ( 0 1 ) 0 4 9 1 2 3 4 5 0 0 0 0 1 9 ( 1 7 ) 2 0 1 0 3 0 ( 1 0 ) A B 1 2 3 4.. ( )86 . (01)04912345000019(17)201030(10)AB1234. GS1-128 . GS1 GS1-128 .. 10mm .. GS1-128 .. (01)04912345000019(17)201030(10)AB1234.. 10 . (01)04912345000019(17)201030(10)AB1234. GS1 .. GS1 . 5-2 5-1 .. 20.. 5-2 . X .. mm ( ) mm ( ) .. GS1- 128 10X 10X ( ") ( ") ( ") ( "). GS1 .. 1X 4 ( ") ( ") ( ") X . (ECC 200). GS1 GS1 system symbol specification table 10 .. (01)04912345000019 (01)04912345000019.. ( 0 1 ) 0 4 9 1 2 3 4 5 0 0 0 0 1 9.. ( 0 1 ) 0 4 9 1 2 3 4 5 0 0 0 0 1 9. X: . (01)04912345000019 (01)04912345000019 (01)04912345000019. (17)201030(10)423 (17)201030(10)466 (17)201030(10)974. 21. GS1 . 5-3 .. 5-3 . X .. mm ( ) mm ( ) .. GS1- 128 10X 10X ( ") ( ") ( ") ( ").

9 GS1 .. 1X, 4 ( ") ( ") ( ") X . (ECC 200). GS1 GS1 system symbol specification table 8 .. ( 0 1 ) 1 4 9 1 2 3 4 5 0 0 0 0 1 6.. ( 0 1 ) 1 4 9 1 2 3 4 5 0 0 0 0 1 6. X: X: . (01)14912345000016 (01)14912345000016. (17)201030(10)0762 (17)201030(10)1482. 22. 6.. GS1-128 ISO/IEC 15416 JIS X0520 GS1 . ISO/IEC 15415 JIS X0526 . A B C D F 5 . C .. (01)04912345000019. (17)201030(10)123.. dpi( ) dpi dot per inch( . ) 1 .. 23. 600dpi 1 600 . 600dpi 600 . 3 4 5 6 . 600 dpi 360 dpi 300 dpi 600dpi 1 . 600dpi 0 254 0 19 . 3 4 . 4 . 600dpi 5-1 . GS1-128 . 5 . 600dpi 5 300dpi 5 . (01)04912345000019 ( 0 1 ) 0 4 9 1 2 3 4 5 0 0 0 0 1 9. 7.. GS1-128 . GS1 .. GS1 .. 24.. 80mm . 50mm . 37mm .. 25. GS1 GS1 . 2016 4 1 . GS1 . Global Trade Item Number . GTIN . Global Location Number . GLN . Serial Shipping Container Code.

10 SSCC . Global Returnable Asset Identifier . GRAI . Global Individual Asset Identifier . GIAI . Global Service Relation Number . GSRN .. Global Document Type Identifier . GDTI . Global Identification Number for . GINC Consignment . Global Shipment Identification . GSIN Number . Global Coupon Number . GCN . Component / Part Identifier . CP . 26. GS1 . ISO/IEC646 .. ! M M. " N N. % O O. & P P. ' Q Q. ( R R. ) S S. * T T. + U U. , V V. - / W W.. X X. / Y Y. 0 Z Z. 1 _ . 2 a a 3 3 b b 4 4 c c 5 5 d d 6 6 e e 7 7 f f 8 8 g g 9 9 h h : i i ; j j < k k = l l > m m ? n n A A o o B B p p C C q q D D r r E E s s F F t t G G u u H H v v I I w w J J x x K K y y L L z z AI (8010) - / . 27.. GS1 AI) . GS1 .. 2017 . A I . 00 n2+n18. (0 9 1 GS1 . SSCC (JAN ) . 18 . 01 n2+n14. 8 12 . (GTIN 13 14 14 GTIN.)