厚生労働省医薬食品局 審査管理課医療機器審査管理室長 )(公印省田各)
Contents
1. 8 GIST 5701 5801 ISO 7494 1996 7494 1 7494 2 10637 K 5 I ENS NAME F SCEN Na PBUH SOL TERT SO K 6 SURI BF GIST 5750 xi 89 K 72. IST 5602 5701 ISO 6875 7494 1996 7494 1 7494 2 6 FAROE 80 NM PB UT DERE D l HST 5602 5701 ISO 6875 7494 1996 7494 1 7494 2 F 7
3. K 20 REKTE K 21 K 22 _ K 23 ARMARE 538590 2
4. IST 5906 5907 ISO 7488 7785 1 7785 2 9997 E 7 IST 5402 5404 5406 5419 5420 5750 5906 5907 5910 5911 ISO 7785 1 7785 2 15606 22374 E 8 AGP FP Y TENSA FE ADO DOE CES SA IST 5750 5906 5907 5910 5911 ISO 7785 1 7785 2 15606 22374 E 9 POE
5. 2 8 6 ES JIS ISO EC 11 2 IIS 9 ISO C 24 12 31 ISO IEC JIS DT MOD 5 5 1 5 2 DIS FDIS JIS DIS FDIS DT MOD
6. SO 7488 9680 1993 9680 F 10 238 038 i HST 5750 5751
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10. 1 2 EA EF 3 5 5 a JS T 14971 D KEIR O
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13. 82 a 1 4 t 1 2 1 3 JS T 0601 1 RU MEC 80601 2 60 te MIS T 0601 1 2 4 JIS C 1010 1 MIS C 1806 1 24 12 31 JIS RU ISO IEC 1 JIS ISO IEC
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16. I D D 1 d IST 5217 1 5419 5750 SO 3630 1 3630 3 7741 D 2 I KDED LARA EA L CH I IST 5602 SO 6875 D 3
17. IST 5910 SO 7488 15606 E A 83 IST 5701 ISO 7494 1996 7494 1 7494 2 E 5 78 HAA ARAL REA ROBA HST 5701 ISO 7494 1996 7494 1 7494 2 E 6 BER ENE JIS T 5504 1 1
18. HST 5602 SO 6875 L A IST 5701 ISO 7494 1996 7494 1 7494 2 L 5 BE HS T 5908 5909 ISO 11498 13294 M M 1 WENGER HST 5602 ISO 6875 M 2
19. I 3 7 f WAROMA BRI PARMAR RBS S5 LIUR 3 8 f 39 1
20. L 550nm 670 nm M 1 5 SO 7488 M 16 ISO 13897 M 17 SO 13897 94
21. IST 5701 SO 7494 1996 7494 1 7494 2 B 8 ZS RHESN RACY ARCELOR E ORL VEHEMET S ST 5217 1 5217 2 i ISO 3630 1 3630 2 B 9 JIEUBURS HEISAEO 7 avi ACH IN ARABIC OTS IST 5801 SO 10637 B 10 mE EL IS T 5801 5906 5908 5910 ISO 7785 1 10637 13294 15606 B 11 H
22. IISO 12233 Photography Electronic still picture cameras Resolution measurements SO 12233 Bs HST 5750 ER BI gt
23. JJS T 0601 1 2 1 2 l b IS C 1806 1 1 7 a GRAM WS JIS THESN CWS BARRO MER E RUR JIS o b JIS
24. IST 5602 5701 5753 ISO 6875 7494 1996 7494 1 7494 2 11498 13294 9680 1993 9680 92 M 3 IST 5602 5701 5753 ISO 6875 7494 1996 7494 1 7494 2 9680 1993 9680 M 4 HE HALE RAT TRESNA F 7 ORB IST 5602 ISO 6875 13897 M 5 BE HORSE OR XSL RCE RUE 83 IST 5602 ISO 6875 M 6 f i REATOR NA
25. BS IST 5502 5906 5907 5417 SO 7785 1 7785 2 8325 H A KOE EJNUIRS PLE H 1 BAAS MECANO RETR BREN SKARUSPKON ETATO IST 5701 ISO 7494 1996 7494 1 7494 2 H 2 83 ABE IST 5801 SO 10637 H3 1 JIS T 5906 5908 5909 5910 ISO 7185 1 11498 13294 15606 H 4 SATE BRAK SSI END REN GUERRA TS TRATAR
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31. IJIS TS505 3_ 3 BUE 2 HST 5750 A 9 RIRES HAAS BME MISH 8501 EN 1071 2 Advanced technical ceramics Methods of test for ceramic coatings Par 2 Determination of coating thickness by the crater grinding method IST 5750 ATO 72
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34. i 1 ISO EC 2 ISO IEC JIS ISO SUR XIX TEC Js JIS T 0601 1 2 IEC IEC 60601 1 2 2001 2007 ISO iSO TC 106 Dentistry IEC EC TC 62 Electrical equipment in medical practice TC 87 Ultrasonics TEC TC 65 Industrial process measurement control and automation TC 66 Safety of measuring control and laboratory equipment TEC ISO TC 194 Biological evaluation of medical devices ISO l I LI 10
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37. RICOTA JIST 5301 5410 M 7 JIS T 5409 f JIST 5409 M 8 a JIST 5906 5907 ISO 7785 1 7785 2 M 9 BERRA AT BAT Arc 0 45 m A IST 5750 5801 5906 5
38. L LI 91 QIS 5701 ISO 7494 1996 7494 1 7494 2 L 2 BE IST 5602 7 ISO 6875 L 3 f
39. GIST 560 SO 6875 3 QST 5602 ISO 6875 4 BERRILKERE 5 REKTE thy IST 5602 SO 6875 5
40. JS 180 9873 1998 Dental hand instruments Reusable mirrors and handles JIS T 5903 MOD Cor 1 2000 1SO 9997 1999 Dental cartridge syringes ISO 10323 1991 Dental rotary instruments Bore diameters for discs and wheels ISO 10637 1999 Dental equipment High and medium volume suction systems JIS T 5801 MOD ISO 10650 1 2004 Dentistry Powered polymerization activators Part 1 Quartz tungsten JIS T 5752 1 MOD halogen lamps L2 Dentistry Powered polymerization activators Part 2 Light emitting ISO 10650 2 2007 diode LED lamps JIS T 5752 2 MOD ISO 11143 2008 Dentistry Amalgam separators d ISO 11144 1995 Dental equipment Connections for supply and waste lines ISO 11193 1 2008 Single use medical examination gloves Part 1 Specification for gloves Amd 1 2012 made from rubber latex or rubber solution ISO 11499 2007 Dentistry Single use cartridges for local anaesthetics 180 128362012 Dentistry Digitizing devices for CAD CAM systems for indirect dental restorations Test methods for assessing accuracy _ ISO 13295 2007 Dentistry Mandrels for rotary instruments Periodontal curettes dental scalers and excavators Part 1 General JIS T5404 MOD 180 13397 1 1995 requirements JIS T 5406 MOD ISO 13397 2 2005 Dentistry Periodontal curettes dental scalers and excavators Part 2 j Amd
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42. UCA DEL lt a 1 2 1 ME ME 2 8 33 O 34 ME
43. PLE FIEROS TISO 21530 Dentistry Materials used for dental equipment surfaces Determination of resistance to chemical disinfectants IST 5301 5302 5402 5404 5406 5416 5417 5418 5420 5752 1 5752 2 5903 ISO 7492 7741 9173 1 9873 9997 10650 1 10650 2 13397 1 13397 2 13397 3 13397 4 15087 1 150872 15087 3 15087 4 15087 5 15087 6 15098 1 15098 2 15098 3 D 4 WERE
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76. IS ISO 1797 1 2011 Dentistry Shanks for rotary instruments Part 1 Shanks made of metals JIS T5504 1 ISO 1797 2 1992 Dental rotary instruments Shanks Part 2 Shanks made of plastics JIS T 55042 ISO 1942 2009 Dentistry Vocabulary ISO 2157 1992 Dental rotary instruments Nominal diameters and designation code TIS T 5503 Dr ISO 3630 1 2008 Dentistry Root canal instruments Part 1 General requirements and test methods ISO 3630 2 2000 Dental root canal instruments Part 2 Enlargers ISO 3630 3 1994 Dental root canal instruments Part 3 Condensers pluggers and spreaders HS T 5217 2 MOD ISO 3630 4 2009 Dentistry Root canal instruments Part 4 Auxiliary instruments ISO 3630 5 2011 Dentistry Endodontic instruments Part 5 Stiaping and cleaning instruments ISO 3823 1 1997 Dental rotary instruments Burs Part 1 Steel and carbide burs ISO 3823 2 2003 Amd 1 2008 Dentistry Rotary bur instruments Part 2 Finishing burs ISO 3964 1982 Dental handpieces Coupling dimensions ISO 4073 2009 ISO 6360 1 2004 Cor 1 2007 Dentistry Information system on the location of dental equipment in the working area of the oral health care provider Dentistry Number coding system for rotary instruments Part 1 General characteristics ISO 6360 2 2004 Amd 1 2011 Ll Dentistry
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123. 1 2012 Periodontal curettes of Gr type _ ISO 13397 3 1996 Bam curettes dental scalers and excavators Part 3 Dental scalers E 75406 MOD ISO 13397 4 1997 Periodontal curettes dental scalers and excavators Part 4 Dental JIS T 5404 MOD excavators Discoid type ISO 13402 1995 Surgical and dental hand instruments Determination of resistance against autoclaving corrosion and thermal exposure Dentistry General requirements for instruments and related accessories ISO 135042012 used in dental implant placement and treatment ISO 14457 2012 Dentistry Handpieces and motors ISO 13897 2003 Cor 1 2003 Dentistry Amalgam capsules ISO 15087 1 1999 Dental elevators Part 1 General requirements ISO 15087 2 2000 Dental elevators Part 2 Warwick James elevators ISO 15087 3 2000 Dental elevators Part 3 Cryer elevators ISO 15087 4 2000 Dental elevators Part 4 Coupland elevators ISO 15087 5 2000 Dental elevators Part 5 Bein elevators ISO 15087 6 2000 Dental elevators Part 6 Flohr elevators ISO 15098 1 1999 Dental tweezers Part 1 General requirements JIS T 5401 MOD ISO 15098 2 2000 Dental tweezers Part 2 Meriam types ISO 15098 3 2000 Dental tweezers Part 3 College types ISO 15606 1999 Dental handpieces Air powered scalers and scaler tips JIS T 5910 MOD s Dentistry Materials used for dental equipment surfaces Determination 180 215302004 of resistance to chemical disinfectants ISO 21533 2003 Dentis
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136. Number coding system for rotary instruments Part 2 Shapes ISO 6360 3 2005 Dentistry Number coding system for rotary instruments Part 3 Specific characteristics of burs and cutters Dentistry Number coding system for rotary instruments Part 4 Specific ISO 6360 4 2004 characteristics of diamond instruments Dentistry Number coding system for rotary instruments Part 5 Specific ISO 6360 5 2007 characteristics of root canal instruments VI Dentistry Number coding system for rotary instruments Pat 6 Specific 180 6360 6 2004 characteristics of abrasive instruments ISO 6360 7 2006 Dentistry Number coding system for rotary instruments Part 7 Specific l characteristics of rhandrels and special instruments ISO 68752011 Dentistry patient chair ISO 7488 1991 Dental amalgamators ISO 7492 1997 Dental explorers JIS T 5402 MOD ISO 7493 2006 Dentistry Operator s stool JIS T 5601 MOD ISO 7494 1 2011 Dentistry Dental units Part 1 General requirements and test methods ISO 7494 2 2003 Dentistry Dental units Part 2 Water and air supply ISO 7711 1 1997 Dental rotary instruments Diamond instruments Part 1 Dimensions Amd 1 2009 requirements marking and packaging JIS T5505 1 MOD ISO 7711 2 2011 Dentistr
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152. t 2 051 Particular requirements for laboratory equipment for mixing and stirring TEC 61326 1 2012 Electrical equipment for measurement control and laboratory use EMC requirements Part 1 General requirements TEC TR 60878 2003 Graphical symbols for electrical equipment in medical practice TEC 80601 2 60 2012 Medical electrical equipment Part 2 60 Particular requirements for basic safety and essential performance of dental equipment 5 3 ANSUADA Specification No 101 2001 Root Canal Instruments General Requirements FDA Guidance 2003 12 02 CIE Technical Report 13 3 1995 67 Class II Special Controls Guidance Document Dental Sonography and Jaw Tracking Devices Method of Measuring and Specifying Colour Rendering Properties of Light Sources 1 AERO HEH
153. try Reusable cartridge syringes intended for intraligamentary injections JSO 21671 2006 Amd 12011 Dentistry Rotary polishers ISO 21672 12012 Dentistry Periodontal probes Part 1 General requirements ISO 21672 2 2012 Dentistry Periodontal probes Part 2 Designation ISO 22374 2005 Dentistry Dental handpieces Electrical powered scalers and scalertips JIS T 5911 FDIS ISO 28319 2010 Dentistry Laser welding ISO TS 22595 1 2006 Dentistry Plant area equipment Part 1 Suction systems ISO TS 22595 2 2008 Dentistry Plant area equipment Part 2 Compressor systems Ultrasonics Dental descaler systems Measurement and declaration of the TEC 61205 1993 output characteristics 66 5 2 pipo TE UE SPESE RS TEC compatibility Requirements and tests HS TEC 60601 1 2005 Cor 1 2006 Cor 2 2007 gt lt Medical electrical equipment Part 1 General requirements for basic Amd i I A 5 safety and essential performance I TIS TO601 1 MOD ISH 11 2008 ISH 12 2009 A Medical electrical equipment Part 1 1 General requirements for safety n TEC 60601 1 1 2000 Collateral standard Safety requirements for medical electrical systems JS T0601 1 1 IDT Medical electrical equipment Part 1 2 General requirements for basic TEC 60601 1 2 2007 safety and essential performance Collateral standard Electromagnetic
154. y Rotary diamond instruments Part 2 Discs 4 a Dentistry Diamond rotary instruments Part 3 Grit sizes designation ISO 7711 3 2004 and colour code ISO 7786 2001 Dental rotary instruments Laboratory abrasive instruments JIS T 5210 i DIS ISO 7787 1 1984 Dental rotary instruments Cutters Part 1 Steel laboratory cutters JIS T 5506 1 MOD ISO 7787 2 2000 Dental rotary instruments Cutters Part 2 Carbide laboratory cutters JIS T 5506 2 DIS ISO 7787 3 1991 Dental rotary instruments Cutters Part 3 Carbide laboratory cutters for JIS T 5506 3 MOD milling machines ISO 7787 4 2002 Dental rotary instruments Cutters Part 4 Miniature carbide laboratory JIS T 5506 4 MOD ISO 7885 2010 Dentistry Sterile injection needles for single use ISO 8282 1994 Dental equipment Mercury and alloy mixers and dispensers ISO 8325 2004 Dentistry Test methods for rotary instruments HS T 5502 DIS ISO 9168 2009 Dentistry Hose connectors for air driven dental handpieces ISO 9173 1 2006 Dentistry Extraction forceps Part 1 General requirements and test _ JIS T 5410 MOD ISO 9173 2 2010 Dentistry Extraction forceps Part 2 Designation ISO 9680 2007 Dentistry Operating lights JIS T 5753 MOD ISO 9687 1993 Dental equipment Graphical symbols 65
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