歯科器械の製造販売承認申請等に必要な電気的安全性評価及び物理的
Contents
1. GIST 590 50 7488 15606 GIST 5701 ISO 7494 1996 7494 1 7494 2 78 OST 570 ISO 7494 1996 7494 1 7494 2 E 6 WAA IS T 5504 12. S ST 5750 5751 7 4 IST 5750 5751 1 5 BR FSC MAREE S
3. GIST 5301 5410 M 7 JIS T 5409 157 5409 BAW EV IST 5906 5007 ISO 7785 1 7785 2 7 0 45 5 HST 5750 5801 5906 5908 5909 5910 5911 USO 7785 1 10637 11498 1329
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17. 050 7488 M 16 5 150 13897 KIR JM MARCA BS 13897 94
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21. GIST 5101 SO 7494 1996 7494 1 7494 2 L 2 _ a QOIS T 5602 ISO 6875 1 3 ADEE RAT SORAS OTERO AT AO IST 5602 ISO 6875 L 4 RAB 4 UST 5701 ISO 7494 1996 7494 1 7494 2 5
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23. 9 mo SS 7478 EAC EBED 90 110 0676 190 nm 385 nm 400 nm 515 nm 315 nm 4 EY 7238 400 nm 515 nm IST 5752 1 5752 2 80 10650 1 10650 2 110 77 7A MICA gt BACH MEE AGERE 9 1 mm 250 mm 2500 GIST 5903 080 9873 111 UV SNS JIST 5753 7 4 9 4 0ST 5753 ISO 9680 112 CIE 13 3 Method of Measuring and Specifying Colour Rendering Properties of Sources QST 5753 SO 9680 133 76 13
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98. 2 JIST 5753 73 7 4 3 ISO 9680 1993 7 2 7 3 2 BAA BE HST 5753 ISO 9680 1993 9680 85 DIS T 5753 7 4 2 ISO 96 1993 427 32 BH GST 5753 ISO 9680 1993 9680 C 4 TURE Ree RTS 5153 MIL ISO 9680 1993 02733 UST 5753 050 9680 1993 9680 5 JIS T 5753 7 4 5 TR XLI ISO 9680 1993 73 4 573 75 SO 9680 1993 9680 6 JIS T 5753 0 7 4 6 ISO 9680 1993 7 3 5 BS IST 5753 80 9680 1993 9680 7 ee 5 JIS T 5753 7 4 7 180 9680 1993 73 6 OS 5753 ISO 9680 1993 9680 ROS SS
99. SEDI lt 00016901 o SERRE AE 0009690 hele ce N SEXOR EE RARE HABER 00055691 x x ew jo Xp 9 BW lt x 4 x ir AE US x EE 2 e 83 Eel RW mix O 2 at g 414 5 S r 98 ee y m 2 z w g 2 RHA 5 FE E a OF lli ACEO BSL II 5 REM 1090 X SIC C LIS WRAY ET MORRO INN d MOMHOREAXEL 01 ATOM 6 5 BAME G EEDBORECUAES MELT 09 2 10908 081 Haec cT 21 09 2 10908 3 COX SMGEVWAS CNIOHENDSBIB D Ly 01 TEMS HS Ge 1 lselselselselselselcelse o 0 lxe lxe le ue ve so e le eelae o olololcwlzelge ze ze ze ze e ze lt e lt e e e erase mona ekoja o e e lxe o ve e vo s oss sss
100. eetere olololo lo 7 oseo ee se c c 4 _ ET Lo ojo o o o wow NC 32555 E SHORE BM SER ER NU BAME SLE HERNE O REMEH EYE v9 C C gt VEE IO SA ABA ORBEA BAG Sc LASS 9 OMG 190810 SIE R ele ele ETIN Seo He Meco1 9081 SE Ss 1 4ESERUPEISIC R 5 ISO IEC ISO 1797 1 2011 ISO 1797 2 1992 150 1942 2009 Dental rotary instruments Shanks Part 2 Shanks made of plastics Dentistry Vocabulary a Dentistry Shanks for rotary instruments Part 1 Shanks made of metals HIS T 5504 2 Dental rotary instruments Nominal diameters and designation code 180 2157 1992 number WS T 5503 Dentistry Root canal instruments Part 1 General requirements and test methods ISO3630 12008 150 3630 2 2000 Dental root canal instruments Part 2 Enlargers MOD 150 3630 3 1994 Dental root canal instruments Part 3 Condensers pluggers and
101. electrical equipment Part 1 General requirements for basic safety and essential performance JIS T 0601 1 IEC 60601 1 1 2000 Collateral standard Safety requirements for medical electrical systems Medical electrical equipment Part 1 1 General requirements for safe nsT0601 1 1 60601 1 2 2007 TEC 60601 1 6 2010 60601 1 8 2006 Medical electrical equipment Part 1 2 General requirements for basic safety and essential performance Collateral standard Electromagnetic compatibility Requirements and tests Medical electrical equipment Part 1 6 General requirements for basic safety and essential performance Collateral standard Usabili 18 T 0601 1 2 MOD Medical electrical equipment Part 1 8 General requirements for basic IS T 60601 1 8 safety and essential performance Collateral Standard General requirements tests and guidance for alarm systems in medical electri equipment and medical electrical systems 60601 1 9 2007 TEC 60601 I SER 2008 Medical electrical equipment Part 1 9 General requirements for basic safety and essential performance Collateral Standard Requirements for environmentally conscious design Medical electrical equipment ALL PARTS TEC 60601 2 10 2012 TEC 61010 1 2010 Cor 1 2011 TEC 61010 2 010 2003 TEC 61010 2 051 2003 IEC 61326 1 2012 ANSVADA Specification N
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108. A Specification 101 A 8 chc JERUB L h JIS JIST 5204 5217 1 5217 2 5301 5401 5402 5404 5406 5407 5408 5409 5413 5415 5416 5417 5419 5420 ont 5701 5751 5753 5801 5903 5906 5907 5910 ISO 3630 1 3630 2 3630 3 6875 7494 1996 7494 1 7494 2 7785 1 7785 2 9873 9997 10637 13295 13397 1 13397 2 13397 3 13397 4 13897 15087 2 15087 3 15087 4 15087 5 15087 6 15098 1 15098 2 15098 3 15606 A 4 JIS
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110. BASOAIRE UKE CHESTS 7233 HEHKWEHEDWPMEIX ISO 21530 Dentistry Materials used for dental equipment surfaces Determination of resistance to chemical disinfectants BF IST 5301 5302 5402 5404 5406 5416 5417 5418 5420 5752 1 5752 2 5903 SO 7492 7741 9173 1 9873 9997 10650 1 1065022 13397 1 13397 2 13397 3 13397 4 15087 1 1087 2 15087 3 150874 15087 5 15087 6 15098 1 15098 2 15098 3 D 4 TREE lt e BREA RACE CODI RESHMA IRIS BERR 230 10 IS T 2107 5204 5217 1 5301 5302 5402 5404 5406 516 5417 5418 5420 5750 5751 5752 1 51522 5903 5906 5907 5908 5909 5910 5911 I
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115. S T 5701 3 1 1 KERR eUis n pi HEUEA REE CIR TORN SHARE OV amp BOR EDUC 1 4 2 HARES 7S IRL TS OMAR 83 a 1 RUB 2 CHE ORTH 5 OC
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118. edical examination gloves Part 1 Specification for gloves made from rubber or rubber solution 150 11499 2007 Dentistry Single use cartridges for local anaesthetics ISO 12836 2012 Dentistry Digitizing devices for CAD CAM systems for indirect dental _ restorations Test methods for assessing accuracy Dentistry Mandrels for rotary instruments ISO 13397 1 1995 Periodontal curettes dental scalers and excavators Part 1 General JIS T 5404 MOD requirements JIS T 5406 MOD ISO 13397 2 2005 Dentistry Periodontal curettes dental scalers and excavators Part 2 Amd 1 2012 Periodontal curettes of Gr type 150 13397 3 1996 curettes dental scalers and excavators Part 3 Dental scalers 1975406 150 13397 4 1997 Periodontal curettes dental scalers and excavators Part 4 Dental JIS T 5404 excavators Discoid type 150 13402 1995 180 13504 2012 ISO 14457 2012 Dentistry Handpieces and motors Denti Surgical and dental hand instruments Determination of resistance against autoclaving corrosion and thermal exposure Dentistry General requirements for instroments and related accessories used in dental implant placement and treatment WS T5911 aes Dental elevators Part 3 Cryer elevators De
119. ke Beto SURE GS H HRH AW RESTOR COR EE NO ONE 01 lt 6 ARNE RIAL EAEO RIO Z TBR lt Pr Ex EBBICIO Z C TTOLOLOL CRI 881 1090 1 5 BEAN C T 21 09 2 10908 AHOT 09710908 OAT 3 COX COX MAE C WpS 1 ZA 2 Q 12 TLLA Z LOL SE ET a BE 1 ss sn S rioria ofl E NN TS EE EE sss el e e we BEB nO 199 RRR ZI0Z0706 sa ik px x a x at 2 4 E x x x BF 4 x m w 0 i 4 211 E a Bi SEG PE 4 s T vivus amp lt 3 2 E lt lt 10 0 1
120. ntal elevators Part 4 Coupland elevators Dental elevators Part 5 Bein elevators ISO 15087 6 2000 Dental elevators Part 6 Flohr elevators Dental tweezers Part 1 General requirements US T5401 MOD Dental tweezers Part 2 Meriam types 5 Dental tweezers Part 3 College types xi ISO 15606 1999 Dental handpieces Air powered scalers and scaler tips JIS T 5910 MOD Dentistry 1815 us i inati 150 21530 2004 d equipment surfaces Determination 15021 5332003 esed Reusable cartridge syringes intended for intraligamentary y 006 Dentistry Rotary polishers 150 21672 1 2012 Dentistry Periodontal probes Part 1 General requirements 18021672 2 2012 Dentistry Periodontal probes Part 2 Designation ISO 22374 2005 Dentistry Dental handpieces Electrical powered scalers and scaler tips 150 28319 2010 Dentistry Laser welding ISO TS 22595 1 2006 Dentistry Plant area equipment Part 1 Suction systems ISO TS 22595 2 2008 TEC 61205 1993 Dentistry Plant area equipment Part 2 Compressor systems Ultrasonics Dental descaler systems Measurement and declaration of the output characteristics 66 5 2 C 60601 1 2005 Cor 1 2006 Cor 2 2007 Amd 1 2012 Ed 3 1 2012 ISH 11 2008 ISH 12 2009 JS Medical
121. o 101 2001 FDA Guidance 2003 12 02 Class Special Controls Guidance Document Dental Sonography and Jaw Tracking Devices Technical Report 13 3 1995 Medical electrical equipment Part 2 10 Particular requirements for the basic safety and essent al performance of nerve and muscle stimulators Safety requirements for electrical equipment for measurement control and laboratory use Part 1 General requirements Safety requirements for electrical equipment for measurement control and laboratory use Part 2 010 Particular requirements for laboratory 5 lectrical equipment for measurement control and laboratory u e Part 2 051 Particular requirements for laboratory equipment for mixing and stirring 5 Electrical equipment for measurement control and laboratory use Juirements Part 1 General re E Medical electrical equipment Part 2 60 Particular requirements for basic safety and essential performance of dental equi 1 Root Canal Instruments General Requirements Method of Measuring and Specifying Colour Rendering Properties of Light Sources 67 1 HARON A LCOS LOJ
122. o OFT URN WS 2 BE Br s Bl 2121 BERHZHOHEBHE o ENERE RHE SRR KR F HERR mar p amsa Z lt AGE NA vn YAN ACER 0005 01 YA AVE ASB 00099404 _ SI DS tate Imm fixi co 4 x A v Z 206 27 si 9065 L sit 0006910 al HTH 0009pL0L GERREG 28D pnm TREKKA 48 4 A Y BMS Hie O cb 2 SLM Re OMEN 33 290 Z SLM MRS C Hes E CT CEDE HAM AE Ry DER RO WS EY lleelololololo seem oso I cessus z amp IX mu B EO6B e EXE BM V O i B A EGET 1 Sim HERR 00000101 ENKS N 9 lt Z 12 Oo RCS OL EBIOICHLOOQ VE Hox eu Z
123. on needles for single use ISO 52821994 Dental equipment Mercury and alloy mixers and dispensers ISO 8325 2004 Dentistry Test methods for rotary instruments 15 T 5502 DIS 150 9168 2009 Dentistry Hose connectors for air driven dental handpieces 150 9173 1 2006 Extraction forceps Part 1 General requirements and test HS T5410 MOD ISO 9173 2 2010 Dentistry Extraction forceps Part 2 Designation 180 9680 2007 Dentistry Operating lights JIS T5753 MOD ISO 9687 1993 Dental equipment Graphical symbols 65 180 13295 2007 Cer 1 2000 RRS ABIS 180 9873 1998 Dental hand instruments Reusable mirrors and handles 81593 MOD 150 1032 Dental cartridge syringes 7 i Dental rotary instruments Bore diameters for discs and wheels ISO 10637 1999 150 10650 1 2004 JST 5801 JIS T 5752 1 MOD Dental equipment High and medium volume suction systems Dentistry Powered polymerization activators Part 1 Quartz tungsten halogen lamps d 180 10650 2 2007 Dentistry Powered polymerization activators Part 2 Light emitting diode LED lamps HS T 5752 2 MOD 150 11143 2008 Dentistry Amalgam separators 7 150 11144 1995 Dental equipment Connections for supply and waste lines 150 11193 1 2008 Amd 1 2012 Single use m
124. racteristics of rhandrels and special instruments Dentistry patient chair Dental amalgamators ISO 6875 2011 150 7488 1991 ISO 7492 1997 Dental explorers NS T 5402 MOD ISO 7493 2006 Dentistry Operator s stool JIS 5601 MOD 150 7494 1 2011 Dentistry Dental units Part 1 General requirements and test methods 150 7494 2 2003 Dentistry Dental units Part 2 Water and air supply 150 7711 1 1997 Dental rotary instruments Diamond instruments Part 1 Dimensions Amd 1 2009 requirements marking and packaging Mob 150 7711 2 201 Dentistry Rotary diamond instruments Part 2 Discs Dentistry Diamond rotary instruments Part 3 Grit sizes designation 150 7711 3 2004 an colons cada 150 7786 2001 Dental rotary instruments Laboratory abrasive instruments JIS T5210 DIS ISO 7787 1 1984 Dental rotary instruments Cutters Part 1 Steel laboratory cutters JIS 5506 1 MOD ISO 7787 2 2000 Dental rotary instruments Cutters Part 2 Carbide laboratory cutters JIS T 5506 2 DIS Dental rotary instruments Cutters Part 3 Carbide laboratory cutters for 7 150 7787 3 1991 milling machines JIS T 5506 3 MOD ISO 7787 4 2002 Dental rotary instruments Cutters Part 4 Miniature carbide laboratory IS T 5506 4 180 7885 2010 Dentistry Sterile injecti
125. s m 4 DEG a x 1 39 wl s RERI 1 s e eae AMALIE FRAP SERRA NE i pos MED gt BEES ATE O ORES AUN REO y E SIE q 09 Hem ACERO GIA exe evang MAFERRCTR MEFERROE E gin Rik Ca Seat ET IE SI 3k pte e Sede d d OWS REREAD 58188 EBORE HERRE L RAE iv BS SEBO HIG NE EES lt gt HEATH LAB eo eoo o ISTSTSTe swan oheja mew mas ele s o o eae u TO om Iv vielo o10 z 01019 28 lool loo ol Eeee Spejspopo v v o 51 00066204 0006540 BE BMY He ee SEG CHEERS 19
126. spreaders Dentistry Root canal instruments Part 4 Auxiliary instruments 150 3630 4 2009 180 3630 5 2011 Dentistry Endodontic instruments Part 5 SHaping and cleaning instruments ISO 3823 1 1997 Dental rotary instruments Burs Part 1 Steel and carbide burs 150 2t 2522109 Dentistry Rotary bur instruments Part 2 Finishing burs JIS T 5217 2 150 3964 1982 Dental handpieces Coupling dimensions Dentistry Information system on the location of dental equipment in the 150 4073 2009 working area of the oral health care provider 150 6360 1 2004 Dentistry Number coding system for rotary instruments Part 1 General Cor 1 2007 _ characteristics i pe 0 Dentistry Number coding system for rotary instruments Part 2 Shapes 3 Dentistry Number coding system for rotary instruments Part 3 Specific ISO 6360 3 2005 characteristics of burs and cutters Dentistry Number coding system for rotary instruments Part 4 Specific i T594390 200 characteristics of diamond iristruments Dentistry Number coding system for rotary instruments Part 5 Specific 180 6360 5 2007 150 6360 6 2004 150 6360 7 2006 characteristics of root canal instruments Dentistry Number coding system for rotary instruments Part 6 Specific characteristics of abrasive instruments Dentistry Number coding system for rotary instruments Part 7 Specific cha
127. t Yr OER Sia RIS Men 88 4 x t 00003107 op orssecc oi Jo Lo wn c B 0 SERENO 0008690 IIBER C oor L RENAA u C LMS CAREW EE MARES 3 SAMAR C E BRA r Supjonly pue 2 ROWS EE EER oo00810 LT T ISI D I DO E K BARAN 0000810 L L LIL T le 566 o I T cc ENAN CEH 0205665 teat MANANCE 0805666 leelolol atore st elelelelele 5 0009660 L ol T T T Tol PTT
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