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. QST 5750 5751 m F 11 F 1 22. IST 5907 5908 5909 ISO 7785 2 10650 1 10650 2 11498 13294 F 2 QIST 5602 ISO 6875 F 3
3. WE 5 3935 ISO 7488 9680 1993 9680 F 9 WE ISO 7488 9680 1993 9680 F 10
4. 3535 JST 5701 5801 ISO 7494 1996 7494 1 7494 2 10637 K 5 K 6 BUE SS GIST 5750 Xu K 7
5. GIST 5750 5751 J 5 2 BA MAE HEC AACA SNS BAM O RMB ORR TES MILT Av 5 fik 600 kO 250 kQ HET ULT ER 100 kO KUHELJ a 15 kQ 4 75 J 6
6. IST 5301 5410 M 7 JS T5409 IST 5409 M 8 IST 5906 5907 ISO 7785 1 7785 2 M 9 BRAT 7 0 43 m 4 IST 5750
7. 5 mm 74 J J 1 2 G k IST 5801 ISO 10637 J 2 ESTHER MARY y NUERA
8. 4 1 1 1 1 1 HS ISO JIST 5417
9. BS GIST 5602 ISO 6875 L 4 IST 5701 ISO 7494 1996 7494 1 7494 2 L 5 IST 5908 5909 ISO 11498 13294 M M 1 IST 5602 ISO 6875 M 2
10. 230 10 IST 2107 5204 5217 1 5301 5302 5402 5404 5406 5416 5417 5418 5420 5750 5751 5903 5906 5907 5908 5909 5910 5911 ISO 3630 1 3630 3 7492 7785 1 7785 2 9873 9997 10650 1 10650 2 11498 13294 13397 1 13397 2 13397 3 133974 15087 1 15087 2 15087 3 15087 4 15087 5 15087 6 15098 1 15098 2 15098 3 22374 D 5 W s MaE i PARO Ide BARE GC 66 ISO 21530 Dentistry Materials used for dental equipment surfaces De
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13. IST 5909 ISO 11498 14 IST 5801 ISO 10637 15 IST 5908 ISO 13294 16 Zeg EE ES H lt EE ER PAI EIERE Eh M e T5 18
14. HST 5910 SO 15606 B 5 H HIST 5750 5910 5911 ISO 15606 22374 B 6 IST 3906 5908 5909 ISO 7785 1 11498 13294 62 din B 7 RAME j BS IST 5701 I
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19. IST 5602 SO 6875 FA REDE H IST 5602 SO 6875 F 5 JIST 5602 5701 ISO 6875 7494 1996 74
20. IST 5602 5701 ISO 6875 7494 1996 7494 1 7494 2 11498 13294 9680 1993 9680 M 3 81 l JIST zem 5701 ISO 6875 7494 1996 7494 1 7494 2 9680 1993 9680 M4 83 IST 5602 ISO 6875 13897 M 5 TRE RAT TEME h 5 BRT 7 CH rO RIBEARARRJEOU CBLEH IST 5602 ISO 6875 M 6
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45. M 1 4 550 nm 670 nm M 1 5 3535 ISO 7488 M 16 ISO 13897 M 1 7 ISO 13897 83
46. 90 110 3 190 nm 385 nm 400 nm 515 nm 515 nm i8 400 nm 515 nm ISO 10650 1 10650 2 10 9 1mm 250mm Gang IST 5903 SO 9873 1 1 UV 400 nm LAF 0SO 9680 12 CIE 13 3 Method of Measuring and Specifying Colour Rendering Properties of Light Sources QSO 9680 CIE 133 13
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98. Specific characteristics of abrasive instruments Dentistry Number coding system for rotary instruments Part 7 Specific characteristics of mandrels and special instruments Dental patient chair Dental amalgamators Dental explorers JIS T 5602 JIS T 5402 JIS PO EKATO ioj Dental rotary instruments Shanks Part 1 Shanks made of metals JIS T 5504 1 MOD ISO 1797 2 1992 Dental rotary instruments Shanks Part 2 Shanks made of plastics JIS T 5504 2 MOD 180 2157 1992 pental Tolary instruments Nominal diameters and designation code TIS T 5503 ST Dentistry Root canal instruments Part 1 General requirements and ISO 3630 1 2008 test methods ISO 3630 2 2000 Dental root canal instruinents Part 2 Enlargers JES T 5217 2 MOD 1SO 3630 3 1994 Dental root canal instruments Part 3 Condensers pluggers and spreaders ISO 3630 4 2009 Dentistry Root canal instruments Part 4 Auxiliary instruments ISO 3823 1 1997 Dental rotary instruments Burs Part 1 Steel and carbide burs ISO 3823 2 2003 Dentistry Rotary bur instruments Part 2 Finishing burs 1SO3964 1982 Dental handpieces Coupling dimensions y Dental equipment Items of dental equipment at the working place ISO 4073 1980 Identification system ISO 6360 1 2004 Dentistry Number coding system for rotary instruments Part 1 Cor 1 2007 General characteristics ISO 6360 2 2004 reed Number co
99. 1 8 8 1 1 1 1 1 1 10 1 2 2 2 1 2 9 2 LI 3 4 E 3 QG 1 3 6 5 4 4 1 4 7 fJIST 0601 1 IST 0601 1 1 6 7 1 4
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103. IST 5701 ISO 7494 1996 7494 1 7494 2 E 5 IST 5701 ISO 7494 1996 7494 1 7494 2 67 E 6 JIS T 5504 1 ki 1 IST 5906 5907 ISO 7488 7785 1 7785 2 9
104. Part 1 Quartz tungsten ISO 10650 1 2004 halogen lamps b Dentistry Powered polymerization activators Part 2 Light emitting ISO 10650 2 2007 diode LED lamps ISO 11143 1999 Dental equipment Amalgam separators ISO 11144 1995 Dental equipment Connections for supply and waste lines ISO 11193 1 2002 d DEUS A Cor 1 2005 Single use medical examination gloves Part 1 Specification for gloves Amd 1 2007 made from rubber latex or rubber solution ISO 11498 1997 Dental handpieces Dental low voltage electrical motors JIS T 5909 MOD ISO 11499 2007 Dentistry Single use cartridges for local anaesthetics ISO 13294 1997 Dental handpieces Dental air motors JIS T 5908 MOD ISO 13295 2007 Dentistry Mandrels for rotary instruments ISO 13397 1 1995 Periodontal curettes dental scalers and excavators Part 1 General JIS T 5404 MOD A requirements JIS T 5406 MOD a Dentistry Periodontal curettes dental scalers and excavators Part 2 ISO 13397 2 2005 Periodontal curettes of Gr type N Periodontal curettes dental scalers and excavators Part 3 Dental ISO 13397 3 1996 scalers H type JIS T 5406 MOD ISO 13397 4 1997 Periodontal curettes dental scalers and excavators Part 4 Dental JIS T 5404 MOD excavators Discoid type ISO 13402 1995 ISO 13897 2003 Cor 1 2003 ISO 15087 1 1999 ISO 15087 2 2000 ISO 15087 3 2000 ISO 15087 5 2000 Surgical and dental hand instrumen
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127. T BEI SERE O E KOMETI BEES V ERUS SER EE IE HESS o HBO B I 2 A II EA Bla E TEmo TOTON OSHS LIE E ES He 2 tHe O FOZ PR OF VEASE H lle EG OEA O LAUKS SS 9b EE TS ojo OIOIOIOIOIOIOIOIO OIOIOIOIOIOIOIO 0000004 0006 0Z E OIOIOIOIOIOIOIOIOIOIO 0009 0 000SPLOL SEC DEIT KV LIH 00078001 SR HMR ODOOTLOL x Ed S x EECH i mi lt 3 o 0 e H E u 4 fi 9 x ES OE 3 PA E TN IE HEU S CHR HEZ HEEE gt II BE LHRH O HEME o LEI Ye AREE Hi YS LNS O RITR El krm p p 2E EEN EE VIVO QB lt Ls ALES FENOMENO ES e FH RT H Ha Z e HRANJENE G9SUKZRBNKEM Y ben ERA LR 386 KL1 53 ka o AVIO T 9081 O SI E Ema cooscr0 o o o o o o 4 e trc 1 9081 O SIS E Bf 8 3 1 ISO IEC ISO 6360 6 2004 JSO 6360 7 2006 ISO 6875 1995 ISO 7488 1991 ISO 7492 1997 Specific characteristics of root canal instruments Dentistry Number coding system for rotary instruments Part 6
128. UES IE Sieg O HUET PEM V EH HRI B 6 PRD HEH LIKE O RRA FALEN BMS EE BO IL A C IM LPMA SLI RERS BY TP ENE Lv SAME OQ YAU a Or a QE BEL I OBS C g C Brgrzi o Q co Verdun J e OPI 03838 E e LH MNO A CLES Z 9 EHEIOA SLES ta GI O O o ojo O O O go E Hl ag co Eg m ey E Ze Ela l le yo Eu XC Bo a ow 2 n AT a a mM ume a g o 8 m AER ve b 32 Oo o le y uk D a da u 9 pum H m U E se o BE mE m Mont m s Gem Hit Ijz 19 2 18 3y xi i ses Sl w m ud amp x S de as at du m eb sin i mr ea eu 1 EE C E CIRCO HYG RANIA Hr zeo EBENE W BES LEO la RENE O BERET TIO BET Y ERlx adnvi FAKEN EE Ere CHS x E A Ik SE XM Sess us E mc au e 1 eororrosre ane Hm o LIKEMA KIG SIGE 8 HEMIO LEE ER SERIE Hinc LEON e Bw eo EH CO Ct EM 8Y OJO ee sup KT 00008195 ojo Kr 000Z9ZSE o ojo OOOTPLOL O O1 0 emp 0000L04 olo LA BE TER 00066404 ki e 4 e u
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130. Z SAH ENO Q 324 AH Sonn cT Y G ojo 10 O ojojojojo ozts Lem 1464 Fe KEMI ojo e O o o o oj o govs LSID 4 Y BH oo e O Jolo ojo BEE 7 X BEER O ojo QA WISH kt A1 o o ojojojojo stes LSID ISKEMIA E A ojo o o o o o TENI e o o o Ey me diis e co6s LSID VE ET elo o oOjojojojo EI av TRIES O O O 0 ojo ojojo DR 5 IES o o e ojo ololololo cops LSID memm Ojo e O ojojojojo sis LSID LOLA 64H e o o o o olo 164266624 ENER olojo 0 O O ojojojojojo Lettre L SID HAL KCL tt ojo 10 ojo o o o o ol IPS LSID BE se ojo 0 O O ojojojojo TPS Lem ICALI ojo e ojo ojo BAY 46 CURA ojo 10 ojo ojo ARA ABE ojo 0 ojo ojo SR a ALM SE E H IER 4 E Ki EY 2 a ula a a Y 2 5 Sla z SR EHE s ID SUN amp mg zm gx s2 a 2z s METRI A E AE M 3 ele e mpajale E oE m ix E Y 25 m I gr x m e ml BE HB de de E af de Gold HELEC LERMA V BEEN HE V HEM Z LHEME BET LS O 000099T 0000ZESE 000 06TE 0000ES8E 0006L90 0009ZZTE 000Zt8 0008b81 00066E 0009481y 0008L9L O00P6LSE O00S8LSE 000198Tb 1 5 H EEE RAO GSR C t r ks LT SEDI Y LBA A RK OSL KR SW WG WES EHS U 9c S Y AMBOSETEL OSI Hey 9 AXE BERI RE CLM BM ch S PUD MOS CS X HIE c EMIL EDI X SELO EC Bto UO TAE Z LHBAO DU AH 2094 0T APT I
131. alarm systems in medical electrical equipment and medical electrical systems Medical electrical equipment Part 1 9 General requirements for basic TEC 60601 1 9 2007 safety and essential performance Collateral Standard Requirements for environmentally conscious design TEC 60601 1 SER 2008 Medical electrical equipment ALL PARTS TEC 60601 2 10 1987 e F E A Medical electrical eguipment Part 2 Particular requirements for the RM 1 safety ofnerve and muscle stimulators JIS T0601 2 10 MOD Te pus T Safety requirements for electrical equipment for measurement control ma 1010 1 MOD Cu 2003 and laboratory use Part 1 General requirements S Safety requirements for electrical equipment for measurement control TEC 61010 2 010 2003 and laboratory use Part 2 010 Particular requirements for laboratory equipment for the heating of materials Safety requirements for electrical equipment for measurement control TEC 61010 2 051 2003 and laboratory use Part 2 051 Partcular requirements for laboratory equipment for mixing and sti F Electrical equipment for SEH control and laboratory use EMC TEC 61326 1 2005 requirements Part 1 General requirements JIS C 1806 1 MOD IEC TR 60878 2003 Graphical symbols for electrical equipment in medical practice 5 3
132. ding system for rotary instruments Part 2 y Dentistry Number coding system for rotary instruments Part 3 TSO 6360 3 2005 Specific characteristics of burs and cutters ISO 63604 2004 Dentistry Number coding system for rotary instruments Part 4 i Specific characteristics of diamond instruments ISO 6360 5 2007 Dentistry Number coding system for rotary instruments Part 5 MOD ISO 9168 2009 ISO 9173 1 2006 Dentistry Hose connectors for air driven dental handpieces Dentistry Extraction forceps Part 1 General requirements and test methods ISO 9173 2 2010 JST 5410 ISO 7493 2006 Dentistry Operator s stool JIS T 5601 MOD ISO 7494 1 2004 Dentistry Dental units Part 1 General requirements and test methods JIS T 5701 MOD ISO 7494 2 2003 Dentistry Dental units Part 2 Water and air supply I Dental rotary instruments Diamond instruments Part 1 Dimensions ISO 7711 1 1997 requirements marking and packaging JIS T 5505 1 MOD ISO 7711 2 1992 Dental rotary instruments Diamond instruments Part 2 Discs JIS T 5505 2 MOD ISO 7711 3 2004 Dentistry Diamond rotary instruments Part 3 Grit sizes designation and colour code ISO 7785 1 1997 Dental handpieces Part 1 High speed air turbine handpieces JIS T 5906 MOD ISO 7785 2 1995 Dental handpieces Part 2 Straight and geared angle handpiec
133. es JIS T 5907 MOD ISO 7786 2001 Dental rotary instruments Laboratory abrasive instruments JIS T 5210 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 Dental rotary instruments Cutters Part 3 Carbide laboratory cutters ISO 7787 3 1991 for milling machines JIS T 5506 3 MOD d Dental rotary instruments Cutters Part 4 Miniature carbide ISO 7787 4 2002 laboratory cutters JIS T 5506 4 MOD ISO 7885 2000 Sterile dental injection needles for single use JIS T 6130 MOD ISO 8282 1994 Dental equipment Mercury and alloy mixers and dispensers ISO 8325 2004 Dentistry Test methods for rotary instruments JIS T 5502 DIS Dentistry Extraction forceps Part 2 Designation ISO 9680 2007 Dentistry Operating lights ISO 9687 1993 Dental equipment Graphical symbols 54 JIS Edd Dental hand instruments Reusable mirrors and handles JST 5903 MOD ISO 9997 1999 Dental cartridge syringes ISO 10323 1991 Dental rotary instruments Bore diameters for discs and wheels 1SO 10637 1999 Dental equipment High and medium volume suction systems JST 5801 MOD E Dentistry Powered polymerization activators
134. lnlolo ojo O mis y GENTES OOOETLOL olojo ojo ol o O O ola ojo olo ol rs Jeer DIR 010166p o 1 Iz HR mE la mi QE xim ia ko EN EE x Ss A zit A E ES ig o E x mim miu KI e DIK E E O m e EN D Sim WEE amp x o e lu amp AE jsl x IA IR ic 218 w ai g t o E ale elzlola z alo SIS x vel mi eleal glm ie gr am fy X E Bl Owl O ml H A E k x xc kE ww alo ple I x isis lela elo u ola mi z de u m mx x 3 iv 121 E am la alalu sv a ml s gla Siaja g Ela i m xo ele s Sa 2 3 2 ea yaa e 4 84 9 4 2 9 42 j OT 6 L v zxw1 10901 SIC Z HIS LOE e EB Bod gr HIE RHEE HOES SEDER V BAET LINERA ER BYE i DE LEMME e BIOS LEC BIS BBE O H Ete usto BEE V HMM Z EH REA KIS 29491 EXC EYRE O LIVA ERX RO ASA EGRESS BR 4 SAME HEHE SZI HESIO LBS TE SENA 6 SN EH EAB CI CANAL A BES ETSI YA A AVE p RETE DEM e AN lt BIER t COR 3 Lc BHL vc d ASCH ER SAM RAKEN LA LAE A A d LEO Y as CHE rad AMA mer aja dainas OO x 8065 L SIL 4065 L SID El Fal cs E EELE seo o o o coss aos at 00006902 O O O 6065 L SID Za NIA E EIE onoseso O O O YAN AOR 000LL
135. lololoiololoiolo v O SEI 4 kl 0007690 0 010 o lololololoiolo lololjoloio o o olviolo BEER asa R 00096904 ojojo ololololololololoiolololololo olo o o gens TsZSL SDB BLE OOOSSEOT eo i o ai DN A yig i i PI EJ z m gt x x l y E E ig o SH al um e x PEE em ele x Wa HE EE Y ese EE ARIETE mee st o zi s x1 mma S80 mm d e x 4 wk z x a iul llo E Sete lm z o ma slo m Mi x x ml ml ua aleje x x Ei w zI x x w 0x v a mu eu wi 2 o Mi Hole 2 8 a ulw a oja ojo lA 2 X a elv a e Fo ramos s a n gt lelg y 9 ZZS 9 E Ga s 4 xcseo a Z 6 91 4 9 4 29 j OI 6 2 v e I x OT 1090 L SIS E E amp H Erste G K DEST HIERHER HES LES Y HEC LUMETI HIRIRIK M HME LEES e Hirst o LKR EZRA O HE Alo HRH V HE S FAMI BIS A HENO B BE O PAGE HS A SALEM BEATA VIE ENT C eS 2199 E E ENE Oro olololololo O ololololololo ojojojojojojo O O OjOJOJOJO O x lolelelelo lololololo ojojojojojojo O O olololololololololo lololololololo oom EE o O lolo ololelololololololo o O O E Lex G EBIBIZIO S SERABUX ORSVHZ88 Ce C LH MNOS e TIERE lt L C e LNT EY LAB T BREISCH 01090 SIF b DEN LS LO WSS
136. rol and automation TC 66 Safety of measuring control and laboratory equipment IEC ISO TC 194 Biological evaluation of medical devices ISO 10 11 JIS ISO IEC BO gt ag ARO ME 5 3 12 vo 0 7 9 mv Q H o v eo 0 i Bou D EN AH RU ra m ww ro o BS Av HEEL TEME RE E UV 1
137. termination of resistance to chemical disinfectants JIST 5602 5701 5751 5801 5908 5909 ISO 6875 7494 1996 7494 1 7494 2 9680 1993 9680 10637 11498 13294 21530 E E 1 IST 5701 5750 5801 ISO 7494 1996 7494 1 7494 2 10637 E 2 IR Su EN
138. tion of the output characteristics TEC 61223 2 3 1994 Evaluation and routine testing in medical imaging departments Part 2 5 Constancy tests Image display devices TEC 61223 2 7 1999 Evaluation and routine testing in medical imaging departments Part 2 7 Constancy tests Equipment for intra oral dental radiography excluding dental panoramic equipment 55 3 2 TEC IEC 60601 1 2005 Ge Sie Medical electrical equipment Part 1 General requirements for basic ISH 11 2008 safety and essential performance ISH 12 2009 Medical electrical equipment Part 1 1 General requirements for safety IEC 60601 1 1 2000 Collateral standard Safety requirements for medical electrical systems JIS T0601 1 1 Di Medical electrical eguipment Part 1 2 General reguirements for basic TEC 60601 1 2 2007 safety and essential performance Collateral standard Electromagnetic compatibility Requirements and tests d Medical electrical equipment Part 1 6 General requirements for basic TEC SOSO 2006 safety and essential performance Collateral standard Usability Medical electrical equipment Part 1 8 General requirements for basic IEC 60601 1 8 2006 safety and essential performance Collateral Standard General vi requirements tests and guidance for
139. ts Determination of resistance against autoclaving corrosion and thermal e Dentistry Amalgam capsules Dental elevators Part 1 General requirements Dental elevators Part 2 Warwick James elevators Dental elevators Part 3 Cryer elevators Dental elevators Part 5 Bein elevators ISO 15087 4 2000 Dental elevators Part 4 Coupland elevators ISO 15087 6 2000 Dental elevators Part 6 Flohr elevators tips ISO 15098 1 1999 Dental tweezers Part 1 General requirements JST 5401 MOD ISO 15098 2 2000 Dental tweezers Part 2 Meriam types El 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 Dentistry Materials used for dental equipment surfaces 180 21530 2004 Determination of resistance to chemical disinfectants 180 21533 2003 Dentistry Reusable cartridge syringes intended for intraligamentary injections ISO 21671 2006 Dentistry Rotary polishers 180 22374 2005 Dentistry Dental handpieces Electrical powered scalers and scaler JST 5911 FDIS 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 TEC 61205 1993 Ultrasonics Dental descaler systems Measurement and declara
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