平成24年度 レーザ機器の安全・安心に関する 調査研究報告書
Contents
1. ISO 14118 IEC 60825 12. 2 3 UP oP SIE Oval BECO CI CS ey AVY AICO Tb AI Ie
3. TEC TC 76 JIS IEC 1980 55 1980 JIS C 6801 JIS C 6802 JIS C6803 JIS C 6804 IEC JIS
4. 4 A B 52 ISO 12100 1 a 4 2 4 3 b
5. 1 1 29 i LE ISO 14118 EERIE ISO 13849 1 5 3 3 3 ISO 12100 1 ISO 12100 2
6. 10 1 200 3 Nd YAG 2 6 P CO CW 20W Yt OH 585nm 10kJ m 450us a 4 p i m A ie og 2 e CO CW 20W Q 30kJ
7. KU R E 28 5 3 2 3
8. D 3 D CPR AED HELLO A he 2
9. ISO 14119 5 3 3 4 Vere SARE Ar UA VAT AIGA SOA Cee YH CHAAR OC GEEA
10. 2 1 mW BR 5 mW 10 kW 4 5
11. EU Regulation EN A 4 520 AV WHA CR DK 122
12. IEC TC 76 Optical radiation safety and laser equipment BERTIZ IEC TC 76 WG 7 High power lasers JWG 10 IEC ISO Safety of lasers and laser equipment in an industrial materials processing environment linked to ISO TC 172 SC 9 WG 7
13. 2 30 kW 1 kW 2 5
14. 2 HiSC PSE LIFT Leadership in Fibre Laser Technology 2 Tailored Joining 10 17 18 12 1 oes Rm fh a F IWS Pes wo Introduction amp Overview i i
15. Wie ol OIG a D 6 10 D 2 b D 3 1 2 X a haps SERENE I CO
16. 8 Lb FRE OEE TAO KES IEC 60825 1 32 IEC 60825 1 4
17. ISO 3864 33 A BF Al A 1 1 Al2 A13 Si SIO A 1 4 Mn Cr Ni Co Al Zn Cu Be Pb Sb Ae Cr Mn C
18. 1 3 5 1ocation with unrestricted and uncontrolled access 1 1 3 6 preventive maintenance HAO TEKUN 3 7 manufacturer 24 1 2 3 8 Gis modification
19. A 4 A 4 1 A 4 2 PSR X A S 35 B B 1 ISO 12100 1 XO ISO 12100 2 B 2 ISO TC 199
20. 3 9 process zone 3 10 production 3 11 service corrective maintenance 3 12 subassembly
21. Q amp A a i i at th NN on 101 AGENDA BARE LED va BEL DMD M R E GLV Grating Light Valve AOM SB It FT 1 DLPOistal Leh ProcesshM RD AF LO 1 Chip DLP Projection DLP Board Pa Processnr a Memo ef ry Projection Lens Fi i Fi Shaping Lens d Color Fitter 4 7 _ r Condensing Lens d N
22. 7 8
23. 1 29 300 1 29 300 1 330 1930 50 1 3 2
24. Si GO SERRE Consultant USA Group Leader Laser and Optical Radiation Dosimetry Group Health Protection Agency UK RE TO eT Se eee EC ER Ee See RE EE A er eae Se 2012 24
25. 2 osim osam iom 2am 235m OS x 3B 2 3m AGENDA 1 2 3 4 5 6 18 3 H iz N E ANSI Z 136 1 IEC 60825 EN JIS C 6802 IEC 60825 IEC 60825 1 21 CFR 1040 11 ANSI EN
26. 21 3 3 1 IEC TC 76 IEOC TC 76JWG 10 ISO 11553 1 FiSC2012 SO 11553 1 ISO 11553 2 ISO 115583 3 EC 60825 4 ISO 11553 1 1 NEG le CAT ee tC es
27. IEC 60825 1 3B 4 Ci
28. 25 um 30 m s 15 2 4 IPG Laser Q CW 0 5 mm 800 W JES 0 18 mm 120 m min 2 um Q CW 4 mm COs
29. WG 1 IEC 60825 1 WG 9 IEC 62471 TC 76 TC 61 Sharon Miller TC 76 2018 9 22 27 THrankfurt 2 2014 3 7 Stability Date a0 Jey Vie ove TC 76 TC61 Sharon Miller TC 76 Secretary TC 27 Industrial electroheating and electromagnetic processing WG JWG 10 3 9 SBP Strategic Business Plan TC 76 Chairman J Dennis SBP
30. CDV DTR 4 5 1 Robert M Weiner 20 2 IRC IEC Central Office Technical Officer Pierre Sebellin IEC OIEC Smart Grid Energy Efficiency Renewable energies TC PC 3 TC 117 Solar Thermal Electric Plants PC 118 Smart Grid User Interface TC 119 Printed Electronics OISO IEC Directive AC 17 2012 CDV 3 AC 21 2012 OPWI Primary Work Item Stage
31. a b c d e va a heed ae ee ee o
32. E 5 3 3 5 EAE IEC 60825 1 ISO 12100 1 XC ISO 12100 2 TEC 60825 4 5 3 2 2
33. 1 m 1 m 250 m s 2 3 EU LIFT LIFT 1 2 Fraunhofer IWS U Klotzbach RU FP7 LIFT LIET 4 009 9 1 2013 8 31 16 9 21 Time Bandwidth Product EOLTTE F 4 Quantel Tampere University of Technology Rofin Basel Lasertech
34. ISO 11553 1 RT WG BEL Frankfurt WG ISO 11553 1 3 6 _ 2013 9 Frankfurt 2 2 2 FiSC 2012 1 FiSC 1 Th FiSC 2012 International Laser Symposium Fiber amp Disc 2012 10 16 17 H International Congress Center Dresden Germany 4E Fraunhofer IWS Dresden 300 28 1 FiSC Fraunhofer IWS Fraunhofer Institut f r Werkstoff und Strahltechnik
35. 1 AEL 5 3 3 5 53 3 TEC 60204 1 ISO 13849 1 3 5 3 3 1 5 3 3 2 TEC 60204 1
36. 5 Vern fame gt Een UA Fra ISO 11553 1 JIS 4 3
37. a b 5 3 3 5 ISO 12100 2 2003 5 2 4 30 a AEL TEC 60204 1
38. FDA CENEREC EC EN 60825 1 EU 2 OK ee i LVD RSE Bl GPSD 0325002 3 gt Ae ia a ng LASER LIGHT SHOW j low high IEC 60825 Class 1 Class 2 Class 3R Class 3B Class 4 Class 1M Class 2M 4000Im 7000Im 20000Im 20 2000 4000 5000Im Rissa Ve is 20 109 3 FDA CDRH FDA CDRH
39. pane EB LFR JIS ERR ORME JIS 20 2
40. 1 7 Information for user 7 OQ IEC 60825 1 specifies protective measures for the primary laser radiation The minimum requirement in the case of potential exposure by a class 3B and class 4 product is to wear protective eyewear rated for the laser power and wavelength TEC 60825 1 specifies protective measures for the primary laser radiation and all other possible hazardous radiation at wavelengths emitted The minimum requirement in the case of potential exposure by a Class 3B or Class 4 product is to wear protective eyewear rated for the laser power and all wavelengths emitted Note For example in the case of diode pumped lasers laser radiation associated with the diode pumping may be emitted in addition to the primary laser radiation or in the case of a frequency multiplied laser system unanticipated primary or harmonic wavelengths may be emitted 2 3 5 1 ISO IEC 11553 ISO IEC 11553 1 2
41. HSLA High Strength Low Alloy Steel 6000 TWI Ni 718 ANSI AWS D17 1 2001 Specification for Fusion Welding for Aerospace Applications TWI 1 8 mm mrad 4 kW 3 2 mm Bosch 1996 2011 15 15 20
42. Much has changed in the use of Lasers Laser poy Classification Simplified Structure of Laser Illuminated for Display and Entertainment Project 1976 2012 Rock n Roll Digital Cinema A FDA gt IEC 60825 1 26 112 4 fj 2001 1 1 8cm 2010 12 2
43. 2 5 3 G 1 100 mm 1 5 mrad 2 5 1 5 mrad 2 11 9 3 2 11 2 1 Influence of magnifiers on ocular exposure levels G Vees R Gilber and K Schulmeister ILSC Paper 503 ILSC 2009 Proceedings Laser Institute of America 39 3 2 3 IEC 60825 1 Ed 2 ISH 02 IEC 60825 1 2
44. JIS ae 1 3 1 24 12 4 CX 2 25 1 24 TEC 8 25 3 6 kK 2 2 1
45. 2 515 nm 150 W 3 343 nm 47 W Quantel 450 nm 800 nm 1 W M2 lt 1 2 580 nm 10 W 633 nm 4 5 W 780 nm 1 W Tampere University of Technology 40 W AOs LTCC Rofin Baasel Lasertech 1 552 nm Er
46. JIS C6802 t 10 800 1000 1200 1400 nm mare 1 O 1M 1 2 RE 2M 2 3R 3B 4 PL
47. 1 2013 25 3 Be 120 A 29 A 1
48. ESA LAR e OFIAPERORARIC EOC OTR PIAL 36 5 3 4 4 3
49. BUR CHOVER LAATRE OZ A 6 ISO 11553 1 IEC 60825 1 7 IEC 60204 1 IEC 60825 1 ISO 11252 XU ISO 12100 2
50. 59 ld KYK KYT ERFA 45S FLT PLGA DAIL
51. 1 2 IEC TC 76 IEC TC 76 WG 8 IEC TC 76 4 2 2012 2013 2 1 12 45 12 50 12 50 13 30
52. Time Bandwidth Product 200 W 500 fs 2 MHz 100 uJ PCF 700 fs 25 W 2 2 ps 100 W EOLITE 1 kW 10 ns EX FORMAT J RE F 100 kHz 10 mJ 40 um 100 um PCF 300 kHz 310W 8 ns 0 4 nm M2 lt 1 1 1 kW
53. 2 6 LFI 2 Tailored Joining Workshop 7 1 8 Fraunhofer IWS Dr J Standfuss 2 CW 1 8 kW 50 um 200 wm 4 kHz x 16 1 m min 20 mm 10 kW 2 4 kW
54. w 4 JBMIA lt 1 gt 2012 09 10 http datapro jomia or jp 113 5 IEC 60825 Ed2 Ed3
55. 2013 2 1 EFR IEC TC76 TC 6 Japan OITDA x x v AGENDA SUA
56. JZID TOZA REM R U FIER ELERT IEDM OL CO RE moe SPIRO A K JIS International Laser Safety Conference ILSI Laser Institute of America LIA March 18 21 2013 Orlando FL USA IEC TC76 2012 10 8 12 HPA 43 2 HHHUHHHHUHHHUHHHHHHHHH Exporting Laser Products to the United States jerodeni2 comcast net Phone 1 301 216 5057 Fax 1 301 216 5052 Legal requirements of the CDRH FDA The legal basis of these requirements is the Radiation Control for Health and Safety Act of 1968 now part of the Food Drug and Cosmetic Act and the regulations published under that authority e References Food Drug and Cosmetic Act Sections 531 ff Code of Federal Regulations Title 21 parts 1000 ff 21 CFR 1000 ff What is required
57. 5 3 2 1 2 3x10 MPE GE IEC 60825 1 ISO 12100 1 ISO 12100 2 MM PPE MPE 5 3 2 1 3
58. ThyssenKrupp Laser technik COs Audi 3 1 ae FiSC2012 Cla Fraunhofer IWS J Hauptmann High Speed Proce
59. 125 ISO OB RTE ISO6161 Ed 1981 Personal eye protectors Filters and eye protectors againstlaserradiation Z O ITC94 SC6 JIS ISO 6161 Ed 1 1981 T 8143 1994 IEC IEC 62471 Photobiological Safety of Lamps and Lamp Systems 62471 Photobiological Safety of Lamps and Lamp Systems TC 76 WG 9 62471 1 TC 76 WG 9 TC 76 WG 9 JIS TC 76 WG 9 TC34 SC 34A JIS AR ETE TS C 0038 2011 JELMA JLA IEC ieee IEC 60601 Medical electrical equipment 60601 2 22IEd 3 2007 Particular requirements for the basic safety and essential performance of surgical cosmetic therapeutic and diagnostic laser equipment TC 76 WG 4 Amdt 2012 TC 76 WG 4 Ed 3 1 2012 TC 76 WG 4 60601 2 57 IEd 2011 1Particular requirements for the basic safety and essential performance of non laser light source equipment intended for therapeutic diag TC 76 WG 4 62471 3 Ed 1 NP Safety of intense pulsed light source equipment Guidelines for the safe use of intense pulsed light source equipment on humans
60. 90 BMBF CuBriLas 1 080 nm 2 515 nm 2 2 Erlangen Nurnberg GS 76 KEIPER CO
61. a b c d 31 e
62. LED IEC 60825 1 1 1 4 15 LED 180nm 1mm 15 2 IEC 60825 JIS C6802 7 ver 8
63. 40 119 0 695 3 18 3 21 ILSC 2013 International Laser Safety Conference 2013 200
64. 0 NH CM Finisar im ui Soe 3 ny Y g se ee e 86 oe Z E Soe ee z ae ee eae DA HH eee oe ee r S 2 e EE oy ce 0 oe NO eS 5 a a E OB oe ns R eee eee 1 Lamp Free 00 3 Ss ee eae z ee eee ae Pr 8 oe 2 0 0 _ ee TE ee ie ee cs Ri 0 oe ce eae E T KODAK Hit Cinema Projector HP M 105 2 IEC 60950 IEC60950 1 2005 4 3 13 5 LED IEC 60825 1 IEC 60825 2 IEC 60825 12 1 LED
65. T2 100 s KMS 18 Stuttgart IFSW PStritt 6 SLT 12 Stuttgart Laser Technology Forum 5 kW 80 mm 4 50 un 80 a 70 60 a 50 AQ ual a 30 c 5 20 N 10 E gt oe ee i 5 See Pane ary a zer 0 js 30 mm Beam Dia
66. ZAR We EE mn 2012 24 EA BE EZ B Z Z LR Z B WE EZ B E B B EZ B B B IEA B AT BE 2012 24 Jerome E Dennis John O Hagan IHI SERNA
67. JIS 1 2 JIS o
68. LED 1 FDA IEC TC76 amp 2 3 111 24 4 LI PAS As of January 2013 Leader Level BARCO Christie CO LASER TECHNOLOGIES DOLBY IMAX Laser Light Engine NEC NECSEL Panasonic PHOEBUS VISION SINOLASER SONY TEXAS INSTRUMENTS USHIO Participant Level Disney Mitsubishi Electric Schneider Observer Level JDSU HARKNESS SCREENS Nichia Philips projectiondesign RealD 4 LIPA
69. 19 JP19 2 CDV cM Bara JP20 2 CEN CEN 4 Document 121009 Response to Comments from Dr Kurtz i ISO 11203 WG ii 4 2e apphed at apphed to
70. JIS QA Timely 2 123 Vo 2 124 2013 3 1 B IEC ISO JIS IEC 60825 Safety of laser products Equipment classification and requirements IEC TC 76 WG 1 8 m Q NO NO
71. 19 ETEEN gp ee hm i eg BiH BARS IPG LE 1 C 3UN 100 kg mbot for COUN and hors package n Two robots with two comesponding laser tools IPG L557 C GUN share a compact double fiber laser system consisting of a fiber laser system L5 2000 S27T with 2 processing fiber outputs and a double controller system DCS1 with combined water chiller and pressure boost system The access of the two robots tn the fiber laser system L5 2000 S2T is coordinated according to the FIFO principle by the double controller system DCS1 that is responsible for both IPG L S1 C GUNS by means of a beam switch BIS IPG Photonics LSS IEC 60825 4 G Beam delivery systems ISO 11553 1 Safety of machinery Laser processing machines Part 1 General safety requirements
72. Convener Mike Barrett Bill Ertle Rlc4e TCT ERONR ZEHAT 3 4 5 2012 9 Hrankfurt 2 2 1 3 IEC TC 76 JWG 10 1 2012 10 9 k 9 30 11 00 am 2 Convener Tom Lieb USA Secretary Mike Barrett UK Erwin Herberer Germany Germany 3 China 1 Japan 1 HPA 1 3 3 1 3 2 76 Didcot Secretariat XX 3 3 FDIS ISO IEC 11553 3 ISO Clit FDIS TIEC CDV 76 462 CDV SO TC 172 SC 9 N 453 CEN Dr P Kurtz 1 TIEC CC_76_462 11553 8 CHAU CHEN 21
73. CS ERAI OLAY SiR MeO xE L FHRHEA RER Protecting for you NPO 4 JISC Japanese Industrial Standards Committee JIS Japanese industrial Standards 10 921 2011 4 1 JSA Japanese Standards Association MENAR AEA JIS JQA Japan rage Assurance Organization 2 w ISO International Organization for Standardization 162 l 212TC 5
74. um NA Stabilized MW cm sr mooow zo soar Yee mumow wo soo m Commercial Diode Laser 1 Commercial 100 0 12 Diode Laser 3 B Over 50x higher brightness than the state of the art in direct diode lasers B Comparable brightness to kW class industrial diode pumped lasers Commercial 200 0 10 Diode Laser 2 2 2 Optoskand tt Cambrige Technology Primes kW Fraunhofer IWS 1 Optoskand
75. TEC TC 76 JIS tk IEC IEC JIS JIS JKA UT ER 24
76. iti 14 2 f preventing vibration of panels by fitting stiffening strips or noise attenuating materials to reduce the radiation of noise and conforming to IEC 60825 4 IEC 60825 4 and conforming to IEC 60825 4 iv IA 5 Replace the 1st sentence in paragraph 2 by The upper bound value of om is about 1 5 dB for the grade 2 and 3 dB for grade 3 measurement methods dealing with the determination of the emission sound pressure level or the sound power level Dr Kurtz 3 IEC 11553 3 T Lieb FDIS CDV 11553 3 WORD ISO M Barrett WORD 2012 12 ISO IEC
77. Hazard Distance 115 32 5 OL Hike Rei ti Z O lt 3 x IEC62471 CIE S009E 2006 x JIS C7550 x 4 x IEC CIE x Threshold Limit Values TLVS x American Conference of Governmental Industrial Hygienists ACGIH x The International Commission for Non lonizing Radiation Protection ICNIRP 38 5 SEHR ET BEEF 2 OL ike Reis JE 2007 2010 2013 ukL dla i1 RG 1 3 3 iE Laser E RG Laser 60825 amp Refer TC 6 12 teed yee TC76 IFF RED Poa Hittin TC61 Laser 60825 Refer Clas
78. 3 amp 3B 4 IEC TC76 2 2007 2013 3 JIS http wwwjjisc goJp 14 106 2 SH TT ATP 2 a IEC TR 60825 3 Laser Light Show 3B
79. Convener S Zimmerman J Pfoutz Didcot TIEC TR 60825 13 Ed 2 2011 Safety of laser products Part 13 Measurements for classification of laser products NOHD 3 WG 4 Safety of medical laser equipment Convener W Gorisch IEC 60601 2 22 Ed 3 Amd 1 Medical Electrical Equipment Particular requirements for basic safety and essential performance of surgical cosmetic therapeutic and diagnostic laser equipment 2012 11 T1EC TR 62471 3 Ed 1 Guidelines for the safe use of intense pulsed light source equipment on humans 2012 10 11 CDV Class 1C IEC 60601 2 22 KO TEC DTR 60825 8 Safety of laser products Part 8 Guidelines for the safe use of laser beams on humans
80. 2 TC 76 W Ertle RR Review Report 2 ISO IEC 11553 2 ISO IEC 11553 2 11 25 3 IEC 60825 4 G ISO 11553 1
81. 62471 lt 110 4 LIPA 2011 5 http www lipainfo org home html 5000 5000Im FDA 5000 OK
82. TC 61 Safety of household and similar electrical appliances TEC 60335 2 XX Household and similar electrical apphances Safety Part 10X Particular requirements for beauty therapy appliances for household and commercial use Class 1C 4 WG 5 Safety of fiber optics communications systems Acting Convener G Zabierek Didcot TC 86 IEC 60825 12 Safety of laser products Part 12 Safety of free space optical communication systems used for transmission of information CD IEC 60825 17 Safety of laser products Part 17 Safety aspects for use of passive optical components and optical cable in high power optical fibre communication systems DTR CD 5 WG 7 High power lasers Convener M Barrett JWG 10 IEC 60825 4 Laser safety of products Par 4 Laser guards
83. 4 kW 30 mm Precitec 1 2 2 HIGHYAG Scheuermann Heihig SPI 0 35 mm
84. A 1 7 A 1 8 flux vapors A 1 9 A110 Zn Se A 2 X A 3
85. Oy er Dlo A 5
86. IEC 60825 1 2007 2 JIS JIS C 6802 2011 TIEC 60825 1 2 2008 1 corrigendum 1 2009 1 interpretation sheet 1 2011 interpretation sheet 2 JIS C 6802 2011 JIS C 6802 2011 SO IEC JIS B 1 ISO 11553 1 2005 Bd 1 0 Safety of machinery Laser processing machines Part 1 General safety requirements 2 IEC 60825 1 2007 Bd 2 0 I SH 01 2009 Safety of laser products Part 1 Equipment classification and requirements 3 IEC 60825
87. 13 30 14 30 IEC TC 76 J Dennis R 14 50 15 50 RE HPA J O Hagan 15 50 16 30 84 56 82 51 72 43 42 4 3 1 HHHHHHHHHHHHHH 00000 24 2012 faa TC76
88. b c ISO 12100 2 2003 5 2 4 53 4
89. en __zet1 SSS Equipment classification and requirements sport Pega 0 60825 6 TS Ed 1 Safety products with optical sources exclusively used for visible information transmission to the human eye 60825 7 ITS Ed 1 Safety products emitting infrared optical radiation exclusively used for wireless free ar data transmission and surveillance 60825 8 TREd 2 2006 Guidelines for the safe use of laser beams on humans 60825 9 TREd 1 1999 Compilation of maximum permission exposure to incoherent optical 60825 10 TR Ed 1 2010 Application guidelines and explanatory notes to IEC 60825 1 ee ee processing environment transmission of information 60825 13 TREd 2 DTR pa rements le fication of laser produs for classification of laser products 60825 14 TR Ed 1 2004 A user s guide eee ee eee and animals Safety aspects for use of passive optical components and optical cables in high power optical fibre communication systems JIS6800 IC6802 2011 EC60825 1Ea2 3007 C6803 2006 IEC60825 2 Ed 3 2004 C6804 2006 EC60825 12 Ed 1 2004 IEC JIS Safety of Laser Products IEC 16
90. UV IR IPG Photonics 6 kW Light sensors Light guide Glas cylinder with or without AR coating Beam in forward direction Back reflected light AT sensor process light UV a Temperature sensor Mode stripper Humidity sensor 1 Optoskand 14 Primes kW 1 Hz 100 Hz Fraunhofer IWS 2 m
91. WG 1 WG 1 Convener D Siney WG 9 Class 1C 2 WG 3 Acting Convener J Pfoutz IEC 60825 13 NOHD anand Condition 2 2 3 WG 4 Convener W Gorisch IEC 60335 2 XX Did sec 36 IEC 60601 2 22 Did sec 87 IEC DTR 60825 8 Did sec 38 IEC 60601 2 22 2018 5 CD IEC DTR 60825 8 2013 Frankfurt TIEC 60335 2 XX
92. 121 FDA A 3 _J O Hagan good EU
93. AC 12 2012 OIEC Website 2012 12 myIEC IEC 2013 10 21 25 New Delhi India 2012 11 10 14 Tokyo Japan A6 FAS UK ONAEFUT 4 2 2 1 2 IEC TC 767WG 7 1 2012 10 9 K 11 00 am 12 30 pm 2 Convener Mike Barrett UK Secretary Tom Lieb USA Germany 3 China 2 Japan 1 HPA 14 3 BE 3 1 3 2 76 Didcot Secretariat XX 3 3 IEC 60824 4 D Erwm Heberer IEC 60824 4 D 2 D
94. IEC 60825 1 9 2 9 3 gt 1 5 mrad 100 mm 2 49 S15 mrad 100 mm 2 Cel 2 BS 1 5 mrad 100 mm Cs gt 1 5 mrad 1 400 nm 1 400 nm 2 3 5 2 2 3 5 mm 3 7mm
95. IEC 60825 1 3 13 workpiece 4 4 1 4 2 SO 12100 1 KO ISO 1200 2 25
96. IEC 60825 1 Ed3 2011 TC76 2012 10 IEC 62471 2013 IEC 62471 114 5 IEC 60825 1 5mrad 0 3mm 200mm 1M oc W m2 sr o 200mm
97. 76 4697RM Melbourne TC 76 3 5 IEC Central Office ISO IEC Guide 51 Safety aspects Guideline for their inclusion in standards XU IEC Guide 104 The preparation of safety publications and the use of basic safety publications and group safety publications 3 6 4 WG 1 WG 1 Optical Radiation Safetyy Convener D Sliney DLHA Sd IEC 60825 1 Edition 3 Safety of laser products Part 1 Equipment classification and requirements 5 Didcot 76 474 CD 2 WG 3 Laser Radiation Measurement
98. 500 1000nm IPL Ti IPL 500 1200nm 550nm ht gt ag 2005 3 24 NPOSAA BALTES IPL LASIK 3 SYS AFR
99. AEL C AEL T 7 1 AEL 2 83 f 3 3 2 1 NO TOTP Ti TEC 60825 1 2007 TOTP 1 ns TEC 60825 1 1ns
100. 1 kW 25 num Ns 20 35 m min Fraunhofer IWS 200 W 8 100 um 2 g min C R K CNC Fertigungstechnik Kriftel SLM Selective Laser Melting 35 um 10 um 100 um 5 mm
101. 2 JIS JIS A 2 J Dennis good FDA
102. 4 4 ISO 11553 1 ISO 11553 1 A S S 1 ISO 11553 1 ISO 12100 1 KO ISO 12100 2 26 5
103. D E MPE AEL F G IEC 60825 JA JIS C6802 2011 I 2005 180nm 1mm Nd T C 2 14mm 70mm oe MPE A O JA Ee 60825 Safety of laser products
104. 1 4 a b c 1 AEL d 1 AEL 5 3 24
105. 3B Laser Light Show Variance 2 APPLICATION FOR A VARIANCE Eon Aceraves OME wo 916 0025 DEPARTMENT OF HEALTH AND HUMAN SERVICES FROM 21 CFR 1040 11 c FORA ssc sz lt aie eee LASER LIGHT SHOW DISPLAY Docker numee OR DEVICE No j Projection system or Gevice may vary from compliance with 21 CFR 1040 11 c In desg or Use whhout the approval of mis application in acconiance wih 2 A t Chec STRUCTION 3 Mal your application to the Dockets Management Eranch HFA 305 Food ana Drug Administration Am 1067 S630 Fishers Lane Rockwile MD 20852 4 Enter et number f assigned Model AAA 1 Class calculation 6 THE APPLICANT REQUESTS THE VARIANCE TO BE IN EFFECT FOR A PERIOD OF _ YEARS FROM THE DATE OF ISSUE fin general the Agency wil aporove a variance for only two years longer period Is requested a justifcaton must De attached as part of the apoiicaton ROU OR LANC gt lt KDD CNO C Alaser display device More than 15 days E A projector tor a taser tgrt show T More than 5 but not more fian 15 days A laser tight show Less than 5 days E Q TOUR IS INTENDED TO RUN FOR O More than months T Omer Spec CEO PROJECTORS ARE INTENDED FOR SALE LEASE OR LOAN TO OTHER LASER LIGHT SHOW PRODUCERS m 1 6 months d PRODUCT IS INTENDED FOR USE IN A J Less than one mont C Planetarium or
106. cx 5mrad lt o lt 100mrad IEC 60825 1 IEC 60825 1 IEC 62471 Sa 5 PS HEEFR RET En OL FER aR IEC 62471 200mm _ 200mm 7mm Risk Group RG RG2
107. D 9 Frankfurt TC76 6 4 4 1 76 475 INF 76 475 INF SBP document for TC 76 B 4 Market Trends High power laser processing systems using flexible fibre beam delivery WG Convener Mike Barrett TC76 Secretary Bill Ertle 2 TC 27 Bill Ertle TC 27 WG TC27 TEC 62471 WG 7 JWG 10 TC 27 WG 9
108. 1 100 mm o gt 1 5 mrad 2 2 38 DED 100 mm 1 5 mrad 2 3 2 3 2 5 a b 100 mm 1 5 mrad 2 5 o gt 1 5 mrad 2 2 5 2
109. 1999 13 3m 1 2 2 0 05 0 2 1999 23 20 9 6 W 460nm 0 85mW 405nm 5mW IPL
110. 24 1 2 3 JIS 4 25 2013 25 3
111. tm ii 2012 24 i 1 E ee ee er err EE ee rer ee ee eT eee ra lt 1 1 1 NS CC Ae EA Ie REUSE Rea ower CN 1 1 2 ee ee eT eT ee eer Teh ee a ee re he eee re eT eee RO ren ree eee 1 1 3 EN EE SR SRE are None leds ager a Pon Seda 2 E KA EEC GE 9 2 1 EE eee eee eT ee Ee ee eee A ee ee CN CC 3 2 2 SARS Wah wh edly OS Sie aw NSK 0 0 NSR CEOs SIA RES ACO E Ae EE 3 2 2 1 IEC TC 76 NE EE EE NE eae ener eee weer S 3 2 2 2 FISOC2012 12 3 E a aya ee ict ig hn ac aaNet gh a EF eee HES 3 1 WERO H ee ee EE E CTT OCT PLCC EE Oe ERE CS eee eee Ter OTe TT II es 29 FER RR EE EE EEE EE SE SE 29 32 SO 11553 1 Ed 1 92 322 TEC 60825 1 Ed 2 0 SHO 38 3 2 3 TEC 600825 1 Ed 2 0 SHO ij 40 4 E Se Lee ee ee ee ee ee RN ee ee SE ere ee ere re eer Lee rT oe A 4 DE RE EE EG EE EE A 4 2 CLE A OLE PEATE PERS EE AEDS
112. 25 2 1 12 50 13 30 1 2 3 4 5 6 1 Regulatory Science 2 2010 22 8
113. 0325002 17 3 25 JIS C6802 2006 2011 1M 2M 3R 3B 4 ei 3B 4 47 6 8 57 47 9 30 32 20120927 1 24 11 20 SF pm 400 700nm
114. 18 ps 50 us O Ti O AEL WM AEL N TOTP TOTP W TOTP 1 ZORE IEC 60825 1 41 4 4 1 1
115. ERT A PEAL EA TAAT A Tie A c 4 3 PY ISO 12100 S 3 5 3 1 5 3 2 5 3 4 5 3 2 5 3 2 1 5 3 2 1 1 1 AEL AEL 2 IEC 60825 1 ISO 12100 1 XU ISO 12100 2
116. 24 2013 25 3 HABA ATE UHRFOAR Y KEIRIN Q http ringring keirinJp 1980 2 21
117. D Proprietary laser guards testing 6 WG 8 Development and maintenance of basic standards Convener J O Hagan A Didcot IEC 60825 1 76 474 CD WG8 IEC DTR 60825 14 IEC TR 60825 5 IEC TR 60825 3 7 WG 9 A coherent sources Convener W Horak A Didcot IEC 62471 2006 Photobiological safety of lamps and laser systems IEC TR 62471 2 2009 Photobiological safety of lamps and lamp systems Part 2 Guidance on manufacturing requirements relating to non laser optical radiation safety IEC TR 62471 4
118. J 60825 1 i Corr 2008 TC 76 WG 1 8 TC 76 WG 1 8 TC 76 WG 1 8 TC 76 WG 1 8 60825 2 Safety of optical fibre communication systems OFCS TC 76 WG 5 TC 76 WG 5 TC 76 WG 5 ISH 2008 TC 76 WG 5 TC 76 WG 5 TC 76 WG 5 TR Ed 2 2008 60825 4 Ed2 2006 Laserguards TC 76 WG 7 TC 76 WG 7 TC 76 WG 7 TC 76 WG 7 TC 76 WG 7 Safety of products emitting infrared optical radiation exclusively used for wireless free air data transmission and surveillance 60825 9 TREd1 1999 Complation of maximum permissible exposure to incoherent optical radiation UE 60825 12 Mm Ha Ed 1 2004 Safety of free space optical communication systems used for transmission of information d 2 CD 60825 13 TR Ed 2 2011 60825 14 TREd 1 2004 A user s guide TR Ed 2 CD 60825 16 ITREdg 1 PWI JIS EEA 60825 17 TREd 1 2010 Safety aspects for use of passive optical components and optical cables in high power optical fibre communication systems TR Ed 2 CD 2010 2011 IEC 60825 1 IEd 2 2007 C 6802 2011 IEC 60825 2 Ed 3 2004 C 6803 2006 Ed 3 2 2010 TC 76 WG 5 TC 76 WG 5 TC 76 WG 3 TC 76 WG 3 TC 76 WG 8 TC 76 WG 8 TC 76 WG 5 TC 76 WG 5 IEC 60825 12Ed 1 2005 C 6804 H23 _ 2006 2006
119. JIS 3 60825 1 Ed 2 2007 equipment classification and requirements JIS C 2011 60825 2 Ed 3 2004 Safety of optical fibre communication systems JIS C 2006 60825 12 Ed 1 2005 Safety of free space Optical communication systems used for transmission of information JIS C 2006 ISO 6161 Ed 1 1981 Personal eye protectors Filters and eye protectors against laser radiation JIS T8143 1994 IEC 62471 Ed 1 2006 Photobiological safety of lamps and lamp systems JIS C7550 2011 IEC 62471 2 TR Ed 1 2009 Guidance on manufacturing requirements relating to Non laser optical radiation safety IEC 62471 4 TR Ed 1 NP Measuring methods IEC 62778 TR Ed 1 2012 Application of IEC 62471 to light sources and luminaires For the assessment of blue light hazard ISO 11553 Safety of Machinery Laser processing machines ISO 11553 1 Ed 1 2005 General safety requirements ISO 11553 2 Ed 1 2007 Safety requirements for hand held laser processing devices ISO 11553 3 Ed 1 CDV Safety requirements for noise red
120. SAC KATS 1 2 3 4 5 6 T SN FE JIS C 6802 20054 FR 2006 9 25 4 8 000 IEC TC76 1972 IEC 60825 TC76 JIS JIS C 6802 JIS C 6802 2005 LED 23 3 22 JIS C 6802 2011 IEC 60825 1 2007 MAMAKU HH A B C GR
121. 4 3m ANSI Z136 1 15 2 5000Im gt 16 7W 1W 300Im Bey 100mm 3cm X 4cm FL 7mm 0 54W 4 16 107 2
122. B3 IEC 60204 1 B 4 EN 563 B5 1 B 6 ISO 2631 B7 BS EN 165 EN 171 EN 207 EN 208 36 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 ISO 2831 1 1997 Mechanical vibration and shock Evaluation of human exposure to whole body vibration Part 1 General requirements ISO 11145 2001 Optics and optical instruments Lasers and laser related equipment Vocabulary and symbols ISO 13850 1996 Safety of machinery Emergency stop Principles for design IEC 60601 2 22 1992 Medical electrical equipment Part 2 Particular requirements for the safety of diagnostic and therapeutic laser equipment IEV 1992 International Electrotechnical Vocabulary EN 165 1995 Personal eye protection Vocabulary EN 166 2001 Personal eye protection Specifications EN 167 2001 Personal eye protection Optical test methods EN 168 2001 Personal eye protection Non optical test methods
123. Germany 7 Italy 1 Japan 11 Netherlands 2 Sweden 1 Switzerland 1 United Kingdom 14 USA 16 UK 3 USA1 4 75 3 1 3 1 UK Didcot HPA HPA BSI Standards Asghar Ashrafi BSI BSI 309 8 925 7 000 32 980 2 000 HPA O Hagan WG 3 2 3 3 76 472A7DA 3 4
124. LI ht Source s MI YT SKART Ya 7 TI HP 1 il vs Conventional Lamp ibl Brightness change Pega te jo Maintain brightness for X 5 20 lifetime ooo Time E HOSS he Light Output Xenon Lamp Characteristics 2 3 of light output is not visible W Sper ur d 10
125. TC 61 adhoc WG 30 NWIP 2013 WG 30 TC 76 WG 4 oo ILS Intense Light Source TEC 60601 2 22 4 WG 5 Acting Convener G Zabierek WG 5 TC 86 NEC IEC 60825 12 CC 2012 60825 17 DTR TIEC 60825 2 RR 5 WG 7 Convener M Barrett Annex D 6 WG 8 Convener O Hagan T1EC TR 60825 3 OHagan J Parkinson ANSI WG 8 3 Orland
126. HPA 2013 European Legislation Objective Products Workplace g Bes Same standard Minimum standard HPA 2013 Prod ucts E gt 4 e Agency e created by the Treaty of Rome in 1958 intended to eliminate trade barriers between Member States with the aim of increasing economic prosperity and contributing to an ever closer union among the peoples of Europe HPA 2013 Product Directives relevant to laser products Laser machines Non battery powered laser equipment Laser communication systems Laser Personal Protective Eyewear HPA 2013 Harmonised Standards e Listed in the Official Journal OJ of the European Union For each specific Directive e Should be listed in the Declaration of Conformity for CE marking C e Shows that product was assessed before being placed on the market and that it meets EU safety health and environmental protection requirements HPA 2013 Standards Process Electrotechnical Devices IEC International European National e g UK HPA 2013 Parallel Voting Committee Draft for Voting CDV Final Draft International Standard FDIS e g IEC 60825 1 and EN 60825 1 vote at the same time HPA 2013 Standards Process Non Electrotechnical A Devices Tor International European National e g UK HPA 2013 Harmonised Standards CENELEC HPA 2013 CEN Harmonised Standards
127. Compliance with the laser safety standard Manufacturer s certification of compliance conformance A product report Importer s declaration FDA Form 2877 Complies with applicable radiation safety standards or Standard does not apply to products being imported Designation of a US agent Designated Agent Annual reports What standard should be used Either and 21 Code of Federal Regulations CFR 1040 10 and 1040 11 or IEC 60825 1 2001 or IEC 60825 1 2007 or and IEC 60601 2 22 for Class 3B or Class 4 medical laser devices Why does CDRH FDA accept so many Standards e CDRH Laser Notice 50 e Which standard is the best to use Who is responsible to the CDRH FDA e The company that imports is legally responsible e What is the importing firm e What is the Designated Agent 21 CFR 1005 25 The CDRH FDA Performance Standards for Laser Products 21 CFR 1040 10 and 1040 11 e Applicability and exceptions 1040 10 a e Applies to all laser products for import or sale in the US except Component laser products Products solely for export from the US Some important definitions 1040 10 b e 1 Accessible emission level e 12 Collateral radiation e 13 Demonstration laser product e 15 Human access e 18 Irradiance and 16 Integrated radiance e 21 Laser product e 23 Laser system Classification 1040 10 c and Accessible emis
128. EN 169 2002 Personal eye protection Filters for welding and related techniques Transmittance requirements and recommended use EN 170 2002 Personal eye protection Ultraviolet filters Transmittance requirements and recommended use EN 171 2002 Personal eye protecton Infrared filters Transmittance requirements recommended use EN 207 1998 Personal eye protection Filters and eye protectors against laser radiation Iaser eye protectors EN 208 1998 Personal eye protection Eye protectors for adjustment work on lasers and laser systems laser adjustment eye protectors EN 563 1994 Safety of machinery Temperatures of touchable surfaces Ergonomics data to establish temperature limit values for hot surfaces EN 1050 1996 Safety of machinery Principles for risk assessment EN 1070 1998 Safety of machinery Terminology 37 3 2 2 IEC 60825 1 Ed 2 ISH 01 IEC 60825 1 2 2007 I SH 01 1 1 9 2 RU 9 3 9 2 9 3 400 nm 1 400 nm 3 RRITE OBES RE
129. JWG 10 ISO TC 172 SC 9 IEC TC 76 7th FiSC 2012 International Laser Symposium Fiber amp Disc RAY 2 2 2 2 1 IEC TC 76 1 2012 10 8 A 12 4 2 Training Centre at the Centre for Radiation Chemical and Environmental Hazards of the Health Protection Agency HPA Chilton Didcot Oxfordshire UK 2 2 1 1 IEC TC 76 1 1 2012 10 8 A 9 30am 12 30pm 2 2012 10 12 A 4 9 30am 12 30pm 2 Chairman Secretary IEC Central Office 13 67 Australia 2 Austria 1 Belgium 1 Canada 1 Chma 10
130. TC 76 WG 4 I SO ISO 11553 Safety of Machinery Laser processing machines 11553 1 IEd1 2005 TC 76 JWG 10 11553 2 Ed 1 2007 Safety requirements for hand held laser processing devices CTC 76 JWG 10 11553 3 IEd1 CDV Safety requirements for noise reduction and noise measurement methods for laser processing machines and hand held laser proq TC 76 JWG 10 IEC IEC 61040 Ed 1 w 2011 Power and energy measuring detectors instruments and equipment for laser radiation 126 24 2013 25 3 112 0014 1 20 10 7 03 5225 6431
131. 1 W Blue beam HPA 2013 Consumer Products E N Agency COMMISSION DECISION of XXX on the safety requirements to be met by European standards for consumer laser products pursuant to Directive 2001 935 EC of the European Parliament and of the Council on general product safety Laser Products Safe to eyes and skin HPA 2013 Workplace Directives relevant to laser work e Risk assessment HPA 2013 Artificial Optical Radiation Directive L 114 38 EN Official Journal of the European Union 27 4 2006 DIRECTIVE 2006 25 EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2006 on the minimum health and safety requirements regarding the exposure of workers to risks arising from physical agents artificial optical radiation 19th individual Directive within the meaning of Article 16 1 of Directive 89 391 EEC HPA 2013 Artificial Optical Radiation Directive HPA 2013 Protection D i rective Agency Artificial Optical Radiation E e Trivial No further action e Dangerous Usually obvious what needs to be done Do not know Needs an assessment Data from manufacturer or supplier HPA 2013 Non Binding Guide to AORD Now available as a CD in all languages of the European Commission HPA 2013 Health Protection m Agency Public Health England HPA 2013 434 HHHHHUHHHHHHHHHHHHHHL
132. 22 ao Ee 2 ISO 3864 1984 Safety colours and safety signs ISO 11252 2004 Lasers and laser related equipment Laser device Minimum requirements for documentation ISO 12100 1 2003 Safety of machinery Basic concepts general principles for design Part 1 Basic terminology methodology ISO 12100 2 2003 Safety of machinery Basic concepts general principles for design Part 2 Technical principles ISO 13849 1 1999 Safety of machinery Safety related parts of control systems Part 1 General principles for design ISO 14118 2000 Safety of machinery Prevention of unexpected start up ISO 14119 1998 Safety of machinery Interlocking devices associated with guards Principles for design and selection IEC 60204 1 1997 Safety of machinery Electrical equipment of machines Part 1 General requirements IEC 60825 1 2001 Safety of laser products Part 1 Equipment classification requirements and user s gu
133. 76 475 INEF B 4 Market trends Secretary 76 Did Sec 41 3 10 10 12 1 A 2 4 1 4 2 4 3 Didcot WG
134. BOLE ERE AS AG ON ORE LORE EE AG ELE ERD IEEE TREE CRETE ERS GETS A 4 3 ENC YLR CELA LCRA GSS PANG MGR LALA OS TERNAL E AESG te COREA TOW REL ERV EE ERED ERLANG SUS CLG BOWSER OS TORT OS A 43 1 ee 43 4 3 2 75 4 3 3 ee 87 4 3 4 I 7 RE EE ee ee ee 100 Bo Ue cae ei cee ee eae E 120 EEE E ae ghee al wae ran Mane ata Margate SE ES EOE Pane dasa an gnen AN 121 A ee eee er A ee ee eer ee ee eee ree eee ee Tre ee 121 B IEC ISO JIS E E E E E E A E E E E E E TES 125 1 1 1
135. Sinar Laser CW 4 kW ETLO40C 2 748 50 um BPP 1 8 mm mrad LIFT F 2 kW M2 1 8 Bystronic Laser CO2 4 mm CO TeraDiode NA 0 11 T 50 um 2 030 W 2 730 MW cm2 sy 2 13 2 TeraDiode
136. m lt 20ns Nd YAG 0 06 0 3 1 2 0 8 0 4 0 2 Nd YAG k Nd YAG wd pini Nd YAG SHG a qi HF Nd YAG 0 02 0 2 Nd YAG 8sec 100MV 30nm 0 1 0 6 Nd YAG Nd YAG 100mJ 6nsec 20Hz gt t k 0 1 0 6 1 2 0 04 1 2 gt 4 HF Nd YAG a wd pini g J pini Nd YAG 8mJ 6nsec Sd Mo V Nd YAG gt t Nk Si HF HEHE NE H E UHS JA e Nd YAG 30 Nd YAG Nd YAG SHG 150mJ Nd YAG 10mJ Nd YAG 1mJ Nd YAG Nd YAG mJ Nd YAG mJ 22 29 Nd YAG Nd YAG Nd YAG Nd YAG 30mJ 10pulse sec Nd YAG 50mJ 0 3mm Nd YAG SHG SFG 0 5 1 2 0 6 1 0 0 7 1 0 0 7 1 0 0 06 0 01 0 06 0 3 1 5 1 2 0 8 0 5 1 5 1 5 0 7 ie E 2
137. other dome projection structure Not applicable Not a tour E mezer O ther Spe m Hoteumote baiiroom or meeting room h PRODUCT UTILIZES THE FOLLOWING LASER EFFECTS 7 Multiple 0 Audience scanning Also includes scanning any accessible unconuoied areas O Reflections tom stationary mimos Cf mirrored surfaces Bean Matrices E Stationary irradiation of rotating miror balls etc C Other Specity PRODUCT IS INTENDED TO BE USED E At onty one Fixed location E At a vartety of Tour locations Service Manual U REASON FOR REQUESTING VARIANC C Comptiance win the Emits of 21 CFR 1040 11 c would resinct the intended use of the product because cog Emt Te output power to the extent that the desired effects would not be sufficently visioie I Other or addnional explanation Specity raf FA 3 a DjA oo 2012 9 ETF11 PDSH CTL PROVISIONAL DECISION ae 60825
138. 1 2007 Ed 2 0 I SH 02 2011 Safety of laser products Part 1 Equipment classification and requirements 3 2 22 3 2 1 ISO 11553 1 Ed 1 ISO 11553 1 1 1 SO 11553 1 3 2 ISO 11553 1 ISO 11553 1 i SA VIL IS A CG M7 A IEC60601 2
139. 10SC 2 570AG 18 083 2009 195 TC172 Optics and Photonics SC9 Electro optical systems 4m SHE A Et Jn Fe aK Zak IEC International Electrotechnical Commission 81 94TC 80SC 404WG 6 146 2011 TC76 Optical radiation safety and laser equipment ER RAO Ss JISC 1 2 3 4 5 2011 7 29 JISC 1 2 3 4 5 BSI DIN AFNOR ANSI SCC AA JISC
140. 4 IEC 11553 3 ISO IEC 11553 3 3 4 ISO IEC 11553 Part 1 Part 2 ISO IEC 11553 3 Part 1 Part 2 Seattle Melbourne 9 Frankfurt 1 ISO IEC 11553 1 2 Scope 1SO IEC 11553 3 a 11553 3 ISO IEC 11553 3 11553 1 2 Scope Scope 3 10 Requirements concerning noise as a hazard are not included in this part of ISO 11553 These requirements are to be found in ISO IEC 11553 3 Safety of machinery Laser processing machines Part 3 Safety requirements for nois
141. Be fit 0 9 1 2 1 2 Ti Sapphire 10mJ IR 0 02 0 7 Ti Sapphire 178 Ti Sapphire 745nm Ti Sapphire 1 Ti Sapphire 0 4 0 8 Ti Sapphire SHG 470um 0 7 1 5 1kW 30 100fsec 1mm gig gA A A G A T DM mM mw mM wd pini 1 2000 12 2 6 Av FIR ee a 2 lt 3 2000 2
142. E Kaen A e Safety of machinery Assessment and reduction of risks arising from radiation emitted by machinery Part 1 General principles Part 2 Radiation emission measurement procedure e Part 3 Reduction of radiation by attenuation or screening HPA 2013 Harmonised Standards CEN e Lasers and laser related equipment vocabulary and symbols e Lasers and laser related equipment documentation Laser processing machines Part 1 General safety requirements Part 2 Hand held laser processing devices HPA 2013 CEN Harmonised Standards E Kaen A e Lasers and laser related equipment measurement test methods e Screens for laser working places safety requirements and testing HPA 2013 Harmonised Standards CEN and CENELEC Medical Devices e Resistance of surgical drapes Part 1 Primary ignition and penetration Part 2 Secondary ignition e Laser resistance of tracheal tube shafts e Marking of tracheal tubes HPA 2013 Harmonised Standards CEN e Personal eye protection equipment Filters and eye protectors against laser radiation laser eye protectors e Personal eye protection Eye protectors for adjustment work on lasers and laser systems laser adjustment eye protectors HPA 2013 Importing Goods CE compliance Purchaser responsible EU Supplier responsible HPA 2013 Consumer ProductS E N Agency
143. Photobiological safety of lamps and lamp systems Part 4 Measuring methods 8 JWG 10 EC ISO Safety of laser equipment in an industrial materials processing environment Convener T Lieb A Didcot FDIS CVD ISO IEC 11553 3 Safety of machinery Laser processing machines Part 3 Safety requirements for noise reduction and noise measurement methods for laser processing machines and hand held laser processing devices and associated auxiliary equipment Accuracy grades 2 CEN 9 AAG Chairman 10 7 AAG REC TEC 62471 CW
144. d e Special certification Variances e Criteria for variances e Contents of variance requests e Timeframes for variance review Reports and notifications Product reDOrts Contents Electronic or paper submittals Supplemental reports Annual reports Accidental radiation occurrence reports Notifications of noncompliance or radiation defect Recalls and corrective actions Notification of purchasers Corrective action plan Exemption from notification and corrective action Additional requirements for medical device laser products e Premarket notification 510k e Premarket approval e Annual registration and listing 4 3 3 HHHHHHHHHHHHHHHH Health _ Protection Agency Dr John O Hagan Chairman BSI EPL 76 Convenor IEC TC76 WG8 Director CIE Division 6 Group Leader Laser and Optical Radiation Dosimetry Group HPA Japanese Laser Safety Symposium Tokyo 1 February 2013 Centre for Radiation Chemical and Environmental Hazards Europe European Union e English EU 27 Candidate countries Current members Candidate and acceding Croatia countries Potential candidate countries HPA 2013 Europe European Economic Area EEA T English European Economic Area EEA European Union Iceland Norway and Liechtenstein HPA 2013 Process of regulation UK Parliament Parliament Commission Council Member States
145. e reduction and noise measurement methods for laser processing machines and hand held laser processing devices and associated auxiliary equipment Accuracy erades 2 ISO IEC 11553 1 2 7 Information for user Seattle Melbourne 8 1 2 physical agents artificial optical radiation 2006 25 EC 7 Information for user Warnings about potential excess exposure to laser radiation should be included in the instructions By relating to machine or device maintenance and service activities 1 2 ISO IEC 11553 1 2 7 Information for user Seattle
146. ents 1040 10 f Note Performance requirements are not engineering specifications Performance requirements include e Protective housing 1 e Beam attenuator 6 e Safety interlocks 2 e Location of controls 7 e Remote interlock e Viewing optics and connector 3 viewports 8 e Key control 4 e Scanning safeguard 9 e Laser radiation emission Manual reset 10 indicator 5 Labeling 1040 10 g Warning logotype labels Protective housing labels Aperture labels e Warning for invisible wavelengths Informational requirements 1040 10 h e User instructions e Brochures and catalogs e Service instructions Modifications 1040 10 i This section applies to companies that buy certified laser products and modify them for resale If the modifications affect any aspect of compliance with the standard the products must be recertified and re reported The modifying company is considered to be a manufacturer Additional requirements for specific purpose laser products 1040 11 e Medical laser products 1040 11 a e Leveling leveling and alignment laser products 1040 11 b e Demonstration laser products 1040 11 c Variances for laser light shows and projectors Laser Notices some Important notices Exemptions from reporting e Laser Notice 50 Laser Notice 50 e Deviations that are allowed e Deviations that are not allowe
147. hk 2007 I SH 02 1 2 8 3 f 3 8 303 1 ns 8 3f 3 3 0 N SME 8 3 3 3 2 TOTP MPE A 3c 400 nm 1 400 nm 8 36 3 3 2 TOTP 1 SN TOTP 7 2 77 AEL Cs AELT C
148. i Systems 2 1 1 1 4 LIFT I 1 1 1 i 3 LIFT II 1 1 1 3 Laser Cutting 4 4 Fine Machining 3 1 1 4 Laser Welding I 2 1 3 Laser Welding II 3 3 18 2 2 2 1 1 2 28 Tailored Welding Symposium 2 FiSC 2 1 Trumpf tt Rofin Sianr Laser Bystronic Laser A A TeraDiode Trumpf Peter Leibinger M amp A Make or Buy Rofin
149. ide IEC 60825 4 1997 Safety of laser products Part 4 Laser guards 3 ISO 12100 1 IEC 60825 1 MITES 23 3 1 machine ISO 12100 1 3 2 laser processing machine FARE 3 3 docation with controlled access RISK 3 4 location with restricted access
150. meter E Coated Aluminium Flate 2 mm Coated Steel Plate 2 mm E Glued Laminated Spruce Wood 18 mm 1 Gypsum Plaster Board 12 5 mm B Gypsum Fiber Board 10 mm B Aircrete 50 mm Medium Density Fiberboard MDF 16mm Glued Laminated Beech Wood 18 mm H Uncoated Chipboard 16mm E Coated Chipboard 16 mm Oriented Strand Board 058 17 mm 4 KELTI PEASE OE COMMA 5 kW 30 mm 2 mm 10 s T8 100 s T2 30 mm ie T3
151. o ILSC 2013 7 WG 9 Convener W Horak TIEC 62471 IEC TC 34 8 JWG 10 Convener T Lieb TISO IEC 11553 3 FDIS CDV ISO IEC 11553 1 2 4 4 1 TC 76 TC 27 Industrial electroheating and electromagnetic processing LO Liaison Officer OV TIX D Sliney A 2 TC 76 TC 94 Personal safety Protective clothing and equipmen LO Liaison Officer VY Tlx R Henderson 3 SBP 76 475 INF 76 Did sec 41 4 WG 9 NWTP
152. o SEKA Zn Cu Be Crt NiO Zn AIS PAH PMMA PVC W CO MRE ORK PAH A 1 6
153. s1 5 2013 IEC 60825 1 ver3 gt IEC 60950 refer IEC 62471 x FB x FDA x EN60825 1 x BA JISC 6802 35 5 oveen IEC TC76 TC 6 Japan OITDA S 6 as 5 Cinema ens 15k 40k Im 6 000 5 000 4 000 3 000 2 000 Business use F 1k 20k Im 7 Si 1 000 Mil Projector Sales W W Business Home Cinema 1 5000
154. sion limits 1040 10 d e Descriptions of the classes e Values of k and k e Limits for collateral radiation Class Accessible Emission Limits Wavelength Emission duration Class I Accessible emission limits 2 4 x 10 9k ko Joules J radiant energy nanometers seconds OX 10 10k ko Watts W radiant power gt 1 0X 10 2to 2 0 X 10 2 2 0 X 10 k ko J radiant energy gt 2 0 X 10 2to 1 0 X 101 7 0 X 1078k kot3 4 J radiant energy gt L400 gt 1 0 X 104to 2 0 X 104 3 9 X 1073k ko J radiant energy but 21 0 X 3 9 X 10 k ko W radiant power lt 1400 and also See paragraph d 4 of this section gt 2 0 X 10 9t0 1 0 X 1ol L0kykot 3 Jem sr 1 integrated radiance gt 1 0 X 101to 1 0 X 10 20x ko Jem 2sr 1 integrated radiance CO 2 0 X 1073k Ko Wcm sr radiance 10 9to 1 0 X 10 radiant energy 10 7to 1 0 X 1 radiant energy 0 radiant power Lo to 1 0 X 7 gt 2500 radiant exposure radiant exposure 6 lt 1 0 X 10 10 radiant exposure 79 Measurement conditions for classification 1040 10 e Radiant power and radiant energy Irradiance and radiant exposure Radiance and time integrated radiance Measurement aperture diameters Performance requirem
155. ssing Applications and Systems 2 3 17 4 kW 4 kW 2 TEC 60825 4 D T3 10 s
156. uction and noise measurement methods for laser processing machines and hand held laser processing devices IEC 60601 2 22 am1 Ed 3 0 Medical electrical equipment Part 2 22 Particular requirements for basic safety and essential performance Of surgical cosmetic therapeutic and diagnostic laser equipment Medical electrical equipment Part 2 57 Particular requirements for the safety and essential performance Of non laser light source equipment intended for therapeutic diagnostic monitoring and cosmetic aesthetic use IEC TR 62471 3 Ed Safety of intense pulsed light source equipment Guidelines for the safe use of intense pulsed light source equipment on humans ADDICT OBA MPE Maximum Permissible Exposure
157. ul D Cinema HPJ 10000 m HPJ 5000 9999 m HPJ 2000 4999 HPJ 0 999 Home Cinema mLV 10KIm lt m Inst High 1 1 ina 1 b 1 es l i Inst Mid Business Inst Low Inst LevelO mST m UST 6 its 700 ry Pata Ee r SS Pi age AES PEE 2011 2012 2013 lt 700 JBMIA 2011 2012 2013 39 6 GaAs 30 GaP InP 70 GaN HE SAARI E amaj oO ee aranza o a
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