IEC 60601-1-2:2014 (ed. 4) (ed. 2) e 2018 4 2 1 1 2 / 1 2.1............... 2 2.2............... 3 2.3.................. 4 3 6 4 6 4.1.................. 6 4.1.1............... 7 4.1.2....... 7 4.1.3............ 7 4.1.4.... 7 4.2............... 7 4.3............... 7 4.3.1.............. 8 4.3.2.............. 9 4.3.3 ( ).............. 10 4.3.4....... 11 4.4................... 11 5 12 6 13 6.1................... 13 6.2.................... 14 6.3................... 14 7 14 7.1 2007.......... 14 7.2................... 15 8 17 1 IEC 60601-1-2 [1] ( ) 1 IEC 60601-1 [2] IEC 60601-2 IEC 60601-1-2 2014 (ed. 4) [1] 2 / 1 3 2 1 (EMC) 2 IEC 60601-1-2 2001 (ed. 2) 2007 (ed. 3) 1
e-ohtama, LTD. MRI 2.1 () CISPR 11 [4] 3 CISPR 32 / CISPR 14-1 CISPR CISPR CISPR 11 CISPR 11 : / 2 1 4 2 ISM 5 6 7 8 3 4 1 2 MRI 5 ISM ( ISM 2.4 2.5 GHz ISM ) 13.553 13.567 MHz 26.957 27.283 MHz 2.4 2.5 GHz CISPR 11 [4] ISM CISPR 11 6 1 2 A 2 ISM 7 8 MRI IEC 60601-1 [2] 10.3 60 40 20 0 20 B A 9 10 0.1 Class A Group 2 Class A Group 1 Class B Group 1 20 1 10 100 1000 1: CISPR 11 ( 10 m) 120 100 80 60 Class A Group 2 (C Class A Group 1 (C Class B Group 1 40 0.1 0.3 1 3 10 30 2: CISPR 11 ( ) () 9 B A AC 100 V AC 230 V B 1 2 A B A B 10 IEC 60601-1-2:2007 (ed.3) A ME 120 100 80 60 40 2
1: ( ; MRI ) ( ) ( ) ( ) () ( ) ( /// ) ( MRI ) RF IEC 61000-3-2 () IEC 61000-3-3 ( / ) 11 12 ISO 7137 11 IEC 61000-3-2 220 240 V IEC 61000-3-3 220 250 V 16 A/ 16 A/ IEC 61000-3-12 IEC 61000-3-11 Annex F.3 IEC 61000-3-2 JIS C 61000-3-2 100 V 200 V 20 A/ IEC 61000-3-3 JIS 12 ( ) 2.2 ( ) 2 13 14 : ( ) RFID 13 14 ( ) 3
(IEC 61000-4-2) ±15 kv 15 RF (IEC 61000-4-3) 16 17 (IEC 61000-4-8) 15 cm 15 IEC 60601-1-2 2001 (ed. 2) 2007 (ed. 3) ±8 kv 5 % ±15 kv ±15 kv IEC 61000-4-2 ( ) 16 RF 1.5 GHz 3.5 GHz 17 0.3 m () P d E = 6 P /d 2 W 0.1 m 85 V/m Annex E : 18 2.3 ISO 7637-2 : IEC 61000-3-11 ( 75 A/ / ) 18 4
IEC 61000-4-2 : ±8 kv : ±2, ±4, ±8, ±15 kv IEC 61000-4-3 80 MHz 2.7 GHz: 3 V/m 80 MHz 2.7 GHz: 10 V/m : 3 : 3 IEC 61000-4-8 50 Hz or 60 Hz, 30 A/m AC IEC 61000-4-4 ±2 kv (100 khz) IEC 61000-4-5 : ±0.5, ±1 kv : ±0.5, ±1, ±2 kv IEC 61000-4-6 0.15 80 MHz: 3 V 0.15 80 MHz: 3 V ISM : 6 V ISM/ : 6 V IEC 61000-4-11 0 % U T ; 0.5 (0, 45, 90, 135, 180, 225, 270, 315 ) 0 % U T ; 1 70 % U T ; 25/30 (50/60 Hz) 0 % U T ; 250/300 (50/60 Hz) DC IEC 61000-4-4 ±2 kv (100 khz) IEC 61000-4-5 : ±0.5, ±1 kv : ±0.5, ±1, ±2 kv IEC 61000-4-6 0.15 80 MHz: 3 V 0.15 80 MHz: 3 V ISM : 6 V ISM/ : 6 V ISO 7637-2 N/A ISO 7637-2 ( ) a IEC 61000-4-2 : ±8 kv : ±2, ±4, ±8, ±15 kv IEC 61000-4-6 0.15 80 MHz: 3 V 0.15 80 MHz: 3 V ISM : 6 V ISM/ : 6 V IEC 61000-4-2 : ±8 kv : ±2, ±4, ±8, ±15 kv IEC 61000-4-4 ±1 kv (100 khz) IEC 61000-4-5 b : ±2 kv IEC 61000-4-6 0.15 80 MHz: 3 V 0.15 80 MHz: 3 V ISM : 6 V ISM/ : 6 V 2: IEC 60601-1-2:2014 (ed. 4) a ECG EEG b 5
(MHz) (W) (V/m) 385 TETRA 400 1.8 27 450 GMRS 460, FRS 460 FM 2 28 710, 745, 780 LTE Band 13, 17 0.2 9 810, 870, 930 GSM 800/900, TETRA 800, iden 820, CDMA 850, LTE Band 5 2 28 1 720, 1 845, 1 970 GSM 1800, CDMA 1900, GSM 1900, 2 28 DECT, LTE Band 1, 3, 4, 25, UMTS 2 450 Bluetooth, WLAN, 802.11 b/g/n, RFID 2 28 2450, LTE Band 7 5 240, 5 500, 5 785 WLAN 802.11 a/n 0.2 9 3: RF IEC 61000-3-12 (16 75 A/ ) IEC 61000-4-13 ( ) MIL STD-461G ( EMC) EUROCAE ED-14G RTCA DO- 160G ( EMC) ISO 11452-8 ( ) ISO 11452-9 ( ) 3 19 ( 5) 19 / 4 4.1 : ; ; ; ; 6
4.1.1 CISPR 11 IEC 61000-4-4 IEC 61000-4-6 RC 20 4.1.2 ( 2 ) ( 4.3.2) 4.1.3 CISPR 11 IEC 61000-4-4 IEC 61000-4-6 4.1.4 20 220 pf 510 Ω 1 4 21 4.2 22 4.3 1 23 ( 4.3.1 ) 24 21 ( 0830006,, 14 8 30 ) 22 (in-situ) 23 1 24 IEC TR 60601-4-2 [7] 7
CISPR 11 1 1 IEC 61000-3-2 230 V 50 Hz 60 Hz IEC 61000-3-3 230 V 50 Hz IEC 61000-4-2 1 1 IEC 61000-4-3 1 1 IEC 61000-4-4 1 1 IEC 61000-4-5 1 1 IEC 61000-4-6 1 1 IEC 61000-4-8 1 50 Hz 60 Hz IEC 61000-4-11 25 % 1 1 4: ( ) 25 ( ITE) 26 4.3.1 25 26 ( ) IEC 60601-1 [2] : (basic safety) (essential performance) IEC 60601-1 27 28 27 ( ) ( ) ( ) 28 ( ) ( ) 8
: 29 30 31 / 29 IEC 60601-1-2 2001 (ed. 2) 2007 (ed. 3) IEC 60601-1-2:2014 (ed. 4) 30 31 artifact 4.3.2 32 33 32 ( ) () 33 9
4.3.3 ( ) IEC 61000-4-2 () ( 34 ) (1) (2) (3) 35 36 34 accessible parts (applied parts; ) ( ) IEC 60601-1 35 ( ) ( ) ESD 36 IEC 60601-1-2 2001 (ed. 2) 2007 (ed. 3) (IEC 60417-5134; ) ESD IEC 60601-1-2:2014 (ed. 4) IEC 61000-4-3 ( RF ) 80 MHz 2.7 GHz 1 khz 80 % AM 37 38 RF IEC 61000-4-3 RFID ISM 39 IEC 61000-4-4 ( / ) AC ( ) DC (3 m ) ( 37 IEC 60601-1-2 2001 (ed. 2) 2007 (ed. 3) / / 2 Hz 38 (dwell time) ( ) 39 10
3 m ) AC DC IEC 61000-4-5 () AC ( ) DC ( 3 m ) AC IEC 61000-4-6 (RF ) AC ( ) DC ( 3 m ) ( ) ( 3 m ) 1/4 (λ/4) 40 ; 1/2 (λ/2) 0.4 m 40 80 MHz λ 3.75 m 0.9 m 1 khz 80 % AM 41 42 IEC 61000-4-11 ( ) DC (AC/DC ) DC DC 43 ISO 7637-2 ( ) 12 V ISO 7637-2 4.3.4 2 44 4.4 ( ) 41 37 42 38 43 DC (AC/DC ) DC ( 4.3) 44 11
Annex G : 1. 2. 3. 4. ( ) 5. / 6. 7. 8. () 9. 10. / 11. Annex E 12. 13. 14. 15. // / 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. ESD 45 ESD 27. 46 5 45 ESD 4.3.3 46 38 12
e-ohtama, LTD. 47 ISO 14971 [3] Annex F ISO 14971 3 ISO 14971 1 48 3 47 : (IEC 60601-1-2:2005 3.108) 48 3: 6 6.1 IEC 60601-1 [2] 13
49 6.2 IEC 60601-1 [2] : 1. MRI 2. 3. 50 4. 5. 51 6. RF 52 7. CISPR 11 A ( 2.1 ) 53 6.3 IEC 60601-1 [2] : 1. 54 2. 3. 55 RF RF 7 7.1 2007 IEC 60601-1-2:2007 (ed. 3) : 1. 49 (IEC 60417-5140; ) 50 WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. 51 WARNING: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. 52 WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the [ ME EQUIPMENT or ME SYSTEM ], including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. 53 NOTE The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radiofrequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment. 54 IEC 60601-1-2 2007 (ed. 3) Table 1 (IEC 60601-1-2 2001 (ed. 2) Table 201 ) manufacturer s declaration 55 ( ) 14
2007 (ed. 3) 2007... 2. ( ) ( ) 3 ( ) ±8 kv ±15 kv ( 3) 5 2007 (ed. 3) 7.2 IEC 60601-1-2 IEC 60601-1-2 EU : 2023 2 28 JIS T 0601-1-2:2012 (IEC 60601-1-2:2001+A1:2004 (ed. 2.1) ) JIS T 0601-2:2018 (IEC 60601-1- 2:2014 (ed. 4) ) JIS T 0601-1-2:2018 0301 1 ( 30 3 1, ) 15
IEC 60601-1-2 ed. 3 IEC 60601-1-2 ed. 4 IEC 61000-4-2 : ±2, ±4, ±6 kv : ±8 kv : ±2, ±4, ±8 kv : ±2, ±4, ±8, ±15 kv IEC 61000-4-3 80 MHz 2.5 GHz: 3 V/m 80 MHz 2.7 GHz: 10 V/m : 3 IEC 61000-4-8 50 Hz or 60 Hz, 3 A/m 50 Hz or 60 Hz, 30 A/m AC IEC 61000-4-4 ±2 kv (5 khz or 100 khz) ±2 kv (100 khz) IEC 61000-4-5 : ±0.5, ±1 kv : ±0.5, ±1 kv : ±0.5, ±1, ±2 kv : ±0.5, ±1, ±2 kv (0 or 180, 90, 270 ) (0, 90, 180, 270 ) IEC 61000-4-6 0.15 80 MHz: 3 V 0.15 80 MHz: 3 V ISM/ : 6 V IEC 61000-4-11 0 % U T ; 0.5 0 % U T ; 0.5 40 % U T ; 5 0 % U T ; 1 (0, 45, 90, 135, 180, 225, 270, 315 ) 70 % U T ; 25 70 % U T ; 25/30 (50/60 Hz) 0 % U T ; 5 s 0 % U T ; 250/300 (50/60 Hz) DC IEC 61000-4-4 ±2 kv (5 or 100 khz) ±2 kv (100 khz) IEC 61000-4-5 : ±0.5, ±1 kv : ±0.5, ±1, ±2 kv IEC 61000-4-6 0.15 80 MHz: 3 V 0.15 80 MHz: 3 V ISO 7637-2 IEC 61000-4-2 : ±2, ±4, ±6 kv : ±8 kv : ±2, ±4, ±8 kv ISM/ : 6 V ISO 7637-2 ( ) : ±2, ±4, ±8, ±15 kv IEC 61000-4-6 0.15 80 MHz: 3 V 0.15 80 MHz: 3 V IEC 61000-4-2 : ±2, ±4, ±6 kv : ±8 kv : ±2, ±4, ±8 kv ISM/ : 6 V : ±2, ±4, ±8, ±15 kv IEC 61000-4-4 ±1 kv (5 or 100 khz) ±1 kv (100 khz) IEC 61000-4-5 : ±2 kv a IEC 61000-4-6 0.15 80 MHz: 3 V 0.15 80 MHz: 3 V ISM/ : 6 V 5: IEC60601-1-2:2007 (ed.3) a 16
IEC 60601-1-2:2007 (ed. 3) IEC 60601-1-2:2014 (ed. 4) (510(k)) IEC 60601-1-2:2007 (ed. 3) 2018 12 31 2016 6 27 3 m IEC 61000-4-6 http://eur-lex.europa.eu/lexuriserv /LexUriServ.do?uri=CONSLEG:1990L0385:20071011:EN:PDF [6] 93/42/EEC, e,, 2013, http://www.emc-ohtama.jp/emc/reference.html [7] IEC TR 60601-4-2, Medical electrical equipment Part 4-2: Guidance and interpretation Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems EU EN 60601-1-2:2015 (IEC 60601-1-2:2014 ) 93/42/EEC [5][6] EN 60601-1-2:2007 2018 12 31 2016 5 13 OJ 2019 1 1 EU EN 60601-1-2:2007 EN 60601-1-2:2015 56 8 [1] IEC 60601-1-2:2014 (ed. 4), Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic disturbances Requirements and tests [2] IEC 60601-1:2005 (ed. 3), Medical electrical equipment Part 1: General requirements for basic safety and essential performance [3] ISO 14971:2007 (ed. 2), Medical devices Application of risk management to medical devices [4] CISPR 11:2009 (ed. 5), Industrial, scientific and medical equipment Radio-frequency disturbance characteristics Limits and methods of measurement [5] 93/42/EEC, Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, 56 c 2017 2018 e-ohtama, LTD. All rights reserved. 17