IEC :2014 (ed. 4) の概要 (ed. 2)

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1 IEC :2014 (ed. 4) (ed. 2) e / ( ) IEC [1] ( ) 1 IEC [2] IEC IEC (ed. 4) [1] 2 / (EMC) 2 IEC (ed. 2) 2007 (ed. 3) 1

2 e-ohtama, LTD. MRI 2.1 () CISPR 11 [4] 3 CISPR 32 / CISPR 14-1 CISPR CISPR CISPR 11 CISPR 11 : / ISM MRI 5 ISM ( ISM GHz ISM ) MHz MHz GHz CISPR 11 [4] ISM CISPR A 2 ISM 7 8 MRI IEC [2] B A Class A Group 2 Class A Group 1 Class B Group : CISPR 11 ( 10 m) Class A Group 2 (C Class A Group 1 (C Class B Group : CISPR 11 ( ) () 9 B A AC 100 V AC 230 V B 1 2 A B A B 10 IEC :2007 (ed.3) A ME

3 1: ( ; MRI ) ( ) ( ) ( ) () ( ) ( /// ) ( MRI ) RF IEC () IEC ( / ) ISO IEC V IEC V 16 A/ 16 A/ IEC IEC Annex F.3 IEC JIS C V 200 V 20 A/ IEC JIS 12 ( ) 2.2 ( ) : ( ) RFID ( ) 3

4 (IEC ) ±15 kv 15 RF (IEC ) (IEC ) 15 cm 15 IEC (ed. 2) 2007 (ed. 3) ±8 kv 5 % ±15 kv ±15 kv IEC ( ) 16 RF 1.5 GHz 3.5 GHz m () P d E = 6 P /d 2 W 0.1 m 85 V/m Annex E : ISO : IEC ( 75 A/ / ) 18 4

5 IEC : ±8 kv : ±2, ±4, ±8, ±15 kv IEC MHz 2.7 GHz: 3 V/m 80 MHz 2.7 GHz: 10 V/m : 3 : 3 IEC Hz or 60 Hz, 30 A/m AC IEC ±2 kv (100 khz) IEC : ±0.5, ±1 kv : ±0.5, ±1, ±2 kv IEC MHz: 3 V MHz: 3 V ISM : 6 V ISM/ : 6 V IEC % 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 ±2 kv (100 khz) IEC : ±0.5, ±1 kv : ±0.5, ±1, ±2 kv IEC MHz: 3 V MHz: 3 V ISM : 6 V ISM/ : 6 V ISO N/A ISO ( ) a IEC : ±8 kv : ±2, ±4, ±8, ±15 kv IEC MHz: 3 V MHz: 3 V ISM : 6 V ISM/ : 6 V IEC : ±8 kv : ±2, ±4, ±8, ±15 kv IEC ±1 kv (100 khz) IEC b : ±2 kv IEC MHz: 3 V MHz: 3 V ISM : 6 V ISM/ : 6 V 2: IEC :2014 (ed. 4) a ECG EEG b 5

6 (MHz) (W) (V/m) 385 TETRA GMRS 460, FRS 460 FM , 745, 780 LTE Band 13, , 870, 930 GSM 800/900, TETRA 800, iden 820, CDMA 850, LTE Band , 1 845, GSM 1800, CDMA 1900, GSM 1900, 2 28 DECT, LTE Band 1, 3, 4, 25, UMTS Bluetooth, WLAN, b/g/n, RFID , LTE Band , 5 500, WLAN a/n : RF IEC (16 75 A/ ) IEC ( ) MIL STD-461G ( EMC) EUROCAE ED-14G RTCA DO- 160G ( EMC) ISO ( ) ISO ( ) 3 19 ( 5) 19 / : ; ; ; ; 6

7 4.1.1 CISPR 11 IEC IEC RC ( 2 ) ( 4.3.2) CISPR 11 IEC IEC pf 510 Ω ( ) ( ,, ) 22 (in-situ) IEC TR [7] 7

8 CISPR IEC V 50 Hz 60 Hz IEC V 50 Hz IEC IEC IEC IEC IEC IEC Hz 60 Hz IEC % 1 1 4: ( ) 25 ( ITE) ( ) IEC [2] : (basic safety) (essential performance) IEC ( ) ( ) ( ) 28 ( ) ( ) 8

9 : / 29 IEC (ed. 2) 2007 (ed. 3) IEC :2014 (ed. 4) artifact ( ) () 33 9

10 4.3.3 ( ) IEC () ( 34 ) (1) (2) (3) accessible parts (applied parts; ) ( ) IEC ( ) ( ) ESD 36 IEC (ed. 2) 2007 (ed. 3) (IEC ; ) ESD IEC :2014 (ed. 4) IEC ( RF ) 80 MHz 2.7 GHz 1 khz 80 % AM RF IEC RFID ISM 39 IEC ( / ) AC ( ) DC (3 m ) ( 37 IEC (ed. 2) 2007 (ed. 3) / / 2 Hz 38 (dwell time) ( ) 39 10

11 3 m ) AC DC IEC () AC ( ) DC ( 3 m ) AC IEC (RF ) AC ( ) DC ( 3 m ) ( ) ( 3 m ) 1/4 (λ/4) 40 ; 1/2 (λ/2) 0.4 m MHz λ 3.75 m 0.9 m 1 khz 80 % AM IEC ( ) DC (AC/DC ) DC DC 43 ISO ( ) 12 V ISO ( ) DC (AC/DC ) DC ( 4.3) 44 11

12 Annex G : ( ) 5. / () / 11. Annex E // / ESD 45 ESD ESD

13 e-ohtama, LTD. 47 ISO [3] Annex F ISO ISO : (IEC : ) 48 3: IEC [2] 13

14 IEC [2] : 1. MRI RF CISPR 11 A ( 2.1 ) IEC [2] : RF RF IEC :2007 (ed. 3) : (IEC ; ) 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 (ed. 3) Table 1 (IEC (ed. 2) Table 201 ) manufacturer s declaration 55 ( ) 14

15 2007 (ed. 3) ( ) ( ) 3 ( ) ±8 kv ±15 kv ( 3) (ed. 3) 7.2 IEC IEC EU : JIS T :2012 (IEC :2001+A1:2004 (ed. 2.1) ) JIS T :2018 (IEC :2014 (ed. 4) ) JIS T : ( , ) 15

16 IEC ed. 3 IEC ed. 4 IEC : ±2, ±4, ±6 kv : ±8 kv : ±2, ±4, ±8 kv : ±2, ±4, ±8, ±15 kv IEC MHz 2.5 GHz: 3 V/m 80 MHz 2.7 GHz: 10 V/m : 3 IEC Hz or 60 Hz, 3 A/m 50 Hz or 60 Hz, 30 A/m AC IEC ±2 kv (5 khz or 100 khz) ±2 kv (100 khz) IEC : ±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 MHz: 3 V MHz: 3 V ISM/ : 6 V IEC % U T ; % U T ; % U T ; 5 0 % U T ; 1 (0, 45, 90, 135, 180, 225, 270, 315 ) 70 % U T ; % U T ; 25/30 (50/60 Hz) 0 % U T ; 5 s 0 % U T ; 250/300 (50/60 Hz) DC IEC ±2 kv (5 or 100 khz) ±2 kv (100 khz) IEC : ±0.5, ±1 kv : ±0.5, ±1, ±2 kv IEC MHz: 3 V MHz: 3 V ISO IEC : ±2, ±4, ±6 kv : ±8 kv : ±2, ±4, ±8 kv ISM/ : 6 V ISO ( ) : ±2, ±4, ±8, ±15 kv IEC MHz: 3 V MHz: 3 V IEC : ±2, ±4, ±6 kv : ±8 kv : ±2, ±4, ±8 kv ISM/ : 6 V : ±2, ±4, ±8, ±15 kv IEC ±1 kv (5 or 100 khz) ±1 kv (100 khz) IEC : ±2 kv a IEC MHz: 3 V MHz: 3 V ISM/ : 6 V 5: IEC :2007 (ed.3) a 16

17 IEC :2007 (ed. 3) IEC :2014 (ed. 4) (510(k)) IEC :2007 (ed. 3) m IEC /LexUriServ.do?uri=CONSLEG:1990L0385: :EN:PDF [6] 93/42/EEC, e,, 2013, [7] IEC TR , Medical electrical equipment Part 4-2: Guidance and interpretation Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems EU EN :2015 (IEC :2014 ) 93/42/EEC [5][6] EN : OJ EU EN :2007 EN : [1] IEC :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 :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 e-ohtama, LTD. All rights reserved. 17

CISPR 35の概要

CISPR 35の概要 CISPR 35 e 2018 3 28 1 1 2 2 2.1 IEC 61000-4-2 ( )......... 2 2.2 IEC 61000-4-3, -4-20, -4-21, -4-6 ( RF )....................... 2 2.3 IEC 61000-4-5 ()............ 2 2.4............. 4 3 4 3.1 EUT............