この規格ページの目次
73
T 0601-1-2 : 2018 (IEC 60601-1-2 : 2014)
参考文献
[1] JIS C 60050-161:1997 EMCに関するIEV用語
注記 原国際規格では,IEC 60050-161:1990,International Electrotechnical Vocabulary. Chapter 161:
Electromagnetic compatibilityを記載している。
[2] IEC 60601-1-2:2007,Medical electrical equipment−Part 1-2: General requirements for basic safety and
essential performance−Collateral standard: Electromagnetic compatibility−Requirements and tests
注記 JIS T 0601-1-2:2012は,IEC 60601-1-2の第2.1版に対応しており,第3版である2007年版に
は対応していない。
[3] IEC 60601-2-27:2011,Medical electrical equipment−Part 2-27: Particular requirements for the basic safety
and essential performance of electrocardiographic monitoring equipment
注記 IEC 60601-2-27の1994年版に対応したJIS T 1304:1998(心電図監視装置)がある。
[4] JIS Z 4751-2-44:2012 医用X線CT装置−基礎安全及び基本性能
注記 原国際規格では,IEC 60601-2-44:2009,Medical electrical equipment−Part 2-44: Particular
requirements for the basic safety and essential performance of X-ray equipment for computed
tomographyを記載している。
[5] JIS Z 4005:2012 医用放射線機器−定義した用語
注記 原国際規格では,IEC/TR 60788:2004,Medical electrical equipment−Glossary of defined terms
を記載している。
[6] IEC/TR 61000-1-1:1992,Electromagnetic compatibility (EMC)−Part 1: General−Section 1: Application and
interpretation of fundamental definitions and terms
[7] IEC/TS 61000-1-2:2001,Electromagnetic compatibility (EMC)−Part 1-2: General−Methodology for the
achievement of the functional safety of electrical and electronic equipment with regard to electromagnetic
phenomena
[8] IEC/TS 61000-1-2:2008,Electromagnetic compatibility (EMC)−Part 1-2: General−Methodology for the
achievement of functional safety of electrical and electronic systems including equipment with regard to
electromagnetic phenomena
[9] IEC/TR 61000-2-5,Electromagnetic compatibility (EMC)−Part 2-5: Environment−Description and
classification of electromagnetic environments
[10] IEC 61000-3-11:2000,Electromagnetic compatibility (EMC)−Part 3-11: Limits−Limitation of voltage
changes, voltage fluctuations and flicker in public low-voltage supply systems−Equipment with rated current
75 A and subject to conditional connection
[11] IEC 61000-3-12:2011,Electromagnetic compatibility (EMC)−Part 3-12: Limits−Limits for harmonic currents
produced by equipment connected to public low-voltage systems with input current > 16 A and 75 A per phase
[12] IEC 61000-4-13:2002,Electromagnetic compatibility (EMC)−Part 4-13: Testing and measurement techniques
−Harmonics and interharmonics including mains signalling at a.c. power port, low frequency immunity tests及
びAmendment 1:2009
[13] JIS C 61000-6-1:2008 電磁両立性−第6-1部 : 共通規格−住宅,商業及び軽工業環境におけるイミュ
ニティ
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74
T 0601-1-2 : 2018 (IEC 60601-1-2 : 2014)
注記 原国際規格では,IEC 61000-6-1:2005,Electromagnetic compatibility (EMC)−Part 6-1: Generic
standards−Immunity for residential, commercial and light-industrial environmentsを記載している。
[14] JIS C 61000-6-2:2008 電磁両立性−第6-2部 : 共通規格−工業環境におけるイミュニティ
注記 原国際規格では,IEC 61000-6-2:2005,Electromagnetic compatibility (EMC)−Part 6-2: Generic
standards−Immunity for industrial environmentsを記載している。
[15] IEC 61496-1:2008,Safety of machinery−Electro-sensitive protective equipment−Part 1: General
requirements and tests
[16] CISPR 16-1-1:2010,Specification for radio disturbance and immunity measuring apparatus and methods−Part
1-1: Radio disturbance and immunity measuring apparatus−Measuring apparatus
Amendment 1:2010
[17] CISPR 16-2-3:2010,Specification for radio disturbance and immunity measuring apparatus and methods−Part
2-3: Methods of measurement of disturbances and immunity−Radiated disturbance measurements
Amendment 1:2010
[18] CISPR 24:2010,Information technology equipment−Immunity characteristics−Limits and methods of
measurement
[19] CISPR 25:2008,Vehicles, boats and internal combustion engines−Radio disturbance characteristics−Limits
and methods of measurement for the protection of on-board receivers
[20] ISO 11451-3:2007,Road vehicles−Vehicle test methods for electrical disturbances from narrowband radiated
electromagnetic energy−Part 3: On-board transmitter simulation
[21] ISO 11452-8:2007,Road vehicles−Component test methods for electrical disturbances from narrowband
radiated electromagnetic energy−Part 8: Immunity to magnetic fields
[22] ISO 11452-9:2010,Road vehicles−Component test methods for electrical disturbances from narrowband
radiated electromagnetic energy−Part 9: Portable transmitters
[23] ISO 14708-3:2008,Implants for surgery−Active implantable medical devices−Part 3: Implantable
neurostimulators
[24] ISO/TR 16142:2006,Medical devices−Guidance on the selection of standards in support of recognized
essential principles of safety and performance of medical devices
[25] JIS Q 17025:2005 試験所及び校正機関の能力に関する一般要求事項
注記 原国際規格では,ISO 17025:2005,General requirements for the competence of testing and
calibration laboratoriesを記載している。
[26] ANSI C63.4:2009,American National Standard for Methods of Measurement of Radio-Noise Emissions from
Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz
[27] ANSI C63.14:2009,American national standard dictionary of electromagnetic compatibility (EMC) ncluding
electromagnetic environmental effects (E3)
[28] AAMI TIR 18:2010,Guidance on electromagnetic compatibility of medical devices in healthcare facilities
[29] ANSI C63.7:2005,American National Standard Guide for Construction of Open-Area Test Sites for Performing
Radiated Emission Measurements
[30] EN 55103-2:2009,Electromagnetic Compatibility−Product family standard for audio, video, audio-visual and
entertainment lighting control apparatus for professional use−Part 2: Immunity
[31] International Telecommunication Union Radio Regulations:2012,
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http://www.itu.int/pub/R-REG-RR-2012
[32] Lena SJGREN and Mats BCKSTRM. Ageing of Shielding Joints, Shielding Performance and Corrosion.
IEEE EMC Society Newsletter, Summer 2005
http://www.emcs.org/acstrial/newsletters/summer05/practical.pdf.
[33] Assessing an Electromagnetic Environment, EMC Test Labs Association (EMCTLA), Technical Guidance Note
number 47 (TGN 47), available at http://www.emctla.co.uk/technical-guidance-notes.aspx.
[34] COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices, OJ No L 169, 12.7.1993, p. 1,
as last amended by Directive 2007/47/EC (OJ No L 247, 21.9.2007, p. 21)
[35] F. BECK and J. SROKA. EMC Performance of Drive Application Under Real Load Condition,, Schaffner
Application Note, 11th March 1999
[36] Guide on EMC for Functional Safety, The Institution of Engineering and Technology (IET), formerly the IEE,
London, UK, 2008, www.theiet.org/factfiles/em c/index.cfm
[37] ICNIRP., Guidelines for Limiting Exposure to Time-Varying Electric, Magnetic, and Electromagnetic Fields (up
to 300 GHz). Health Physics, 74 (4): pp. 494-522, 1998
[38] MIL-STD-461G:2010,Department of Defense Interface Standard−Requirements for the control of
electromagnetic interference characteristics of subsystems and equipment
[39] EUROCAE ED-14G:2011,Environmental Conditions and Test Procedures for Airborne Equipment
[40] RTCA DO-160G:2010,Environmental conditions and test procedures for airborne equipment
[41] United States Code of Federal Regulation, Title 21, Food and Drugs: Parts 1 to 1499,
http://www.gpo.gov/fdsys/browse/collectionCfr.action・collectionCode=CFR
[42] Overview of techniques and measures related to EMC for Functional Safety, The Institution of Engineering and
Technology (IET), formerly the IEE, London, UK, 2013, www.theiet.org/factfiles/emc/emcoverview.cfm
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附属書JA
(参考)
定義した用語の索引
五十 定義した用語 定義している規格及び
音順 細分箇条
あ アラームシステム(ALARM SYSTEM) JIS T 0601-1:2017,3.143
アラーム状態(ALARM CONDITION) JIS T 0601-1:2017,3.141
アラーム信号(ALARM SIGNAL) JIS T 0601-1:2017,3.142
アラーム設定値(ALARM LIMIT) IEC 60601-1-8:2006+Amd.1:2012,
3.3
い 意図する使用(INTENDED USE) JIS T 0601-1:2017,3.44
イミュニティ(IMMUNITY) 3.8
イミュニティ試験レベル(IMMUNITY TEST LEVEL) 3.9
え 永久設置形(PERMANENTLY INSTALLED) JIS T 0601-1:2017,3.84
(電磁)エミッション[(ELECTROMAGNETIC)EMISSION] 3.4
ME機器(ME EQUIPMENT) JIS T 0601-1:2017,3.63
MEシステム(ME SYSTEM) JIS T 0601-1:2017,3.64
お 大形ME機器(LARGE ME EQUIPMENT) 3.12
大形MEシステム(LARGE ME SYSTEM) 3.13
か 外装(ENCLOSURE) JIS T0601-1:2017,3.26
外装ポート(ENCLOSURE PORT) 3.7
形式試験(TYPE TEST) JIS T0601-1:2017,3.135
間欠モード(INTERMITTENT MODE) 3.11
患者(PATIENT) JIS T0601-1:2017,3.76
患者結合(PATIENT-COUPLED) 3.15
患者結合部(PATIENT-COUPLING PART) 3.16
患者接続部(PATIENT CONNECTION) JIS T0601-1:2017,3.78
き 偽陰性アラーム状態(FALSE NEGATIVE ALARM CONDITION) IEC 60601-1-8:2006+Amd.1:2012,
3.20
危害(HARM) JIS T 0601-1:2017,3.38
危険状態(HAZARDOUS SITUATION) IEC 60601-1-12:2014,3.40
基礎安全(BASIC SAFETY) JIS T 0601-1:2017,3.10
基本性能(ESSENTIAL PERFORMANCE) JIS T 0601-1:2017,3.27
客観的証拠(OBJECTIVE EVIDENCE) JIS T 0601-1:2017,3.72
救急医療環境(EMERGENCY MEDICAL SERVICES ENVIRONMENT) IEC 60601-1-12:2014,3.1
偽陽性アラーム状態(FALSE POSITIVE ALARM CONDITION) IEC 60601-1-8:2006+Amd.1:2012,
3.21
く クラスII(CLASS II) JIS T 0601-1:2017,3.14
け 携帯形(PORTABLE) JIS T 0601-1:2017,3.85
検証(VERIFICATION) JIS T 0601-1:2017,3.138
こ 高周波,HF(HIGH FREQUENCY) JIS T 0601-2-2:2014,201.3.218
公称(NOMINAL) JIS T 0601-1:2017,3.69
高優先度(HIGH PRIORITY) IEC 60601-1-8:2006+Amd.1:2012,
3.22
固定形,固定(した)(FIXED) JIS T 0601-1:2017,3.30
さ 在宅医療環境(HOME HEALTHCARE ENVIRONMENT) IEC 60601-1-11:2010,3.2
残留リスク(RESIDUAL RISK) JIS T 0601-1:2017,3.100
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77
T 0601-1-2 : 2018 (IEC 60601-1-2 : 2014)
五十 定義した用語 定義している規格及び
音順 細分箇条
し 実効放射電力(ERP)(EFFECTIVE RADIATED POWER) 3.1
重大さ(SEVERITY) JIS T 0601-1:2017,3.114
商用電源系(PUBLIC MAINS NETWORK) 3.18
情報技術機器(ITE)(INFORMATION TECHNOLOGY EQUIPMENT) 3.10
信号入出力部(SIP/SOP)(SIGNAL INPUT/OUTPUT PART) JIS T 0601-1:2017,3.115
身体装着形(BODY-WORN) JIS T 0601-1:2017,3.144
せ 正常状態(NORMAL CONDITION) JIS T 0601-1:2017,3.70
正常な使用(NORMAL USE) JIS T 0601-1:2017,3.71
製造業者(MANUFACTURER) JIS T 0601-1:2017,3.55
静電気放電(ESD)(ELECTROSTATIC DISCHARGE) 3.6
責任部門(RESPONSIBLE ORGANIZATION) JIS T 0601-1:2017,3.101
そ 操作者(OPERATOR) JIS T 0601-1:2017,3.73
装着部(APPLIED PART) JIS T 0601-1:2017,3.8
た 超短波療法機器(SHORT-WAVE THERAPY EQUIPMENT) JIS T 0601-2-3:2015,201.3.206
ち 中優先度(MEDIUM PRIORITY) IEC 60601-1-8:2006+Amd.1:2012,
3.28
て 定格(RATED) JIS T 0601-1:2017,3.97
低電圧(LOW VOLTAGE) 3.14
手持形(HAND-HELD) JIS T 0601-1:2017,3.37
電気手術器(HF SURGICAL EQUIPMENT) JIS T 0601-2-2:2014,201.3.222
電気手術器の附属品(HF SURGICAL ACCESSORY) JIS T 0601-2-2:2014,201.3.221
電源コード(POWER SUPPLY CORD) JIS T 0601-1:2017,3.87
電磁環境(ELECTROMAGNETIC ENVIRONMENT) 3.5
電磁妨害(ELECTROMAGNETIC DISTURBANCE) 3.3
電磁両立性(EMC)(ELECTROMAGNETIC COMPATIBILITY) 3.2
と 等電位化導線(POTENTIAL EQUALIZATION CONDUCTOR) JIS T 0601-1:2017,3.86
特殊環境(SPECIAL ENVIRONMENT) 3.20
な 内部電源(の)(INTERNALLY POWERED) JIS T 0601-1:2017,3.46
は ハザード(HAZARD) JIS T 0601-1:2017,3.39
ふ 附属品(ACCESSORY) JIS T 0601-1:2017,3.3
附属文書(ACCOMPANYING DOCUMENT) JIS T 0601-1:2017,3.4
プロセス(PROCESS) JIS T 0601-1:2017,3.89
ほ 保護接地線(PROTECTIVE EARTH CONDUCTOR) JIS T 0601-1:2017,3.93
ポート(PORT) 3.17
む 無線周波数(RF)(RADIO FREQUENCY) 3.19
め 明瞭に見える(CLEARLY LEGIBLE) JIS T 0601-1:2017,3.15
よ 予測耐用期間(EXPECTED SERVICE LIFE) JIS T 0601-1:2017,3.28
り リスク(RISK) JIS T0601-1:2017,3.102
リスクアセスメント(RISK ASSESSMENT) JIS T0601-1:2017,3.104
リスクコントロール(RISK CONTROL) JIS T0601-1:2017,3.105
リスク評価(RISK EVALUATION) JIS T0601-1:2017,3.106
リスク分析(RISK ANALYSIS) JIS T0601-1:2017,3.103
リスクマネジメント(RISK MANAGEMENT) JIS T0601-1:2017,3.107
リスクマネジメントファイル(RISK MANAGEMENT FILE) JIS T0601-1:2017,3.108
JIS T 0601-1-2:2018の引用国際規格 ISO 一覧
- IEC 60601-1-2:2014(IDT)
JIS T 0601-1-2:2018の国際規格 ICS 分類一覧
- 33 : 電気通信工学.オーディオ及びビデオ工学 > 33.100 : 電磁両立性(EMC) > 33.100.20 : イミュニティ
- 33 : 電気通信工学.オーディオ及びビデオ工学 > 33.100 : 電磁両立性(EMC) > 33.100.10 : エミッション
JIS T 0601-1-2:2018の関連規格と引用規格一覧
- 規格番号
- 規格名称