Medical electrical equipment—Part 1-2:General requirements for basic safety and essential performance—Collateral standard:Electromagnetic compatibility—Requirements and tests
Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—
Collateral standard: Electromagnetic compatibility—Requirements and tests
1 Scope, object and related standards
1.1 *Scope
This part applies to the basic safety and essential performance of Medical Electrical Equipment and Medical Electrical Systems, hereafter referred to as ME Equipment and ME Systems.
This part applies to electromagnetic compatibility of ME Equipment and ME Systems.
Note: The clauses and subclauses with asterisk (*) in this part are described in Annex A.
1.2 Object
The object of this part is to specify general requirements and tests for electromagnetic compatibility of ME Equipment and ME Systems. They are in addition to the requirements of the general standard and serve as the basis for particular standards.
1.3 Related standards
1.3.1 GB 9706.1
For ME Equipment and ME Systems, this part complements GB 9706.1.
When referring to GB 9706.1 or to this part, either individually or in combination, the following conventions are used:
——“the general standard” designates GB 9706.1 alone;
——"this part” designates YY 9706.102 alone;
——“this standard" designates the combination of the general standard and this part.
1.3.2 Particular standards
A requirement in a particular standard takes priority over the corresponding requirement in this part.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB 4343.1 Electromagnetic compatibility requirements for household appliances, electric tools and similar apparatus—Part 1: Emission (GB 4343.1-2018, CISPR 14-1: 2011, IDT)
GB 4824 Industrial, scientific and medical (ISM) radio-frequency equipment—Disturbance characteristics—Limits and methods of measurement (GB 4824-2013, CISPR 11: 2010, IDT)
GB/T 5465.2-2008 Graphical symbols for use on electrical equipment—Part 2: Graphical symbols (IEC 60417 DB: 2007, IDT)
GB/T 6113.102 Specification for radio disturbance and immunity measuring apparatus and methods—Part 1-2: Radio disturbance and immunity measuring apparatus—Coupling devices for conducted disturbance measurements (GB/T 6113.102-2018, CISPR 16-1-2: 2014, IDT)
GB/9254 Information technology equipment—Radio disturbance characteristics—Limits and methods of measurement (GB/T 9254-2008, CISPR 22: 2006, IDT)
GB 9706.1-2020 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance (IEC 60601-1: 2012, MOD)
GB 17625.1 Electromagnetic compatibility—Limits—Limits for harmonic current emissions (equipment input current ≤16A per phase) (GB 17625.1-2012, IEC 61000-3-2: 2009, ID)
GB/T 17625.2 Electromagnetic compatibility (EMC)—Limits—Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤16A per phase and not subject to conditional connection (GB/T 17625.2-2007, IEC 61000-3-3: 2005, IDT)
GB/T 17626.2 Electromagnetic compatibility (EMC)—Testing and measurement techniques—Electrostatic discharge immunity test (GB/T 17626.2-2018, IEC 61000-4-2: 2008, IDT)
GB/T 17626.3 Electromagnetic compatibility—Testing and measurement techniques—Radiated radio-frequency electromagnetic field immunity test (GB/T 17626.3—2016, IEC 61000-4-3: 2010, IDT)
GB/T 17626.4-2018 Electromagnetic compatibility—Testing and measurement techniques—Electrical fast transient/burst immunity test (IEC 61000-4-4: 2012, IDT)
GB/T 17626.5 Electromagnetic compatibility—Testing and measurement techniques—Surge immunity test (GB/T 17626.5-2008, IEC 61000-4-5: 2014, IDT)
GB/T 17626.6-2017 Electromagnetic compatibility—Testing and measurement techniques—Immunity to conducted disturbances, induced by radio-frequency fields (IEC 61000-4-6: 2013, IDT)
GB/T 17626.8 Electromagnetic compatibility—Testing and measurement techniques—Power frequency magnetic field immunity test (GB/T 17626.8-2006, IEC 61000-4-8: 2001, IDT)
GB/T 17626.11 Electromagnetic compatibility—Testing and measurement techniques—Voltage dips, short interruptions and voltage variations immunity tests (GB/T 17626.11-2008, IEC 61000-4-11: 2004, IDT)
GB/T 17743 Limits and methods of measurement of radio disturbance characteristics of electrical lighting and similar equipment (GB/T 17743-2017, CISPR 15: 2015, IDT)
YY 9706.108-2021 Medical electrical equipment—Part 1-8: General requirements for basic safety and essential performance—Collateral standard: General requirements, test and guidance for alarm systems in medical electrical equipment and medical electrical systems (IEC 60601-1-8: 2012, MOD)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB 9706.1-2020 and YY 9706.108-2021 and the following apply.
Note 1: Where the terms “voltage” and “current” are used in this part, they mean the r.m.s. values of an alternating, direct or composite voltage or current unless stated otherwise.
Note 2: The term “electrical equipment” is used to mean ME Equipment or other electrical equipment. This part also uses the term “equipment” to mean ME Equipment or other electrical or non-electrical equipment in the context of an ME System.
3.1
(immunity) compliance level
level less than or equal to the immunity level for which the ME Equipment or ME System meets the requirements of the applicable subclause of 6.2
Note: Additional requirements for compliance levels are specified in 5.2.2.
3.2
*degradation (of performance)
undesired departure in the operational performance of ME Equipment or an ME System from its intended performance
Note 1: The term "degradation" can apply to temporary or permanent failure.
Note 2: It is modified from GB/T 4365-2003, Definition 161-01-19.
3.3
*effective radiated power; ERP
power required at the input of a lossless reference antenna to produce, in a given direction at any specified distance, the same power flux density as that radiated by a given device
Note 1: As used by the ITU and as used in Chapter 712 of the IEV, the term “effective radiated power” appears without qualification only when the reference antenna is a half-wave dipole.
Note 2: It is modified from GB/T 4365-2003, Definition 161-04-16.
3.4
*electromagnetic compatibility; EMC
ability of ME Equipment or an ME System to function satisfactorily in its electromagnetic environment without introducing intolerable electromagnetic disturbances to anything in that environment
Note: It is modified from GB/T 4365-2003, Definition 161-01-07.
3.5
*electromagnetic disturbance
any electromagnetic phenomenon that may degrade the performance of a device, equipment or system
Note 1: An electromagnetic disturbance may be electromagnetic noise, an unwanted signal or a change in the propagation medium itself.
Note 2: It is modified from GB/T 4365-2003, Definition 161-01-05.
3.6
(electromagnetic) emission
phenomenon by which electromagnetic energy emanates from a source
[GB/T 4365-2003, Definition 161-01-08]
3.7
electromagnetic environment
totality of electromagnetic phenomena existing at a given location
Note: In general, the electromagnetic environment is time dependent and its description may need a statistical approach.
[GB/T 4365-2003, Definition 161-01-01]
3.8
electromagnetic noise
time-varying electromagnetic phenomenon apparently not conveying information and which may be superimposed on or combined with a wanted signal
[GB/T 4365-2003, Definition 161-01-02]
3.9
electrostatic discharge
transfer of electric charge between objects of different electrostatic potentials in proximity or through direct contact
[GB/T 4365-2003, Definition 161-01-22]
3.10
*exclusion band
frequency band for intentional receivers of RF electromagnetic energy that extends from -5 % to +5 % of the frequency, or frequency band, of reception for frequencies of reception greater than or equal to 80 MHz and from -10 % to +10 % of the frequency, or frequency band, of reception for frequencies of reception less than 80 MHz
Note: Other definitions of this term are sometimes used for other purposes in national radio regulations.
3.11
*function
clinically significant operation that the ME Equipment or ME System is intended to perform in the diagnosis, treatment or monitoring of a patient or for compensation or alleviation of disease, injury or disability
3.12
IEC 60601 test level
immunity test level specified in 6.2 by this part or a particular standard
3.13
*immunity (to a disturbance)
ability of ME Equipment or an ME System to perform without degradation in the presence of an electromagnetic disturbance
Note: It is modified from GB/T 4365-2003, Definition 161-01-20.
3.14
immunity level
maximum disturbance level at which a given electromagnetic disturbance is applied to a device, equipment, or system while it still works properly and maintains the required performance level
[GB/T 4365-2003, Definition 161-03-14]
3.15
immunity test level
level of a test signal used to simulate an electromagnetic disturbance when performing an immunity test
[GB/T 4365-2003, Definition 161-04-41]
3.16
information technology equipment; ITE
equipment designed for the purpose of:
a) receiving data from an external source (such as a data input line or via a keyboard);
b) performing some processing functions on the received data (such as computation, data transformation or recording, filing, sorting, storage, transfer of data);
c) providing a data output (either to other equipment or by the reproduction of data or images)
Note: This definition includes electrical or electronic units or systems that predominantly generate a multiplicity of periodic binary pulsed electrical or electronic waveforms and are designed to perform data processing functions such as word processing, electronic computation, data transformation, recording, filing, sorting, storage, retrieval and transfer, and reproduction of data as images.
[GB/T 4365-2003, Definition 161-05-04]
3.17
*large ME Equipment or ME System
ME Equipment or ME System that cannot fit within a 2m × 2m × 2.5m volume, excluding cables, but including distributed ME Systems
3.18
*life-supporting ME Equipment or ME System
ME Equipment or ME System that includes at least one function that is intended to actively keep alive or resuscitate patients and the failure of which to comply with the requirements of 6.2.1.10 is likely to lead to serious injury or death of a patient
3.19
*low voltage
line-to-line or line-to-neutral voltage that is less than or equal to 1,000 V a.c. or 1,500 V d.c.
3.20
*operating frequency
fundamental frequency of a signal, electrical or non-electrical, that is set in ME Equipment or an ME System intended to control a physiological parameter
3.21
*patient-coupled ME Equipment or ME System
ME Equipment or ME System that contains at least one applied part whereby contact with the patient provides a sensing or treatment point necessary for the normal operation of the ME Equipment or ME System and provides a path for electromagnetic energy, whether coupled conductively, capacitively or inductively and whether intended or unintended
3.22
*physiological simulation frequency
fundamental frequency of a signal, electrical or non-electrical, used to simulate a physiological parameter such that the ME Equipment or ME System will operate in a manner consistent with use on a patient
3.23
*professional ME Equipment or ME System
ME Equipment or ME System for use by healthcare professionals and that is not intended for sale to the general public
Note: It is modified from GB/T 4365-2003, Definition 161-05-05.
3.24
*public mains network
low voltage electricity power lines to which all categories of consumers have access
3.25
*radio frequency; RF
frequency in the portion of the electromagnetic spectrum that is between the audio-frequency portion and the infrared portion; frequency useful for radio transmission
Note: The limits are generally accepted to be 9 kHz to 3,000 GHz.
3.26
type A professional ME Equipment or ME System
professional ME Equipment or ME System that complies with GB 4824 group 2 Class B except for the third harmonic of the fundamental frequency of the ME Equipment or ME System, in which case the third harmonic complies with the group 2 Class A electromagnetic radiation disturbance limit
Note: See subclause 6.1.1.1 f).
4 General requirements
4.1 General requirements for electromagnetic compatibility of ME Equipment and ME Systems
4.1.1 *Electromagnetic compatibility
ME Equipment and ME Systems shall not emit electromagnetic disturbances that could affect radio services, other equipment or the essential performance of other ME Equipment and ME Systems. ME Equipment and ME Systems shall have adequate immunity to be able to provide its basic safety and essential performance in the presence of electromagnetic disturbances.
Consider compliance to exist if the requirements of this part are met.
4.1.2 Non-medical electrical equipment
Electrical equipment that is not ME Equipment and that is supplied as part of an ME System is exempt from the EMC testing requirements of this part provided all of the following conditions are met (see also Annex G):
a) the electrical equipment that is not ME Equipment complies with applicable international EMC standards;
b) both the emissions and immunity of the electrical equipment that is not ME Equipment have been determined not to adversely affect the basic safety or essential performance of the ME system;
c) the emissions of the electrical equipment that is not ME Equipment have been determined not to cause the emissions of the ME System to exceed applicable limits.
Check compliance by inspection of the documents for this determination and other appropriate documents or certificates or, if this determination is not performed, by inspection of the documents to verify that the electrical equipment that is not ME Equipment has been tested in accordance with this part.
4.2 *Single fault condition for ME Equipment
For EMC testing, the single fault condition requirements of the general standard do not apply.
5 Identification, marking and documents
5.1 Marking on the outside of ME Equipment or ME Equipment parts
Foreword i
Introduction iv
1 Scope, object and related standards
2 Normative references
3 Terms and definitions
4 General requirements
5 Identification, marking and documents
6 Electromagnetic compatibility
Annex A (Informative) General guidance and rationale
Annex B (Informative) Guide to marking and labeling requirements for ME Equipment and ME Systems
Annex C (Informative) Example completion of Table 1 through Table
Annex D (Informative) Guidance in classification according to GB
Annex E (Informative) Guidance applied to particular standards
Annex F (Informative) Electromagnetic environment
Annex G (Informative) Guidance for determining if electrical equipment that is not ME Equipment and that is used in an ME System is exempt from the EMC test requirements of this part
Annex H (Informative) Mapping between the elements of YY 0505-2012 and this part
Figure 1 Instructions for completing Table 1 for GB 4824 ME Equipment and ME Systems [see 5.2.2.1 c)]
Figure 2 Instructions for completing Table 1 for GB 4343 and GB/T 17743 ME Equipment [see 5.2.2.1 c)]
Figure 3 Instructions for completing Table 2 [see 5.2.2.1 f)]
Figure 4 Instructions for completing Table 3 and Table 5 for life-supporting ME Equipment and ME Systems (see 5.2.2.2)
Figure 5 Instructions for completing Table 4 and Table 6 for ME Equipment and ME Systems that are not life-supporting (see 5.2.2.2)
Figure A.1 Example of cable arrangement for radiated immunity test [see 6.2.3.2 h)]
Figure A.2 Examples showing maximum dimension for ME Equipment with one and with two cables [See 6.2.6.1 e) and f)]
Figure G.1 Procedure for determining if electrical equipment that is not ME Equipment and that is used in an ME System is exempt from the EMC test requirements of this collateral standard (see 4.1.2 and 6.2.1.4)
Table 1 Guidance and manufacturer’s declaration – electromagnetic emissions – for ME Equipment and ME Systems [see 5.2.2.1 c)]
Table 2 Guidance and manufacturer’s declaration – electromagnetic immunity –for all ME Equipment and ME Systems [see 5.2.2.1 f)]
Table 3 Guidance and manufacturer’s declaration – electromagnetic immunity – for life-supporting ME equipment and ME Systems (see 5.2.2.2)
Table 4 Guidance and manufacturer’s declaration – electromagnetic immunity – for ME Equipment and ME Systems that are not life-supporting (see 5.2.2.2)
Table 5 Recommended separation distances between portable and mobile RF communications equipment and the ME Equipment or ME System – for life-supporting ME Equipment and ME Systems (see 5.2.2.2)
Table 6 Recommended separation distances between portable and mobile RF communications equipment and the ME Equipment or ME System – for ME Equipment and ME Systems that are not life-supporting (see 5.2.2.2)
Table 7 Guidance and manufacturer’s declaration – electromagnetic immunity for life-supporting ME Equipment and ME Systems that are specified for use only in a shielded location [See 5.2.2.3 d)]
Table 8 Guidance and manufacturer’s declaration – electromagnetic immunity for ME Equipment and ME Systems that are not life-supporting and are specified for use only in a shielded location [See 5.2.2.3 d)]
Table 9 Modulation frequency, physiological simulation frequency and operating frequency
Table 10 Immunity test levels for voltage dips
Table 11 Immunity test levels for voltage interruption
Table B.1 Marking on the outside of ME Equipment, ME Systems or their parts
Table B.2 Accompanying documents, instructions for use
Table B.3 Accompanying documents, technical description
Table C.1 Example (1) completion of Table
Table C.2 Example (2) completion of Table
Table C.3 Example (3) completion of Table
Table C.4 Example completion of Table
Table C.5 Example (1) test, immunity and compliance level
Table C.6 Example completion of Table
Table C.7 Example completion of Table
Table C.8 Example completion of Table
Table C.9 Example completion of Table
Table C.10 Example (2) test, immunity and compliance level
Table C.11 Example completion of Table
Table C.12 Example (3) test, immunity and compliance level
Table C.13 Example completion of Table
Table F.1 Electromagnetic environment
Table H.1 Mapping between the elements of the YY0505-2012 and this part
ICS 11.140
C 30
YY
中华人民共和国医药行业标准
YY 9706.102—2021
代替YY 0505—2012
医用电气设备 第1-2部分：基本安全和基本性能的通用要求 并列标准：电磁兼容 要求和试验
Medical electrical equipment—Part 1-2：General requirements for
basic safety and essential performance—Collateral standard：Electromagnetic
compatibility—Requirements and tests
(IEC 60601-1-2：2007，MOD)
2021-03-09发布 2023-05-01实施
国家药品监督管理局 发布
引言
医用电气设备和医用电气系统建立具体的专门的电磁兼容性标准的需求已成为人们普遍的共识。
尤其是电磁发射标准，对保护安全业务、其他医用电气设备和医用电气系统、非医用电气设备(如计算机)和无线电通信(如无线电广播／电视、电话、无线电导航)是至关重要的。
更为重要的是，电磁抗扰度标准对确保医用电气设备和医用电气系统的安全是必不可少的。电磁兼容性(见3.4)不同于GB 9706.1所覆盖的其他安全方面，这是因为所有的医用电气设备和医用电气系统在正常使用的环境里存在着不同严酷程度的电磁现象，并且按照定义，为实现电磁兼容性，设备在其预期环境中一定要“符合要求运行”。这意味着传统的与安全有关的单— 故障概念不适用于电磁兼容性标准。电磁骚扰环境可类比于环境温度、湿度和大气压力。医用电气设备和医用电气系统可能在产品合格周期内的任何时间经受预期范围内的环境条件。如同大气压力和湿度，医用电气设备或医用电气系统的操作者可能一直不会意识到环境电平。本部分规定的抗扰度试验电平(IEC 60601试验电平)代表在常规医疗使用环境下的环境条件范围。因此，期望医用电气设备和医用电气系统的性能在此条件下是正常的。
医用电气设备和医用电气系统用于医疗实践是因为它们能提供所需的功能。如果医用电气设备或一个医用电气系统对在正常使用环境中的预期干扰因缺乏抗扰度而不能提供所需的功能.那么这种对医疗实践的干扰不能视为可接受的情况。
本部分认为，为确保医用电气设备和医用电气系统按预期设计和运行，制造商、责任方和操作者要共担责任。医用电气设备或医用电气系统制造商的职责是以符合本部分的要求进行设计和制造，并对责任方或操作者公开信息，以便维持一个可兼容的电磁环境使医用电气设备或医用电气系统能按预期运行。
由于医学实践涉及许多专业，必然会有医用电气设备和医用电气系统被设计用来运行各种功能。有一些功能，例如：患者的微弱信号测量，该微弱信号电平与本部分所规定的电磁抗扰度试验中耦合到医用电气设备和医用电气系统的电磁噪声电平相比是很低的。由于许多这样的医用电气设备和医用电气系统的医疗受益已被证明，所以如能提供基于物理方面、技术方面或生理方面限制的充分理由，本部分允许降低抗扰度试验电平。在此情况下，要求制造商公开医用电气设备或医用电气系统满足本部分性能要求的电平，并规定使用环境的电磁特性和如何建立这样的环境，以使医用电气设备或医用电气系统按预期运行。
本部分也认为某些环境可能需要更高的抗扰度电平。确定如何识别可能需要更高抗扰度电平的环境以及宜采用多高的电平的研究，正在进行中。
最后，本部分认为对于生命支持医用电气设备和生命支持医用电气系统，为了建立更宽的安全裕量，即使在常规医疗使用环境下使用，也需要有更高的抗扰度电平。因此，本部分对生命支持医用电气设备和医用电气系统规定了附加要求。
本部分以IEC／SC 62A、IEC／TC 77(包括网络在内的电气设备之间的电磁兼容性)和CISPR(国际无线电干扰特别委员会)制订的现行IEC标准为基础。
本部分规定的电磁兼容性要求通常适用于通用标准3.63和3.64中定义的医用电气设备和医用电气系统。对于某些类型的医用电气设备和医用电气系统，这些要求可能需要按照专用标准的特殊要求加以修改。鼓励专用标准的编写者在应用本部分时参照附录E的指南。
医用电气设备第1-2部分：
基本安全和基本性能的通用要求
并列标准：电磁兼容 要求和试验
1 范围、目的和相关标准
1.1 *范围
本部分适用于医用电气设备和医用电气系统(以下分别称ME设备和ME系统)的基本安全和基本性能。
本部分适用于ME设备和ME系统的电磁兼容性。
注：本部分中带星号(*)的章和条在附录A中有相关说明。
1.2 目的
本部分规定了ME设备和ME系统电磁兼容性的通用要求和试验。这些通用要求和试验除了是通用标准的要求，还作为专用标准的基础。
1.3 相关标准
1.3.1 GB 9706.1
对于ME设备和ME系统，本部分是GB 9706.1的补充。
当参照GB 9706.1或本部分时，无论是单独参照还是组合参照，使用下列约定：
——“通用标准”仅指GB 9706.1；
——“本部分”仅指YY 9706.102；
——“本标准”指通用标准和本部分的组合。
1.3.2 专用标准
专用标准的要求优先于本部分的相应要求。
2 规范性引用文件
下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件，仅注日期的版本适用于本文件。凡是不注日期的引用文件，其最新版本(包括所有的修改单)适用于本文件。
GB 4343.1 家用电器、电动工具和类似器具的电磁兼容要求 第1部分：发射(GB 4343.1—2018，CISPR 14-1：2011，IDT)
GB 4824工业、科学和医疗(ISM)射频设备 骚扰特性 限值和测量方法(GB 4824—2013，CISPR 11：2010，IDT)
GB／T 5465.2—2008 电气设备用图形符号 第2部分：图形符号(IEC 60417 DB：2007，IDT)
GB／T 6113.102 无线电骚扰和抗扰度测量设备和测量方法规范 第1-2部分：无线电骚扰和抗扰度测量设备 传导骚扰测量的耦合装置(GB／T 6113.102—2018，CISPR 16-1-2：2014，IDT)
GB／T 9254 信息技术设备的无线电骚扰限值和测量方法(GB／T 9254—2008，CISPR 22：2006，IDT)
GB 9706.1—2020 医用电气设备 第1部分：基本安全和基本性能的通用要求(IEC 60601-1；2012，MOD)
GB 17625.1 电磁兼容 限值 谐波电流发射限值(设备每相输入电流≤16A)(GB 17625.1—2012，IEC 61000-3-2：2009，IDT)
GB／T 17625.2 电磁兼容 限值 对每相额定电流≤16A且无条件接入的设备在公用低压供电系统中产生的电压变化、电压波动和闪烁的限制(GB／T 17625.2—2007，IEC 61000-3-3：2005，IDT)
GB／T 17626.2 电磁兼容 试验和测量技术 静电放电抗扰 度试验(GB／T 17626.2—2018，1EC 61000-4-2：2008，1DT)
GB／T 17626.3 电磁兼容 试验和测量技术 射频电磁场辐射抗扰度试验(GB／T17626.3—2016，IEC 61000-4-3：2010，IDT)
GB／T 17626.4—2018 电磁兼容 试验和测量技术 电快速瞬变脉冲群抗扰度试验(IEC61000-4-4：2012，IDT)
GB／T 17626.5 电磁兼容 试验和测量技术 浪涌(冲击)抗扰度试验(GB／T 17626.5—2008，IEC 61000-4-5：2014，IDT)
GB／T 17626.6—2017 电磁兼容 试验和测量技术 射频场感应的传导骚扰抗扰度(IEC61000-4-6：2013，IDT)
GB／T 17626.8 电磁兼容 试验和测量技术 工频磁场抗扰度试验(GB／T 17626.8—2006，IEC 61000-4-8：2001，IDT)
GB／T 17626.11 电磁兼容 试验和测量技术 电压暂降、短时中断和电压变化的抗扰度试验(GB／T 17626.11—2008，IEC 61000-4-11：2004，IDT)
GB／T 17743 电气照明和类似设备的无线电骚扰特性的限值和测量方法(GB／T 17743—2017，CISPR 15：2015，IDT)
YY 9706.108—2021 医用电气设备 第1-8部分：基本安全和基本性能的通用要求 并列标准：通用要求，医用电气设备和医用电气系统中报警系统的测试和指南(IEC 60601-1-8：2012，MOD)
3 术语和定义
GB 9706.1—2020和YY 9706.108—2021界定的以及下列术语和定义适用于本文件。
注1：除非另有说明，本部分中使用的术语“电压”和“电流”是指交直流或复合电压或电流的均方根值。
注2：术语“电气设备”是指ME设备或其他电气设备。本部分也使用术语“设备”来指代ME系统中的ME设备、其他电气设备或非电气设备。
3.1
(抗扰度)符合电平 (immunity) compliance level
小于或等于ME设备或ME系统满足6.2相应条款要求时的抗扰度电平。
注：符合电平的附加要求在5.2.2中有规定。
3.2
*(性能)降低 degradation(of performance)
ME设备或ME系统的工作性能非期望地偏离它的预期性能。
注1：术语“降低”可用于暂时失效和永久失效。
注2：改写GB／T 4365—2003，定义161-01-19。
3.3
*有效辐射功率 effective radiated power；ERP
在给定方向的任一规定距离上，为产生与给定装置相同的辐射功率通量密度而需要在无损耗参考天线输入端施加的功率。
注1：在ITU和IEV的712章中使用的术语“有效辐射功率”，仅当参考天线是半波偶极子时才不受条件限制。
注2：改写GB／T 4365—2003，定义 161-04-16。
3.4
*电磁兼容性 electromagnetic compatibility；EMC
ME设备或ME系统在其电磁环境中能符合要求运行且不对该环境中任何事物构成不能承受的电磁骚扰的能力。
注：改写GB／T 4365—2003，定义161-01-07。
3.5
*电磁骚扰 electromagnetic disturbance
任何可能引起装置、设备或系统性能降低的电磁现象。
注1：电磁骚扰可能是电磁噪声、无用信号或传播媒介自身的变化。
注2：改写GB／T 4365—2003，定义161-01-05。
3.6
(电磁)发射 (electromagnetic) emission
从源向外发出电磁能的现象。
[GB／T 4365—2003，定义161-01-08]
3.7
电磁环境 electromagnetic environment
存在于给定场所的所有电磁现象的总和。
注：通常，电磁环境是与时间相关的，对它的描述可能需要用统计的方法。
[GB／T 4365—2003，定 义161-01-01]
3.8
电磁噪声 electromagnetic noise
一种明显不传送信息的时变电磁现象，它可能与有用信号叠加或组合。
[GB／T 4365—2003，定 义161-01-02]
3.9
静电放电 electrostatic discharge
具有不同静电电位的物体相互靠近或直接接触引起的电荷转移。
[GB／T 4365—2003，定义 161-01-22]
3.10
*占用频带 exclusion band
预期用于接收射频电磯能的接收机频带。当接收频率大于或等于80MHz时，接收频率或频带可从－5％延伸到＋5％；当接收频率小于80MHz时，接收频率或频带可从－10％延伸到＋10％。
注：在国家无线电法规中，有时该术语的其他定义被用作其他目的。
3.11
*功能 function
ME设备或ME系统预期对患者进行诊断、治疗或监护的临床主要作用或对疾病、伤害或残疾进行补偿或缓解的临床主要作用。
3.12
IEC 60601 试验电平IEC 60601 test level
本部分中6.2或专用标准中规定的抗扰度试验电平。
3.13
*(对骚扰的)抗扰度 immunity( to a disturbance)
存在电磁骚扰的情况下，ME设备或ME系统不降低运行性能的能力。
注：改写GB／T 4365—2003，定义161-01-20。
3.14
抗扰度电平 immunity level
将某给定电磁骚扰施加于某一装置、设备或系统而其仍能正常工作并保持所需性能等级时的最大骚扰电平。
[GB／T 4365—2003，定义161-03-14]
3.15
抗扰度试验电平 immunity test level
进行抗扰度试验时，用来模拟电磁骚扰试验信号的电平。
[GB／T 4365—2003，定义161-04-41]
3.16
信息技术设备 information technology equipment；ITE
用于以下目的设备：
a) 接收来自外部源的数据(例如通过键盘或数据输入线)；
b) 对接收到的数据进行某些处理(如计算、数据转换、记录、建档、分类、存贮和传送)；
c) 提供数据输出(或送至另一设备或再现数据或图像)。
注：这个定义包括那些主要产生各种周期性二进制电气或电子脉冲波形，并实现数据处理功能的单元或系统：诸如文字处理、电子计算、数据的转换、记录、建档、分类、存贮、恢复及传递，以及用图像再现数据等。
[GB／T 4365—2003，定义161-05-04]
3.17
*大型ME设备或ME系统 large ME equipment or ME system
不能在2m×2m×2.5m的空间内安装的ME设备或ME系统，其中不包括电缆，但包括分布式ME系统。
3.18
*生命支持ME设备或ME系统 life-supporting ME equipment or ME system
至少包括一种预期有效地维持患者生命或复苏功能的ME设备或ME系统，且一旦该功能不能满足6.2.1.10要求就很可能导致患者严重的伤害或死亡。
3.19
*低电压 low voltage
相线与相线或相线与中线之间小于或等于交流10000V或直流1500V的电压。
3.20
*工作频率 operating frequency
在ME设备或ME系统中设定用来控制某种生理参数的电信号或非电信号的基频。
3.21
*与患者耦合的ME设备或ME系统 patient-coupled ME equipment or ME system
无论是传导耦合还是电容耦合或电感耦合，至少含有一个应用部分的ME设备或ME系统，通过与患者的接触以提供ME设备或ME系统正常运行所需要的感知或治疗点，并提供一个预期或非预期的电磁能路径。
3.22
*生理模拟频率 physiological simulation frequency
用于模拟生理参数的电信号或非电信号的基频，使得ME设备或ME系统以一种与用于患者时相一致的方式运行。
3.23
*专用ME设备或ME系统 professional ME equipment or ME system
由专业医护人员使用且预期不向公众出售的ME设备或ME系统。
注：改写GB／T 4365—2003，定义161-05-05。
3.24
*公共电网 public mains network
所有各类用户可以接入的低电压电力线路。
3.25
*射频 radio frequency；RF
位于音频和红外频谱之间的电磁频谱中，用于无线电信号传播的频率。
注：通常采用的范围是9kHz～3000GHz。
3.26
A型专用ME设备或ME系统 type A professional ME equipment or ME system
专用ME设备或ME系统符合GB 48242组B类(除基频的第三次谐波)，而第三次谐波符合2组A类电磁辐射骚扰限值的ME设备或ME系统。
注：见6.1.1.1 f)。
4 通用要求
4.1 ME设备和ME系统的电磁兼容性通用要求
4.1.1 *电磁兼容性
ME设备和ME系统不应发射影响无线电业务、其他设备或其他ME设备和ME系统基本性能的电磁骚扰。存在电磁骚扰的情况下，ME设备和ME系统应具有足够的抗扰度，以能够提供其基本安全和基本性能。
如果满足本部分的要求，即认为符合要求。
4.1.2 非医用电气设备
作为ME系统的一部分的非医用电气设备.如果满足以下所有条件，可免于本部分要求的电磁兼容性试验(参见附录G)：
a) 非医用电气设备符合适用的国家或国际电磁兼容性标准；
b) 判定非医用电气设备的发射和抗扰度不会对ME系统的基本安全和基本性能产生不利的影响；
c) 判定非医用电气设备不会导致ME系统的发射超过适用的限值。
通过检查判定文件和其他相应的文件或证书来检验符合性。如果未经判定，则通过检查能证实此非医用电气设备已根据本部分规定进行试验的文件来检验符合性。
4.2 *ME设备的单一故障状态
对电磁兼容性试验，通用标准的单一故障状态要求不适用。
5 标识、标记和文件
5.1 ME设备或ME设备部件的外部标记
5.1.1 *包含射频发射器或利用射频电磁能诊断或治疗的ME设备或ME设备部件的外部标记包含射频发射器的ME设备和ME系统或要利用射频电磁能诊断或治疗的ME设备和ME系统，应标记GB／T 5465.2—2008中的5140的非电离辐射符号。该符号图形如下所示。
5.1.2 使用6.2.2.2c)中规定的免予试验的连接器的ME设备或ME设备部件的外部标记
对于ME设备和ME系统.如果使用6.2.2.2c)中规定的免予试验的连接器，则应在每个免予试验的连接器附近标记GB／T 5465.2—2008中的5134的静电放电敏感性符号。该符号图形如下所示。
5.1.3 规定仅用于屏蔽场所的ME设备和ME系统的外部标记
规定仅用于屏蔽场所的ME设备和ME系统，应标记警示标识，以告示其仅用于指定类型的屏蔽场所(见5.2.2.3)。
通过检查5.1的要求来检验是否符合要求。
5.2 随附文件
5.2.1 使用说明书
5.2.1.1 适用于所有ME设备和ME系统的要求
使用说明书应包括下列信息：
a) 医用电气设备需要有关于电磁兼容性特别预防措施以及根据随附文件提供的电磁兼容性信息进行安装和使用的声明；
b) 便携式和移动式射频通信设备可能影响医用电气设备的声明。
5.2.1.2 适用于使用6.2.2.2c)中规定免予试验的连接器的ME设备和ME系统的要求
对于使用6.2.2.2c)中规定的免予试验的连接器的ME设备和ME系统.使用说明书应包括下列信息：
a) 静电放电警示符号(如5.1.2图形符号所示)；
b) 警示：请勿接触标有静电放电警示符号的连接器的插针，请勿在没有使用静电放电预防措施的情况下连接这些连接器；
c) *有关静电放电预防措施的规定；
d) *建议对各有关员工进行静电放电警示符号的解释和静电放电预防措施的培训；
e) *有关静电放电预防措施培训基本内容的规定。
5.2.1.3 患者生理信号的最小幅值或最小值
对于没有手动灵敏度调节和制造商规定了患者生理信号最小幅值或最小值的ME设备和ME系统(见6.2.1.7第一个破折号)，使用说明书应包括下列信息：
a) 患者生理信 号的最小幅值或最小值；
b) 警示：ME设备或ME系统以低于上述规定的最小幅值或最小值运行可能导致不准确结果。
5.2.1.4 *适用于A型专用ME设备和ME系统的要求
如果A型专用ME设备或A型专用ME系统预期在家用设施中使用或连接到公共电网[见6.1.1.1f]，使用说明书还应包括以下警示或等同说明：
警示：本设备／系统预期仅由专业医护人员使用。本设备／系统可能导致无线电干扰或扰乱附近设备的运行。可能有必要采取减缓措施，比如重新调整[ME设备或ME系统]的方向、位置或屏蔽相应场地。
“[ME设备或ME系统]”应由ME设备或ME系统的型号或类型参考号代替。
通过检查使用说明书来检验是否符合5.2.1的要求。
5.2.2 技术说明书
5.2.2.1 适用于所有ME设备和ME系统的要求
对于所有ME设备和ME系统，随附文件应包括下列信息：
a) *列出ME设备或ME系统的制造商声明符合6.1和6.2要求的所有电缆、电缆的最大长度(若适用)、换能器及其他附件。不影响符合这些条款要求的附件不需列出。既可对附件、换能器和电缆作一般的规定(如屏蔽串行电缆、负载阻抗)，也可对它们作特殊的规定(如制造商、型号或部件号)。
注：由ME设备或ME系统的制造商作为内部部件的备件出售的换能器和电缆不必列出。
b) *警示：除ME设备或ME系统的制造商作为内部部件的备件出售的换能器和电缆外，使用规定外的附件、换能器和电缆可能导致ME设备或ME系统发射的增加或抗扰度的降低。
c) *按下列规定顺序完成表1，参见附录C的例子。图1中的流程是对GB 4824 ME设备和ME系统逐项填写表1的图表式要求，图2中的流程是对GB 4343和GB／T 17743设备逐项填写表1的图表式要求。
——对于GB 4824 ME设备和ME系统，“[ME设备或ME系统]”应由ME设备或ME系统的型号或类型参考号代替。
