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
中華人民共和國醫藥行業標準
YY 9706.102—2021
代替YY 0505—2012
醫用電氣設備 第1-2部分：基本安全和基本性能的通用要求 并列標準：電磁兼容 要求和試驗
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發布 2023-05-01實施
國家藥品監督管理局 發布
引言
醫用電氣設備和醫用電氣系統建立具體的專門的電磁兼容性標準的需求已成為人們普遍的共識。
尤其是電磁發射標準，對保護安全業務、其他醫用電氣設備和醫用電氣系統、非醫用電氣設備(如計算機)和無線電通信(如無線電廣播／電視、電話、無線電導航)是至關重要的。
更為重要的是，電磁抗擾度標準對確保醫用電氣設備和醫用電氣系統的安全是必不可少的。電磁兼容性(見3.4)不同于GB 9706.1所覆蓋的其他安全方面，這是因為所有的醫用電氣設備和醫用電氣系統在正常使用的環境里存在著不同嚴酷程度的電磁現象，并且按照定義，為實現電磁兼容性，設備在其預期環境中一定要“符合要求運行”。這意味著傳統的與安全有關的單— 故障概念不適用于電磁兼容性標準。電磁騷擾環境可類比于環境溫度、濕度和大氣壓力。醫用電氣設備和醫用電氣系統可能在產品合格周期內的任何時間經受預期范圍內的環境條件。如同大氣壓力和濕度，醫用電氣設備或醫用電氣系統的操作者可能一直不會意識到環境電平。本部分規定的抗擾度試驗電平(IEC 60601試驗電平)代表在常規醫療使用環境下的環境條件范圍。因此，期望醫用電氣設備和醫用電氣系統的性能在此條件下是正常的。
醫用電氣設備和醫用電氣系統用于醫療實踐是因為它們能提供所需的功能。如果醫用電氣設備或一個醫用電氣系統對在正常使用環境中的預期干擾因缺乏抗擾度而不能提供所需的功能.那么這種對醫療實踐的干擾不能視為可接受的情況。
本部分認為，為確保醫用電氣設備和醫用電氣系統按預期設計和運行，制造商、責任方和操作者要共擔責任。醫用電氣設備或醫用電氣系統制造商的職責是以符合本部分的要求進行設計和制造，并對責任方或操作者公開信息，以便維持一個可兼容的電磁環境使醫用電氣設備或醫用電氣系統能按預期運行。
由于醫學實踐涉及許多專業，必然會有醫用電氣設備和醫用電氣系統被設計用來運行各種功能。有一些功能，例如：患者的微弱信號測量，該微弱信號電平與本部分所規定的電磁抗擾度試驗中耦合到醫用電氣設備和醫用電氣系統的電磁噪聲電平相比是很低的。由于許多這樣的醫用電氣設備和醫用電氣系統的醫療受益已被證明，所以如能提供基于物理方面、技術方面或生理方面限制的充分理由，本部分允許降低抗擾度試驗電平。在此情況下，要求制造商公開醫用電氣設備或醫用電氣系統滿足本部分性能要求的電平，并規定使用環境的電磁特性和如何建立這樣的環境，以使醫用電氣設備或醫用電氣系統按預期運行。
本部分也認為某些環境可能需要更高的抗擾度電平。確定如何識別可能需要更高抗擾度電平的環境以及宜采用多高的電平的研究，正在進行中。
最后，本部分認為對于生命支持醫用電氣設備和生命支持醫用電氣系統，為了建立更寬的安全裕量，即使在常規醫療使用環境下使用，也需要有更高的抗擾度電平。因此，本部分對生命支持醫用電氣設備和醫用電氣系統規定了附加要求。
本部分以IEC／SC 62A、IEC／TC 77(包括網絡在內的電氣設備之間的電磁兼容性)和CISPR(國際無線電干擾特別委員會)制訂的現行IEC標準為基礎。
本部分規定的電磁兼容性要求通常適用于通用標準3.63和3.64中定義的醫用電氣設備和醫用電氣系統。對于某些類型的醫用電氣設備和醫用電氣系統，這些要求可能需要按照專用標準的特殊要求加以修改。鼓勵專用標準的編寫者在應用本部分時參照附錄E的指南。
醫用電氣設備第1-2部分：
基本安全和基本性能的通用要求
并列標準：電磁兼容 要求和試驗
1 范圍、目的和相關標準
1.1 *范圍
本部分適用于醫用電氣設備和醫用電氣系統(以下分別稱ME設備和ME系統)的基本安全和基本性能。
本部分適用于ME設備和ME系統的電磁兼容性。
注：本部分中帶星號(*)的章和條在附錄A中有相關說明。
1.2 目的
本部分規定了ME設備和ME系統電磁兼容性的通用要求和試驗。這些通用要求和試驗除了是通用標準的要求，還作為專用標準的基礎。
1.3 相關標準
1.3.1 GB 9706.1
對于ME設備和ME系統，本部分是GB 9706.1的補充。
當參照GB 9706.1或本部分時，無論是單獨參照還是組合參照，使用下列約定：
——“通用標準”僅指GB 9706.1；
——“本部分”僅指YY 9706.102；
——“本標準”指通用標準和本部分的組合。
1.3.2 專用標準
專用標準的要求優先于本部分的相應要求。
2 規范性引用文件
下列文件對于本文件的應用是必不可少的。凡是注日期的引用文件，僅注日期的版本適用于本文件。凡是不注日期的引用文件，其最新版本(包括所有的修改單)適用于本文件。
GB 4343.1 家用電器、電動工具和類似器具的電磁兼容要求 第1部分：發射(GB 4343.1—2018，CISPR 14-1：2011，IDT)
GB 4824工業、科學和醫療(ISM)射頻設備 騷擾特性 限值和測量方法(GB 4824—2013，CISPR 11：2010，IDT)
GB／T 5465.2—2008 電氣設備用圖形符號 第2部分：圖形符號(IEC 60417 DB：2007，IDT)
GB／T 6113.102 無線電騷擾和抗擾度測量設備和測量方法規范 第1-2部分：無線電騷擾和抗擾度測量設備 傳導騷擾測量的耦合裝置(GB／T 6113.102—2018，CISPR 16-1-2：2014，IDT)
GB／T 9254 信息技術設備的無線電騷擾限值和測量方法(GB／T 9254—2008，CISPR 22：2006，IDT)
GB 9706.1—2020 醫用電氣設備 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 電磁兼容 限值 諧波電流發射限值(設備每相輸入電流≤16A)(GB 17625.1—2012，IEC 61000-3-2：2009，IDT)
GB／T 17625.2 電磁兼容 限值 對每相額定電流≤16A且無條件接入的設備在公用低壓供電系統中產生的電壓變化、電壓波動和閃爍的限制(GB／T 17625.2—2007，IEC 61000-3-3：2005，IDT)
GB／T 17626.2 電磁兼容 試驗和測量技術 靜電放電抗擾 度試驗(GB／T 17626.2—2018，1EC 61000-4-2：2008，1DT)
GB／T 17626.3 電磁兼容 試驗和測量技術 射頻電磁場輻射抗擾度試驗(GB／T17626.3—2016，IEC 61000-4-3：2010，IDT)
GB／T 17626.4—2018 電磁兼容 試驗和測量技術 電快速瞬變脈沖群抗擾度試驗(IEC61000-4-4：2012，IDT)
GB／T 17626.5 電磁兼容 試驗和測量技術 浪涌(沖擊)抗擾度試驗(GB／T 17626.5—2008，IEC 61000-4-5：2014，IDT)
GB／T 17626.6—2017 電磁兼容 試驗和測量技術 射頻場感應的傳導騷擾抗擾度(IEC61000-4-6：2013，IDT)
GB／T 17626.8 電磁兼容 試驗和測量技術 工頻磁場抗擾度試驗(GB／T 17626.8—2006，IEC 61000-4-8：2001，IDT)
GB／T 17626.11 電磁兼容 試驗和測量技術 電壓暫降、短時中斷和電壓變化的抗擾度試驗(GB／T 17626.11—2008，IEC 61000-4-11：2004，IDT)
GB／T 17743 電氣照明和類似設備的無線電騷擾特性的限值和測量方法(GB／T 17743—2017，CISPR 15：2015，IDT)
YY 9706.108—2021 醫用電氣設備 第1-8部分：基本安全和基本性能的通用要求 并列標準：通用要求，醫用電氣設備和醫用電氣系統中報警系統的測試和指南(IEC 60601-1-8：2012，MOD)
3 術語和定義
GB 9706.1—2020和YY 9706.108—2021界定的以及下列術語和定義適用于本文件。
注1：除非另有說明，本部分中使用的術語“電壓”和“電流”是指交直流或復合電壓或電流的均方根值。
注2：術語“電氣設備”是指ME設備或其他電氣設備。本部分也使用術語“設備”來指代ME系統中的ME設備、其他電氣設備或非電氣設備。
3.1
(抗擾度)符合電平 (immunity) compliance level
小于或等于ME設備或ME系統滿足6.2相應條款要求時的抗擾度電平。
注：符合電平的附加要求在5.2.2中有規定。
3.2
*(性能)降低 degradation(of performance)
ME設備或ME系統的工作性能非期望地偏離它的預期性能。
注1：術語“降低”可用于暫時失效和永久失效。
注2：改寫GB／T 4365—2003，定義161-01-19。
3.3
*有效輻射功率 effective radiated power；ERP
在給定方向的任一規定距離上，為產生與給定裝置相同的輻射功率通量密度而需要在無損耗參考天線輸入端施加的功率。
注1：在ITU和IEV的712章中使用的術語“有效輻射功率”，僅當參考天線是半波偶極子時才不受條件限制。
注2：改寫GB／T 4365—2003，定義 161-04-16。
3.4
*電磁兼容性 electromagnetic compatibility；EMC
ME設備或ME系統在其電磁環境中能符合要求運行且不對該環境中任何事物構成不能承受的電磁騷擾的能力。
注：改寫GB／T 4365—2003，定義161-01-07。
3.5
*電磁騷擾 electromagnetic disturbance
任何可能引起裝置、設備或系統性能降低的電磁現象。
注1：電磁騷擾可能是電磁噪聲、無用信號或傳播媒介自身的變化。
注2：改寫GB／T 4365—2003，定義161-01-05。
3.6
(電磁)發射 (electromagnetic) emission
從源向外發出電磁能的現象。
[GB／T 4365—2003，定義161-01-08]
3.7
電磁環境 electromagnetic environment
存在于給定場所的所有電磁現象的總和。
注：通常，電磁環境是與時間相關的，對它的描述可能需要用統計的方法。
[GB／T 4365—2003，定 義161-01-01]
3.8
電磁噪聲 electromagnetic noise
一種明顯不傳送信息的時變電磁現象，它可能與有用信號疊加或組合。
[GB／T 4365—2003，定 義161-01-02]
3.9
靜電放電 electrostatic discharge
具有不同靜電電位的物體相互靠近或直接接觸引起的電荷轉移。
[GB／T 4365—2003，定義 161-01-22]
3.10
*占用頻帶 exclusion band
預期用于接收射頻電磯能的接收機頻帶。當接收頻率大于或等于80MHz時，接收頻率或頻帶可從－5％延伸到＋5％；當接收頻率小于80MHz時，接收頻率或頻帶可從－10％延伸到＋10％。
注：在國家無線電法規中，有時該術語的其他定義被用作其他目的。
3.11
*功能 function
ME設備或ME系統預期對患者進行診斷、治療或監護的臨床主要作用或對疾病、傷害或殘疾進行補償或緩解的臨床主要作用。
3.12
IEC 60601 試驗電平IEC 60601 test level
本部分中6.2或專用標準中規定的抗擾度試驗電平。
3.13
*(對騷擾的)抗擾度 immunity( to a disturbance)
存在電磁騷擾的情況下，ME設備或ME系統不降低運行性能的能力。
注：改寫GB／T 4365—2003，定義161-01-20。
3.14
抗擾度電平 immunity level
將某給定電磁騷擾施加于某一裝置、設備或系統而其仍能正常工作并保持所需性能等級時的最大騷擾電平。
[GB／T 4365—2003，定義161-03-14]
3.15
抗擾度試驗電平 immunity test level
進行抗擾度試驗時，用來模擬電磁騷擾試驗信號的電平。
[GB／T 4365—2003，定義161-04-41]
3.16
信息技術設備 information technology equipment；ITE
用于以下目的設備：
a) 接收來自外部源的數據(例如通過鍵盤或數據輸入線)；
b) 對接收到的數據進行某些處理(如計算、數據轉換、記錄、建檔、分類、存貯和傳送)；
c) 提供數據輸出(或送至另一設備或再現數據或圖像)。
注：這個定義包括那些主要產生各種周期性二進制電氣或電子脈沖波形，并實現數據處理功能的單元或系統：諸如文字處理、電子計算、數據的轉換、記錄、建檔、分類、存貯、恢復及傳遞，以及用圖像再現數據等。
[GB／T 4365—2003，定義161-05-04]
3.17
*大型ME設備或ME系統 large ME equipment or ME system
不能在2m×2m×2.5m的空間內安裝的ME設備或ME系統，其中不包括電纜，但包括分布式ME系統。
3.18
*生命支持ME設備或ME系統 life-supporting ME equipment or ME system
至少包括一種預期有效地維持患者生命或復蘇功能的ME設備或ME系統，且一旦該功能不能滿足6.2.1.10要求就很可能導致患者嚴重的傷害或死亡。
3.19
*低電壓 low voltage
相線與相線或相線與中線之間小于或等于交流10000V或直流1500V的電壓。
3.20
*工作頻率 operating frequency
在ME設備或ME系統中設定用來控制某種生理參數的電信號或非電信號的基頻。
3.21
*與患者耦合的ME設備或ME系統 patient-coupled ME equipment or ME system
無論是傳導耦合還是電容耦合或電感耦合，至少含有一個應用部分的ME設備或ME系統，通過與患者的接觸以提供ME設備或ME系統正常運行所需要的感知或治療點，并提供一個預期或非預期的電磁能路徑。
3.22
*生理模擬頻率 physiological simulation frequency
用于模擬生理參數的電信號或非電信號的基頻，使得ME設備或ME系統以一種與用于患者時相一致的方式運行。
3.23
*專用ME設備或ME系統 professional ME equipment or ME system
由專業醫護人員使用且預期不向公眾出售的ME設備或ME系統。
注：改寫GB／T 4365—2003，定義161-05-05。
3.24
*公共電網 public mains network
所有各類用戶可以接入的低電壓電力線路。
3.25
*射頻 radio frequency；RF
位于音頻和紅外頻譜之間的電磁頻譜中，用于無線電信號傳播的頻率。
注：通常采用的范圍是9kHz～3000GHz。
3.26
A型專用ME設備或ME系統 type A professional ME equipment or ME system
專用ME設備或ME系統符合GB 48242組B類(除基頻的第三次諧波)，而第三次諧波符合2組A類電磁輻射騷擾限值的ME設備或ME系統。
注：見6.1.1.1 f)。
4 通用要求
4.1 ME設備和ME系統的電磁兼容性通用要求
4.1.1 *電磁兼容性
ME設備和ME系統不應發射影響無線電業務、其他設備或其他ME設備和ME系統基本性能的電磁騷擾。存在電磁騷擾的情況下，ME設備和ME系統應具有足夠的抗擾度，以能夠提供其基本安全和基本性能。
如果滿足本部分的要求，即認為符合要求。
4.1.2 非醫用電氣設備
作為ME系統的一部分的非醫用電氣設備.如果滿足以下所有條件，可免于本部分要求的電磁兼容性試驗(參見附錄G)：
a) 非醫用電氣設備符合適用的國家或國際電磁兼容性標準；
b) 判定非醫用電氣設備的發射和抗擾度不會對ME系統的基本安全和基本性能產生不利的影響；
c) 判定非醫用電氣設備不會導致ME系統的發射超過適用的限值。
通過檢查判定文件和其他相應的文件或證書來檢驗符合性。如果未經判定，則通過檢查能證實此非醫用電氣設備已根據本部分規定進行試驗的文件來檢驗符合性。
4.2 *ME設備的單一故障狀態
對電磁兼容性試驗，通用標準的單一故障狀態要求不適用。
5 標識、標記和文件
5.1 ME設備或ME設備部件的外部標記
5.1.1 *包含射頻發射器或利用射頻電磁能診斷或治療的ME設備或ME設備部件的外部標記包含射頻發射器的ME設備和ME系統或要利用射頻電磁能診斷或治療的ME設備和ME系統，應標記GB／T 5465.2—2008中的5140的非電離輻射符號。該符號圖形如下所示。
5.1.2 使用6.2.2.2c)中規定的免予試驗的連接器的ME設備或ME設備部件的外部標記
對于ME設備和ME系統.如果使用6.2.2.2c)中規定的免予試驗的連接器，則應在每個免予試驗的連接器附近標記GB／T 5465.2—2008中的5134的靜電放電敏感性符號。該符號圖形如下所示。
5.1.3 規定僅用于屏蔽場所的ME設備和ME系統的外部標記
規定僅用于屏蔽場所的ME設備和ME系統，應標記警示標識，以告示其僅用于指定類型的屏蔽場所(見5.2.2.3)。
通過檢查5.1的要求來檢驗是否符合要求。
5.2 隨附文件
5.2.1 使用說明書
5.2.1.1 適用于所有ME設備和ME系統的要求
使用說明書應包括下列信息：
a) 醫用電氣設備需要有關于電磁兼容性特別預防措施以及根據隨附文件提供的電磁兼容性信息進行安裝和使用的聲明；
b) 便攜式和移動式射頻通信設備可能影響醫用電氣設備的聲明。
5.2.1.2 適用于使用6.2.2.2c)中規定免予試驗的連接器的ME設備和ME系統的要求
對于使用6.2.2.2c)中規定的免予試驗的連接器的ME設備和ME系統.使用說明書應包括下列信息：
a) 靜電放電警示符號(如5.1.2圖形符號所示)；
b) 警示：請勿接觸標有靜電放電警示符號的連接器的插針，請勿在沒有使用靜電放電預防措施的情況下連接這些連接器；
c) *有關靜電放電預防措施的規定；
d) *建議對各有關員工進行靜電放電警示符號的解釋和靜電放電預防措施的培訓；
e) *有關靜電放電預防措施培訓基本內容的規定。
5.2.1.3 患者生理信號的最小幅值或最小值
對于沒有手動靈敏度調節和制造商規定了患者生理信號最小幅值或最小值的ME設備和ME系統(見6.2.1.7第一個破折號)，使用說明書應包括下列信息：
a) 患者生理信 號的最小幅值或最小值；
b) 警示：ME設備或ME系統以低于上述規定的最小幅值或最小值運行可能導致不準確結果。
5.2.1.4 *適用于A型專用ME設備和ME系統的要求
如果A型專用ME設備或A型專用ME系統預期在家用設施中使用或連接到公共電網[見6.1.1.1f]，使用說明書還應包括以下警示或等同說明：
警示：本設備／系統預期僅由專業醫護人員使用。本設備／系統可能導致無線電干擾或擾亂附近設備的運行。可能有必要采取減緩措施，比如重新調整[ME設備或ME系統]的方向、位置或屏蔽相應場地。
“[ME設備或ME系統]”應由ME設備或ME系統的型號或類型參考號代替。
通過檢查使用說明書來檢驗是否符合5.2.1的要求。
5.2.2 技術說明書
5.2.2.1 適用于所有ME設備和ME系統的要求
對于所有ME設備和ME系統，隨附文件應包括下列信息：
a) *列出ME設備或ME系統的制造商聲明符合6.1和6.2要求的所有電纜、電纜的最大長度(若適用)、換能器及其他附件。不影響符合這些條款要求的附件不需列出。既可對附件、換能器和電纜作一般的規定(如屏蔽串行電纜、負載阻抗)，也可對它們作特殊的規定(如制造商、型號或部件號)。
注：由ME設備或ME系統的制造商作為內部部件的備件出售的換能器和電纜不必列出。
b) *警示：除ME設備或ME系統的制造商作為內部部件的備件出售的換能器和電纜外，使用規定外的附件、換能器和電纜可能導致ME設備或ME系統發射的增加或抗擾度的降低。
c) *按下列規定順序完成表1，參見附錄C的例子。圖1中的流程是對GB 4824 ME設備和ME系統逐項填寫表1的圖表式要求，圖2中的流程是對GB 4343和GB／T 17743設備逐項填寫表1的圖表式要求。
——對于GB 4824 ME設備和ME系統，“[ME設備或ME系統]”應由ME設備或ME系統的型號或類型參考號代替。
