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(yī)藥行業(yè)標(biāo)準(zhǔn)
YY 9706.102—2021
代替YY 0505—2012
醫(yī)用電氣設(shè)備 第1-2部分：基本安全和基本性能的通用要求 并列標(biāo)準(zhǔn)：電磁兼容 要求和試驗(yàn)
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(fā)布 2023-05-01實(shí)施
國家藥品監(jiān)督管理局 發(fā)布
引言
醫(yī)用電氣設(shè)備和醫(yī)用電氣系統(tǒng)建立具體的專門的電磁兼容性標(biāo)準(zhǔn)的需求已成為人們普遍的共識。
尤其是電磁發(fā)射標(biāo)準(zhǔn)，對保護(hù)安全業(yè)務(wù)、其他醫(yī)用電氣設(shè)備和醫(yī)用電氣系統(tǒng)、非醫(yī)用電氣設(shè)備(如計(jì)算機(jī))和無線電通信(如無線電廣播／電視、電話、無線電導(dǎo)航)是至關(guān)重要的。
更為重要的是，電磁抗擾度標(biāo)準(zhǔn)對確保醫(yī)用電氣設(shè)備和醫(yī)用電氣系統(tǒng)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?yàn)樗械尼t(yī)用電氣設(shè)備和醫(yī)用電氣系統(tǒng)在正常使用的環(huán)境里存在著不同嚴(yán)酷程度的電磁現(xiàn)象，并且按照定義，為實(shí)現(xiàn)電磁兼容性，設(shè)備在其預(yù)期環(huán)境中一定要“符合要求運(yùn)行”。這意味著傳統(tǒng)的與安全有關(guān)的單— 故障概念不適用于電磁兼容性標(biāo)準(zhǔn)。電磁騷擾環(huán)境可類比于環(huán)境溫度、濕度和大氣壓力。醫(yī)用電氣設(shè)備和醫(yī)用電氣系統(tǒng)可能在產(chǎn)品合格周期內(nèi)的任何時(shí)間經(jīng)受預(yù)期范圍內(nèi)的環(huán)境條件。如同大氣壓力和濕度，醫(yī)用電氣設(shè)備或醫(yī)用電氣系統(tǒng)的操作者可能一直不會意識到環(huán)境電平。本部分規(guī)定的抗擾度試驗(yàn)電平(IEC 60601試驗(yàn)電平)代表在常規(guī)醫(yī)療使用環(huán)境下的環(huán)境條件范圍。因此，期望醫(yī)用電氣設(shè)備和醫(yī)用電氣系統(tǒng)的性能在此條件下是正常的。
醫(yī)用電氣設(shè)備和醫(yī)用電氣系統(tǒng)用于醫(yī)療實(shí)踐是因?yàn)樗鼈兡芴峁┧璧墓δ?。如果醫(yī)用電氣設(shè)備或一個(gè)醫(yī)用電氣系統(tǒng)對在正常使用環(huán)境中的預(yù)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(yī)療實(shí)踐的干擾不能視為可接受的情況。
本部分認(rèn)為，為確保醫(yī)用電氣設(shè)備和醫(yī)用電氣系統(tǒng)按預(yù)期設(shè)計(jì)和運(yùn)行，制造商、責(zé)任方和操作者要共擔(dān)責(zé)任。醫(yī)用電氣設(shè)備或醫(yī)用電氣系統(tǒng)制造商的職責(zé)是以符合本部分的要求進(jìn)行設(shè)計(jì)和制造，并對責(zé)任方或操作者公開信息，以便維持一個(gè)可兼容的電磁環(huán)境使醫(yī)用電氣設(shè)備或醫(yī)用電氣系統(tǒng)能按預(yù)期運(yùn)行。
由于醫(yī)學(xué)實(shí)踐涉及許多專業(yè)，必然會有醫(yī)用電氣設(shè)備和醫(yī)用電氣系統(tǒng)被設(shè)計(jì)用來運(yùn)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(guī)定的電磁抗擾度試驗(yàn)中耦合到醫(yī)用電氣設(shè)備和醫(yī)用電氣系統(tǒng)的電磁噪聲電平相比是很低的。由于許多這樣的醫(yī)用電氣設(shè)備和醫(yī)用電氣系統(tǒng)的醫(yī)療受益已被證明，所以如能提供基于物理方面、技術(shù)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(yàn)電平。在此情況下，要求制造商公開醫(yī)用電氣設(shè)備或醫(yī)用電氣系統(tǒng)滿足本部分性能要求的電平，并規(guī)定使用環(huán)境的電磁特性和如何建立這樣的環(huán)境，以使醫(yī)用電氣設(shè)備或醫(yī)用電氣系統(tǒng)按預(yù)期運(yùn)行。
本部分也認(rèn)為某些環(huán)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(huán)境以及宜采用多高的電平的研究，正在進(jìn)行中。
最后，本部分認(rèn)為對于生命支持醫(yī)用電氣設(shè)備和生命支持醫(yī)用電氣系統(tǒng)，為了建立更寬的安全裕量，即使在常規(guī)醫(yī)療使用環(huán)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(yī)用電氣設(shè)備和醫(yī)用電氣系統(tǒng)規(guī)定了附加要求。
本部分以IEC／SC 62A、IEC／TC 77(包括網(wǎng)絡(luò)在內(nèi)的電氣設(shè)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(xiàn)行IEC標(biāo)準(zhǔn)為基礎(chǔ)。
本部分規(guī)定的電磁兼容性要求通常適用于通用標(biāo)準(zhǔn)3.63和3.64中定義的醫(yī)用電氣設(shè)備和醫(yī)用電氣系統(tǒng)。對于某些類型的醫(yī)用電氣設(shè)備和醫(yī)用電氣系統(tǒng)，這些要求可能需要按照專用標(biāo)準(zhǔn)的特殊要求加以修改。鼓勵專用標(biāo)準(zhǔn)的編寫者在應(yīng)用本部分時(shí)參照附錄E的指南。
醫(yī)用電氣設(shè)備第1-2部分：
基本安全和基本性能的通用要求
并列標(biāo)準(zhǔn)：電磁兼容 要求和試驗(yàn)
1 范圍、目的和相關(guān)標(biāo)準(zhǔn)
1.1 *范圍
本部分適用于醫(yī)用電氣設(shè)備和醫(yī)用電氣系統(tǒng)(以下分別稱ME設(shè)備和ME系統(tǒng))的基本安全和基本性能。
本部分適用于ME設(shè)備和ME系統(tǒng)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(guān)說明。
1.2 目的
本部分規(guī)定了ME設(shè)備和ME系統(tǒng)電磁兼容性的通用要求和試驗(yàn)。這些通用要求和試驗(yàn)除了是通用標(biāo)準(zhǔn)的要求，還作為專用標(biāo)準(zhǔn)的基礎(chǔ)。
1.3 相關(guān)標(biāo)準(zhǔn)
1.3.1 GB 9706.1
對于ME設(shè)備和ME系統(tǒng)，本部分是GB 9706.1的補(bǔ)充。
當(dāng)參照GB 9706.1或本部分時(shí)，無論是單獨(dú)參照還是組合參照，使用下列約定：
——“通用標(biāo)準(zhǔn)”僅指GB 9706.1；
——“本部分”僅指YY 9706.102；
——“本標(biāo)準(zhǔn)”指通用標(biāo)準(zhǔn)和本部分的組合。
1.3.2 專用標(biāo)準(zhǔn)
專用標(biāo)準(zhǔn)的要求優(yōu)先于本部分的相應(yīng)要求。
2 規(guī)范性引用文件
下列文件對于本文件的應(yīng)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(fā)射(GB 4343.1—2018，CISPR 14-1：2011，IDT)
GB 4824工業(yè)、科學(xué)和醫(yī)療(ISM)射頻設(shè)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(shè)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(shè)備和測量方法規(guī)范 第1-2部分：無線電騷擾和抗擾度測量設(shè)備 傳導(dǎo)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(shù)設(shè)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(yī)用電氣設(shè)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(fā)射限值(設(shè)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(shè)備在公用低壓供電系統(tǒng)中產(chǎn)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(yàn)和測量技術(shù) 靜電放電抗擾 度試驗(yàn)(GB／T 17626.2—2018，1EC 61000-4-2：2008，1DT)
GB／T 17626.3 電磁兼容 試驗(yàn)和測量技術(shù) 射頻電磁場輻射抗擾度試驗(yàn)(GB／T17626.3—2016，IEC 61000-4-3：2010，IDT)
GB／T 17626.4—2018 電磁兼容 試驗(yàn)和測量技術(shù) 電快速瞬變脈沖群抗擾度試驗(yàn)(IEC61000-4-4：2012，IDT)
GB／T 17626.5 電磁兼容 試驗(yàn)和測量技術(shù) 浪涌(沖擊)抗擾度試驗(yàn)(GB／T 17626.5—2008，IEC 61000-4-5：2014，IDT)
GB／T 17626.6—2017 電磁兼容 試驗(yàn)和測量技術(shù) 射頻場感應(yīng)的傳導(dǎo)騷擾抗擾度(IEC61000-4-6：2013，IDT)
GB／T 17626.8 電磁兼容 試驗(yàn)和測量技術(shù) 工頻磁場抗擾度試驗(yàn)(GB／T 17626.8—2006，IEC 61000-4-8：2001，IDT)
GB／T 17626.11 電磁兼容 試驗(yàn)和測量技術(shù) 電壓暫降、短時(shí)中斷和電壓變化的抗擾度試驗(yàn)(GB／T 17626.11—2008，IEC 61000-4-11：2004，IDT)
GB／T 17743 電氣照明和類似設(shè)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(yī)用電氣設(shè)備 第1-8部分：基本安全和基本性能的通用要求 并列標(biāo)準(zhǔn)：通用要求，醫(yī)用電氣設(shè)備和醫(yī)用電氣系統(tǒng)中報(bào)警系統(tǒng)的測試和指南(IEC 60601-1-8：2012，MOD)
3 術(shù)語和定義
GB 9706.1—2020和YY 9706.108—2021界定的以及下列術(shù)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(shù)語“電壓”和“電流”是指交直流或復(fù)合電壓或電流的均方根值。
注2：術(shù)語“電氣設(shè)備”是指ME設(shè)備或其他電氣設(shè)備。本部分也使用術(shù)語“設(shè)備”來指代ME系統(tǒng)中的ME設(shè)備、其他電氣設(shè)備或非電氣設(shè)備。
3.1
(抗擾度)符合電平 (immunity) compliance level
小于或等于ME設(shè)備或ME系統(tǒng)滿足6.2相應(yīng)條款要求時(shí)的抗擾度電平。
注：符合電平的附加要求在5.2.2中有規(guī)定。
3.2
*(性能)降低 degradation(of performance)
ME設(shè)備或ME系統(tǒng)的工作性能非期望地偏離它的預(yù)期性能。
注1：術(shù)語“降低”可用于暫時(shí)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(guī)定距離上，為產(chǎn)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(shù)語“有效輻射功率”，僅當(dāng)參考天線是半波偶極子時(shí)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(shè)備或ME系統(tǒng)在其電磁環(huán)境中能符合要求運(yùn)行且不對該環(huán)境中任何事物構(gòu)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(shè)備或系統(tǒng)性能降低的電磁現(xiàn)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(fā)射 (electromagnetic) emission
從源向外發(fā)出電磁能的現(xiàn)象。
[GB／T 4365—2003，定義161-01-08]
3.7
電磁環(huán)境 electromagnetic environment
存在于給定場所的所有電磁現(xiàn)象的總和。
注：通常，電磁環(huán)境是與時(shí)間相關(guān)的，對它的描述可能需要用統(tǒng)計(jì)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(shí)變電磁現(xiàn)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(zhuǎn)移。
[GB／T 4365—2003，定義 161-01-22]
3.10
*占用頻帶 exclusion band
預(yù)期用于接收射頻電磯能的接收機(jī)頻帶。當(dāng)接收頻率大于或等于80MHz時(shí)，接收頻率或頻帶可從－5％延伸到＋5％；當(dāng)接收頻率小于80MHz時(shí)，接收頻率或頻帶可從－10％延伸到＋10％。
注：在國家無線電法規(guī)中，有時(shí)該術(shù)語的其他定義被用作其他目的。
3.11
*功能 function
ME設(shè)備或ME系統(tǒng)預(yù)期對患者進(jìn)行診斷、治療或監(jiān)護(hù)的臨床主要作用或?qū)膊?、傷害或殘疾進(jìn)行補(bǔ)償或緩解的臨床主要作用。
3.12
IEC 60601 試驗(yàn)電平IEC 60601 test level
本部分中6.2或?qū)Ｓ脴?biāo)準(zhǔn)中規(guī)定的抗擾度試驗(yàn)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(shè)備或ME系統(tǒng)不降低運(yùn)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(shè)備或系統(tǒng)而其仍能正常工作并保持所需性能等級時(shí)的最大騷擾電平。
[GB／T 4365—2003，定義161-03-14]
3.15
抗擾度試驗(yàn)電平 immunity test level
進(jìn)行抗擾度試驗(yàn)時(shí)，用來模擬電磁騷擾試驗(yàn)信號的電平。
[GB／T 4365—2003，定義161-04-41]
3.16
信息技術(shù)設(shè)備 information technology equipment；ITE
用于以下目的設(shè)備：
a) 接收來自外部源的數(shù)據(jù)(例如通過鍵盤或數(shù)據(jù)輸入線)；
b) 對接收到的數(shù)據(jù)進(jìn)行某些處理(如計(jì)算、數(shù)據(jù)轉(zhuǎn)換、記錄、建檔、分類、存貯和傳送)；
c) 提供數(shù)據(jù)輸出(或送至另一設(shè)備或再現(xiàn)數(shù)據(jù)或圖像)。
注：這個(gè)定義包括那些主要產(chǎn)生各種周期性二進(jìn)制電氣或電子脈沖波形，并實(shí)現(xiàn)數(shù)據(jù)處理功能的單元或系統(tǒng)：諸如文字處理、電子計(jì)算、數(shù)據(jù)的轉(zhuǎn)換、記錄、建檔、分類、存貯、恢復(fù)及傳遞，以及用圖像再現(xiàn)數(shù)據(jù)等。
[GB／T 4365—2003，定義161-05-04]
3.17
*大型ME設(shè)備或ME系統(tǒng) large ME equipment or ME system
不能在2m×2m×2.5m的空間內(nèi)安裝的ME設(shè)備或ME系統(tǒng)，其中不包括電纜，但包括分布式ME系統(tǒng)。
3.18
*生命支持ME設(shè)備或ME系統(tǒng) life-supporting ME equipment or ME system
至少包括一種預(yù)期有效地維持患者生命或復(fù)蘇功能的ME設(shè)備或ME系統(tǒng)，且一旦該功能不能滿足6.2.1.10要求就很可能導(dǎo)致患者嚴(yán)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(shè)備或ME系統(tǒng)中設(shè)定用來控制某種生理參數(shù)的電信號或非電信號的基頻。
3.21
*與患者耦合的ME設(shè)備或ME系統(tǒng) patient-coupled ME equipment or ME system
無論是傳導(dǎo)耦合還是電容耦合或電感耦合，至少含有一個(gè)應(yīng)用部分的ME設(shè)備或ME系統(tǒng)，通過與患者的接觸以提供ME設(shè)備或ME系統(tǒng)正常運(yùn)行所需要的感知或治療點(diǎn)，并提供一個(gè)預(yù)期或非預(yù)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(shù)的電信號或非電信號的基頻，使得ME設(shè)備或ME系統(tǒng)以一種與用于患者時(shí)相一致的方式運(yùn)行。
3.23
*專用ME設(shè)備或ME系統(tǒng) professional ME equipment or ME system
由專業(yè)醫(yī)護(hù)人員使用且預(yù)期不向公眾出售的ME設(shè)備或ME系統(tǒng)。
注：改寫GB／T 4365—2003，定義161-05-05。
3.24
*公共電網(wǎng) 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(shè)備或ME系統(tǒng) type A professional ME equipment or ME system
專用ME設(shè)備或ME系統(tǒng)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(shè)備或ME系統(tǒng)。
注：見6.1.1.1 f)。
4 通用要求
4.1 ME設(shè)備和ME系統(tǒng)的電磁兼容性通用要求
4.1.1 *電磁兼容性
ME設(shè)備和ME系統(tǒng)不應(yīng)發(fā)射影響無線電業(yè)務(wù)、其他設(shè)備或其他ME設(shè)備和ME系統(tǒng)基本性能的電磁騷擾。存在電磁騷擾的情況下，ME設(shè)備和ME系統(tǒng)應(yīng)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(rèn)為符合要求。
4.1.2 非醫(yī)用電氣設(shè)備
作為ME系統(tǒng)的一部分的非醫(yī)用電氣設(shè)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(yàn)(參見附錄G)：
a) 非醫(yī)用電氣設(shè)備符合適用的國家或國際電磁兼容性標(biāo)準(zhǔn)；
b) 判定非醫(yī)用電氣設(shè)備的發(fā)射和抗擾度不會對ME系統(tǒng)的基本安全和基本性能產(chǎn)生不利的影響；
c) 判定非醫(yī)用電氣設(shè)備不會導(dǎo)致ME系統(tǒng)的發(fā)射超過適用的限值。
通過檢查判定文件和其他相應(yīng)的文件或證書來檢驗(yàn)符合性。如果未經(jīng)判定，則通過檢查能證實(shí)此非醫(yī)用電氣設(shè)備已根據(jù)本部分規(guī)定進(jìn)行試驗(yàn)的文件來檢驗(yàn)符合性。
4.2 *ME設(shè)備的單一故障狀態(tài)
對電磁兼容性試驗(yàn)，通用標(biāo)準(zhǔn)的單一故障狀態(tài)要求不適用。
5 標(biāo)識、標(biāo)記和文件
5.1 ME設(shè)備或ME設(shè)備部件的外部標(biāo)記
5.1.1 *包含射頻發(fā)射器或利用射頻電磁能診斷或治療的ME設(shè)備或ME設(shè)備部件的外部標(biāo)記包含射頻發(fā)射器的ME設(shè)備和ME系統(tǒng)或要利用射頻電磁能診斷或治療的ME設(shè)備和ME系統(tǒng)，應(yīng)標(biāo)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(guī)定的免予試驗(yàn)的連接器的ME設(shè)備或ME設(shè)備部件的外部標(biāo)記
對于ME設(shè)備和ME系統(tǒng).如果使用6.2.2.2c)中規(guī)定的免予試驗(yàn)的連接器，則應(yīng)在每個(gè)免予試驗(yàn)的連接器附近標(biāo)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(guī)定僅用于屏蔽場所的ME設(shè)備和ME系統(tǒng)的外部標(biāo)記
規(guī)定僅用于屏蔽場所的ME設(shè)備和ME系統(tǒng)，應(yīng)標(biāo)記警示標(biāo)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(yàn)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(shè)備和ME系統(tǒng)的要求
使用說明書應(yīng)包括下列信息：
a) 醫(yī)用電氣設(shè)備需要有關(guān)于電磁兼容性特別預(yù)防措施以及根據(jù)隨附文件提供的電磁兼容性信息進(jìn)行安裝和使用的聲明；
b) 便攜式和移動式射頻通信設(shè)備可能影響醫(yī)用電氣設(shè)備的聲明。
5.2.1.2 適用于使用6.2.2.2c)中規(guī)定免予試驗(yàn)的連接器的ME設(shè)備和ME系統(tǒng)的要求
對于使用6.2.2.2c)中規(guī)定的免予試驗(yàn)的連接器的ME設(shè)備和ME系統(tǒng).使用說明書應(yīng)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(biāo)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(yù)防措施的情況下連接這些連接器；
c) *有關(guān)靜電放電預(yù)防措施的規(guī)定；
d) *建議對各有關(guān)員工進(jìn)行靜電放電警示符號的解釋和靜電放電預(yù)防措施的培訓(xùn)；
e) *有關(guān)靜電放電預(yù)防措施培訓(xùn)基本內(nèi)容的規(guī)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(diào)節(jié)和制造商規(guī)定了患者生理信號最小幅值或最小值的ME設(shè)備和ME系統(tǒng)(見6.2.1.7第一個(gè)破折號)，使用說明書應(yīng)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(shè)備或ME系統(tǒng)以低于上述規(guī)定的最小幅值或最小值運(yùn)行可能導(dǎo)致不準(zhǔn)確結(jié)果。
5.2.1.4 *適用于A型專用ME設(shè)備和ME系統(tǒng)的要求
如果A型專用ME設(shè)備或A型專用ME系統(tǒng)預(yù)期在家用設(shè)施中使用或連接到公共電網(wǎng)[見6.1.1.1f]，使用說明書還應(yīng)包括以下警示或等同說明：
警示：本設(shè)備／系統(tǒng)預(yù)期僅由專業(yè)醫(yī)護(hù)人員使用。本設(shè)備／系統(tǒng)可能導(dǎo)致無線電干擾或擾亂附近設(shè)備的運(yùn)行?？赡苡斜匾扇p緩措施，比如重新調(diào)整[ME設(shè)備或ME系統(tǒng)]的方向、位置或屏蔽相應(yīng)場地。
“[ME設(shè)備或ME系統(tǒng)]”應(yīng)由ME設(shè)備或ME系統(tǒng)的型號或類型參考號代替。
通過檢查使用說明書來檢驗(yàn)是否符合5.2.1的要求。
5.2.2 技術(shù)說明書
5.2.2.1 適用于所有ME設(shè)備和ME系統(tǒng)的要求
對于所有ME設(shè)備和ME系統(tǒng)，隨附文件應(yīng)包括下列信息：
a) *列出ME設(shè)備或ME系統(tǒng)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(guī)定(如屏蔽串行電纜、負(fù)載阻抗)，也可對它們作特殊的規(guī)定(如制造商、型號或部件號)。
注：由ME設(shè)備或ME系統(tǒng)的制造商作為內(nèi)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(shè)備或ME系統(tǒng)的制造商作為內(nèi)部部件的備件出售的換能器和電纜外，使用規(guī)定外的附件、換能器和電纜可能導(dǎo)致ME設(shè)備或ME系統(tǒng)發(fā)射的增加或抗擾度的降低。
c) *按下列規(guī)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(shè)備和ME系統(tǒng)逐項(xiàng)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(shè)備逐項(xiàng)填寫表1的圖表式要求。
——對于GB 4824 ME設(shè)備和ME系統(tǒng)，“[ME設(shè)備或ME系統(tǒng)]”應(yīng)由ME設(shè)備或ME系統(tǒng)的型號或類型參考號代替。
