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YY 0505-2012
Medical electrical equipment.Part 1-2. General requirements for safety.Collateral standard. Electromagnetic compatibility.Requirements and tests
ICS 11.140
People's Republic of China pharmaceutical industry standards
YY 0505-2012/IEC 60601-1-2.2004
Replacing YY 0505-2005
(IEC 60601-1-2.2004, IDT)
Issued on. 2014-01-01 2012-12-17 implementation
State Food and Drug Administration issued
Table of Contents
Introduction Ⅲ
Introduction Ⅳ
The first chapter outlines
1 Scope and purpose 1
2 Terms and definitions 1
3 4 General requirements
6 Identification, marking and documents 5
The second to fourth in
The fifth chapter of unwanted or excessive radiation hazard protection
36 20 Electromagnetic Compatibility
Part VI to the tenth chapter
Appendix A (informative) total preparation instructions and guidelines 34
Annex B (informative) Table 201 to Table 208 Example 55
Appendix C (Informative Appendix) GB 4824 Classification Guide 64
Appendix D (Informative Appendix) YY 0505 applied to specific standard guidelines 66
Annex E (informative) Electromagnetic Environment 67
Annex F (normative) Normative documents 68
Annex G (informative) Basic performance determination guide 70
Non-medical electrical equipment Annex H (informative) within the system from EMC testing requirements of this standard determination guide 71
FIG completion table 201 201 --- description of equipment and systems 12 GB 4824
FIG completion table 202 201 --- description of GB 4343 and GB 17743 13 equipment and systems
Figure 203 14 202 The table below shows complete
FIG completion table 203 and 204 205 --- table shows the life support equipment and systems 18
FIG completion table 204 and 205 206 --- table describes non-life-support equipment and systems 18
Figure A.1 radiated immunity test cable arrangement example of FIG. 53
Figure A.2 have a cable and two cable devices maximum size of the example of Figure 54
Figure H.1 non-medical electrical equipment within the system whether from the present standard EMC test requirements determination process 71
YY 0505-2012/IEC 60601-1-2.2004
Table 201 Guidance and manufacturer's declaration electromagnetic emission --- --- 11 for all equipment and systems
Table 202 Guidance and manufacturer's declaration electromagnetic immunity --- --- 14 for all equipment and systems
Table 203 Guidance and manufacturer's declaration electromagnetic immunity --- --- life support equipment and systems 15
Table 204 Guidance and manufacturer's declaration electromagnetic immunity --- --- non-life-support equipment and systems 16
Table 205 Recommended separation distance between portable and mobile RF communications equipment and devices or systems --- and life support equipment
System 17
Table 206 Recommended separation distance between portable and mobile RF communications equipment and devices or systems --- non-life-support equipment and
System 17
Table 207 Guidance and manufacturer's declaration electromagnetic immunity --- --- provisions for shielding only place life support equipment and systems
Non-Life Table 208 Guidance and manufacturer's declaration electromagnetic immunity --- --- provisions for shielding only place equipment and support
System 20
Table 209 modulation frequency, physiological simulation frequency and operating frequency 26
Table 210 voltage sag immunity test level 32
Table 211 voltage interruptions immunity test level 32
Examples Table B.1 Table 201 (1) 55
Examples Table B.2 Table 201 (2) 55
Examples Table B.3 Table 201 (3) 56
Table B.4 Examples Table 202 56
Table B.5 immunity and instances in line with the level of the test (1) 57
Examples B.6 Table 203. Table 58
Table Example B.7 table 205 59
Examples Table B.8 table 204 60
Table Example B.9 table 206 60
Table B.10 immunity and instances in line with the level of the test (2) 61
Table 62 207 Table B.11 Examples
Table B.12 immunity and instances in line with the level of the test (3) 62
Table 63 208 Table B.13 Examples
Table E.1 electromagnetic environment 68
YY 0505-2012/IEC 60601-1-2.2004
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
Safety standards for medical electrical equipment is mainly composed of a first part of the "General requirements for safety" and the second part of the "requirements for safety."
This standard GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety" parallel standards. In addition to this criteria,
GB 9706.1-2007 other relevant collateral standard are.
--- GB 9706.15-2008 "Medical electrical equipment - Part 1-1. General requirements for safety Collateral standard. medical electrical systems
Safety requirements "(IEC 60601-1-1.2000, IDT);
--- GB 9706.12-1997 "Medical electrical equipment Part 1. General requirements for safety, Collateral Standard. diagnostic X-ray provided
General requirements for radiation protection equipment "(idt, IEC 60601-1-3.1994);
--- YY/T 0708-2009 "Medical electrical equipment - Part 1-4. General requirements for safety Collateral Standard. Programmable electrical medical
Gas systems "(IEC 60601-1-4.2000, IDT);
--- YY 0709-2009 "Medical electrical equipment - Part 1-8. General requirements for safety Collateral standard. General requirements for medical electrical
Gas equipment and medical electrical systems tests and guidance "alarm systems (IEC 60601-1-8.2003, IDT)
This standard replaces YY 0505-2005 "Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard. Electromagnetic compatibility
Requirements and testing. "
This standard compared with YY 0505-2005, the main differences are as follows.
--- In order to be consistent with basic standards of the original standards made some editorial changes, such as. "Radiation of radio frequency electromagnetic fields" to "radio frequency electromagnetic
Field radiation "," RF "to" RF ";
--- Increased requirements A type of special equipment and systems;
--- Normative increased YY 0709-2009, remove the IEC 60601-1. 1988 (see Appendix F);
--- Added Appendix G, Appendix H;
The term --- Chapter 2 of this standard and terms of reference is represented by V bold.
This standard is identical with IEC 60601-1-2.2004 (2.1 version), namely IEC 60601-1-2.2001 A1.2004 "Medical Electrical Equipment
Part 1-2. General requirements for safety Collateral standard. Electromagnetic compatibility requirements and tests. " This standard and IEC 60601-1-2.2004
(Version 2.1) as compared to editorial changes made the following.
--- According to GB/T 1.1 for some formatting has been modified;
--- For other international standards quoted in the standard, if it has converted to our standards, this standard will be replaced by the corresponding international standard number
The number of national standards, and as noted in Appendix F relational;
--- In order to facilitate editing, appendix three-letter code was adjusted to a letter, such as the appendix AAA adjusted to Appendix A;
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This standard by the National Standardization Technical Committee medical appliances (SAC/TC10) and focal points.
This standard was drafted. Shanghai Medical Device detection, Liaoning Cape Medical Systems Co., Ltd., Siemens Shanghai Medical Equipment Co.,
the company.
The main drafters of this standard. Liu Jinglin, high school, handsome cattle, Tianyan Fang, Wang Weiming Jiang years, Zhou East.
This standard replaces the standards previously issued as follows.
--- YY 0505-2005.
YY 0505-2012/IEC 60601-1-2.2004
In recent years, with the high sensitivity of electronic technology is widely used in medical electrical equipment and new communications technologies, such as personal communication systems, cellular
Telephone, the rapid development in all spheres of social life; not only their own medical electrical equipment will emit electromagnetic energy, the impact of radio communications
Services and work around other devices, but also in its use by the surrounding environment may also interfere with communications equipment, such as electromagnetic energy emitted making
A pair of patient injury. Electromagnetic compatibility for medical electrical equipment as it relates to public health and safety, and a growing concern to all countries.
The necessity of medical electrical equipment and medical electrical systems (referred to in this collateral standard equipment and systems) standards for electromagnetic compatibility has become
Widespread consensus.
Electromagnetic emission standards developed primarily for protection. safety services, other equipment and systems, non-medical electrical equipment (such as computers), radio communication
Information (such as radio/TV, telephone, radio, navigation). Electromagnetic immunity standards developed primarily to ensure the safety of equipment and systems.
Electromagnetic compatibility (see the definition 2.204) Unlike other security GB 9706.1 covered, because all the equipment and systems
In normal use of the system environment there are different severities of electromagnetic phenomena, and specifies that it expects the device to form an electromagnetic environment
Compatible must be "satisfied to run." This means that the traditional concept of a single fault does not apply to security-related electromagnetic compatibility standards.
IEC 60513 describes the difference between safety standards and performance standards is often unclear. Equipment and systems used in medical practice because
As they provide the required functionality. If the devices and systems 1) the expected event in the normal use of the environment due to lack of immunity and can not be mentioned
For the required function, the case of medical practice and unacceptable interference will occur. Therefore, IEC 60601-1-2 standard and the second edition of the first edition
The difference is. the anticipated degree of electromagnetic disturbance power in peacetime, establishing a minimum baseline performance.
This standard is considered between manufacturers, customers and users to ensure that the equipment and system design and operation as expected have a shared responsibility.
Equipment or system manufacturer's responsibility is to meet the requirements of this standard design and manufacturing, and customer or user of public information for peacekeeping
Achieve the purpose of retaining devices or systems compatible electromagnetic environment can run as expected.
Because medical practice includes many professional and therefore need to design multi-functional devices and systems. Some features, such as. micro-patient
Weak signal measurement, electromagnetic immunity tests of the weak signal level specified in this standard is coupled to the electromagnetic noise level of equipment and systems
It is very low in comparison. Because many of these devices and systems have been shown to have benefits, so it based on the physical aspects, technical aspects or physiological side
Limitation surfaces provide sufficient grounds to consider under this standard allows reduced immunity test level. In this case, the manufacturer must be open
Equipment or system to meet the level of the standard performance requirements, and provides for the use of the electromagnetic characteristics of the environment and how to create such an environment, so that the device
Or the system is running as expected.
This standard also think some environments may require a higher level of immunity. How to determine may require a higher level of immunity to the environment
And should provide the kind of level, we are being studied.
The standard recognizes that the life-support equipment and systems, in order to establish a broader safety margin, even in a normal environment to make medical use
Used, it must have a higher level of immunity. Therefore, the standard of life support equipment and systems provides for additional requirements.
This standard TC62/SC62A, TC77 (electromagnetic compatibility including network, including electrical devices) and CISPR (International Wireless
Special Committee on the current IEC standard electrical interference) developed based.
This standard specifies electromagnetic compatibility requirements are generally applicable to equipment and systems as described in 1.201. For certain types of devices
And systems, these requirements may need to be modified by the special requirements of specific standards. Encourage specific standard writers refer to Appendix D for
Application of this standard guidelines.
1) This standard, "or" sometimes can be understood as including the "and."
YY 0505-2012/IEC 60601-1-2.2004
Medical electrical equipment -
Part 1-2. General requirements for safety
Collateral standard. Electromagnetic compatibility requirements and tests
The first chapter outlines
1 Scope and purpose
1.201 * Range
This standard applies to medical electrical equipment and medical electrical systems (hereinafter referred to equipment and systems) electromagnetic compatibility.
1.202 purpose
This standard for electromagnetic compatibility and system specifies requirements and test, and as a specific standard electromagnetic compatibility requirements and tests
2 Terms and definitions
GB 9706.1-2007, GB 9706.15-2008, YY 0709-2009 and YY/T 0316-2008 and defined following surgery
Terms and definitions apply to this document.
(Immunity) in line with the level (immunity) compliancelevel
Less than or equal to the device or system meets the immunity level of the requirements of the corresponding provisions 36.202.
Note. The level of compliance with the additional requirements are specified in in.
2.202 *
(Performance) reduced degradation (ofperformance)
Equipment or system performance undesirably deviates from its expected performance.
Note. The term "decrease" can be used for temporary failure and permanent failure.
Note. Adapted from GB/T 4365-2003,161-01-19.
2.203 *
Effective radiated power effectiveradiatedpower; ERP
In any given direction a predetermined distance, to produce given the same means radiated power flux density must be no loss of reference
Antenna input power applied.
Note. The term used in the ITU and in Chapter 712 of the IEV "effective radiated power" only when the reference antenna is a half-wave dipole when unrestricted.
Note. Adapted from GB/T 4365-2003,161-04-16.
2.204 *
Electromagnetic compatibility electromagneticcompatibility; EMC
Equipment or system in its electromagnetic environment to work properly and does not constitute impermissible electromagnetic interference to anything in that environment
Note. Adapted from GB/T 4365-2003,161-01-07.
YY 0505-2012/IEC 60601-1-2.2004
2.205 *
Electromagnetic disturbance electromagneticdisturbance
May cause any device, equipment or system performance electromagnetic phenomena.
Note 1. The electromagnetic disturbance may be electromagnetic noise, unwanted signal or a change in the propagation medium itself.
Note 2. Modified from GB/T 4365-2003,161-01-05.
(Electromagnetic) emission (electromagnetic) emission
The phenomenon of electromagnetic energy emitted from the source outward.
[GB/T 4365-2003,161-01-08]
2.207 *
Electromagnetic environment electromagnetic environment
To exist in the sum of all electromagnetic phenomena in a given place.
Note 1. In general, the electromagnetic environment is related to time, you may need to be described by statistical methods.
Note 2. Modified from GB/T 4365-2003,161-01-01.
Electromagnetic noise electromagnetic noise
When a clear message of change does not transmit electromagnetic phenomenon, which may be combined with or superimposed on the useful signal.
[GB/T 4365-2003,161-01-02]
Electrostatic discharge electrostaticdischarge; ESD
Objects with different electrostatic potentials near or in direct contact with each other due to charge transfer.
[GB/T 4365-2003,161-01-22]
2.211 *
Occupied band exclusionband
Expected band RF receiver for receiving the electromagnetic energy. When the receiving frequency is greater than or equal to 80MHz, or the reception frequency band can be
Extending from -5% to 5%; when the receiving frequency is less than 80MHz, the reception frequency or frequency band may extend from 10% to 10%.
Note. At the national radio regulations, other definitions of the term is sometimes used for other purposes.
2.212 *
(Device or system) function function (ofanequipmentorsystem)
Equipment or system is expected to patient diagnosis, treatment or major clinical monitoring role.
IEC 60601 test level IEC 60601testlevel
The Standard 36.202 or specific standards set forth in immunity test level.
2.214 *
(Of harassment) immunity immunity (toadisturbance)
Equipment or system is facing capacity without reducing electromagnetic disturbance operational performance.
Note. Adapted from GB/T 4365-2003,161-01-20.
Immunity level immunitylevel
The maximum for a given electromagnetic disturbance is applied to a device, equipment or system which is still functioning and maintain the required level of performance when
Level of disturbance.
[GB/T 4365-2003,161-03-14]
YY 0505-2012/IEC 60601-1-2.2004
2.216 *
Immunity Test level immunitytestlevel
When immunity test to simulate electromagnetic disturbance level test signal.
Note. Adapted from GB/T 4365-2003,161-04-41.
IT equipment informationtechnologyequipment; ITE
Equipment used for the following purposes.
a) receiving data from an external source (e.g., via a keyboard or data input line);
b) Data received some processing (such as computation, data transformation, recording, filing, sorting, storage and transport);
c) providing a data output (or sent to another device or reproduction of data or images).
Note. This definition includes those mainly produce various electrical or electronic periodic binary pulse waveform, and the data processing unit or system functions. such as
Word processing, computing, data conversion, recording, filing, sorting, storage, transfer and recovery, as well as image reproduction data.
[GB/T 4365-2003,161-05-04]
2.218 *
Large equipment or systems largeequipmentorsystem
Equipment or systems can not be installed within 2m × 2m × 2.5m space, which does not include cable, but includes a distributed system.
2.219 *
Life support devices or systems life-supportingequipmentorsystem
Comprising at least one is expected to effectively maintain the equipment or system life or recovery of function in patients, and once the feature is not satisfied
36.202.1j) requirements are likely to result in serious patient injury or death.
2.220 *
Low voltage lowvoltage
Less than or equal to 1000V ac or 1500V dc voltage between phase and phase or phase and neutral.
2.221 *
Medical electrical systems (hereinafter referred to as the "System") medicalelectricalsystem
A combination of multiple devices, including at least one for medical electrical equipment and connected via the function or use of transportable multi-plug socket
NOTE. When the device is connected to the system, medical electrical equipment should be included within the system.
[GB 9706.15-2008, the definition 2.201]
2.222 *
Operating Frequency operatingfrequency
Setting electrical or non-electrical signal is used to control certain physiological parameters in the device or system fundamental frequency.
2.223 *
Devices or systems coupled with the patient's patient-coupledequipmentorsystem
Application contains at least a portion of the equipment or system, through contact with the patient to provide a sense of the normal operation of equipment or systems required
Or known treatment sites, expected or unexpected, and provides a path of electromagnetic energy, whether it is a conductor coupling or inductive coupling or capacitive coupling.
2.224 *
Physiological analog frequency physiologicalsimulationfrequency
To simulate physiological parameter group frequency electrical signal or an electrical signal, so that the device or system to a patient with a phase-coherent manner
Type operation.
2.225 *
Public grid publicmainsnetwork
Users can access all types of low-voltage power lines.
YY 0505-2012/IEC 60601-1-2.2004
2.226 *
RF radiofrequency; RF
Located audio and infrared spectrum of the electromagnetic spectrum between the frequency of a radio signal for transmission.
Note. The scope is commonly used in 9kHz ~ 3000GHz.
2.227 *
Special equipment or systems professionalequipmentorsystem
And it is expected to be used by health care professionals do not sell equipment or system to the public.
Note. Adapted from GB/T 4365-2003161-05-05.
A special type of device or system typeAprofessionalequipmentorsystem
Special equipment or system conforms to GB 48242 Group Class B (in addition to the fundamental frequency of the third harmonic), and the third harmonic electromagnetic compliance with Class A Group 2
Radiation disturbance limits of equipment or system.
Note. See 36.201.1a) 6).
3 General requirements
General requirements for electromagnetic compatibility of equipment and systems 3.201
3.201.1 * Electromagnetic Compatibility
Equipment and systems should not affect the emission of radio services, other equipment or other devices and systems for basic performance of electromagnetic disturbance, and the set
Basic performance equipment and systems shall comply with the requirements of the electromagnetic disturbance immunity.
If you meet the requirements of this standard, that is considered to meet the requirements.
3.201.2 basic performance
Unless all the features of the basic properties of the identified devices or systems (basic properties of identification guides, see Appendix G), otherwise the device or system
It should be considered as a basic immunity test performance [see 36.202.1j)]. Basic performance shall be stated in the ACCOMPANYING DOCUMENTS.
By examining the accompanying documents to verify compliance with the requirements, if there is no identification, you can confirm by checking all functions of a device or system
Performance has been able to document testing in accordance with the provisions of 36.202 to verify compliance.
3.201.3 medical electrical equipment
Medical electrical equipment should meet the requirements of this standard.
If you meet the requirements of this standard, that is considered to meet the requirements.
3.201.4 non-medical electrical equipment
Electrically non-medical electrical equipment as part of a system to provide, if they can prove all of the following conditions may be exempted from the requirements of this standard
Magnetic compatibility test (see Appendix H).
a) non-medical electrical equipment complies with the applicable national or international standards for electromagnetic compatibility;
b) emission and immunity confirmed non-medical electrical equipment does not adversely affect the basic performance of the system or security;
c) confirmed that non-medical electrical equipment does not lead to the transmission system exceeds the applicable limits;
Confirmed by appropriate documents and other documents or certificates to verify compliance with requirements, if no confirmed through inspection
Non-medical electrical equipment can confirm that the file has been tested in accordance with the provisions of this standard to verify compliance.
* 3.201.5 General test status
Electromagnetic compatibility test for the General Standard on single fault condition requirement does not apply.
YY 0505-2012/IEC 60601-1-2.2004
6 Identification, marking and documentation
The external tag 6.1.201 device or device components * includes a radio frequency transmitter or the use of radio frequency electromagnetic energy diagnosis or treatment of an external marking device or piece of equipment
Equipment and systems contain radio transmitters, or to make use of radio frequency electromagnetic energy diagnostic or therapeutic devices and systems, the following shall be marked non-ionizing
Radiation symbol (GB/T 5465.2-5140). use 36.202.2b) external tag connector 3) shall be exempt from the provisions of the test device or piece of equipment
For equipment and systems, if 36.202.2b) 3) are exempt from the provisions of the test connection, it must be represented by the following electrostatic discharge
Electrical sensitivity symbol mark, and the mark should be exempted from the test near each connector (GB/T 5465.2-5134).
The external tag provisions for shielding only place equipment and systems
Shall only place for shielding devices and systems, warning signs should be marked to notice it only for the specified type of shielding properties [see].
By checking to verify compliance.
6.8 random file Instructions
A) requirements applicable to all equipment and systems
Instructions should include the following information.
1) Medical electrical equipment requires special tips for electromagnetic compatibility and electromagnetic compatibility according to the letter accompanying documents provided
Interest instructions for installation and use;
2) portable and mobile RF communications equipment can affect medical electrical equipment instructions.
b) apply to the use 36.202.2b) 3) are exempt from the requirements of the connector testing equipment and systems
For 36.202.2b) connector 3) shall be exempt from the provisions of the test equipment and systems, using the instructions shall include the following
1) reproducing ESD warning symbol (GB/T 5465.2-5134, as shown ESD susceptibility symbol
2) Warning. should not touch the connector labeled ESD warning symbol pins, and unless ESD precautions
Shi, not otherwise connected to these connectors are formed;
3) * For ESD precautions regulations;
4) * Recommendation on relevant employees accepted ESD warning symbol interpretation and ESD precautions training;
YY 0505-2012/IEC 60601-1-2.2004
5) * For ESD precautions prescribed basic training content.
c) minimum amplitude or minimum patient physiological signals
For without a manual sensitivity adjustment and manufacturers specify the minimum patient physiological signal amplitude or minimum equipment and systems [see
36.202.1g), first dash], using the instructions shall include the following information.
1) The minimum amplitude of physiological signals of a patient or a minimum value;
2) Warning. device or system being less than the minimum amplitude or minimum run may lead to inaccurate results.
d) * A type applications that require specialized equipment and systems
If A dedicated device or system is expected to use or connected to the public grid in a home facility [see 36.201.1a) 6)], so that
With instructions shall also include the following warning or equivalent Note.
Warning. This equipment/system is expected to only be used by health care professionals. The device/system may cause radio interference or disturbance attached
Running near the device. It may be necessary to take mitigation measures, such as re-adjust the [device or system] direction, location, or shield
Appropriate venue.
Model or type instead of "[device or system]" should be the device or system.
By checking to verify compliance. SHEET
A) requirements applicable to all equipment and systems
For all devices and systems, random file should include the following information.
1) * Lists device or system manufacturer's declaration of compliance with the maximum length of 36.201 and 36.202 all required cables, cables
Degree (if applicable), transducers, and other accessories. These provisions do not affect compliance with the requirements of the Annex need not be listed. Both on the
Accessories, transducers and cables for general provisions (eg shielded serial cable, load impedance), but also to make them special
Provisions (such as make, model or part number).
Note. the manufacturer of the device or system as the internal components of the sale of spare parts and transducer cable need not be listed.
2) * Warning. In addition to the manufacturer of the device or system components sold as spare parts for internal transducers and cables, the use of provisions
Attachment of the transducer and the cable may result in reduced emission of equipment or system or increase immunity.
2) See Appendix B for example, these changes should be done in sequence.
3) Before changing the reference table 201 of the line number.
3) * 201 Table 2 following changes), 3). 201 GB 48......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.