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YY 0505-2012: Medical electrical equipment. Part 1-2: General requirements for safety. Collateral standard: Electromagnetic compatibility. Requirements and tests
YY 0505-2012
Medical electrical equipment.Part 1-2. General requirements for safety.Collateral standard. Electromagnetic compatibility.Requirements and tests
ICS 11.140
C30
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
Foreword
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
introduction
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
Foundation.
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.
2.201
(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 6.8.3.201 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 ...