YY/T 0841-2023_English: PDF (YY/T0841-2023)
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Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
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YY/T 0841-2023
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Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment
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YY/T 0841-2011
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| Standard ID | YY/T 0841-2023 (YY/T0841-2023) | | Description (Translated English) | Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.040 | | Word Count Estimation | 49,422 | | Date of Issue | 2023-09-05 | | Date of Implementation | 2025-09-15 | | Older Standard (superseded by this standard) | YY/T 0841-2011 | | Drafting Organization | Shanghai Medical Device Inspection and Research Institute, Shenzhen Mindray Biomedical Electronics Co., Ltd., Shanghai Siemens Medical Devices Co., Ltd. | | Administrative Organization | National Medical Appliances Standardization Technical Committee (SAC/TC 10) | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the testing, or cycles, of medical electrical equipment and medical electrical systems (hereinafter referred to as ME equipment and ME systems) that comply with GB 9706.1 and their components before delivery, during maintenance, inspection, after repair and other services. Sex testing requirements. This document does not specify requirements for repairs, parts exchanges and changes to ME EQUIPMENT or ME SYSTEMS. This standard applies to ME equipment and ME systems conforming to GB 9706.1 and their components. This document does not apply to the assessment of whether the design of ME EQUIPMENT, ME SYSTEM or some other equipment complies with their relevant standards. This document does not apply to the assembly of ME systems. Regarding the assembly of ME systems, see Chapter 16 of GB 9706.1-2020. | | Standard ID | YY/T 0841-2011 (YY/T0841-2011) | | Description (Translated English) | Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.040.55 | | Word Count Estimation | 43,417 | | Date of Issue | 2011-12-31 | | Date of Implementation | 2013-06-01 | | Quoted Standard | GB 4793.1; GB 4793.5; GB 4793.6; GB/T 5465.2; GB 16895.24; GB/T 17045; GB/T 18216.1 | | Adopted Standard | IEC 62353-2007, IDT | | Drafting Organization | Shanghai Medical Device Testing | | Administrative Organization | National Standardization Technical Committee of Medical electrical equipment | | Regulation (derived from) | State Food and Drug Administration Notice No. 106 of 2011 | | Proposing organization | National Standardization Technical Committee medical appliances (SAC/TC 10) | | Issuing agency(ies) | China Food and Drug Administration | | Summary | This standard applies to IEC 60601-1 for medical electrical equipment (hereinafter referred to as ME devices), medical electrical systems (hereinafter referred to as ME systems) and their parts prior to delivery, maintenance, check, service and repair in the post- or in some cases testing cyclical side test to assess their safety. If the device is not designed in accordance with IEC 60601-1, in reference to the design of the safety standards and instructions for use of the information in the case can also be used in this standard requirements. This standard specifies the number of allowable values ??listed in the table, they relate to the different versions of IEC 60601-1, the standard is concerned, the use of measurement methods and equipment or ME ME Which version of the system in accordance with the standards related to the design. This standard includes the following sections: "General requirements" contains general provisions under consideration, and "Dedicated requirement" that more equipment for the particular type of ME or ME system provisions. These terms and "General requirements" used together. This standard does not apply to equipment used to assess ME, ME or some other system equipment design meets their standards. This standard does not define the requirements for the following activities: repair, interchangeable parts, and ME equipment or ME system refuse changes. This standard also applies to testing after repair. Testing should be in accordance with the scope and repair work provided by the manufacturer to define the appropriate guidance documents. This standard is not intended to define the periodic test interval. If the manufacturer does not provide for such an interval, Appendix F, can help determine this interval. |
YY/T 0841-2023. Medical electrical equipment Periodic testing and post-repair testing of medical electrical equipment
ICS 11.040
CCSC30
Pharmaceutical Industry Standards of the People's Republic of China
Replace YY/T 0841-2011
Medical electrical equipment
Periodic testing and post-repair testing of medical electrical equipment
(IEC 62353.2014,MOD)
Published on 2023-09-05
Implemented on 2025-09-15
Released by the State Drug Administration
Table of contents
Preface III
Introduction IV
1 range 1
2 Normative reference documents 1
3 Terms and Definitions 1
4 Requirements 7
4.1 *General requirements 7
4.2 Pre-delivery, post-change and post-repair testing8
4.3 *Periodic testing 9
5*Test 9
5.1 Overview 9
5.2 Visual inspection 9
5.3 Measurement 9
5.4 Functional testing 21
6 Test results and evaluation 21
6.1 Test report 21
6.2 Assessment 22
Appendix A (informative) General guidance and rationale 23
Appendix B (informative) Test sequence 30
Appendix C (Normative) Requirements for measuring equipment and measuring circuits for protective earth resistance and leakage current 32
Appendix D (informative) Patient environment 35
Appendix E (Normative) Leakage current allowable value in GB 9706.1 36
Appendix F (informative) Test interval 39
Appendix G (informative) Test file example 40
Appendix H (Informative) Notes on Testing ME Systems 41
Reference 43
Figure 1 Measurement circuit of protective grounding resistance of ME equipment. The equipment has been disconnected from the power supply network for 10 seconds.
Figure 2 Measurement circuit for the protective earth resistance of ME equipment or ME system. ME equipment or ME system cannot be supplied from the power supply due to functional reasons.
It is disconnected from the power grid or has a permanent connection to the power supply grid11
Figure 3 Between the power supply part of the measuring network and the protective earthing point of Class I ME equipment, between the power supply part of the network and Class I ME equipment and Class II ME
Circuit for measuring the insulation resistance between accessible conductive parts of equipment (not earthed)13
Figure 4 Measurement of the insulation resistance between the power supply part of the measuring network and the applied part of Class I or Class II ME equipment forming a patient connection
Circuit 13
Figure 5 Measurement between the type F applied part constituting the patient connection and the protective earth of Class I ME equipment, the type F application part constituting the patient connection
Measurement of the insulation resistance between parts and accessible conductive parts (not earthed) of Class I ME equipment and Class II ME equipment
Circuit 13
Figure 6 Measuring circuit for measuring leakage current of ME equipment---alternative method 16
Figure 7 Measurement circuit for measuring equipment leakage current---Direct method 17
Figure 8 Measurement circuit for measuring equipment leakage current---Difference method 18
Figure 9 Measuring circuit for measuring applied part leakage current "F-type applied part" --- Substitution method 19
Figure 10 Measuring circuit for measuring the leakage current of the applied part---Network power supply voltage is applied to the F-type applied part---Direct method 20
Figure 11 Measurement circuit for measuring leakage current in the applied part of equipment with internal power supply --- direct method 20
Figure A.1 Class I ME equipment with accessible conductive parts of the enclosure not grounded26
Figure A.2 Plug-in Class I ME equipment26
Figure A.3 Plug-in Class II ME equipment27
Figure A.4 Plug-in Class I ME equipment with mains power supplied to the applied part27
Figure A.5 Plug-in Class II ME equipment with mains power supplied to the applied part28
Figure B.1 Test sequence 30
Figure B.2 Measuring leakage current (non-permanently installed Class I ME equipment) 31
Figure C.1 Example of measuring device and its frequency characteristics33
Figure D.1 Example of patient environment (Figure A.9 in GB 9706.1-2020) 35
Figure G.1 Test file example 40
Table 1 Symbol Legend 11
Table 2 Insulation resistance value 14
Table 3 Allowable value of leakage current21
Table A.1 Objects of this document and parts of which they may be concerned 23
Table A.2 Reasons for choosing different measurement methods28
Table E.1 Continuous leakage current allowable value in GB 9706.1-1995 and GB 9706.1-2007 36
Table E.2 Contact leakage current, ground leakage current, patient leakage current and
Patient auxiliary current allowable value 37
Table E.3 Allowable value of patient leakage current under special test conditions defined in 8.7.4.7 of GB 9706.1-2020 38
Preface
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents"
Drafting.
This document replaces YY/T 0841-2011 "Medical Electrical Equipment Periodic Testing and Post-Repair Testing of Medical Electrical Equipment" and is consistent with
Compared with YY/T 0841-2011, in addition to structural adjustments and editorial changes, the main technical changes are as follows.
---Added the definition of "configuration" and "phase-to-ground voltage" (see 3.8, 3.17);
---Added some terms in GB 9706.1-2020 (see 3.28, 3.31, 3.33, 3.35);
---Deleted the definition of "normal state" (see 3.26 of the.2011 version);
---The test method of protective earth resistance has been changed to adapt to the test of ME system in GB 9706.1-2020 (see 5.3.2,.2011 edition
of 5.3.2);
---Added insulation resistance test method (see 5.3.3);
---Added the method of equipment leakage current testing, and explained the relevant content (see 5.3.4.1);
---Added some required values (see Table 2).
This document is modified to adopt IEC 62353.2014 "Medical Electrical Equipment Periodic Testing and Post-Repair Testing of Medical Electrical Equipment".
The technical differences between this document and IEC 62353.2014 and their reasons are as follows.
---Replaced IEC 60601-1.2005 and IEC 60601-1.2005 AMD1.2012 with normative reference GB 9706.1, to
Adapt to my country’s technical conditions;
---Replaced IEC 61010-1 (see Appendix C) with the normatively quoted GB 4793.1 to adapt to my country's technical conditions;
---Replaced IEC 61010-031 (see Appendix C) with the normatively quoted GB 4793.5 to adapt to my country's technical conditions;
---Replaced IEC 61140 (see 6.2) with the normatively quoted GB/T 17045 to adapt to my country's technical conditions;
---Replaced IEC 61557-1 (see Appendix C) with the normatively quoted GB/T 18216.1 to adapt to my country's technical conditions;
---Replaced IEC 61557-2 (see Appendix C) with the normatively cited GB/T 18216.2 to adapt to my country's technical conditions;
---Replaced IEC 61557-4 (see Appendix C) with the normatively quoted GB/T 18216.4 to adapt to my country's technical conditions.
This document also has the following editorial changes.
---Deleted some explanatory content in the scope and moved this part to the introduction;
---Move the overall requirements for testing in the scope to 4.1;
---Replaced IEC 60417 with the informative reference GB/T 5465.2 (see 3.45, 3.46, 3.47, Appendix A);
---Added some comments.
Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents.
This document is proposed by the National Medical Products Administration.
This document is under the jurisdiction of the National Technical Committee for Standardization of Medical Electrical Appliances (SAC/TC10).
This document was drafted by. Shanghai Medical Device Inspection and Research Institute, Shenzhen Mindray Biomedical Electronics Co., Ltd., Shanghai Siemens
MEDICAL DEVICES LIMITED.
The main drafters of this document. Zhuo Zhuo, Tao Hua, Bao Hua, Feng Xiaoyun, Feng Guangzhou, and Zhou Jiajie.
The previous versions of this document and the documents it replaces are as follows.
---First released in.2011 as YY/T 0841-2011;
---This is the first revision.
introduction
This document is intended to evaluate medical electrical equipment and medical electrical systems and their components before delivery, maintenance, inspection, and repair.
and security in other services. This document gives some tables of allowable values, which relate to different versions of GB 9706.1.
For the purpose of this document, the measurement method used is independent of which version of the standard the ME EQUIPMENT or ME SYSTEM is designed to comply with.
This document does not require intervals for periodic testing. If the manufacturer does not specify such an interval, Appendix F provides the relevant
Information and easy to use. Testing of electrical installations such as power supply networks and associated wiring in healthcare premises is outside the scope of this document. These tests
Please refer to GB/T 16895.24.
This document defines the following.
--- "General requirements", including terms of general concern, and;
---"Special requirements", that is, more provisions for special types of ME equipment or ME systems. These terms, together with the General Requirements
use.
As part of the risk management process, GB 9706.1-2020 requires manufacturers to consider how to ensure medical safety throughout the product’s service life.
Safety of electrical equipment and medical electrical systems. As part of the risk management process, the manufacturer may have defined maintenance procedures,
This includes defining the respective tests for medical electrical equipment and medical electrical systems.
The manufacturer may define the necessary measurement settings and methods, including performance assurance tests, in the instructions for use or other accompanying documentation.
This document provides consistent testing procedures.
If the equipment is not designed in accordance with GB 9706.1, you can still use this device by referring to the safety standards of the equipment and the information in the instruction manual.
requirements in the document.
Medical electrical equipment
Periodic testing and post-repair testing of medical electrical equipment
1 Scope
This document specifies medical electrical equipment and medical electrical systems (hereinafter referred to as ME equipment and ME systems) that comply with GB 9706.1
and requirements for testing or periodic testing of their components before delivery, during maintenance, inspection, after repair and other services.
This document does not specify requirements for repairs, parts exchanges and changes to ME EQUIPMENT or ME SYSTEMS.
This document applies to ME equipment and ME systems complying with GB 9706.1 and their components.
This document does not apply to the assessment of whether the design of ME EQUIPMENT, ME SYSTEM or some other equipment complies with their relevant standards.
This document does not apply to the assembly of ME systems. Regarding the assembly of the ME system, see Chapter 16 of GB 9706.1-2020.
Note. In this document, the unspecified version of GB 9706.1 refers to GB 9706.1-1995, GB 9706.1-2007 or GB 9706.1-2020.
2 Normative reference documents
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations
For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to
this document.
GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use Part 1.General requirements (GB 4793.1-2007,
IEC 61010-1.2001,IDT)
GB 4793.5 Safety requirements for electrical equipment for measurement, control and laboratory use Part 5.Hand-held probes for electrical measurement and testing
Safety requirements for components (GB 4793.5-2008, IEC 61010-031.2002, IDT)
GB 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and basic performance (GB 9706.1-2020,
IEC 60601-1.2012, MOD)
GB/T 17045 General parts of electric shock protection devices and equipment (GB/T 17045-2020, IEC 61140.2016, IDT)
GB/T 18216.1 Testing of electrical safety protection measures for low-voltage power distribution systems with AC 1000V and DC 1500V and below,
Measuring or monitoring equipment Part 1.General requirements (GB/T 18216.1-2021, IEC 61557-1.2019, IDT)
GB/T 18216.2 Testing of electrical safety protection measures for low-voltage power distribution systems with AC 1000V and DC 1500V and below,
Measuring or monitoring equipment Part 2.Insulation resistance (GB/T 18216.2-2021, IEC 61557-2.2019, IDT)
GB/T 18216.4 Testing of electrical safety protection measures for low-voltage power distribution systems with AC 1000V and DC 1500V and below,
Measuring or monitoring equipment Part 4.Ground resistance and equipotential ground resistance (GB/T 18216.4-2021, IEC 61557-4.2019,
IDT)
3 Terms and definitions
The following terms and definitions apply to this document.
Note. Because of the different measurement methods used, some definitions are different from those in GB 9706.1.
3.1
ME EQUIPMENT, other than APPLIED PARTS, that is accessible to the patient, or comes into contact with the patient through the operator, or may come into contact with the patient through the operator
......
YY/T 0841-2011
Medical electrical equipment.Recurrent test and test after repair of medical electrical equipment
ICS 11.040.55
C30
People's Republic of China pharmaceutical industry standards
Medical electrical equipment -
Medical electrical equipment periodically test after test and repair
(IEC 62353.2007, IDT)
Issued on. 2011-12-31
2013-06-01 implementation
State Food and Drug Administration issued
Table of Contents
Introduction Ⅲ
1 Scope 1
2 Normative references 1
3 Terms and definitions 2
4 requires 7
4.1 General Requirements * 7
4.2 Before delivery, testing and repair changed after 8
4.3 * 8 periodic test
5 * Test 8
5.1 Overview 8
Visual inspection 8 5.2
5.3 Measurement 9
5.4 Functional Test 19
6 test results and evaluation 19
6.1 Test Report 19
6.2 Evaluation 20
Appendix A (informative) total preparation instructions and guidelines 21
Annex B (informative) Test sequence 26
Annex C (normative) protection grounding resistance and leakage current measuring equipment and measuring circuit 29
Annex D (informative) Environmental 32 patients
Appendix E (Informative Appendix) IEC 60601-1 leakage current allowable value 33
Annex F (informative) test interval 36
Annex G (informative) Test report form 37
References 38
Figure 1 ME equipment protective earth resistance measurement circuit, disconnect the device from the power network 10
2 ME device or ME system of FIG protective earth resistance measurement circuit. ME device or ME system because reason can not function
Disconnected from the supply network, or a permanent connection with the supply network 10
Figure 3 measurement device leakage current measurement circuit --- substitution 13
4 measuring device leakage current measurement circuit 14 --- direct method
5 measurement device leakage current measurement circuit 15 --- Difference Method
Figure 6 Measurement Application Part leakage current measurement circuit "F-type applied part" --- substitution 15
Figure 7 Application Part measuring leakage current measurement circuit --- supply voltage is applied to the F-type applied part --- direct method 16
8 measuring the internal power supply electrical equipment for medical application of some of the leakage current measurement circuit --- direct method 16
Between 9 measuring net power supply section and class Ⅰ protected ground equipment, network equipment power supply section and Class Ⅰ unprotected ground accessible
Between conductive parts and power supply network and part of Class Ⅱ equipment ACCESSIBLE conductive parts between the insulation resistance test circuit 18
10 measuring net power supply section and the insulation resistance test circuit connection between the application part of the patient 18
11 between the protective earth measurements showing the configuration of a patient connected applications Part F and Class Ⅰ equipment constituting F-type patient connections
Application Part Ⅰ class equipment and unprotected ground and accessible between the conductive portion constituting the F-type applied part patient connections
Accessible and Ⅱ type of equipment insulation resistance between the conductive portion of the measurement circuit 19
Figure B.1 test sequence 26
Figure B.2 measuring leakage currents (Class Ⅰ ME equipment) 27
Figure B.3 measure leakage current (Ⅱ Class ME equipment and unprotected ground class Ⅰ ME devices accessible conductive part) 28
Figure C.1 measuring device and the frequency characteristics of Example 30
Patient environment Figure D.1 Example 32
Figure G.1 test report form 37
Table 1 Symbol Legend 11
Table 2 leakage current allowable value 17
Table A.1 for this standard objects and they may be concerned about section 21
Table A.2 choose different measurement methods of the reasons 23
Table E.1 Continuous drain current threshold value (From GB 9706.1-2007) 33
Table E.2 Under normal conditions and single fault condition contact leakage current, earth leakage current, patient leakage current and patient auxiliary
Current threshold value (excerpt from IEC 60601-1.2005) 34
Table E.3 in IEC 60601-1. special test mode defined in 8.7.4.7 of the 2005 Patient leakage current threshold value 35
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
After the 2007 "medical electrical equipment and medical electrical equipment repair periodic test. This standard uses the translation method identical with IEC 62353
test". The standard IEC 62353.2007 made the following editorial changes.
--- According to Chinese customs for some formatting has been modified;
--- For the international standard quoted in the standard, if it has converted to our standards, international standard number of this standard will replace the corresponding references
National standard (due to the IEC 60601-1 standard criteria mentioned involves three versions, unless otherwise specified, in order to facilitate
Understood not replace it with a national standard number GB 9706.1).
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.
The main drafters of this standard. Ho Chun, Qiu Yuan, Xie Qiong.
Medical electrical equipment -
Medical electrical equipment periodically test after test and repair
1 Scope
This standard applies to IEC 60601-1 medical electrical equipment (hereinafter referred to as ME equipment), medical electrical systems (hereinafter referred to as ME system
EC) and their components prior to delivery, maintenance, and inspection, test and repair service in the post or in some cases, periodic tests to
Assess their security. If the device is not designed in accordance with IEC 60601-1, in reference to the design of the safety standards and instructions for use information
Under the circumstances, it can also be used in this standard requirements.
This standard contains some table lists the permissible value, they relate to different versions of the IEC 60601-1. The present standard terms, the use of
Methods of measurement and ME device or ME system in accordance with what version of the design criteria unrelated.
This standard includes the following sections.
--- "General requirements" contains general provisions under consideration, and
--- "Special requirements" that more provisions for special types of ME device or ME system. These provisions of the "General Requirements"
With use.
Note 1. At this stage, there is no special requirements.
This standard does not apply to equipment used to assess ME, ME system or some other device design meets their standards.
This standard does not define the requirements for the following activities. Change repairs, parts exchange and ME device or ME system.
Note 2. All follow the manufacturer's recommendations for maintenance, inspection, service and repair are performed so that the device continues to comply with the standard device is designed to use. otherwise
Shall be evaluated and verified for compliance with the applicable requirements.
This standard also applies to the test after the repair. Appropriate tests shall be in accordance with the scope of the guidance document and manufacturers to provide repair work
definition.
This standard is not intended to define a periodic test intervals. If the manufacturer does not provide for such a time interval, Appendix F can help ensure
Given this interval.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB 4793.1 measurement, control and laboratory safety requirements for electrical equipment Part 1. General requirements (GB 4793.1-
2007, IEC 61010-1.2001, IDT)
GB 4793.5 measurement, control and laboratory safety requirements for electrical equipment - Part 5. electrical measurement and test using a handheld probe
Safety requirements for components (GB 4793.5-2008, IEC 61010-031.2002, IDT)
GB 4793.6 measurement, control and laboratory safety requirements for electrical equipment - Part 6. Laboratory Materials special heating equipment
Specific requirements (GB 4793.6-2008, IEC 61010-2-010.2005, IDT)
GB/T 5465.2 Graphical symbols for electrical equipment (GB/T 5465.2-2008, IEC 60417.2007, IDT)
The first part of GB 16895.24 7-710 Electrical installations of buildings. special installations or locations medical locations (GB 16895.24-
2005, IEC 60364-7-710.2002, IDT)
GB/T 17045 Universal Protection against electric shock devices and equipment (GB/T 17045-2008, IEC 61140.2001, IDT)
GB/T 18216.1 1000V AC and 1500V DC low voltage distribution systems Electrical Safety Measures test, measurement
......
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