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Medical electrical equipment -- Part 1: General requirements for safety. 1 -- Collateral standard: Safety requirements for medical electrical systems
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Medical electrical equipment Part 1: General requiements for safety 1. Collateral standard: Safety requirements for medical electrical systems
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GB 9706.15-2008: PDF in English GB 9706.15-2008
Medical electrical equipment.Part 1. General requirements for safety.1.Collateral standard. Safety requirements for medical electrical systems
ICS 11.040
C30
National Standards of People's Republic of China
GB 9706.15-2008/IEC 60601-1-1.2000
Replacing GB 9706.15-1999
Medical Electrical Equipment
Part 1-1. General requirements for safety
Collateral standard. Safety requirements for medical electrical systems
(IEC 60601-1-1.2000, IDT)
Published 2008-12-15
2010-02-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China issued
Table of Contents
Introduction Ⅲ
The first chapter outlines 1
1. Scope and object 1
2 1 Terms and definitions
3 1 General Requirements
6 to identify, mark and file 2
The second environmental conditions 3
10 environmental conditions 3
Title III protection against electric shock hazard 3
16 of the housing and the shield 3
17 3 isolation
19 Continuous leakage currents and patient auxiliary current 3
Title IV of the mechanical hazard protection 4
4 moving member 22
The fifth chapter of unnecessary or excessive radiation hazard protection 4
Title VI protection four pairs of mixed flammable anesthetic gas ignition hazard
Title VII of the ultra-mild other safety hazard protection 4
Overflow 44, liquid spill, leak, moisture, into the liquid, cleaning, disinfection, sterilization and compatibility 4
49 power supply interruption 4
5 accuracy and prevent the risk of data output from the eighth chapter of the work
Chapter 9. abnormal operation and fault state; 5 Test Environment
52 failure and abnormal operation state 5
Structural requirements tenth chapter 5
Component assembly 5 and 56
Mains supply portion 57, and the wiring components 5
58 and connected to the protective grounding terminal 6 ---
6 and wiring structure 59
FIG patient environment 201 Example 6
Annex AAA (informative) overall guidelines and preparation instructions 7
Appendix BBB (informative) Medical electrical equipment in combination with a non-medical device 10 electrically Examples
(Normative) Appendix CCC Normative References 12
(Informative) Reference 13 APPENDIX DDD
Annex the EEE (normative) requirements for transportable porous plug 14
Appendix FFF (informative) Portable porous plug Application Example 15
GB 9706.15-2008/IEC 60601-1-1.2000
Foreword
All technical contents of this section GB 9706 are mandatory.
"Medical Electrical Equipment" safety standard series consists of two parts;
--- Part 1. General requirements for safety;
--- part 2. requirements for the safety.
Part 1 wherein in addition to other criteria in this section further comprises.
--- GB 9706.1 Medical Electrical Equipment Part 1. General requirements for safety;
--- YY0505 Medical Electrical Equipment Part 1-2. General requirements for safety Collateral Standard. EMC requirements and test;
--- GB 9706.12 Medical Electrical Equipment Part 1-3. General requirements for safety Collateral Standard. Diagnostic X-ray radiation apparatus
General requirements for protection;
This is Part 15.
This section is equivalent to using 60601-1-1 IEC .2000 "Medical Electrical Equipment Part 1. General requirements for safety Collateral Standard. Medical
Electrical system security requirements. "
This part is an international standard quoted in the standard Ruoyi into our standard main differences compared with the IEC 60601-1-1, this section
The International Standard quoted replaced with the corresponding number of criteria.
This partial replacement GB 9706.15-1999 "Medical electrical equipment. General requirements for safety. Collateral standard. medical electrical
System security requirements. "
This compared with GB 9706.15-1999 main portion changes as follows.
--- Terms and Definitions section were adjusted;
--- random file system (6.8.201) section requires increased;
--- Continuous leakage currents and patient auxiliary current content (Chapter 19) were adjusted accordingly;
--- connector (56.3.201) section requires increased;
--- line protection (59.201) removed some requirements;
--- appendix BBB adjustment has been made.
Section of this appendix CCC, EEE is normative appendix, the AAA Appendices, Appendix the BBB, DDD Appendices, Appendix data is FFF
Appendix.
This section proposed by the State Food and Drug Administration.
This part of the jurisdiction of the National Medical Electrical Standardization Technical Committee (SAC/TC10).
This section is detected by the Shanghai Medical Device drafted.
This part mainly drafted. He Jun, Huang Jiahua, Lu E.
This section replaces the following previously issued as follows.
--- GB 9706.15-1999.
GB 9706.15-2008/IEC 60601-1-1.2000
Medical Electrical Equipment
Part 1-1. General requirements for safety
Collateral standard. Safety requirements for medical electrical systems
The first chapter outlines
Scope 1 and object
1.2011) Scope
1) This paper provisions "" explanatory appendix AAA "overall guidance and preparation instructions."
This section applies to medical electrical systems (see definition of 2.201) security. This section provides for the protection of patients, operators and the environment
Provide necessary security requirements.
2 Terms and Definitions
In parallel to this standard, the term appears in bold, which is defined in its definition is consistent GB 9706.1.
Standard "voltage", "current" refers to the RMS AC, DC, or composite voltage or current.
For purposes of this section the following additional definitions apply.
2.201
A combination of multiple devices, wherein at least one of the medical electrical equipment and connections, or using transportable porous interconnected by socket function.
NOTE. If the device connected to the system, Medical electrical equipment to be included within the system. (See Appendix BBB and Appendix Example FFF)
2.202
Any space intentional or unintentional contact may occur between the components or other system components accessible human patient with the patient and the system (see
FIG. 201).
2.203
For safety reasons, to prevent unwanted transfer between the system components of voltage or current, and with input and output portions of the member or portion
Piece combination.
2.204
Two or more jack socket, when the composition or integrally connected with the flexible wire or wires intended, is connected to the mains supply, conveniently
To move from one another.
Note. Moveable porous plug may be separate parts or as part of a medical, non-medical devices.
2.205
Electrical or other connection, comprising means for transmitting signals and/or power connector and/or other substances.
3 General requirements
System General Requirements 3.201
After the system is installed or subsequent modifications, should not result in a safety hazard.
GB 9706.15-2008/IEC 60601-1-1.2000
A system should provide.
--- within the patient environment, to achieve the same level of safety requirements for medical electrical equipment GB 9706.1, and
--- environment outside the patient, to achieve the non-medical device relative to other national electrical safety standard (ISO or IEC or safety standards) requirements
The security level should be.
As to meet the requirements of 3.201.1,3.201.2,3.201.3 and 3.201.4 can be considered to meet the requirements. In one system,
Its material or structure or equipment used in the different components and 3.201.2 3.201.1 mentioned, it may prove equally if security
Full level, should be accepted.
Medical electrical equipment 3.201.1
Medical electrical equipment shall meet the requirements of its associated dedicated GB 9706.1 standards.
By checking the corresponding documents or certificates to verify compliance.
3.201.2 non-medical electrical equipment
Non-medical electrical equipment associated with the device should meet the safety standards (IEC standards or national standards, ISO standards), see Appendix
Record DDD.
Only basic insulation to prevent electric shock device is not applied to the system.
By checking the corresponding documents or certificates to verify compliance.
3.201.3 specific power
Specific power supply in line with 10.2.2.201 should meet the requirements of GB 9706.1 or prove it has the same level of security.
Note. should be combined or modified by the system power consumption of a computing system to ensure that the transportable porous plug can withstand the power consumption and record it.
By checking the corresponding documents or certificates to verify compliance.
3.201.4 system
After the installation or subsequent modifications, the system should meet the requirements of this standard parallel.
Through the inspection, testing or analysis of the provisions of the relevant provisions to verify compliance requirements.
You should only consider the risk of multiple devices coupled to internal components of the system caused.
The safety tests should be repeated in the system standards have been carried out independently of the device.
Testing should be carried out under the following conditions.
● Unless otherwise provided in this section, otherwise under normal conditions, and
● under the operating conditions specified system manufacturer.
6 to identify, mark and file
6.8.201 random file system
System (including the modified system) shall be accompanied by documented safety and the intended use of all necessary data.
These documents should include.
a) random file for each medical electrical equipment (see 6.8 GB 9706.1-2007);
b) non-medical file for each random-like electrical equipment;
c) the following information.
--- if applicable, of each device of the system consisting of cleaning, disinfection, sterilization described;
--- additional safety measures should be implemented during system installation;
--- which parts of the system environment suitable for use in a patient;
--- additional measures should be implemented during preventive maintenance;
--- Portable porous plug placed on the ground should not be warned;
--- Other additional transportable porous outlet or extension cord should not be warned of the access system;
--- components not predetermined warning system components should not access the system;
--- system using any removable receptacle type cellular maximum allowable load;
GB 9706.15-2008/IEC 60601-1-1.2000
--- Portable porous socket provided by the system, only the composition of the device for explaining the power supply system;
Description --- When the system consisting of the non-medical electrical device is intended to be portable multi-socket power isolation transformer with a directly with
Risk wall socket connection;
--- the access apparatus will be described the electrical system components of the non-movable type cellular risk socket;
--- To ensure the safety of any environmental conditions (see the Tenth Canto General Standard);
--- operator from touching description should not 16.201 mentioned member and the patient.
d) Recommendations
--- installers, to recommend that system was installed to allow the user to achieve the best results, and;
--- for the user to perform all cleaning, adjustment, disinfection and sterilization procedures prescribed herein.
By checks to verify compliance.
The second environmental conditions
10 environmental conditions
10.2.2.201 power supply
System power supply device from the additional equipment, the manufacturer should provide.
Title III protection against electric shock hazard
16 and shield housing
16.201 shell
Patients with non-medical environment components within electrical devices, without the use of tools to cover, rear connectors removed, routine maintenance may be
And calibration work an operator touches, the operating voltage of the AC component should not exceed 25V, 60V DC or peak, by press
In GB 9706.1-2007 17g) one of the methods 1) to 5) of the supply network power supply isolated.
By checks to verify compliance.
17 isolation
17.201 electrical isolation
If the connection between the different functions of the device and other systems in the system caused by the leakage current exceeds the allowable value, e.g., an emergency call
System or data processing system, safety measures should be used with the isolation device.
Such security measures to provide suitable electrical isolation between devices and/or systems and other systems, the spacer should have a fault condition
Appears in the dielectric strength of the highest voltage on the isolation means adapted, creepage distance and clearance.
Check the following manner.
The dielectric strength of the basic insulation should withstand 9706.1-2007 GB Chapter 20 in the section between the input and output of the isolation device
test.
Each part of the test terminal are shorted together.
From GB test voltage in table 5 9706.1-2007.
The reference voltage (U) or to the maximum rated supply voltage for the device is a multi-phase phase-neutral supply voltage line. For the internal power source is provided
Preparation, the reference voltage is AC 250V.
19 Continuous leakage currents and patient auxiliary current
19.201 leakage current
19.201.1 housing leakage current
Under normal conditions, in a patient environment, housing or system components from the leakage current between the system components should not exceed 0.1mA.
GB 9706.15-2008/IEC 60601-1-1.2000
Note. In this section, the device leakage current can reach the outer surface of the housing is considered to be the leakage current.
In the case where the protective conductor or similar conductor interrupt Movable sockets or porous non-permanent installation of the device, the patient environment
The housing from leakage current between the system components or system components should not exceed 0.5mA.
If the entire system or parts are powered by a multi-socket transportable, protective earth conductor can shift porous plug of formula
Leakage current should not exceed 0.5mA.
19.201.2 patient leakage current
Under normal conditions, B, and patients with type BF leakage current should not exceed application part 0.1mA, CF patients applications drain portion
Flow should not exceed 0.01mA.
Leakage current was measured by using measuring and inspection in GB 19.4e 9706.1-2007) the means to verify compliance
19.201.1 and 19.201.2 requirements.
19.201.3 signal input part is connected or the signal output portion
If the input signal is connected through a predetermined portion of the medical electrical equipment and/or the signal output part of the device only a predetermined random file,
When used to meet the requirements of GB 9706.1-2007 19.2b) of the first dash and/or 19.2c), and should the signal input part and/or letter
Signal output connected to a predetermined portion of the apparatus. For Class I devices but, if the specified device is not connected to the common grounding system protection, should
Using an isolation device (in the case of Table BBB.201 3).
By checks to verify compliance.
Title IV of the mechanical hazard protection
Moving member 22
22.7.201 protective measures
When the moving components in the system may cause safety hazards, 22.7 GB 9706.1-2007 system shall request hypo
Protection measures. For example, the emergency braking device.
By checks to verify compliance.
The fifth chapter of unnecessary or excessive radiation hazard protection
Title VI of the risk protection ignite flammable anesthetic gases mixed
Note. See 44.7.201.
Title VII of the ultra-mild other security risk protection
Overflow 44, liquid spill, leak, moisture, into the liquid, cleaning, disinfection, sterilization and compatibility
44.7.201 cleaning, disinfection and sterilization
See Appendix AAA information.
49 power supply interruption
49.201 power supply interruption
System should be designed to ensure that the power supply system of any medical device or medical electrical devices interrupted and resumed when, in addition to the intended function of
Interrupt, but does not cause a safety hazard.
With each related to a power supply interruption and resumption to verify compliance.
GB 9706.15-2008/IEC 60601-1-1.2000
The accuracy and prevent the risk of data output from the eighth chapter of the work
Chapter 9. abnormal operating and fault states; Environmental Testing
52 abnormal operating and fault states
52.1.201
Note. For the prevention of dangerous claim programmable medical electrical systems functions described in IEC 60601-1-4. Care should be taken, such as the influence of telematics.
Tenth Canto structural requirements
Component assembly 56 and
56.3.201 connection
Electrical, hydraulic, and the connecting end of the connector and aerodynamic design and manufacture of gas, should prevent accessible connector is not properly connected,
Danger and security caused by disassembly without tools.
--- the connector should meet the general criteria 17g) requirements;
--- unless it can be shown not to cause dangerous safety, otherwise the patient circuit wire plug connection, it should be designed to not get into the same
The system may be located on another receptacle patient environment.
By checks to verify compliance and, if possible, attach the head exchange, to confirm the safety hazard does not exist (leakage current exceeds
Value in the normal state, movement, temperature, radiation, etc.).
Mains supply portion 57, and the wiring components
57.2 network device power connectors and power input socket, etc.
Note. To prevent inadvertent access to other need not affect the system security devices, and power requirements of the fixed network connector. The system rewiring is very dangerous and
The tie beyond the standard range, and 6.8.201 has warned.
Movable porous plug 57.2.201
Tools to be used with medical access devices for portable multi-socket, or receptacle should be transportable porous isolation transformer.
By checks to verify compliance.
Isolating transformer and transportable porous plug should meet the requirements of the Appendix EEE.
57.10 creepage and clearance distances
Isolation means 57.10.201
Creepage distance and clearance of the isolation device 201 to comply with Table.
The reference voltage (U) or to the maximum rated supply voltage for the device is a multi-phase phase-neutral supply voltage line. For the internal power source is provided
Preparation, the reference voltage is AC 250V.
Table creepage distances and clearances isolation device 201
U/V
DC 15 3,675,150,300,450,600,800 900 1200
12 is AC 3,060,125,250,400,500,660 750 1000
Clearance/mm 0.8 1 1.2 1.6 2.5 3.5 4.5 6 6.5 9
Creepage distance/mm 1.7 2 2.3 3 4 6 8 10.5 12 16
Note. The table cited in claim GB 9706.1-2007 from Table 16 pairs of basic insulation or supplementary insulation.
By checks to verify compliance.
GB 9706.15-2008/IEC 60601-1-1.2000
58 and connected to the protective grounding terminal ---
58.201 protective earthing system
When the protective earth connection should be made when any device in the system is removed, without disrupting any protective grounding part of the system unless
And cut off the power supply portion.
And all of the ground conductor wire power cord should be protected with a wiring.
Any additional protective conductor system should be permanently connected to the moving member and Africa only a tool to remove.
By checks to verify compliance.
And a wiring structure 59
Protection 59.201 lines
Different devices connected to the system wires should have protection against mechanical damage.
By checks to verify compliance.
Note. the dimensions of non-limiting.
Examples patient environment 201 of FIG.
GB 9706.15-2008/IEC 60601-1-1.2000
Appendix AAA
(Informative)
The total preparation instructions and guidelines
1.201 range
This section is for the assembly and marketing of a combination of electrical equipment manufacturers comprising one or more medical electrical equipment used. This equipment can be
Each independently be a part of the housing or within one or a combination of the above.
This portion is also used when the medical industry for medical researchers assembly electrical system. In this case, the electrical equipment required design standards for the
Engineering knowledge to ensure that the system meets all the requirements of this standard.
Modern electronic technology and biomedical technology and the rapid development of medical practice, making more complex and diverse medical electrical
System Medical electrical equipment-substituted single patient diagnosis, treatment and monitoring.
Such a system is more applicable to different fields (not limited to the medical field) devices connected directly or indirectly in the composition. meets the
GB 9706.1 standard for medical electrical equipment can be connected non-medical and other electrical equipment. Each non-medical electrical equipment may comply with the
Requirements of safety standards in its areas of expertise, usually they do not meet the requirements for medical electrical equipment safety standards, therefore, possible shadow
Sound safety of the entire system.
Both for the electrical equipment housed in the diagnosis, treatment or the patient's medical care room, may be disposed in a non-medical doctors practice without
With room. Medical the room, electrical equipment may be placed inside or outside the defined region of the patient's environment.
In medical practice there are two possible situations.
a) The standard parallel exclusions
Medical electrical equipment work simultaneously, i.e., different medical electrical device connected to a patient simultaneously, but between devices
Not interconnected. Such medical electrical equipment may interfere with each other, for example, a high-frequency surgical operating room equipment may impact on
Patient monitoring equipment.
Note. Instructions for each medical electrical equipment may help.
b) This standard applies to the case of parallel
By the medical electrical equipment, electrical equipment and possibly for non-medical diagnosis or treatment on a patient, and permanent or temporary
Connection system thereof. For example. an X-ray diagnostic inspection system with a camera of the endoscope, patient monitor, with
A personal computer ultrasound apparatus, CT or magnetic resonance imaging system.
In various parts of such a system, it may be positioned inside or outside the patient's environment, but is still within a room or medical disposed
Room in a non-medical, for example, disposed in the distribution data processing apparatus or between rooms.
2.201 medical electrical systems
The basic principle allows the use of transportable porous plug within the system.
For maximum safe level without departing predetermined GB 9706.1, transportable multi-socket connection with a power supply network subject to certain conditions
Pieces. Additional requirements 57.2.201 transportable porous structure should meet the requirements of the socket GB 9706.1 Medical electrical equipment.
2.202 patient environment
Space is difficult to diagnose, monitor and treat the specified size range only. Of patient environment 201 shown in FIG been obtained in practice
To verify.
2.203 isolation means
The combination of the device as a system, may relate to power and/or signal transmission line is connected. Such connections have the same separation.
Movable porous plug 2.204
Definitions from GB 2099.1.
Use Portable porous plug is sometimes necessary, but at the same advantages and disadvantages, which should be carefully considered, on balance.
For the following reasons, it may require the use of transportable porous plug.
GB 9706.15-2008/IEC 60601-1-1.2000
--- minimize the number of power supply electrical cord on the floor;
--- even if an insufficient number of fixed network power outlet, but is still available to all therapeutic or diagnostic equipment;
--- improve mobility with a variety of devices on the same trolley;
--- reduction potential difference of the protective earth line, to be lower than a potential difference of some fixing means.
For the following reasons, we should avoid the use of transportable porous plug.
--- for the combined leakage current may lead to.
● Under normal conditions of earth leakage current is too large;
● protective earth conductor transportable porous plug housing due to the interruption the large leakage current.
--- Power supply available depending on whether a single fixed network reliability electrical outlet;
--- supply may be completely interrupted, it may take a long time to restart the entire system;
--- electric device on only a single protective earth connection; compared with the system each device directly grounded relative reliability
Poor;
--- protective grounding impedance increases.
Obviously, the installation according to the relevant specifications, the best solution is to install a sufficient number of fixed network outlet.
2.205 functional connectivity
In the definition of medical electrical systems, it allows non-medical electrical power to the medical devices may be connected by electrical equipment function. This power supply
This standard requires parallel limits (see 3.201.3 and 10.2.2.201) by.
"Others" may include a plurality of phrase case of mechanical connection, an optical connection or a wireless connection or the like.
General requirements 3.201 pairs system
Relevant documents relevant standards compliance may be the manufacturer's declaration of conformity or test certificate issued by the agency.
3.201.3 specific power
Security after the system is assembled by one or more of the measures implemented, such as.
Medical electrical equipment --- own security measures, such as the isolation of the relevant line;
--- a medical device isolation device as an electrical accessory (see 17.201);
--- a system accessory device isolation;
--- isolation transformer;
--- additional protective earth conductor.
4.7g non-medical electrical equipment may be in GB 9706.1-2007), 6.8.2h), 19.1c) and 17, the medical electrical
Providing a specific power device. The power supply shall meet the requirements of the particular GB 9706.1 or GB 3.4 Proof and the accreditation 9706.1-2007
It has the same degree of safety. See IEC 60513 as a guide.
3.201.4 System
The system is often determined by its properties modified; the present standard does not contain modifications within the parallel system a separate component.
6.8.201 random file system
Directly for the heart of the system, which should provide a random file information such as number of aspects.
--- rubber gloves;
--- use cock made of an insulating material;
The minimum distance between component devices and systems --- patient (patient environment......
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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