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GB 9706.15-2008: Medical electrical equipment -- Part 1: General requirements for safety. 1 -- Collateral standard: Safety requirements for medical electrical systems
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
1.2011) 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 patie...