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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 comp...