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GB 9706.5-2008: Medical electrical equipment -- Part 2-1: Particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV
GB 9706.5-2008
Medical electrical equipment.Part 2-1. Particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV
ICS 11.040.60
C43
National Standards of People's Republic of China
GB 9706.5-2008/IEC 60601-2-1.1998
Replacing GB 9706.5-1992
Medical Electrical Equipment
Requirements for the safety of electron accelerators
(IEC 60601-2-1.1998, 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
Introduction Ⅳ
The first chapter outlines 1
And a range of object 1
2 Terms and Definitions 2
General claim 4 Test 4
5 Category 5
6 to identify, mark and file 6
The second environmental conditions 8
10 environmental conditions 8
Title III of the danger of electric shock protection 8
8 and shield 16 of the housing
18 protective earth, and ground potential equalization function 10
19 Continuous leakage currents and patient auxiliary current 10
Title IV of protection against mechanical hazards 10
22 moving member 10
27 pneumatic and hydraulic power 12
28 pedants 12
The fifth chapter of unnecessary or excessive radiation hazard protection 12
Ionizing radiation safety requirements 13 29
36 29 Electromagnetic Compatibility
Title VI protection 29 pairs mixed flammable anesthetic gas ignition hazard
Chapter 9. abnormal operating and fault states; Environmental Testing 29
52 abnormal operation and fault status 29
Tenth chapter 30 structural requirements
Mains supply portion 57, and the wiring 30 Component
Appendix L (normative) --- reference publications mentioned in section 36
Annex AA (informative) Chinese index 37
English 41 Index
GB 9706.5-2008/IEC 60601-2-1.1998
Foreword
All technical contents of this section is mandatory.
"Medical Electrical Equipment" safety standard series consists of two parts.
--- Part 1. General requirements for safety;
--- part 2. requirements for the safety.
This part is the safety requirements, Part 5 9706 GB .
This section is equivalent to using IEC 60601-2-1.1998 "Medical electrical equipment energy of 1MeV ~ 50MeV medical electron accelerators
Requirements for safety "and its amendments No. 1.2002.
For ease of use, this section following editorial changes made.
--- omitted IEC 60601-2-1.1998 "Medical electrical equipment energy of 1MeV ~ 50MeV medical electron accelerators for Private
With the requirements "of the Foreword, Introduction and Appendix BB, an increase of this preface;
--- Annex L of this section is normative, which referred to the "General Standard Appendix L" refers in GB 9706.1-2007
Appendix L. Appendix AA this section is informative appendix;
--- For other international standards referenced standards, Ruoyi into our standards, this section replace the corresponding national standards with international numbers
Standard number, and indicate the correspondence relationship Annex L.
This partial replacement GB 9706.5-1992 "Medical electrical equipment 1 ~ 50MeV energy for the safety of medical electron accelerators
Claim".
This compared with GB 9706.5-1992 main portion changes as follows.
--- with GB 9706.1-2007 combination. In accordance with the general requirements of the standard, this part made modified accordingly;
--- increased in parallel standards such as IEC 60601-1-4, YY0505;
--- marking requirements for control devices and instruments made more excision, some parts of the original standard has been incorporated
GB/T 18987-2003; and
--- an increasing demand for use of the specification;
--- do more excision of technical specification requirements;
--- motion members presented more detailed requirements;
--- additions and changes to the ionizing radiation safety requirements;
--- is equivalent to using a single 1 edit IEC 60601-2-1.2002 Content. beam limiter total system leak limit provided (see in this section
29.3.1.1);
--- increased demand for non-normal operation and fault conditions;
--- omitted and assembly requirements of the components;
--- additions and changes to the accompanying drawings;
--- Added Appendix L (informative).
Appendix L of this part of the appendix is an informative annex AA.
This section proposed by the State Food and Drug Administration.
This part of the National Standardization Technical Committee medical radiation therapy, nuclear medicine and radiation dosimetry Equipment Standardization Technical Committee
Will (SAC/TC10/SC3) centralized.
This section was drafted. Beijing Medical Device Testing.
The main drafters of this section. Liu Yi, Sun Zhuohui, Wang Peichen, SONG Lian there.
This section was first released in November 1992, this is the first revision.
GB 9706.5-2008/IEC 60601-2-1.1998
introduction
If the device to the patient is given a non-desired dose or equipment design does not meet the electrical and mechanical safety standards, the use of electronic
Accelerator could do harm to the patient when radiation therapy; if not adequately control electron accelerator radiation and design (or) a defective treatment room
, The device may also hurt people nearby.
This section developed a design, manufacturing requirements electron accelerator for radiation therapy manufacturers should be observed, but it does not attempt to specification
Best performance is required speed. The object of this is to determine the current operation of such safety equipment necessary to consider the design point, provided it gives
Preparation of some performance degradation limit, if the performance of the device below these limits, the device can be considered to be in some trouble state, at this time should be
Interlocking means is operated to stop the continued operation.
It should be noted that prior to installation, the manufacturer shall provide a certificate of compliance related to the type tested at random file should package
Reports containing expressed in the form of field test report for this device test personnel to fill during installation.
GB 9706.5-2008/IEC 60601-2-1.1998
Medical Electrical Equipment
Requirements for the safety of electron accelerators
The first chapter outlines
Except as follows, common standard Benpian Cap shall apply.
1 Scope and purpose
1.1 Scope
supplement.
This section includes the type and field tests were applied to an electron accelerator) for producing and certain mounting 2) where.
--- intended for radiation treatment of human medical practice, including its operating parameters can be automatically controlled by a programmable electronic subsystem (PESS)
The number of the selection and display apparatus;
--- under normal conditions (NC), and in normal use, X radiation beam output from the apparatus and/or electron beam radiation.
● nominal energy of 1MeV to 50 MeV;
● at 1m from the radiation source, the maximum absorbed dose 3) rate between 0.001Gy · s-1 and 1Gy · s-1;
● normal therapeutic distance (of NTDs) from the radiation source between 0.5m and 2M;
---Simultaneously
● For normal use, obtain the appropriate license under the guidance of qualified personnel or personnel with special skills required by the medical applications
The operator operates, for a particular clinical purposes. i.e., a fixed or mobile radiation treatment beam radiation therapy;
● By using the manual method recommended maintenance;
● quality assurance and calibration of inspection by a qualified person on a regular bas...