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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 basis;
● specified in the technical specification under the environmental conditions and power supply conditions.
1.2 Purpose
supplement.
Requirements of this proposed aimed at ensuring the safety of ionizing radiation electron accelerator to enhance the security of its electrical and mechanical aspects of the trial and regulations
Test method to verify compliance with these requirements.
Note. This section will help ensure that the equipment employed.
● When a power failure and ensure patient safety during sports equipment;
● a preselected type of radiation output, and the nominal energy absorbed dose;
● using a fixed radiation therapy, radiation treatment beam moves, the beam shaping device and the like, according to the radiation beam with respect to a preselected relationship between the patient's patient
Irradiation; while ensuring the patient, the operator and other personnel or the environment from unnecessary harm.
1) See ICRP33128 ~ 134 and 144 ~ 156.
2) In this section, all involve mounting means installed in the user premises.
3) In this section, all according to absorbed dose refers to the dose absorbed in water.
1.3 Specific Standard
supplement.
1.3.101 relationships with other standards and documents
Note. See Appendix L normative standard reference documents.
GB 9706.5-2008/IEC 60601-2-1.1998
1.3.102 GB 9706.1 (GB 9706.1-2007, IEC 60601-1. 1988, IDT)
Requirements of this priority over all other criteria. It GB 9706.1-2007 "Medical Electrical Equipment Part 1. General Safety
Requirements "(IEC 60601. 1988 and its amendments No. 1 to change a single 1991) used in combination, hereinafter referred to as common standards. As with common standards, requirements
The test methods followed.
Some articles, chapters, bars, there is no universal standard in this part of the corresponding article, chapter, article, may not be relevant, then the implementation of common standards
These articles, chapters, bars, must not be modified. If the universal standard in a part, perhaps related, but not used, will be present for this section is given a
A description. Unless otherwise stated, all provisions of common standards must be adopted. "This section" refers to a common standard, and this section.
Part of this section, chapter, article number consistent with common standards. The following common standards and tied for standard text changes, the provisions of
Words.
--- "replace", the General Standard Cap means or strip completely replaced by the provisions of this section;
--- "complementary" means that the provisions of this part attached to the requirements of common standards;
--- "Edit", did that mean that the General Standard modify chapter or section as described in this section.
For supplementary to those provisions common standard, a chart or table numbered starting from 101, supplemented by the letter Appendix AA, BB and other identification,
Supplementary items listed by aa), bb), etc. represent.
1.3.103 GB/T 18987 "radiotherapy apparatus Coordinates, movements and scales" (GB/T 18987-2003, IEC 61217.1996,
IDT)
GB/T 18987 gives the movement of the device name, identification scale, the direction guidance aspects their zero position and movement of the added value
(See 6.3.101).
1.5 Collateral Standard
supplement.
1.5.101 GB 9706.15 "Medical Electrical Equipment Part 1-1. General Requirements for Safety Collateral Standard. safety to medical electrical systems
Seeking "(GB 9706.15-1999, idt IEC 60601-1-1.1995)
The collateral standard does not apply.
1.5.102 YY0505 "Medical Electrical Equipment Part 1-2. General requirements for safety Collateral Standard. EMC requirements and tests"
(YY0505-2005, IEC 60601-1-2.2001, IDT)
EMC requirements and test in Chapter 36.
NOTE. YY0505-2005/IEC 60601-1-2.2001 suitable for medical electrical equipment and ITE (information technology equipment) for use in medical applications. electronic
Accelerator and ITE part, without exception, must comply with YY0505-2005; it is not yet fully established in addition to the contents of this section in Chapter 36
In addition, these requirements and whether it should be modified test.
1.5.103 GB 9706.12 "Medical electrical equipment. General requirements for safety III. Collateral standard diagnostic X-ray radiation device
General requirements radio protection "(GB 9706.12-1997, idt IEC 60601-1-3.1994)
The collateral standard does not apply.
1.5.104 IEC 60601-1-4
Programmable electronic subsystem (PESS) Requirements and test to see 29.1.15 and 52.1b).
2 Terms and Definitions
2.1 parts equipment, auxiliary equipment and accessories
supplement.
Note. Appendix AA and English index in the order listed in the definition of terms and their provenance.
Supplementary definition.
2.1.101
And for measuring the irradiation time reaches a predetermined time irradiation of the device is terminated.
GB 9706.5-2008/IEC 60601-2-1.1998
2.1.102
Electron beam radiation beam limiting device.
2.1.103
It means the radiation head supporting device.
2.1.104
Contemplated from the target/center electron window surface can be seen, the end of the beam limiting device is cast on a geometrical plane perpendicular to the reference axis
shadow. This radiation field geometry may be defined at any distance. This distance, refers to X-radiation to the front surface of the target, means of electron radiation
To electronic window.
2.1.105
System performance can only rely on physical movement and rewiring to change.
2.1.106
Pause irradiation and movement, without having to re-select operating conditions to continue irradiation.
2.1.107
Field of the radiation are moved relative to the patient or to absorbed dose distribution of radiation therapy schedule performed by changing the schedule.
2.1.108
a) for electron radiation, given by the manufacturer, used to characterize the radiation beam energy. This available energy is approximately equal to the surface of the phantom measurements
The most probable energy Ep, 0 (see section 3.3 Report No. ICRU35; energy Ep, 0).
b) For X-radiation, given by the manufacturer, used to characterize the radiation beam energy.
2.1.109
a) for the electron irradiation, along a predetermined reference axis, the electron beam from the electron beam limiter window to tip or to a predetermined distance from the plane;
b) the X-radiation, along a predetermined reference axis, the distance from the front surface of the target to isocenter; isocentric device does not, it is to
Plane a predetermined distance.
2.1.110
Programmable electronic subsystem (PESS) control apparatus, allows the operator ...