GB 9706.5-2008 PDF in English
GB 9706.5-2008 (GB9706.5-2008) PDF English
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Medical electrical equipment -- Part 2-1: Particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV
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Medical electrical equipment. Particular requirements for the safety of medical electron accelerators in the range 1 MeV to 50 MeV
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GB 9706.5-2008: PDF in English 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 to enter a sequence of keystrokes or reset input normal use interlocking
Into. Another keystroke sequence can be input into the adjustment and maintenance mode.
2.1.111
A support member combination patient.
2.1.112
A dual channel combination dose monitoring system. As a primary dose monitoring system, as a secondary channel other dose monitoring system.
2.1.113
Approved by the competent authorities, with the requisite knowledge and after the necessary training, to complete the prescribed duties of staff.
GB 9706.5-2008/IEC 60601-2-1.1998
2.1.114
Properties of particles constituting the radiation or waves, whether radiation is electron radiation or X radiation.
2.1.115
A dual combination of channel monitoring system dose, dose monitoring the count reaches a preselected value, two radiation dose monitoring system can be terminated.
2.1.116
In the phantom surface thereof is located a certain predetermined distance, the reference axis, the absorbed dose at a maximum depth of 0.5mm absorbent
Volume ratio.
2.1.117
After installation, the test of a component or device, to determine whether or not meet the required standards.
2.1.118
Stop irradiation and movement, if not re-select all of the operating conditions (that is, return to the pre-state), irradiation can not start again.
Note. The following events will terminate irradiation and stop motion.
● dosage monitoring unit reaches a preselected value;
● achieve a preselected time;
● a beam stop deliberate manual operation;
● a locking action;
● moving beam radiation therapy, when more than a preselected angle or linear dimensions.
2.1.119
Penetrating radiation beam detector.
2.1.120
By the manufacturer of the instrument or device a specially designed test done to determine if the design meets the required standards.
General requirements Test 4
4.1 Test
supplement.
4.1.101 test grading
Cap portion 29 defines the three field type test and two test methods, and requires the following.
● A class type test. the device design and analysis of radiation safety measures provided. This analysis involves work to meet safety requirements
As a principle or structural measures, which must be set forth in the technical design specification.
● Class B type testing/field trials. direct view of the test or measurement devices or functions. This test must be present specific standard gauge
Test Method given. It must not change during the test device or circuit structures operating state (including error state) conditions
Under carried out.
● C class type testing/field trials. set as a function of test or measurement equipment. The test must comply with the principles set out in this section, now
Field test methods must be included in the technical specification. When the test method requires changes to operating conditions or a circuit device structure in the
When carried out under the test should be carried out by the manufacturer or its agents or under their direct supervision.
GB 9706.5-2008/IEC 60601-2-1.1998
Category 5
replace.
Equipment and its application part must be done in Chapter 6. The markers and/or recognition to classify. These include.
5.1 by type of protection against electric shock of points.
--- is a Class I equipment.
5.2 according to the degree of protection against electric shock of points.
--- is a type B application part.
5.3 Press GB 4208 (IEC 60529) [see 6.1L)] degree of protection of the partial immersion as detailed in.
--- Unless otherwise specified, is IPX0.
5.4 disinfection or sterilization method according to the recommended instructions for use.
5.5 security extent by mixing a flammable anesthetic gas and air or the mixed gas of oxygen and nitrous oxide or point.
--- apparatus belongs can not be used in a flammable mixture with air or anesthetic gas and oxygen or nitrous oxide situation.
Work by 5.6 points.
--- Unless otherwise specified, are intermittent load continuous operation of the equipment.
Added. Table 101
Table 101 to support field test Chapter 29, in the technical specification required data
To comply with Article
Class A type test
The data illustrate
Class B type testing
The results and details
Class C type test
The results and details
C-level tests specified site
Methods and test conditions
29.1.1.1 b), d), e) d) a), b), c)
29.1.1.2 a), b) b), c) b)
29.1.1.3 d), e), f)
29.1.1.4 a), b), c) b), c)
29.1.1.5 a) b)
29.1.2 a), b), c) b), c)
29.1.3 b), c), d), e) b), c), d), e)
29.1.4 a), b), c), d), e), f), g)
29.1.5 e) e)
29.1.6 e), h) f), g) e), f), g), h)
29.1.7.1 d)
29.1.7.2 d)
29.1.7.3.1
29.1.7.3.2 d)
29.1.9 b)
29.1.10 e)
29.1.11
29.1.12 a), c)
29.1.13 a)
29.1.14 a), b) a), b)
GB 9706.5-2008/IEC 60601-2-1.1998
TABLE 101 (CONTINUED)
To comply with Article
Class A type test
The data illustrate
Class B type testing
The results and details
Class C type test
The results and details
C-level tests specified site
Methods and test conditions
29.1.15
29.2.1
29.2.2
29.2.3
29.3.1.1 a), b), c), d)
29.3.1.2 c) a) 1), a) 2), b) c)
29.3.2
29.3.3
29.3.4 or
29.4.1 a), b)
29.4.2
29.4.3 b) a)
29.4.4
29.4.5
Note. means no special requirements other provisions.
6 to identify, mark and file
6.1 member external device or tag
d) marked on the device and replaceable component the minimum requirements
supplement.
All external non-adjustable and interchangeable beam limiting device and the electron beam collimator must be clearly marked at normal therapeutic distance
Distance from the normal therapeutic radiation field size and geometry at the tip.
Each wedge may be manually replaceable filter must clearly have an identification mark.
z) a removable protector
supplement.
During installation, if it is to meet all the requirements of the requirements of this section or in part by the state installed, you should check whether the installation to
Requirements, field test results should be recorded in the report.
6.2 Internal marking device or device component
supplement.
aa) the radiation head cover is removed, it must be exposed universal standard table D. No. 1 14 mark, pointing out. "Attention random access to files!."
And marking instrument controller 6.3
supplement.
6.3.101 moving member and a predetermined scale indication
You must provide.
a) each moving in the form of a digital scale or indication;
b) light field indicating its position in the reference axis;
c) the reference axis, from the front surface of the radiation source from the patient's skin or to scale a digital indication (from the source skin); identifying all movements
The direction of increasing values of zero and must conform to GB/T 18987 (see FIG. 108) requirements.
By viewing, testing whether it meets the requirements.
GB 9706.5-2008/IEC 60601-2-1.1998
6.7 lights and buttons
a) Indicator Color
supplement.
The color must meet the following requirements in the treatment console (TCP) or other board surface of the indicator lights.
● yellow radiation beam 4);
● readiness green 4);
4) in the treatment room or other places, above labeled "4)" The state may require urgent action or attention, and therefore can be used in these locations
Different colors specified in Table 3 common standards.
● unexpected circumstances occur, urgent need to terminate the machine running red;
● Preset status with other colors.
In the following cases, light emitting diodes (LEDs) are not considered as an indicator.
--- console on either treatment, does not require special indication for all colors by light-emitting diodes of the same color
(LEDs) are given, and
--- particular color indicating the requirement is clearly discernible.
6.8 random file
6.8.1 Overview
supplement.
NOTE. manual and technical specification, constitute part of the random file. In addition to the technical specifications set forth in Table 101 to perform site trial of Chapter 29
Essential experimental data, the present section also requests information in the random file, manual and technical specification of column in table 102 chapters.
6.8.2 Manual
a) general content
supplement.
--- Manual must include the following.
● All interlocks and other features of the apparatus described radiation safety;
● test indicates its normal operation;
● should recommend periodic testing of this kind;
● When the device in normal use, the dielectric strength of the ionizing radiation of certain components and/or mechanical strength may affect the damage
When safety performance, it is recommended to view or replace such parts intervals.
j) environmental protection
supplement.
Note. Users of radiological protection advisers should normally be responsible for identifying and disposing of radioactive materials personnel.
To assist users of radiation protection adviser, you must provide the following information.
--- When following normal use, the distance normal therapeutic radiation energy and the corresponding maximum dose rates.
● X radiation (if with or without additional filtration device can be used normally, the two sets of data are given);
● electronic radiation.
--- for X-radiation and electron radiation, the radiation field geometry the maximum normal therapeutic marked at a distance of shapes and sizes;
--- the following positions relative to the radiation head accessible site.
● the front surface of the target, and;
● electronic window;
--- the direction of the radiation beam can be achieved;
--- if the use of a beam-shielding, it is given energy transmittance of each of the X-radiation;
--- guidelines and precautions to identify possible radioactive device or piece of equipment, operation and disposal.
GB 9706.5-2008/IEC 60601-2-1.1998
6.8.3 SHEET
a) Overview
supplement.
When --- normal use, detailed on the environmental conditions and supply conditions.
Supplementary items.
aa) information field test used.
Technical specification must include.
--- A class type described test results;
--- Class B and C type test details and results;
--- C-class methods and test conditions specified in field trials;
Note 1. listed in Table 101, to verify compliance with the terms of Chapter 29 requirements for field tests.
--- shows how to generate a said fault condition. If you can not generate, and then shows how to generate a signal that may be generated
Source as close as possible to the test signal and the test signal is confirmed by simulation described is a special fault conditions that may arise
signal.
Note. In some cases, a test signal may simulate more than one fault condition.
--- Description field after the completion of the test device is reset to normal use and how to verify that the normal state.
Note 2. The person responsible for the field test results should be recorded in the report, this report forms part of random files; in addition, to field test report should
Less include.
● site user's name and address;
● marking device type (model number) and serial number;
● names of all personnel involved in the testing, title, address and services involved in the trial date;
● environmental conditions and power supply conditions;
● or the actual situation when different data can not be obtained by the part of the test conditions, the manufacturer of the instrument or the methods given.
Compliance is by looking at the technical specifications, test.
The second environmental conditions
Except as follows, "General Standard" in the chapter of the chapter shall apply.
10 environmental conditions
supplement.
Note. See 1.1 third dash, point 4 and 6.8.3a) supplement.
10.2.2 Power
a) Equipment shall apply the following power.
modify.
The second dash amended as follows.
--- source resistance low enough to ensure that the voltage fluctuates between the load and no-load steady state no more than ± 5%.
Title III protection against electric shock hazard
Except for the following supplementary, "General Standard" in the chapter of the chapter shall apply.
16 and shield housing
supplement.
aa) When the requirements of this chapter wholly or partly met by the mounted state, must be specified in the test methods random file.
By looking at the installation and testing should, verify compliance, field test results should be recorded in the report, see 57.1a).
GB 9706.5-2008/IEC 60601-2-1.1998
supplement.
Table 102 bar provides chapter and section requires information in a random file, manual and technical specification
Note. The following reference test is designed to help test the effectiveness of compliance with the requirements document.
Test Reference Manual random file SHEET
1 1.1
2 1.1
3 4.1.101
4 5.4
5 6.1d) by the GB 9706.1 6.8.1/6.1d)
6 6.2aa)
......
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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