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GB 9706.201-2020: Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
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Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
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GB 9706.201-2020
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Basic data | Standard ID | GB 9706.201-2020 (GB9706.201-2020) | | Description (Translated English) | Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV | | Sector / Industry | National Standard | | Classification of Chinese Standard | C43 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 47,430 | | Date of Issue | 2020-12-24 | | Date of Implementation | 2023-05-01 | | Older Standard (superseded by this standard) | GB 9706.5-2008 | | Quoted Standard | GB/T 18987-2015; IEC/TR 60788-2004 | | Adopted Standard | IEC 60601-2-1-2014, MOD | | Regulation (derived from) | National Standard Announcement No. 31 of 2020 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | | Summary | This standard applies to the basic safety and basic performance of therapeutic electron accelerators with an energy of 1 MeV to 50 MeV, hereinafter referred to as ME equipment. This standard includes type tests and field tests, which are respectively applicable to the manufacture and certain installation aspects of electron accelerators: intended for radiotherapy in human medical practice, including the ability to automatically control its operating parameters by the programmable electronic subsystem (PESS) The selection and display of equipment. Under normal conditions and in normal use, the X-radiation beam and/or electron radiation beam output by the device: nominal energy is 1 MeV to 50 MeV; the maximum absorbed dose rate is 0.001 at 1 m from the radiation source Gy��s^(-1), and 1 Gy��s^(-1); normal treatment distance (NTDs) distance | GB 9706.201-2020: Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
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Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
ICS 11:040:60
C43
National Standards of People's Republic of China
Replace GB 9706:5-2008
Medical Electrical Equipment Part 2-1: Energy is
Basic safety of 1MeV to 50MeV electron accelerator
And basic performance specific requirements
1MeVto50MeV
(IEC 60601-2-1:2014, MOD)
Released on 2020-12-24 Implemented on 2023-05-01
State Administration for Market Regulation
Issued by the National Standardization Management Committee
Table of contents
Preface Ⅲ
Introduction Ⅴ
201:1 Scope, purpose and related standards 1
201:2 Normative references 2
201:3 Terms and Definitions 3
201:4 General requirements 5
201:5 General requirements for ME equipment testing 6
201:6 Classification of ME equipment and ME systems 6
201:7 ME equipment identification, marking and documentation 6
201:8 Protection against electric shock hazards of ME equipment 11
201:9 Protection of ME equipment and ME systems against mechanical hazards 11
201:10 Protection against unwanted or excessive radiation hazards 14
201:11 Protection against over-temperature and other hazards 30
201:12 Accuracy of controllers and instruments and protection of dangerous outputs 30
201:13 Hazardous and fault conditions of ME equipment 31
201:14 Programmable Medical Electrical System (PEMS) 31
201:15 Structure of ME equipment 31
201:16 ME System 32
201:17 Electromagnetic compatibility of ME equipment and ME system 32
201:101 Electronic imaging device (e:g: EPID) 32
206 Availability 33
Figure:201:101 Stray X-radiation limit in electron radiation (201:10:1:2:102:1) 33
Figure:201:102 X-radiation relative surface dose limit (201:10:1:2:102:2) 34
Figure:201:103 front view --- used for leakage radiation requirements (201:10:1:2:103 and:201:10:1:2:104) 34
Figure:201:104 X-radiation average leakage radiation 24 measuring points (201:10:1:2:103:2:1) 35
Figure:201:105 Electron radiation-the limit of leakage radiation passing through the beam limiter (201:10:1:2:103:2:2) 36
Figure:201:106 Leakage radiation measurement point in electron radiation (201:10:1:2:103:2:2) 36
Figure:201:107 Average leakage radiation outside M area 24 measurement points (201:10:1:2:103:3) 37
Figure:201:108 Motion and scale of ME equipment 38
Appendix 39
Appendix B (informative appendix) Test sequence 40
Appendix I (informative appendix) ME system aspects 41
References 42
Foreword
GB 9706 "Medical Electrical Equipment" is divided into the following parts:
---Part 1: General requirements for basic safety and basic performance;
---Part 1-3: General requirements for basic safety and basic performance Parallel standard: Radiation protection of diagnostic X-ray equipment;
---Part 2-1: Specific requirements for the basic safety and basic performance of electron accelerators with energy from 1MeV to 50MeV;
---Part 2-2: Special requirements for the basic safety and basic performance of high-frequency surgical equipment and high-frequency accessories;
---Part 2-3: Special requirements for basic safety and basic performance of short-wave treatment equipment;
---Part 2-4: Special requirements for the basic safety and basic performance of cardiac defibrillators;
---Part 2-5: Special requirements for the basic safety and basic performance of ultrasonic physical therapy equipment;
---Part 2-6: Special requirements for the basic safety and basic performance of microwave therapy equipment;
---Part 2-8: Special requirements for the basic safety and basic performance of therapeutic X-ray equipment with an energy of 10kV to 1MV;
---Part 2-11: Special requirements for basic safety and basic performance of gamma beam therapy equipment;
---Part 2-12: Special requirements for the basic safety and basic performance of intensive care ventilators;
---Part 2-13: Special requirements for basic safety and basic performance of anesthesia workstations;
---Part 2-16: Specific requirements for basic safety and basic performance of hemodialysis, hemodiafiltration and hemofiltration equipment;
---Part 2-17: Special requirements for basic safety and basic performance of automatic control brachytherapy after-installation equipment;
---Part 2-18: Specific requirements for basic safety and basic performance of endoscopic equipment;
---Part 2-19: Special requirements for basic safety and basic performance of infant incubators;
---Part 2-22: Special requirements for basic safety and basic performance of laser equipment for surgery, plastic surgery, treatment and diagnosis;
---Part 2-24: Specific requirements for basic safety and basic performance of infusion pumps and infusion controllers;
---Part 2-25: Special requirements for basic safety and basic performance of electrocardiograph;
---Part 2-26: Specific requirements for the basic safety and basic performance of EEG machines;
---Part 2-27: Special requirements for basic safety and basic performance of ECG monitoring equipment;
---Part 2-28: Special requirements for the basic safety and basic performance of medical diagnostic X-ray tube components;
---Part 2-29: Specific requirements for the basic safety and basic performance of radiotherapy simulators;
---Part 2-36: Specific requirements for the basic safety and basic performance of in vitro lithotripsy equipment;
---Part 2-37: Special requirements for the basic safety and basic performance of ultrasonic diagnostic and monitoring equipment;
---Part 2-39: Specific requirements for the basic safety and basic performance of peritoneal dialysis equipment;
---Part 2-43: Special requirements for the basic safety and basic performance of interventional X-ray equipment;
---Part 2-44: Special requirements for the basic safety and basic performance of X-ray computed tomography equipment;
---Part 2-45: Special requirements for the basic safety and basic performance of mammography equipment and mammography stereotaxic devices;
--- Part 2-54: Specific requirements for the basic safety and basic performance of X-ray photography and fluoroscopy equipment;
---Part 2-60: Special requirements for basic safety and basic performance of dental equipment;
---Part 2-63: Special requirements for the basic safety and basic performance of extraoral imaging dental X-ray machines;
---Part 2-65: Specific requirements for the basic safety and basic performance of intraoral imaging dental X-ray machines;
---Part 2-66: Special requirements for basic safety and basic performance of hearing equipment and hearing equipment system:
This part is Part 2-1 of GB 9706:
This section was drafted in accordance with the rules given in GB/T 1:1-2009:
This part replaces GB 9706:5-2008 "Medical Electrical Equipment Part 2: Electron acceleration with energy from 1MeV to 50MeV
Compared with GB 9706:5-2008, the main technical content changes are as follows:
---Added some terms and definitions (see:201:3:201,:201:3204,:201:3:205,:201:309,:201:322,:201:323
And:201:224):
---Added some new technologies in radiotherapy:
● Stereotactic radiosurgery (SRS) and stereotactic radiotherapy (SRT) (see:201:323,:201:322,
201:10:1:2:101:9);
● Intensity Modulated Radiotherapy (IMRT) (see:201:3:209);
● Electronic Field Imaging Device (EPID) (see:201:3:205,:201:101);
● Moving beam therapy (dynamic therapy) (see:201:3:211,:201:10:1:2:101:6):
---Added the relevant requirements of the programmable medical electrical system (PEMS) (see:201:14):
This part uses the redrafting law to amend and adopt IEC 60601-2-1:2014 "Medical Electrical Equipment Part 2-1: Energy is 1MeV
Special requirements for basic safety and basic performance of up to 50MeV electronic accelerator:
The technical differences between this part and IEC 60601-2-1:2014 and the reasons are as follows:
---Regarding normative reference documents, this section has made adjustments with technical differences to adapt to my country's technical conditions and adjustments:
The situation is collectively reflected in:201:2 "Normative Reference Documents", and the specific adjustments are as follows:
● Replace IEC 60601-1 (see:201:2 and related provisions) with GB 9706:1 which is modified to adopt international standards;
● Replace IEC 61217:1996 (see:201:2 and related provisions) with GB/T 18987-2015 equivalent to the international standard:
--- Deleted "Note 3" in:201:1:1 in the international standard;
--- Delete the "Note" in:201:3 in the international standard;
---Modified "IEC 61217:1996" in the international standard:201:2 to "IEC 61217:2008";
---IEC 60976:2007 in the references is replaced by GB 15213-2016:
This section also made the following editorial changes:
---The term index of the international standard has been deleted:
Please note that certain contents of this document may involve patents: The issuing agency of this document is not responsible for identifying these patents:
This part is proposed and managed by the State Drug Administration:
The previous versions of the standards replaced by this part are as follows:
---GB 9706:5-1992, GB 9706:5-2008:
Introduction
For electron accelerators for the purpose of radiotherapy, if the device that transmits the dose to the patient fails, or the device design does not meet the electrical requirements:
In accordance with the requirements of mechanical safety standards, patients may be injured during use: If the equipment itself cannot adequately control the radiation, or the design of the treatment room
Inappropriate, it may also injure other people nearby:
This part sets out the requirements that manufacturers who design and manufacture electron accelerators for radiotherapy should comply with, but it is not an attempt to specify accelerators:
Optimal performance requirements: The purpose of this section is to determine the current design points to be considered for the safe operation of such equipment: This section sets the
If the performance of the equipment is lower than these limits, it can be considered that the equipment is in a certain fault state: At this time, the interlocking device should
Action to prevent the equipment from continuing to run:
In order to ensure basic performance and avoid unsafe conditions, if the limit in:201:10 is exceeded, the interlock will prevent, interrupt or terminate the irradiation:
Each requirement specifies the type test (completed by the manufacturer) and/or field test (not necessarily completed by the manufacturer): Of course, according to the system
According to the agreement between the manufacturer and the user, the field test may or may not be completed by the manufacturer:
Considering that the manufacturer cannot provide field test data before the equipment is installed, the data measured in the field test should be in the form of the field test report:
Type, compiled into the accompanying documents by the on-site installer of the equipment:
GB 15213 is the performance standard for electron accelerators used in radiotherapy:
Medical Electrical Equipment Part 2-1: Energy is
Basic safety of 1MeV to 50MeV electron accelerator
And basic performance specific requirements
201:1 Scope, purpose and related standards
Except for the following, general standard 1) Chapter 1 applies:
1) The general standard refers to GB 9706:1-2020 "Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Basic Performance":
201:1:1 Scope
replace:
This section applies to the basic safety and basic performance of therapeutic electron accelerators with energy from 1MeV to 50MeV, hereinafter referred to as
ME equipment:
This part includes type tests and field tests, which are applicable to the manufacture and certain installation aspects of electron accelerators:
---It is intended to be used in radiotherapy in human medical practice, including the ability to automatically control its operation by the programmable electronic subsystem (PESS)
Parameter selection and display equipment:
---Under normal conditions and in normal use, the X-radiation beam and (or) electron radiation beam output by the device:
● The nominal energy is 1MeV to 50MeV;
● At 1m away from the radiation source, the maximum absorbed dose rate is between 0:001Gy·s-1 and 1Gy·s-1;
● The normal treatment distance (NTDs) is between 0:5m and 2m from the radiation source:
at the same time,
---Expected to be used for:
● For normal use, under the guidance of the corresponding licensed or qualified personnel, it is necessary to have the skills required for special medical applications
Operated by operators for specific clinical purposes, such as fixed radiation therapy or moving beam radiation therapy;
● Maintain according to the method recommended in the instruction manual;
● Regular quality assurance and calibration inspections by qualified personnel:
Note 1: In this section, all involved installation refers to the installation at the location of the responsible party:
Note 2: All the absorbed doses involved in this section refer to the absorbed dose in water:
GB/T 18987-2015 gives the naming of the equipment movement, the marking of the scale, their zero position and the direction of the movement increase value:
Guide (see:201:7:4:11):
GB 15213 specifies methods for testing and publishing the functional characteristics of medical electron accelerators: The purpose of this standard is to facilitate different manufacturers
Comparison between accelerator-based ME equipment: GB 15213 does not include safety requirements, so it does not need to be consistent with this section: this
In addition, it should also be noted that the test specified in GB 15213 does not guarantee that a medical electron accelerator meets the claim during its working life:
Features:
201:1:2 Purpose
replace:
The purpose of this part is to establish specific requirements for the basic safety and basic performance of electron accelerators with energy from 1MeV to 50MeV, and to regulate
Set test methods to verify compliance with these requirements:
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