YY/T 0976-2016Medical electrical equipment-Dosimeters with ionization chambers as used in radiotherapy (English PDF)
医用电气设备放射治疗用电离室剂量计
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 23, 2016
Implementation date
January 1, 2017
Scope
YY/T 0976-2016 is the English-translated version of 医用电气设备放射治疗用电离室剂量计.
YY/T 0976-2016 is the Chinese pharmaceutical industry standard for dosimeters used in radiotherapy, the instruments that measure absorbed dose to water or air kerma, and their spatial distribution, in beams of photons, electrons, protons and heavy ions.
It sets the performance requirements for such dosimeters and the tests for them, covering the response and its energy and directional dependence, the linearity and the stability, the leakage and the environmental influences.
The dose monitoring system built into a treatment machine and the well-type chambers used to calibrate brachytherapy sources are outside its scope. Issued on 23 March 2016, it has applied since 1 January 2017.
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Document preview — YY/T 0976-2016
National Standard of the People's Republic of China
- ICS
- 11.040.50
- Classification
- C 43
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- 1 Scope and Purpose
- 1.1 Scope
- 1.2 Purpose
- 2 normative reference document
- 3 Terms and definitions
- 4 General requirements
- 4.1 Basic safety and main performance
- 4.2 Performance requirements
- 4.3 Reference value and standard test value
- 4.4 General test conditions and methods
- 4.5 List
- 4.6 Classification of equipment according to variation limits
- 5.1 Overview
- 5.4 Specific performance requirements for parallel plate ionization chambers
- 5.5 Specific performance requirements for non-sealed ionization chambers
- 6.1 Overview
- 6.3 Specific performance requirements for dosimeters
- 6.4 Specific performance requirements for dosages
- 6.5 Dedicated performance requirements for battery-powered measuring components
- 6.6 Dedicated performance requirements for measuring components of networked power supply
- 7.1 Overview
- 7.2 General performance requirements for stability testing equipment
- 8.2 Structural requirements for measuring components
- 8.3 Structural requirements for stability testing equipment
- 9 mark
- 9.1 Marking requirements for ionization chamber assemblies
- 9.2 Marking requirements for measuring components
- 9.3 Marking requirements for stability testing equipment
- 9.4 Marking requirements for mold bodies or capsules
- 10 random file
- 10.1 random files for ionization chamber components
- 10.2 Random files for measuring components
- 10.3 Stable documents for stability testing devices
- 10.4 Formal and built-in files
- Appendix A (informative) Values, Errors and Uncertainty
- Appendix B (normative) Test device for cable flutter
- Appendix C (Normative Appendix) Measurement Uncertainty Reference
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard uses the translation method equivalent to the use of IEC 60731.:2011 "medical appliances for radiation therapy with ionization chamber dosimeter" preparation.
And the normative reference in this standard international documents are consistent with the relationship between China's documents are as follows.
GB 4793.1-2007 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1. General requirements (IEC 61010 - 1..2001, IDT);
Graphical symbols for electrical equipment (all parts) (IEC 60417 all parts);
GB 9706.10-1997 Medical electrical equipment - Part 2. Particular requirements for the safety of X-ray generating devices (IEC 601-2-8. 1987, IDT);
GB 15213-2016 Performance and test methods for medical electron accelerators (IEC 60976.:2007, NEQ);
Electrical and electronic measuring equipment - Random documentation (IEC 61187.:1993, IDT); GB/T 16511-1996 Medical diagnostic X - ray equipment - Determination of characteristics - Radiation conditions (IEC 61267.:1994, IDT); YY/T 0481-2004;
YY 0505-2012 Medical electrical equipment - Part 1-2. General requirements for safety - Parallel standards. Electromagnetic compatibility requirements and tests (IEC 60601-1-2.:2004, IDT);
GB 4793.1-2007 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1. General requirements (IEC 61010 - 1..2001, IDT);
Standard documents for electrical and electronic measuring equipment (IEC 61187.:1993, IDT) GB/T 16511-1996.
For ease of use, this standard has been modified as follows.
- the introduction of IEC 60731.:2011 preface and introduction, increased the preamble;
--- For other international standards cited in the standard, if it has been converted into our standard, this standard uses our standard number to replace the corresponding international Standard;
--- with decimal point "." Instead of decimal point ",";
- In accordance with JJF 1059.1 "Measurement of uncertainty assessment and representation" provisions, delete the standard uncertainty before the value of the sign.
1 Scope and purpose
1.1 Scope
This standard specifies the performance requirements for dosimeters for radiotherapy. The dosimeter measures photons, electrons, protons or weights for radiotherapy Ion absorption field of water absorption dose (rate) or air kerma (rate) and its spatial distribution.
Radiation Therapy device-owned dose monitoring system and well-type ionization chamber for calibration of near-distance treatment centers and their stability test devices are not Within the scope of this standard. This standard applies to the following types of dosimeters.
a) Work grade dosimeters
1) measuring the specific kinetic energy or dose of the radiation beam in air or motif;
2) Measure the patient dose on the surface or inside of the active skin.
b) Reference level dosimeters commonly used to calibrate work stage dosimeters.
Note. The reference level dosimeter can also be used as a working grade dosimeter.
c) Scanning grade dosimeters equipped with automatic water molds for measuring relative dose distributions.
1.2 Purpose
The purpose of this standard is.
- to determine the radiotherapy dosimeter performance should meet the requirements;
--- specification to determine the performance of the method to meet the requirements. Provides three levels of performance.
--- Applicable to lower standards of work grade dosimeters;
--- Applicable to higher standards for reference grade dosimeters;
--- Special standard for scanning level dosimeters.
2 Normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 3358.1-2009 Statistical vocabulary and symbols - Part 1. General statistical terms and terms for probabilities (ISO 3534- 1..2006, IDT)
Medical electrical equipment - Diagnostic radiology dosages for X-ray tube voltage non-access measurements YY/T 0722-2009 Instrument (IEC 61676.:2002, IDT)
ISO /IEC GUIDE98-3..2008 Uncertainty of measurement - Part 3. Guidance on the expression of measurement uncertainty (GUM.
1995) [Uncertaintyofmeasurement-Part 3. Guidetotheexpressionofuncertaintyinmeasurement (GUM..1995)]
ISO /IEC GUIDE99..2007 International Metrology Vocabulary Basic and General Concepts and Related Terms (VIM) [International
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 69 pages — is available in the English PDF.
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