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YY/T 0894-2013 English PDF

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YY/T 0894-2013: Medical electrical equipment. Dosimetric instruments as used in brachtherapy. Instruments based on well-type ionization chambers
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YY/T 0894-2013English439 Add to Cart 4 days [Need to translate] Medical electrical equipment. Dosimetric instruments as used in brachtherapy. Instruments based on well-type ionization chambers Valid YY/T 0894-2013

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Basic data

Standard ID YY/T 0894-2013 (YY/T0894-2013)
Description (Translated English) Medical electrical equipment. Dosimetric instruments as used in brachtherapy. Instruments based on well-type ionization chambers
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C43
Classification of International Standard 11.040.50
Word Count Estimation 19,153
Quoted Standard GB/T 2900.81-2008; GB/T 19629-2005; GB/T 20012-2005; IEC 60417; IEC 60601-1-2005; IEC 60731-1997; IEC/TR 60788-2004; IEC 61187; ISO/IEC GUIDE 99
Adopted Standard IEC 62467-1-2009; MOD
Regulation (derived from) State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies: well type ionization chamber measurements and ancillary components (see Chapter 3 definitions) Performance and certain structural requirements, for the determination of a quantity, example: for a given type after proper calibratio

YY/T 0894-2013: Medical electrical equipment. Dosimetric instruments as used in brachtherapy. Instruments based on well-type ionization chambers


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Medical electrical equipment.Dosimetric instruments as used in brachtherapy.Instruments based on well-type ionization chambers ICS 11.040.50 C43 People's Republic of China pharmaceutical industry standards Medical electrical equipment brachytherapy dose Instruments based on well type ionization chamber instrument (IEC 62467-1.2009, MOD) Issued on. 2013-10-21 2014-10-01 implementation China Food and Drug Administration released

Table of Contents

Introduction Ⅲ Introduction Ⅳ 1 Scope 1 2 Normative references 1 3 Terms and definitions 2 4 General requirements 4 4.1 Performance Requirements 4 4.2 measuring assembly 5 4.3 of 5 types of source 4.4 was measured 5 4.5 Reference conditions and standard test conditions 5 4.6 General test conditions 6 Structure and properties of the relevant requirements of 4.7 6 4.8 Test 7 member Limit performance characteristics 7 5 5.1 Insert the source location and repeatability 7 5.2 effective length 8 Display resolution 5.3 8 5.4 Settling Time 8 Leakage current 5.5 8 8 5.6 Stability 6 affected by the amount of the impact of changes in the limits 9 6.1 Overview 9 6.2 ionization chamber - Composite loss 9 6.3 Operating voltage 9 6.4 air pressure 10 6.5 air pressure changes and the radiation detector equilibration time 10 6.6 Temperature and humidity 11 6.7 length of the response 11 6.8 Electromagnetic Immunity 11 7 logo 11 7.1 Well type ionization chamber assembly 11 7.2 measuring assembly 11 8 random file 12 8.1 Overview 12 8.2 Use of the instrument 12 8.3 Document 12 References 13 Table 1 Reference conditions and standard test conditions 6 Table 2 Affected Amount of change limits 9 Table 3 test temperature and humidity conditions of 11

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. This standard uses the translation method to modify the use of IEC 62467-1.2009 "Medical electrical equipment brachytherapy dose Instruments 1 Part I. Based on the well type ionization chamber of the instrument. " For ease of use, this standard made the following editorial changes. --- English title delete "Part 1"; --- The term "air kerma strength" to "air kerma rate of strength", the English term corresponding increase in "rate" word, but set Meaning the content is consistent; --- The term "total uncertainty" was changed to "the combined standard uncertainty", terms and definitions English content changes have occurred; --- Deleted the term index portion; --- Deleted international standards foreword; --- Use the decimal symbol instead of the international standard decimal symbol ",". ","; --- For other international standards quoted in the standard, if it has converted to our standards, this standard replaces the use of the International Standard Standard. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This standard was proposed by the China Food and Drug Administration. This standard by the National Standardization Technical Committee appliances medical radiotherapy, nuclear medicine science equipment at the Technical Committee and the radiation dose (SAC/TC10/SC3) centralized. This standard was drafted. Beijing Medical Device Testing. The main drafters of this standard. Wangpei Chen, Chen Jing, SONG Lian there.

Introduction

Currently well type ionization chamber instrument for a wide range of brachytherapy sources indicate the need to develop a measure of the well type ionization chamber instrument We agreed on the amount of the standard and test methods. Brachytherapy source output measurement analytical measurement and diagnostic nuclear medicine source Significantly different requirements, which will translate into measuring device requirements. For both applications, in many cases use similar instruments; however Instead, those instruments for brachytherapy sources there are more stringent requirements. Such a device is a combined system comprising a ionization chamber and An electronic circuit, wherein the ionization chamber and suitable electronic integrated circuits, or which it is connected, the electronic circuit is adapted to convert the ionization current Source measured amount of reading. Resulting ionization current can be read or as the accumulated charge (current versus time integral) directly, and then convert it to The applicable amount of air kerma rate intensity (reference air kerma rate) or the absorbed dose to water and the like. Works ionization chamber is known, in this Not repeated. In addition, the reading device is also applicable to the treatment of many cases, and it is known. Although the amount used in this standard is more than moving air release The rate of energy intensity, other amounts (such as the reference air kerma rate), the same as its principle. In principle, the dose volume was measured to be integral, under specified conditions can thus be deduced dosimetric quantity. air kerma rate strength, reference Air kerma rate or absorbed dose to water at a certain depth. Signal is generated by the ionization chamber current or charge, conforming IEC 60731 registration The static measurements, the current or charge by means of a specific type of source calibration factor to convert the amount of dose for the school of interest. Medical electrical equipment brachytherapy dose Instruments based on well type ionization chamber instrument

1 Scope

This standard specifies the well type ionization chamber measurements and ancillary components (see Chapter 3 defined) performance and certain structural requirements for the determination of a The amount of, for example. after a given type of appropriate calibration source for brachytherapy photon radiation field intensity in the air kerma rate Degrees or reference air kerma rate, or photons and β radiation field at a depth of water absorbed dose. The criteria include quantitative methods adapted brachytherapy sources. This amount may be air kerma rate or intensity at 1m from the source Reference air kerma rate, or at a certain depth (for example. 2mm or 5mm) absorbed dose to water. The measurement of the amount by Various existing well type ionization chamber or system implementation. This standard applies to include and β-ray photons, including the intended use of low-dose, high Dose rate brachytherapy intravascular measurement products. This standard does not apply to medical applications of nuclear instrumentation. Limited to the application of this In the well type ionization chamber as a detector of the instrument. The instrument uses a measuring chamber (inserted into a body cavity) or organizations radioactive output (insert human tissue) sealed sources. The purpose of this standard are. a) the establishment of the well type chamber system satisfactory performance requirements, and b) providing a standardized method for determining compliance with the performance. This standard does not involve security Well type ionization chamber system. Well type ionization chamber system are not covered by this standard environment for patients. Well type Electrical ionization chamber system security, see IEC 61010-1. Electrometer measurement system, see IEC 60731.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB/T 2900.81-2008 Electrotechnical terminology Nuclear Instruments Physical phenomena and basic concepts (IEC 60050-393.2003, IDT) GB/T 19629-2005 Medical electrical equipment - X-ray diagnostic imaging used in the ionization chamber and (or) semiconductor detector dose Meter (IEC 61674.1997, IDT) GB/T 20012-2005 Medical electrical equipment dose area product meter (IEC 60580.2003, IDT) IEC 60417 Graphical symbols for electrical equipment (Graphicalsymbolsforuseonequipment) IEC 60601-1.2005 Medical electrical equipment. Part 1. Basic safety and essential performance General requirements (Medicalelectrical equipment-Part 1. Generalrequirementsforbasicsafetyandessentialperformance) IEC 60731.1997 Medical electrical equipment used in radiotherapy ionization chamber dosimeter (Medicalelectrical equipment-Dosimeterswithionizationchambersasusedinradiotherapy) IEC /T R60788.2004 Medical electrical equipment - defined indexes (Medicalelectricalequipment-Glossaryof definedterms) IEC 61187 Electrical and electronic measuring equipment - Documentation (Electricalandelectronicmeasuringequipment-Doc- umentation) ISO /IEC Guide 99 international basic and common terminology Metrology (VIM)

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