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GB 9706.13-2008 English PDF

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GB 9706.13-2008: Medical electrical equipment -- Part 2: Particular requirements for the safety of automatically-controlled brachytherapy after loading equipment
Status: Obsolete

GB 9706.13: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
GB 9706.13-2008English874 Add to Cart 4 days [Need to translate] Medical electrical equipment -- Part 2: Particular requirements for the safety of automatically-controlled brachytherapy after loading equipment Obsolete GB 9706.13-2008
GB 9706.13-1997English799 Add to Cart 3 days [Need to translate] Medical electrical equipment--Part 2: Particular requirements for the safety of remote-controlled automatically-driven gamma-ray afterloading equipment Obsolete GB 9706.13-1997

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Basic data

Standard ID GB 9706.13-2008 (GB9706.13-2008)
Description (Translated English) Medical electrical equipment -- Part 2: Particular requirements for the safety of automatically-controlled brachytherapy after loading equipment
Sector / Industry National Standard
Classification of Chinese Standard C43
Classification of International Standard 11.040.60
Word Count Estimation 22,259
Date of Issue 2008-12-15
Date of Implementation 2010-02-01
Older Standard (superseded by this standard) GB 9706.13-1997
Adopted Standard IEC 60601-2-17-2004, IDT
Regulation (derived from) Announcement of Newly Approved National Standards No. 21 of 2008 (No. 134 overall)
Issuing agency(ies) General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary This Chinese standard specifies the use dedicated afterloading brachytherapy technique for patients with type automatic control equipment safety requirements. This standard applies toutomatic controlled after-loading equipment requirements, this device and only use containing ��, �� and neutron sealed radioactive sources, sealed radioactive sources can be automatically sent from the source storage device inside the treatment applied to the source location and Back from the source storage device treatment position, designed to come into contact with patients, source drive mechanism should be pre-programmed by the control timer or timing device control, automatically complete the movement of radioactive sources. Control timer or timing device may be a programmable electronic subsystems PESS (a computer or microprocessor), it can be non-programmable electronic systems. The requirements of this standard equipment under the supervision of qualified personnel to use, regular maintenance

GB 9706.13-2008: Medical electrical equipment -- Part 2: Particular requirements for the safety of automatically-controlled brachytherapy after loading equipment


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Medical electrical equipment.Part 2. Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment ICS 11.040.60 C43 National Standards of People's Republic of China GB 9706.13-2008/IEC 60601-2-17.2004 Replacing GB 9706.13-1997 Medical Electrical Equipment Part 2. Automatic Control brachytherapy Safety requirements for equipment installed after (IEC 60601-2-17.2004, 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

Preface Ⅰ Introduction Ⅱ The first chapter outlines 1 1. Scope and object 1 2 Terms and Definitions 2 3 General requirements 4 General claim 4 Test 4 5 Category 4 6 to identify, mark and file 5 The second environmental conditions 7 10 environmental conditions 7 Title III of the danger of electric shock protection 7 Title IV of protection against mechanical hazards 7 The fifth chapter of unnecessary or excessive radiation hazard protection 7 29 X-ray radiation 7 30 α, β, γ neutron radiation and other particle radiation 8 Title VI of the risk protection ignite flammable anesthetic gases mixed 14 Title VII of the over-temperature and other security risk protection 14 The accuracy of the risk protection and output data of the eighth chapter work 14 Accuracy of operating data 14 50 Chapter 9. abnormal operating and fault states; Environmental Testing 15 52 failure and abnormal operation state 15 Tenth chapter 16 structural requirements Annex L (normative) Normative References 17 Chinese Index 18 English 20 Index GB 9706.13-2008/IEC 60601-2-17.2004

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 section requirements for safety, is part of the 13 GB 9706. This section is equivalent to using IEC 60601-2-17.2004 "Medical Electrical Equipment Part 2. Automatic Control installation brachytherapy Equipment requirements for the safety. " For ease of use, made in this section, the following editorial changes. hereinafter "present standard" to "in this section." This partial replacement GB 9706.13-1997 "Medical Electrical Equipment Part II. After a remote γ-ray apparatus driven automatic safety device Particular requirements. " This section compared with GB 9706.13-1997, was modified in the following areas. --- standard name from "automatic remote loading driven after γ-ray equipment requirements for safety" to "automatic brachytherapy Safety requirements for equipment installed after "; --- This section is broader than the scope of GB 9706.13-1997, and applies to all installed after the use of technology for patient treatment close Treatment automatic control devices, and includes only the β, γ and neutron radiation source after sealing apparatus installed; --- parallel standard portion according to the present GB 9706.15-2008, IEC 60601-1-2 and IEC 60601-1-4 relatively GB 9706.13- 1997 by the NA becomes applicable. Annex L of this portion is a normative, Annex AA is an information appendix. This section proposed by the State Food and Drug Administration. This part of the National Standardization Technical Committee medical radiation therapy, nuclear medicine and dosimetry equipment at the Technical Committee (SAC / TC10/SC3) centralized. This part of the drafting unit. China Nuclear Power Institute of equipment manufacturer, Beijing Medical Device Testing. The main drafters of this section. Zhou Jianming, SONG Lian there, Han Yong, Jiao spring camp. This section replaces the following previously issued as follows. --- GB 9706.13-1997. GB 9706.13-2008/IEC 60601-2-17.2004

Introduction

If the equipment fails to give close brachytherapy dose design or equipment does not meet the requirements of patient safety standards for medical electrical equipment Requirements, the use of close brachytherapy device patients can be compromised. If the device itself fails to sufficiently shield the radiation source in the reservoir Endogenous and (or) shielding design of the treatment room is not sufficient, then the device may cause damage to nearby equipment personnel. This identifies the manufacturer specific standard should be installed after the automatic control equipment design and manufacturing brachytherapy compliance requirements, but unknown DESCRIPTION OF THE PREFERRED fine performance requirements of the device, the purpose of determining the design for the basic safety related operating functions of the member. This specific standard Set a limit to reduce device performance, when it exceeds the limit the scope of the present can be considered a fault condition, the radiation source can interlock return reservoir Endogenous and then prevent the continued operation of the device. GB 9706.13-2008/IEC 60601-2-17.2004 Medical Electrical Equipment Part 2. Automatic Control brachytherapy Safety requirements for equipment installed after The first chapter outlines Except for the following modifications, GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety" (hereinafter referred to as "secure universal Requirements ") Chapter shall apply. Scope 1 and object In addition to these changes, "General requirements for safety" of this chapter apply. 1.1 Scope supplement. 1.1.101 This standard specifies the specific safety requirements of automatic control devices for patients after loading with brachytherapy techniques. 1.1.102 This section specifies the requirements for automatic control of the loading device type, the device --- and containing only the β, γ and neutron sealed radioactive sources; --- can automatically sealed radioactive sources to the treatment site within the applicators to return from the reservoir and a reservoir source from the treatment site; --- is designed to contact with a patient; --- source should drive mechanism by a preset control timer or timing program controlling means, moving the radiation source is automatically completed. Total control When the timing device, or may be a programmable electronic subsystem PESS (computer or microprocessor), it may not be electrically programmable Subsystem. This part of device requirements 1.1.103 --- under the supervision of qualified personnel; --- regular maintenance; --- maintenance on a regular basis by the user. This section requires the use of sealed radioactive sources is not specified, the other requirements for sealed radioactive standards (see 6.8.3). 1.1.104 requires this section based on the following assumptions. --- treatment plan to be effective, given the appropriate treatment parameters; --- source intensity radioactive source equipment is known. To ensure completion of the treatment parameters can be preset apparatus, this part of the special requirements. --- chosen by the radiation source with respect to the selected combination may be applied to the source and positioned within the movable applicators; --- irradiation at selected time, selected by a combination of radiation source radiation is administered; --- equipment operators or other personnel around will not cause unnecessary harm. 1.2 Purpose instead. Purpose of this standard is to establish a dedicated apparatus after the automatic control device brachytherapy specifications and test requirements for the safety test. this Special safety standards required only raised the total of functional requirements, without providing special technical methods of its implementation. 1.3 Specific Standard supplement. GB 9706.13-2008/IEC 60601-2-17.2004 Relations with the General Standard 1.3.101 Dedicated to understanding the present binding standard GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety" (hereinafter referred to as A universal standard), this standard is a general standard specific additions and modifications, inspection and test simultaneously to follow the requirements of common standards. The articles in this special standard, consistent with chapter numbers, bar and "common standards". For the "universal standards" and tied for standard text change More, with the following words, he said. "Instead of" means "General Standard" Chapter strip or entirely replaced by the standard-specific chapter or section. "Complementary" refers to specific provisions of this Standard requires added "General Standard" in. "Modify" means "General Standard" Chapter or provision of this specific standard provisions as indicated above has been modified. For added "General Standard" in the article, figures, or tables are numbered starting from 101, supplemented by the letter Appendix AA, BB and so marked, make up Charge of the project with aa), bb), etc. represent. The term "in the present section" refers to a common reference standard must be present and the specific standard. This is no specific standard at the respective chapter, chapter or article, the "General Standard" in the article, or chapter shall apply, without making a change. It should be noted that any suitable part of the "General Standards", in this specific standard explanation has been given, although these parts This may correspond to specific standard. This standard requires special preference to the respective requirements of common standards. 1.3.102 relationships with other standards and documents NOTE. See Appendix L (normative). 1.5 Collateral Standard supplement. 1.5.101 GB 9706.15-1999 All of that parallel application of the criteria. 1.5.102 IEC 60601-1-2 All of that parallel application of the criteria. 1.5.103 GB 9706.12-1997 The collateral standard does not apply. 1.5.104 IEC 60601-1-4 All of that parallel application of the criteria.

2 Terms and Definitions

In addition to these changes, "General requirements for safety" of this chapter apply. supplement. Given in "General requirements for safety" and standard parallel and the following terms and definitions apply. Note 1. The specific standard terminology index terms listed in alphabetical order and the original reference defined. Note 2. In the present specific standard, the irradiating means that the patient receives the entire course of treatment in the treatment position and a treatment time, the radiation source does not belong to the transmission time Healing period. Note 3. In the specific standard, the term "operator" during their therapy control denotes brachytherapy device; term "user" means a close representation of the Therapy equipment use and maintenance of the units and individuals responsible. The term "radiation therapy physician" and "radiation therapy experts" not to use this specific standard, It represents the observation and personnel responsible for a given patient treatment prescribed dose. 2.1 parts and accessories and attachments Additional definitions. 2.1.101 Use the following abbreviations in this section. --- PESS programmable electronic subsystem; --- SFC single fault condition; GB 9706.13-2008/IEC 60601-2-17.2004 --- TCP treatment console. 2.1.102 Β source in the water along the perpendicular bisector 2mm absorbed dose rate at which the unit is Gy/s. 2.1.103 Using one or more of a cavity for sealed radioactive sources,, superficial and radiotherapy in the tube between organizations. 2.1.104 Radiation therapy, the condition does not choose to run again after the irradiation treatment interruption and restart. 2.1.105 Radioactive sources or radioactive sources chains in selected residence time of the treatment site. 2.1.106 Reference air kerma rate γ source for brachytherapy, with at Gy 1m/s FIG. Note. The representation allows the use of multiple (one thousandth, megabytes, etc.). 2.1.107 Radiation therapy, when the selection is completed and verified by the operating conditions and not by irradiation interrupt reach ready state, away from the ready state The beginning of irradiation. 2.1.108 Stop irradiation before irradiation is terminated, this does not stop with the possibility of re-select operating conditions to continue treatment. 2.1.109 With or without applicators to one or more of a radioactive source into the body lumen (e.g., blood vessels, respiratory tract, gastrointestinal tract, etc.) of Radiation Therapy. 2.1.110 Neutron source for the dose rate brachytherapy, with at Gy 1m/s FIG. 2.1.111 Acknowledged by the competent authorities have engaged in some kind of professional career. 2.1.112 Some arrangement for sealed radioactive sources after loading apparatus can be separated by a non-radioactive spacer, before each irradiation may be permanently Or selectively combined together. Radiation source chain is typically selected to give a particular dose distribution. 2.1.113 In air after attenuation and scatter correction, the reference distance is air kerma rate of 1m. Note. reference air kerma rate KR intensity ratio similar to the air release kinetic SK used in the USA, which is equal to the kinetic energy release rate ratio of air and free space along In the center of the radiation source from the radiation source to the product of the perpendicular distance from the square of the calibration points. GB 9706.13-2008/IEC 60601-2-17.2004 2.1.114 γ source intensity radiation source is used to specify the device, β source strength or neutron source strength. 2.1.115 Radiation therapy, or stop to prevent further irradiation (eg. Returns the ready state), and no reselection operation and reconfirmation When the conditions are, no restart irradiation possibilities. 2.1.116 Transmitted by the radiation source is a reservoir to the treatment site or the process is transferred by a reservoir to the treatment site. 2.1.117 During the radiotherapy, the irradiation parameters of the patient described aspects, such as the energy radiation, absorbed dose, treatment time. 2.1.118 Treatment includes the sum of all the dwell times.

3 General requirements

"General requirements for safety" of this chapter apply. General requirements Test 4 In addition to these changes, "General requirements for safety" of this chapter apply. 4.1 Test supplement. To complete the test safely be careful. For example. If possible, analog source. The specific standard in this type of test, Routine testing can be used by the manufacturer during manufacture and installation and mounting assembly performed. Category 5 instead. Equipment and its application classification section must be labeled and (or) identification specified in Chapter 6. These include. 5.1 divided by type of protection against electric shock. Apparatus within the scope of this class Ⅰ device should be. 5.2 points according to the degree of protection against electric shock. Unless otherwise specified, the application part within the scope of this application should be the B-type portion. 5.3 according to the degree of protection against harmful inlet points (see GB 4208). Unless otherwise specified, within the scope of this device should be no special protective equipment (IPX0). 5.4 recommended by the manufacturer of disinfection and sterilization methods points. 5.5 degree of security used by mixing with a gas mixture where gas or oxygen or nitrous oxide and anesthetic gas and air in flammable point. Unless otherwise specified, within the scope of this apparatus should not be in a mixed gas and oxygen or an alkylene oxide or a flammable anesthetic gas and air Apparatus for use in a mixed gas where nitrogen. 5.6 points by working the system. Within the scope of this device should be suitable for continuous operation of the apparatus. GB 9706.13-2008/IEC 60601-2-17.2004 6 to identify, mark and file In addition to these changes, "General requirements for safety" of this chapter apply. External marking device or apparatus components 6.1 z) a removable protector instead. When the device is not available for two or more alternative applications (ie. to use a particular function of a protection device removed), they should When the device statement. By examining a random file to verify compliance. Supplementary items. aa) the appropriate parts of the device should be easy to recognize in a clear, permanent marker fixed to shows. 1) the maximum total for each radionuclide source device design strength; 2) indicate potentially dangerous radioactive ionizing radiation symbol (see Annex L GB 18871-2002); 3) If a reservoir is used only in a restricted access a predetermined treatment chamber (see 30.1.1); 4) If an additional external supply (e.g. air). bb) apparatus for multiple pieces of radiation sources, an additional means (e.g. PESS) should have a permanent and easy selection identifying each channel The selected radioactive sources. cc) should be permanent attachment device to indicate that the name is stored in a reservoir radionuclide source intensity and Calibration date. dd) each interchangeable applicators, applicators in the appropriate position on the package should be a permanent identification mark or separate. ee) a significant asymmetry (e.g. bendable or partial protection), and can be inserted into a patient to different orientations of a rigid clinically applied Source, a recommendation is used in the random file after the outer radiographic or other appropriate test methods shall be inserted orientation identification Mark. NOTE. Some claim administration activity brachytherapy source (e.g.. Ci of or Bq) should also be indicated. 6.7 lights and buttons a) Indicator Color instead. When the indicator used in the treatment console or another console, a light color which meet the following requirements. It calls for immediate emergency measures against accidental operating status. red; Radiation source is in the treatment position. yellow; Radioactive source in transmission. Yellow (flashing); Ready state. Green; The power switch is closed, but not yet ready state. white. State of the device should be indicated, in addition can also be indicated by the color or shape or location indicator of the accompanying text. In addition to the loading device operating near the patient, rather than in the treatment chamber for the radiation source is indicated on the console in the transmission Or treating appropriate position indicator color is red. This requires the user to color observed in the treatment room the red indicator should immediately take urgent Measures. 6.8 random file 6.8.2 Manual d) cleaning, disinfection and sterilization in contact with the patient member supplement. Instructions for use should contain. When applicators for wet or steam sterilization, applicators lumen of residual liquid, then the residue Possible warning of danger to the other components of the liquid left in the system. These warnings should include a residual liquid seal Radiation Corrosion hazard and a source of damage to the drive mechanism. GB 9706.13-2008/IEC 60601-2-17.2004 e) from the network power supply apparatus with additional power source and instead. Instructions shall comprising. a battery power supply and other additional internal periodic inspection, maintenance and operation of the charging method and the push Recommended period. Supplementary items. aa) testing interlocking means Instructions shall comprising. operating cycle and the recommended test methods for all interlocks. Security bb) test connector If the source device has a radiation source to a drive mechanism and a channel is connected to the source is applied, using the test specification shall contain even Description connector safety operating procedures. cc) the required procedures dedicated control timer fault Instructions shall contain. Description of the special procedures required for the control failure timer (see 30.3.2). dd) returns a failure radiation source is a reservoir device Instructions shall contain. a case of failure to take when the radiation source is a reservoir return Recommended procedures and the Recommended emergency equipment needs. ee) delivered dose Instructions shall comprising. a radiation source from the reservoir specified source transmits its way back to the treatment site, a predetermined bit 50.1.4 Air kerma (or absorbed dose) on the data set. Manual should be recommended to determine the expected total delivered dose, if necessary, to allow the dose to be considered in the calculation. Instructions shall contain Warning. If the source is sent repeatedly from the reservoir and retracting the radiation source during treatment, may be affected at Accuracy party dose. ff) limit the passage and applicators Instructions should provide. --- specific diameter of the normal operation of the minimum allowed bending radius of the applicators and a channel; --- cloth can not meet the channel coherence state bits required 50.2.1 and applicators, and should deal with the clinical device With an explanation of the relationship between (see 1.1.104); --- characteristics of any obstructions impede passage of radioactive sources or radioactive sources chains and free movement of the applicators. gg) checking pollution Manual leakage of radioactive radiation source should be advised to make appropriate checks. hh) asymmetric inspection of applicators When appropriate (see 6.1), using recommended instructions should be asymmetric orientation applicators or other radiographic examination. i) inspection and maintenance functions User manual should be advised of the equipment, especially the source of the drive mechanism, regular function tests and maintenance to ensure equipment Continued safe use. When necessary, the instructions for use should be recommended test simulated radiation source. j) transfer time limit radiation source Instructions for use should contain a radioactive source from a reservoir to the treatment site transmits its way back to the maximum transmission time, if not There are restrictions must be declared. kk) Check the radiation source intensity Manual measurement methods employed should be recommended nationally recommended strength measurement each radiation source and the newly received device with Unit value used for comparison. 6.8.3 SHEET a) Overview GB 9706.13-2008/IEC 60601-2-17.2004 supplement. Technical specification provides for. 1) whether the source device and the reservoir is limited to a restricted access in the treatment room (see 30.1.1); 2) radionuclide equipment design, the maximum radiation exposure radiation source and a reservoir source's intensity; 3) radiation source chain (if any) allowed a range of combinations; 4) whether to allow access to equipment used in the radiation source from other suppliers, if the predetermined dimensions and tolerances should be allowed cladding radioactive sources; 5) radioactive sources should be consistent with international standards and other special requirements; 6) whether to allow the equipment used to obtain from other suppliers applicators, if allowed to be related to a predetermined dimensions and tolerances, and the source is recommended for administration Whether the positioning device and reliability requirements of the connection test; 7 radiation source positioning error) during the treatment, the residence time of transmission time error and error. Technical specification should further provide. 8) In all the fault condition, special requirements of this standard can not guarantee that indicates the location of the radiation source in a reservoir outside the filter; 9) radiation monitoring is recommended to use a separate type adapted irradiation near the patient; 10) use of a separate monitor radiation, any radiation monitor adjacent the portion of the device should be able to give a visual indication and irradiated To run correctly under the anticipated maximum radiation dose levels; After 11) mains supply fails, the monitoring of radiation continues to run and give an indication of several hours irradiation (e.g.. backup battery). Technical specification shall contain. a remote device connected to a detailed description of the interrupt (see 30.1.8). Technical specification shall contain. Guidance on identification may be represented, and operation of the processing device or radioactive components and Prevention. Technical specification should be given one or more doses of representative clinical application distribution, it should consider the impact of the dose distribution of applicators. The second environmental conditions 10 environmental c...

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