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GB 9706.265-2021: Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
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Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
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GB 9706.265-2021
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Basic data | Standard ID | GB 9706.265-2021 (GB9706.265-2021) | | Description (Translated English) | Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment | | Sector / Industry | National Standard | | Classification of Chinese Standard | C43 | | Word Count Estimation | 32,355 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB 9706.265-2021: Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Medical electrical equipment - Part 2-65.Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
ICS 11.040.50
C43
National Standards of People's Republic of China
Medical electrical equipment-Part 2-65.Intraoral imaging dentistry
Special requirements for basic safety and basic performance of X-ray machines
Released on 2021-02-20
2023-05-01 implementation
State Administration of Market Supervision and Administration
Issued by the National Standardization Management Committee
Table of contents
Foreword Ⅲ
201.1 Scope, purpose and related standards 1
201.2 Normative references 2
201.3 Terms and Definitions 3
201.4 General requirements 4
201.5 General requirements for ME equipment testing 4
201.6 Classification of ME equipment and ME systems 4
201.7 Marking, marking and documentation of ME equipment 4
201.8 Protection of ME equipment against electric shock hazard 6
201.9 Protection of ME equipment and ME systems against mechanical hazards 7
201.10 Protection against unwanted or excessive radiation hazards (sources) 7
201.11 Protection against over-temperature and other hazards (sources) 7
201.12 Accuracy of control and instrumentation and protection of hazardous output 8
201.13 Dangerous situations and fault states 8
201.14 Programmable Medical Electrical System (PEMS) 8
201.15 Structure of ME equipment 8
201.16 ME System 8
201.17 Electromagnetic compatibility of ME equipment and ME systems 8
202 Electromagnetic compatibility---requirements and tests 8
203 Radiation protection of diagnostic X-ray equipment 8
Appendix 17
Appendix C (informative appendix) External marking of ME equipment, ME system or its components 18
Appendix AA (informative appendix) Special guidelines and reasons 19
Appendix BB (informative appendix) The component identification of the dental X-ray intraoral system related to the defined terms in this section 24
References 26
Medical electrical equipment-Part 2-65.Intraoral imaging dentistry
Special requirements for basic safety and basic performance of X-ray machines
201.1 Scope, purpose and related standards
In addition to the following, Chapter 1 of the general standard 1) applies.
1) The general standard is 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 intraoral imaging dental X-ray machines and their main components, hereinafter referred to as ME equipment.
The scope of this section is limited to X-ray machines containing high-voltage transformer components in the X-ray tube assembly.
This section does not apply to dental X-ray machines for extraoral imaging.
Note 1.The X-ray generator in the intraoral imaging dental X-ray machine will always contain an X-ray combination handpiece. Therefore, in this section, the X-ray tube set
The concept of parts is replaced by an X-ray combined handpiece.
Note 2.For example, the main components can be X-ray combined handpiece and electronic X-ray image receiver.
Note 3.Photostimulated phosphor plates and their readers (hardware and software) are not included in the scope of this section because they
We do not use electrical components in the patient environment, nor are they ME equipment.
ME devices that belong to the scope of GB 9706.263, GB 9706.244, IEC 60601-2-54, GB 9706.245 or GB 9706.243
Equipment and ME systems are not included in the scope of this section. The scope of application of this part does not include radiation therapy simulators and bone or tissue
Absorption densitometer does not include dental fluoroscopy equipment.
Within the scope of this part, the provisions of this special standard will replace and replace GB 9706.3-2000 Medical Electrical Equipment Part 2.
Special requirements for the safety of high-voltage generators for diagnostic X-ray generators" and GB 9706.14-1997 "Medical Electrical Equipment Part 2.X
Special Requirements for the Safety of Auxiliary Equipment of X-ray Equipment.
Note 4.The requirements for X-ray generators and ancillary equipment, that is, the aforementioned GB 9706.3 and GB 9706.14, have been included in GB 9706.1-2020 or dedicated
Standard. Therefore, GB 9706.3 and GB 9706.14 are not part of the GB 9706 standard system for intraoral imaging dental X-ray machines.
All the requirements of the combined X-ray tube assembly have been covered by this part, and GB 9706.228 does not apply to those specified in this special standard.
ME equipment.
201.1.2 Purpose
replace.
The purpose of this section is to establish specific requirements for basic safety and basic performance of ME equipment for intraoral imaging dental X-ray photography.
201.1.3 Parallel standards
Supplement.
This special standard refers to Chapter 2 of the general standard and the applicable parallel standards listed in.201.2 of this special standard.
YY0505 and GB 9706.103 are applicable after chapter 202 and chapter 203 are amended respectively.
YY0709, IEC 60601-1-10, IEC 60601-1-11 and IEC 60601-1-12 are not applicable.
Note. Operators of intraoral imaging dental X-ray machines are accustomed to the auditory signals required by this specific standard, rather than the concept in YY0709.Therefore YY0709
not applicable.
201.1.4 Specific standards
replace.
This part is a special standard in the GB 9706 series of standards. Special standards can be modified, replaced or deleted general standards or parallel standards
The requirements contained in the standards are applicable to the ME equipment under consideration, and other basic safety and basic performance requirements may also be added.
Specific standard requirements take precedence over general standards.
In this section, GB 9706.1-2020 is referred to as the general standard. Parallel standards are indicated by their standard numbers.
The numbering of chapters and articles in this part corresponds to the general standard by adding the prefix "201" (for example,.201.1 in this special standard corresponds to the general standard).
(In accordance with the content of Chapter 1), or by adding the prefix "20×" to correspond to the applicable parallel standard, where × is the international standard corresponding to the parallel standard.
The last digit of the number (for example, 202.4 in this special standard corresponds to the content of Chapter 4 in the parallel standard IEC 60601-1-2, in this special standard
203.4 corresponds to the content of Chapter 4 in the parallel standard IEC 60601-1-3, etc.).
Changes to the text of the general standard require the use of the following words.
"Replacement" means that the chapters and articles of the general standard or applicable parallel standards are completely replaced by the terms of this specific standard.
"Supplement" refers to the provisions of this special standard that supplement the requirements of general standards or applicable parallel standards.
"Modification" refers to the modification of the chapters and articles of general standards or applicable parallel standards in accordance with the description of the provisions of this special standard.
As a supplement to the general standard, the numbering of bars, figures and tables starts from.201.101.However, since the number defined in the general standard changes from 3.1
To 3.147, therefore, the definitions supplemented in this specific standard are numbered starting from.201.3.201.The numbers of the supplementary appendices are AA, BB, etc., supplement
The project numbers are aa), bb), etc.
The bars, graphs or tables added to the parallel standard are numbered starting from 20×, where "×" is the parallel standard number, for example, 202 corresponds to
IEC 60601-1-2, 203 corresponds to IEC 60601-1-3, etc.
The term "this standard" is a collective term for general standards, any applicable parallel standards and this specific standard.
If there are no corresponding chapters and articles in this special standard, the chapters and articles in the general standard or applicable parallel standards, even if they may not be relevant,
Also apply. For any part of the general standard or applicable parallel standards, even if it may be relevant, if it is not adopted, this specific standard will
Give instructions.
201.2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document.
In addition to the following, Chapter 2 of the general standard applies.
replace.
GB 9706.1-2020 Medical electrical equipment Part 1.General requirements for basic safety and basic performance (IEC 60601-1.
2012, MOD)
GB 9706.103-2020 Medical electrical equipment Part 1-3.General requirements for basic safety and basic performance
Radiation protection of diagnostic X-ray equipment (IEC 60601-1-3.2013, MOD)
Supplement.
YY/T 0063 Focus characteristics of medical diagnostic X-ray tube components for medical electrical equipment (YY/T 0063-2007, IEC 60336.
2005, IDT)
YY0505 Medical Electrical Equipment Part 1-2.General Safety Requirements Collateral Standard. Electromagnetic Compatibility Requirements and Tests
(YY0505-2012,IEC 60601-1-2.2004,IDT)
IEC TR60788.2004 Definition and Glossary of Medical Electrical Equipment (Medicalelectricalequipment-Glossary
ofdefinedterms)
201.3 Terms and definitions
In addition to the following, the terms and definitions defined by GB 9706.1-2020, applicable parallel standards and IEC TR60788.2004 apply
In this document.
Supplement.
201.3.201
Dental
The patient’s oral and maxillofacial area, including the dentition.
[Source. GB 9706.263-2020,.201.3.202]
201.3.202
Dose area product doseareaproduct
The product of the cross-sectional area of the X-ray beam and the average air kerma passing through that area. The unit is gray square meters (Gy∙m2).
[Source. IEC 60601-2-54.2009,.201.3.203]
201.3.203
Electronic X-ray image receiver electronicX-rayimagereceptor
X-ray image receiver using electronic conversion method.
[Source. GB 9706.263-2020,.201.3.205]
201.3.204
Exitfieldsize
The size of the radiation field at the end of the dental photography cone determined by the beam limiting device.
Note. The dental photography cone can guarantee the minimum focal distance. Generally speaking, the beam limiting device is a part of the dental photography cone.
201.3.205
Extra-oral imaging
The X-ray image receiver is located outside the oral cavity for dental X-ray photography.
[Source. GB 9706.263-2020,.201.3.206]
201.3.206
Interlock
Unless a certain predetermined condition works, measures to prevent the start and continuous operation of ME equipment.
[Source. IEC 60601-2-54.2009,201.3.207]
201.3.207
Intra-oral imaging
Dental X-ray photography in which all or part of the X-ray image receiver is located in the oral cavity.
[Source. GB 9706.263-2020,201.3.208]
201.3.208
One-peakhighvoltagegenerator
Powered by a single-phase power supply, the output is unrectified or rectified, but there is only one peak voltage output in each power supply cycle.
Health.
201.3.209
Two-peakhighvoltagegenerator
Powered by a single-phase power supply, the output rectified voltage has two peak high-voltage generators in each power supply cycle.
201.3.210
X-ray monoblock assembly
The X-ray tube assembly that contains the high-voltage transformer assembly.
a) The rated network power voltage of the ME equipment, in volts (V); see 7.2.1 and 7.2.6 in the general standard;
b) The number of phases, see 7.2.1 and 7.2.6 in the general standard;
c) Frequency, in Hertz (Hz); see 7.2.1 and 7.2.6 in the general standard;
d) The maximum allowable value of the apparent resistance of the power supply network, in ohms;
e) The overcurrent release characteristics required by the power supply network.
Note. This requirement is derived from 6.1j) of GB 9706.3-2000.
Additional terms.
201.7.2.101 Beam limiting device
If it is removable during normal use, the beam limiting device should provide the following marks.
---Required in 7.2.2 of the general standard.
---Series name or respective identification mark.
---Indicating the size of the injection field by size or graphically. If the ejection field size is described graphically, then it should be used
Use the instructions to describe this type of approach.
---Additional filtration, if the additional filtration value is greater than the equivalent 0.2mmAl.
Compliance is checked by inspection.
201.7.8.1 Indicator color
Supplement.
7.8 in the general standard does not apply to X-ray related status indications, 203.6.4.2 and 203.6.4.11 should apply.
201.7.9 Attached documents
201.7.9.1 Overview
Supplement.
Note 1.Appendix C Table.201.C.102 lists the requirements of this special standard, these requirements are general requirements to supplement the declaration requirements in the accompanying documents.
The accompanying documents shall contain the manufacturer's recommended quality control procedures and test instructions for the ME equipment implemented by the responsible party. in
The acceptance criteria and test frequency for each test should be included.
In addition, for electronic X-ray image receivers, the accompanying documents should include.
---Description of the operation method required to display images for diagnostic purposes according to the intended use;
Note 2.For example, the minimum number of pixels and recognizable gray levels required by the display screen.
---The nominal range of air kernal energy of the image receiver required to achieve the intended use;
---In order to achieve the typical loading factor and the recommended value of focal skin distance required for the air kerma kinetic energy.
Compliance is checked by checking the accompanying documents.
201.7.9.2 Instructions for use
201.7.9.2.1 Overview
Additional terms.
201.7.9.2.1.101 Load factors
The loading factors shall be described in the ME equipment operating instructions as follows. The following combinations and data should be stated.
a) X-ray tube voltage setting value;
b) X-ray tube current setting value;
c) Setting value or range of irradiation time;
d) If different from b), the maximum X-ray tube current under each X-ray tube voltage setting;
e) If different from c), the maximum and minimum irradiation time under each X-ray tube voltage and X-ray tube current setting value.
Check whether it meets the requirements by checking the instruction manual.
201.7.9.2.1.102 Beam limiting device
The size of the outgoing field provided by the beam limiting device should be stated in the operating instructions and technical specifications.
Check whether it meets the requirements by checking the instruction manual.
201.7.9.3 Technical Specification
Additional terms.
201.7.9.3.101 X-ray source assembly
In addition to the data identified in accordance with the requirements of 7.2 of the general standard, the technical description of the integrated X-ray source assembly shall be specified as follows.
a) Technical requirements for the reference axis involved in the target angle and focus characteristics of the X-ray source assembly;
b) The target angle to the specified reference axis;
c) Focus position;
d) According to YY/T 0063, the nominal value of the focal point suitable for the specified reference axis is determined;
e) The size of the shooting field provided by the beam limiting device.
Check whether it meets the requirements by checking the technical description.
Additional terms.
201.7.9.101 Power supply network requirements
Information on the rated input power of the dental X-ray generator for intraoral imaging should also include.
● Appropriate description of the maximum allowable power supply network apparent resistance or power supply network specification requirements used in the facility; and
● The description of the specification requirements for the overcurrent release of the power supply network.
201.8 Protection of ME equipment against electric shock hazard
In addition to the following, Chapter 8 of the general standard applies.
201.8.5 Isolation of components
201.8.5.1 Measures of Protection (MOP)
Additional terms.
201.8.5.1.101 Additional limits on voltage, current or energy of dental X-ray generators for intraoral imaging
Measures should be taken to prevent unacceptable high voltages from appearing in the mains part of the network or in any other low-voltage circuits.
Note 1.It can be achieved by the following measures, such as.
--- Between the high-voltage and low-voltage circuits, add a layer of winding or conductive shielding connected to the protective ground terminal;
---If the external path is interrupted, an over-voltage may be generated between the terminals connected to the external path, and it should be jumpered between the terminals of the external device
Voltage limiting device.
The design data and structure should be checked to verify compliance with the requirements.
Note 2.This requirement is derived from 15bb in GB 9706.3-2000).
201.8.7 Leakage current and patient auxiliary current
201.8.7.3 *Allowable value
c) Amend as follows.
For non-permanently installed X-ray generators, the contact current in a single fault state should not exceed 2mA.
Note. This relaxation of general standard requirements does not apply to patient leakage current.
e) Amend as follows.
For a permanently installed X-ray generator, the allowable value of the ground leakage current is both in the normal state and the single fault state
20mA.
201.8.8.3 *Dielectric strength
Supplement.
In addition to 8.8.3 of the general standard, the high-voltage circuit of the X-ray combined handpiece should be tested as follows.
The test voltage of the high-voltage circuit should be 1.1 to 1.15 times of the maximum nominal X-ray tube voltage of the X-ray combined handpiece. If unable
Connect the high-voltage circuit, then the voltage can be measured indirectly.
The test voltage application time of the high-voltage circuit of the X-ray combined handpiece is the maximum allowable irradiation under normal use as specified in the accompanying document
Twice the time. The test was repeated 3 times, and the minimum interval between each test was 2 min.
For a single-peak high-voltage generator, if the X-ray tube voltage of the no-load half-cycle is higher than the loaded half-cycle, the test reference for the high-voltage circuit
The voltage should use a no-load half cycle.
If during the dielectric strength test, there is a risk of the transformer overheating during the test, then it is allowed to perform at a higher power supply frequency
test.
201.9 Protection of ME equipment and ME system against mechanical hazards
In addition to the following, Chapter 9 of the general standard applies.
201.9.8.4 Systems with mechanical guards
Additional terms.
201.9.8.4.101 Mechanical protection device
Ropes, chains or belts that run side by side with certain ropes, chains or belts can also be used if they are not loaded during normal use.
Think of it as a mechanical protection device.
Ropes, chains or belts used as mechanical guards should be easy to inspect, and appropriate inspection instructions should be given in the accompanying documents.
Compliance is checked by functional testing and inspection of accompanying documents.
201.10 Protection against unwanted or excessive radiation hazards (sources)
Chapter 10 of the general standard applies.
Note. The parallel standard GB 9706.103 cited in the general standard is covered by Chapter 203 of this document.
201.11 Protection against over-temperature and other hazards (sources)
In addition to the following, Chapter 11 of the general standard applies.
Additional terms.
201.11.101 *Protection against over-temperature of X-ray combined handpiece
The temperature limit does not apply to the inside of the protective shell of the X-ray combined handpiece.
The temperature of the painted metal surface of the X-ray combination handpiece that can be touched by the operator during expected use and the patient occasionally touches
To exceed the temperature specified in Table 23 of the General Standard, but should not exceed 65°C.
201.12 Accuracy of control and instrumentation and protection of hazardous outputs
Chapter 12 of the general standard applies.
Note. According to 12.4.5.1 of the general standard, see 203.6.4.3 of this document for dose-related content.
201.13 Dangerous situations and fault states
Chapter 13 of the general standard applies.
201.14 Programmable Medical Electrical System (PEMS)
Chapter 14 of the general standard applies.
201.15 Structure of ME equipment
Chapter 15 of the general standard applies.
201.16 ME system
Chapter 16 of the general standard applies.
201.17 Electromagnetic compatibility of ME equipment and ME systems
Chapter 17 of the general standard applies.
202 Electromagnetic compatibility---requirements and tests
In addition to the following, YY0505 applies.
Additional terms.
202.101 Basic performance immunity test
The manufacturer can reduce the additional potential basic performance test requirements listed in Table.201.101 to one contract through the risk management process.
Appropriate level.
When testing in accordance with the selected requirements, the manufacturer needs to consider the sensitivity and possibility of the EMC environment through the risk management process.
EMC conditions and severity, the possibility and benefits of unacceptable risks.
The accuracy of the test equipment used to evaluate the immunity of ME equipment should not be affected by the electromagnetic conditions under test.
The test equipment should not affect the immunity test of the ME equipment.
Only non-intrusive testing methods should be used.
The ME equipment under test for immunity test should not be changed.
Compliance is checked by checking the risk management documents.
203 Radiation protection of diagnostic X-ray equipment
In addition to the following, GB 9706.103 is applicable.
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