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GB 9706.263-2020: Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
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Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
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GB 9706.263-2020
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Basic data | Standard ID | GB 9706.263-2020 (GB9706.263-2020) | | Description (Translated English) | Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment | | Sector / Industry | National Standard | | Classification of Chinese Standard | C43 | | Classification of International Standard | 11.040.50 | | Word Count Estimation | 31,384 | | Date of Issue | 2020-11-17 | | Date of Implementation | 2023-05-01 | | Quoted Standard | GB 9706.1-2020; GB 9706.12; YY 0505; YY/T 0063; IEC 60601-2-29-2008; IEC 60601-2-54-2009; IEC/TR 60788-2004; IEC 61910-1-2014 | | Adopted Standard | IEC 60601-2-63-2017, MOD | | Regulation (derived from) | National Standard Announcement No. 25 of 2020 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | | Summary | This standard specifies the basic safety and performance requirements of ME equipment for extraoral imaging dental X-ray photography. | GB 9706.263-2020: Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
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Medical electrical equipment - Part 2-63.Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
ICS 11.040.50
C43
National Standards of People's Republic of China
Medical electrical equipment-Part 2-63.Extraoral imaging dentistry
X-ray machine basic safety and basic performance special requirements
2020-11-17 released
2023-05-01 implementation
State Administration for Market Regulation
Issued by the National Standardization Management Committee
Table of contents
Foreword Ⅰ
201.1 Scope, purpose and related standards 1
201.2 Normative references 3
201.3 Terms and Definitions 3
201.4 General requirements 4
201.5 General requirements for ME equipment testing 5
201.6 Classification of ME equipment and ME systems 5
201.7 Marking, marking and documentation of ME equipment 5
201.8 Protection of ME equipment against electric shock hazard 7
201.9 Protection of ME equipment and ME systems against mechanical hazards 8
201.10 Protection against unwanted or excessive radiation hazards (sources) 8
201.11 Protection against over-temperature and other hazards (sources) 9
201.12 Control and instrument accuracy and protection against hazardous outputs 9
201.13 Dangerous situations and fault states 9
201.14 Programmable Medical Electrical System (PEMS) 9
201.15 Structure of ME equipment 9
201.16 ME System 9
201.17 Electromagnetic compatibility of ME equipment and ME systems 9
202 Electromagnetic Compatibility-Requirements and Testing 9
203 Radiation protection of diagnostic X-ray equipment 9
Appendix 18
Appendix C (informative appendix) External marking of ME equipment, ME system or its components 19
Appendix AA (informative appendix) special guide and principle explanation 20
References 25
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 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 the 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.Special 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.Special 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 2-63 of GB 9706.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
This part uses the redrafting law to amend and adopt IEC 60601-2-63.2017 ``Medical Electrical Equipment Part 2-63.Extraoral Imaging Dental
Special requirements for the basic safety and basic performance of X-ray machines.
The technical differences between this part and IEC 60601-2-63.2017 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 60601-1.2012 (see.201.2 and related provisions) with GB 9706.1-2020 which is modified to adopt international standards;
● Replace IEC 60601-1-2 with YY0505 which is equivalent to adopting international standards (see.201.1.3 and related provisions);
● Replace IEC 60336 (see.201.7.9.3) with YY/T 0063 equivalent to the international standard;
● Replace IEC 60601-1-3.2008/AMD1.2013 with GB 9706.12 equivalent to the international standard (see.201.2 and related provisions);
--- Deleted the content of "IEC 60601-1-3" and "AnnexB" in 203.6.3.1, and added the description of "priority number system", which is in harmony with the current domestic standards.
This section has made the following editorial changes.
---The foreword and introduction of international standards have been deleted;
--- The note in 203.4.101.1 has been deleted, which is in harmony with the current domestic standards;
--- Deleted the words "replacement" and "addition" in the normative references;
---All terms are represented in bold;
---The term index is 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.
Medical electrical equipment-Part 2-63.Extraoral imaging dentistry
X-ray machine basic safety and basic performance special requirements
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 extraoral imaging dental X-ray machines (hereinafter referred to as ME equipment). The range includes
ME system for this type of ME equipment.
Note 1.Including oral surface body layer equipment, cephalometric equipment and dental volume reconstruction equipment defined in.201.3.203 (hereinafter referred to as DVR).
Note 2.DVR includes dental CBCT (cone beam computed tomography), and other names in some regions, such as DVT (digital volume tomography);
DVR also includes tomosynthesis imaging.
Note 3.It may include imaging of other anatomical parts (such as hands) required for dental treatment (such as orthodontic treatment).
Note 4.It may include imaging of anatomical parts of interest to ENT (ear, nose, throat) professional physicians.
The scope of this part is limited to the following X-ray equipment.
---X-ray tube components containing high-voltage transformer components and
---The geometric relationship between the X-ray source, the patient's required imaging location, and the X-ray image receiver is preset, and
During the period of use, the operator cannot change arbitrarily.
Note 5.Intraoral imaging dental X-ray machines are not within the scope of this section.
Note 6.The distance from the focus to the image receiver and the distance from the focus to the subject are preset in the dental X-ray machine for extraoral imaging.
Note 7.Due to the above restrictions, dental X-ray machines that are not within the scope of this section can use the applicable clauses of IEC 60601-2-54 with this section.
ME equipment within the scope of GB 9706.18, IEC 60601-2-54, GB 9706.24, IEC 60601-2-65 or GB 9706.23
And the ME system is not within the scope of this special standard. The scope of application of this part also does not include radiation therapy simulation equipment and bone or group
Density absorption equipment does not include dental fluoroscopy equipment.
Within the specified scope, the provisions of this special standard will replace and replace GB 9706.3-2000 Medical Electrical Equipment Part 2.Diagnosis
Special requirements for the safety of high-voltage generators for X-ray generators and GB 9706.14-1997 Medical Electrical Equipment Part 2.X-ray
Special requirements for the safety of auxiliary equipment of cable equipment.
Note 8.The requirements for X-ray generators and ancillary equipment, namely GB 9706.3 and GB 9706.14 described above, have been included in GB 9706.1-2020
Or special standards. Therefore, GB 9706.3 and GB 9706.14 are not applicable to the GB 9706 standard system to which the extraoral imaging dental X-ray machine belongs
section.
All the requirements of the combined X-ray tube assembly have been covered by this section, so unless the X-ray tube assembly is replaceable,
GB 9706.11 also does not apply to the ME equipment specified in this special standard.
Note 9.The requirements for dental X-ray machines in the previous version of the parallel standard GB 9706.12 and the special standard GB 9706.11 have been extracted and included in this section
Scored.
Note 10.In the scope of this special standard, the X-ray tube assembly of the X-ray equipment refers to the X-ray combined handpiece.
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