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GB 9706.229-2021: Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
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Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
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GB 9706.229-2021
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Basic data | Standard ID | GB 9706.229-2021 (GB9706.229-2021) | | Description (Translated English) | Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators | | Sector / Industry | National Standard | | Classification of Chinese Standard | C43 | | Word Count Estimation | 21,25 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB 9706.229-2021: Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
---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 2-29.Particular requirements for the basic safety and essential performance of radiotherapy simulators
ICS 11.040.60
C43
National Standards of People's Republic of China
Replace GB 9706.16-2015
Medical Electrical Equipment Part 2-29.
Basic safety and basic performance of radiation therapy simulator
Dedicated requirements
(IEC 60601-2-29.2008, MOD)
Issued on 2021-08-10 and implemented on 2023-05-01
State Administration of Market Supervision and Administration
Issued by the National Standardization Management Committee
Table of contents
Foreword Ⅰ
Introduction Ⅲ
201.1 Scope, purpose and related standards 1
201.2 Normative references 2
201.3 Terms and Definitions 2
201.4 General requirements 3
201.5 General requirements for ME equipment testing 3
201.6 Classification of ME equipment and ME systems 3
201.7 ME equipment identification, marking and documentation 3
201.8 Protection of ME equipment against electric shock hazard (source) 5
201.9 Protection of ME equipment and ME system against mechanical hazards 5
201.10 Structure of ME equipment 12
201.11 Protection against over-temperature and other hazards 12
201.12 Accuracy of controllers and instruments and protection against dangerous outputs 12
201.13 Hazardous Situations and Failure Conditions of ME Equipment 12
201.14 Programmable Medical Electrical System (PEMS) 12
201.15 Structure of ME equipment 12
201.16 ME System 12
201.17 Electromagnetic compatibility of ME equipment and ME systems 12
Appendix 13
Appendix C (informative appendix) Guidance requirements for marking and labeling of ME equipment and ME systems 14
Appendix AA (informative appendix) Special guidance and reasons 15
Reference 16
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 the basic safety and basic performance of electron accelerators with an energy of 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 shortwave 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 the basic safety and basic performance of the anesthesia workstation;
---Part 2-16.Specific requirements for the basic safety and basic performance of hemodialysis, hemodiafiltration and hemofiltration equipment;
---Part 2-17.Special requirements for the basic safety and basic performance of automatic control brachytherapy after-installation equipment;
---Part 2-18.Specific requirements for the 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.Specific requirements for the 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.Special 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.Special 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.The basic safety and basic performance of mammography equipment and mammography stereotaxic devices
Require;
---Part 2-54.Special 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.Special 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 2-29 of GB 9706.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces GB 9706.16-2015 ``Medical Electrical Equipment Part 2.Special Requirements for the Safety of Radiotherapy Simulators'', and
Compared with GB 9706.16-2015, the main technical changes are as follows.
---Chapter number and order are revised in accordance with the content of IEC 60601-2-29.2008 (see.201.1~201.17);
---Modified some terms and definitions (see.201.3).
This part uses the redrafting law to amend and adopt IEC 60601-2-29.2008 "Medical Electrical Equipment Part 2-29.Radiation Therapy Mode"
Specific requirements for the basic safety and basic performance of the proposed aircraft.
The technical differences between this part and IEC 60601-2-29.2008 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 the chapter "Normative Reference Documents", and the specific adjustments are as follows.
● Replace IEC 61217 with GB/T 18987-2015, which is equivalent to adopting international standards.
This section has made the following editorial changes.
--- Deleted some informative "Notes";
---The term index at the end of the international standard text has been deleted.
Please note that some of the 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.
The previous releases of the standards replaced by this part are as follows.
---GB 9706.16-1999, GB 9706.16-2015.
Introduction
The requirements determined in this section serve as the manufacturer's basis for the design and manufacture of radiation therapy simulators. This section does not attempt to determine
For its optimal performance requirements, its purpose is to determine those currently considered essential for the safe operation of such ME equipment
Design features. This article sets a limit for the degradation of ME equipment performance. When the limit is reached, the ME equipment is considered to be in a fault state. example
For example, when a component fails, the interlocking action needs to be triggered correspondingly to prevent the continued operation of the ME equipment.
Medical Electrical Equipment Part 2-29.
Basic safety and basic performance of radiation therapy simulator
Dedicated requirements
201.1 Scope, purpose and related standards
In addition to the following, Chapter 1 of the general standard applies.
201.1.1 Scope
replace.
This part of GB 9706 applies to the basic safety and basic performance of radiation therapy simulators, hereinafter referred to as ME equipment.
If a clause or sub-clause is specifically intended to apply only to ME equipment or ME systems, the title and content of the clause or sub-clause
Will be explained. If this is not the case, this clause or sub-clause applies to ME equipment and ME systems.
In addition to 7.2.13 and 8.4.1 of the general standard, the expected physiological effects of the ME equipment or ME system within the scope of this part are caused by
There are no specific requirements for hazards in this section.
Note. See General Standard 4.2.
201.1.2 Purpose
replace.
The purpose of this section is to establish specific requirements for basic safety and basic performance of radiotherapy simulators (as defined in.201.3.204).
201.1.3 Parallel standards
Supplement.
This section refers to Chapter 2 of the General Standard and applicable parallel standards listed in.201.2.
The following collateral standards are not applicable.
---IEC 60601-1-10.
201.1.4 Specific standards
replace.
In the GB 9706 series, the special standards can be modified, replaced or deleted according to the special ME equipment under consideration, the general standards and parallel standards
The requirements contained in the standards. And can add other basic safety and basic performance requirements.
The requirements of specific standards take precedence over the requirements of general standards.
In this section, GB 9706.1-2020 is referred to as the general standard. Parallel standards are represented by their respective standard numbers.
The numbering of chapters and articles in this part is prefixed with "201" to correspond to the general standard (for example,.201.1 in this part corresponds to the first chapter of the general standard).
Chapter), or add the prefix “20×” to correspond to the applicable parallel standard, where “×” is the last digit of the international standard number corresponding to the parallel standard (example
For example, 202.4 in this part corresponds to the content of Chapter 4 in the collateral standard YY9706.102, and 203.4 in this part corresponds to the collateral standard
The contents of Chapter 4 in GB 9706.103, etc.).
Standardize changes to the text of the general standard by using the following words.
"Replacement" means that the chapter or article of the general standard or the applicable parallel standard is completely replaced by the content of this part.
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