|
US$759.00 · In stock
Delivery: <= 6 days. True-PDF full-copy in English will be manually translated and delivered via email.
GB 9706.243-2021: Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB 9706.243-2021 | English | 759 |
Add to Cart
|
6 days [Need to translate]
|
Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
| Valid |
GB 9706.243-2021
|
PDF similar to GB 9706.243-2021
Basic data | Standard ID | GB 9706.243-2021 (GB9706.243-2021) | | Description (Translated English) | Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures | | Sector / Industry | National Standard | | Classification of Chinese Standard | C43 | | Word Count Estimation | 41,446 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB 9706.243-2021: Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
---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 2-43.Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
ICS 11.040.50
C43
National Standards of People's Republic of China
Replace GB 9706.23-2005
Medical electrical equipment
Part 2-43.Interventional operation of X-ray equipment
Special requirements for basic safety and basic performance
(IEC 60601-2-43.2017, MOD)
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 3
201.5 General requirements for testing of ME equipment 5
201.6 Classification of ME equipment and ME systems 5
201.7 ME equipment identification, marking and documentation 5
201.8 Protection of ME equipment against electric shock hazard 8
201.9 Protection of ME equipment and ME systems against mechanical hazards 8
201.10 Protection against unwanted or excessive radiation hazards (sources) 10
201.11 Protection against over-temperature and other hazards (sources) 10
201.12 Accuracy of controllers and instruments and protection of dangerous outputs 11
201.13 Dangerous situations and fault states 13
201.14 Programmable Medical Electrical System (PEMS) 13
201.15 Structure of ME equipment 13
201.16 ME System 14
201.17 Electromagnetic compatibility of ME equipment and ME system 14
202 Electromagnetic Interference---Requirements and Tests 14
203 Radiation protection of X-ray diagnostic equipment 14
Appendix 23
Appendix AA (informative appendix) Special guidelines and explanations 24
Appendix BB (Normative Appendix) Spurious Radiation Distribution Chart 30
Appendix CC (informative appendix) Comparison of the second and first editions of IEC 60601-2-43 33
Reference 36
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.Special 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
Claim;
---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 2-43 of GB 9706.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
This Part replaces GB 9706.23-2005 "Medical Electrical Equipment Part 2-43.Special Requirements for the Safety of Interventional X-ray Equipment
Compared with GB 9706.23-2005, the main technical changes are as follows.
---Modified the scope and purpose of the standard application (see.201.1, see Chapter 1 of the.2005 edition);
---Added the definition of the terms "image display delay" and "emergency perspective" (see.201.3);
---Added basic performance requirements (see.201.4);
---Added requirements for quality control procedures, anti-liquid and emergency instructions (see.201.7);
---Added requirements for dust and other particle source protection and enclosure protection levels (see.201.11);
---Added the image display delay, the recording of the image direction, the usability of perspective in network activities, and the appropriate mask of the subtraction image
Location, image measurement function and emergency power supply requirements (see.201.12);
---Added the requirements for loading status indication, last frame image storage and limiting radiation output (see 203.6);
--- Deleted the terms "perspective guided intrusion operation", "intervention reference point", "dose area product", "reference air kerma" and "operation model"
The definition of "style" (see Chapter 2 of the.2005 edition);
--- Deleted the additional requirements of environmental conditions for temperature (see Chapter 10 of the.2005 edition);
---The half price requirement for X-ray equipment has been deleted, which has been covered by GB 9706.103-2020.Informative appendix deleted
Intervention reference point (see 29.201.2 in the.2005 edition).
This part uses the redrafting law to modify and adopt IEC 60601-2-43.2017 ``Medical Electrical Equipment Part 2-43.Interventional Operations X
Specific requirements for basic safety and basic performance of radiographic equipment.
The technical differences between this part and IEC 60601-2-43.2017 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 the chapter "Normative Reference Documents", and the specific adjustments are as follows.
● Replace IEC 60601-1.2012 with GB 9706.1-2020, which is modified to adopt international standards;
● Replace IEC 60601-1-3.2013 with GB 9706.103-2020, which is modified to adopt international standards;
● Replace IEC 60601-2-54.2015 with GB 9706.254-2020, which is modified to adopt international standards;
● Replace IEC 60601-1-2.2014 with YY0505 which is equivalent to adopting international standards;
● Removed IEC 62220-1.2003.
This section also made the following editorial changes.
---Delete the note that prompts the amendment of the international standard to add content;
---The term index at the end of the text has been deleted.
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 9706.23-2005.
Medical electrical equipment
Part 2-43.Interventional operation of X-ray equipment
Special requirements for basic safety and basic performance
201.1 Scope, purpose and related standards
In addition to the following, the general standard 1) Chapter 1 applies.
1) The general standard in this section refers to GB 9706.1-2020.
201.1.1 *Scope
replace.
This part is applicable to the manufacturer’s declaration of the basis of X-ray equipment suitable for fluoroscopy guided interventional operations (hereinafter referred to as interventional X-ray equipment).
This safety and basic performance. The scope of this section does not include, in particular.
---Radiotherapy equipment;
---Computer tomography equipment;
---Accessories expected to enter the patient's body;
--- Mammography X-ray equipment;
---Dental X-ray equipment.
Note 1.Appendix AA gives examples of the use of interventional X-ray equipment in accordance with this section for fluoroscopy guided interventional operations.
Note 2.The specific requirements for magnetic navigation devices and interventional X-ray equipment used in the operating room environment are not considered in this section.
There are no specific requirements for use. In any case, such devices or applications still comply with the requirements of the general terms.
Note 3.Interventional X-ray equipment used in cross-sectional imaging mode (sometimes described as cone-beam CT) is covered by this part, not by GB 9706.244
cover. The current standard does not consider additional requirements for cone beam CT operations.
Interventional X-ray equipment declared by the manufacturer to be suitable for fluoroscopy guided interventional operations. If the system does not include a patient support device, this is exempted.
Part of the patient support device clause.
If a clause or clause is specifically applicable to interventional X-ray equipment, or only applicable to ME systems, the title of the clause or clause and
The content should be stated. If this is not the case, this clause or clause applies to both interventional X-ray equipment and ME systems, as the case may be
Depends.
Note 4.See General Standard 4.2.
201.1.2 Purpose
replace.
The purpose of this section.
---Determine specific basic safety and basic performance requirements for the design and manufacture of X-ray equipment for fluoroscopy guided interventional operations, fluoroscopy guides
Refer to.201.3.203 for the definition of guided intervention.
---Provide special information of this type of interventional X-ray equipment to help responsible parties and operators manage the possible impact caused by these operations
Radiation risk for patients or employees and risk of equipment failure.
201.1.3 Parallel standards
Supplement.
The applicable parallel standards cited in this section are listed in Chapter 2 of the General Standards and.201.2 of this section.
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB 9706.243-2021_English be delivered?Answer: Upon your order, we will start to translate GB 9706.243-2021_English as soon as possible, and keep you informed of the progress. The lead time is typically 4 ~ 6 working days. The lengthier the document the longer the lead time. Question 2: Can I share the purchased PDF of GB 9706.243-2021_English with my colleagues?Answer: Yes. The purchased PDF of GB 9706.243-2021_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet. Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.
|