|
US$1059.00 · In stock
Delivery: <= 7 days. True-PDF full-copy in English will be manually translated and delivered via email.
GB 9706.254-2020: Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB 9706.254-2020 | English | 1059 |
Add to Cart
|
7 days [Need to translate]
|
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
| Valid |
GB 9706.254-2020
|
PDF similar to GB 9706.254-2020
Basic data | Standard ID | GB 9706.254-2020 (GB9706.254-2020) | | Description (Translated English) | Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy | | Sector / Industry | National Standard | | Classification of Chinese Standard | C43 | | Classification of International Standard | 11.040.50 | | Word Count Estimation | 57,596 | | Date of Issue | 2020-12-24 | | Date of Implementation | 2023-05-01 | | Adopted Standard | IEC 60601-2-54-2018, MOD | | Regulation (derived from) | National Standard Announcement No. 31 of 2020 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | | Summary | This standard applies to the basic safety and basic performance of ME equipment and ME systems intended for projection and indirect fluoroscopy. GB 9706.23 applies to ME equipment and ME systems used for intermediary operations, and refers to the applicable requirements of this special standard. This standard does not apply to ME equipment and ME systems intended for bone or tissue absorption densitometers, computed tomography, mammography, dentistry or radiotherapy. This standard does not apply to radiation therapy simulators. If a certain chapter is only applicable to ME equipment, or only applicable to ME systems, the title and content of the chapter will be explained. If this is not the case, the regulations apply to both ME equipment and ME systems. | GB 9706.254-2020: Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
---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 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
ICS 11:040:50
C43
National Standards of People's Republic of China
Medical Electrical Equipment Part 2-54:
Basic safety and safety of X-ray photography and fluoroscopy equipment
Special requirements for basic performance
(IEC 60601-2-54:2018, MOD)
2020-12-24 release
2023-05-01 implementation
State Administration for Market Regulation
Issued by the National Standardization Management Committee
Table of contents
Preface Ⅲ
201:1 Scope, purpose and related standards 1
201:2 Normative references 2
201:3 Terms and Definitions 2
201:4 General requirements 4
201:5 General requirements for ME equipment testing 4
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 9
201:10 Protection against unwanted or excessive radiation risks (sources) 13
201:11 Protection against over-temperature and other hazards (sources) 13
201:12 Accuracy of controllers and instruments and protection of dangerous outputs 13
201:13 Dangerous conditions and fault states of ME equipment 14
201:14 Programmable Electrical Medical System (PEMS) 14
201:15 Structure of ME equipment 14
201:16 ME System 14
201:17 Electromagnetic compatibility of ME equipment and ME systems 14
202 Electromagnetic compatibility---requirements and tests 14
203 Radiation protection of diagnostic X-ray equipment 15
Appendix 45
Appendix C (informative appendix) External marking of ME equipment, ME system or its components 46
Appendix AA (informative appendix) General guidance and principle explanation 48
Reference 51
Figure 203:101 Out-of-focus radiation area 31
Figure 203:102 The deviation of the coverage image receiving area 32
Figure 203:103 The deviation of the visible indication of the X-ray field 35
Figure 203:104 Stray radiation test (X-ray beam level, X-ray source assembly is located under the patient support device) 42
Figure 203:105 Stray radiation test (X-ray beam is vertical, X-ray source assembly is located under the patient support device) 43
Figure 203:106 Stray radiation test (X-ray beam level, X-ray source assembly is located above the patient support device) 43
Figure 203:107 Stray radiation test (X-ray beam is vertical, X-ray source assembly is located on the patient support device) 44
Table:201:101 Potential basic performance requirements 4
Table 203:101 Repeatability and linearity verification test 21
Table 203:102 Test load 22 for automatic exposure control
Table 203:103 Attenuation during measurement of air kerma kinetic energy 24
Table 203:104 X-ray beam attenuation equivalent 37
Table 203:105 Application category 39
Table 203:106 Primary protective shielding requirements 39
Table 203:107 Spurious radiation in the effective occupied area 41
Table:201:C:101 External marking of ME equipment or its parts 46
Table:201:C:102 Clauses required to be described in the accompanying documents 46
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 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 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 basic safety and basic performance of gamma beam therapy equipment;
---Part 2-12: Special requirements for 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: Specific 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: Specific 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: The basic safety and basic performance of mammography equipment and mammography stereotaxic devices
Claim;
--- 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 2-54 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 60601-2-54:2018 ``Medical Electrical Equipment Part 2-54: X-ray Photography
Special requirements for basic safety and basic performance of fluoroscopy equipment:
The technical differences between this part and IEC 60601-2-54:2018 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 clauses
Text);
● Replace IEC 60601-1-3:2013 (see:201:2 and related
Provisions);
● Replace IEC 60580:2000 (see:201:2) with GB/T 20012-2005 which is equivalent to adopting international standards;
● Replace IEC 60336 with YY/T 0063 which is equivalent to adopting international standards;
● Replace IEC 60806 with YY/T 0479 equivalent to adopting 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 60601-1-8:2003 (see:201:1:3) with YY0709-2009, which is equivalent to the international standard;
● Removed IEC 62220-1-1:2015 (not cited in the standard):
--- Delete the last sentence of the third paragraph in the International Standard:201:1:3 "Alotherpublishedcolateralstandardsinthe
IEC 60601-1seriesapplyaspublished":
This section has made the following editorial changes:
---All terms are represented in bold;
--- Amend "Meet local regulations" in 203:6:3:101 to "Meet Chinese regulations";
---The term index of the international standard has been 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 2-54:
Basic safety and safety of X-ray photography and fluoroscopy equipment
Special requirements for basic performance
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 basicity of ME equipment and ME systems that are expected to be used for projection and indirect fluoroscopy:
can: GB 9706:23 applies to ME equipment and ME systems used for interventional operations, and refers to the applicable requirements of this special standard:
This section does not apply to ME intended for bone or tissue absorption densitometer, computed tomography, mammography, dentistry or radiotherapy:
Equipment and ME system: This section does not apply to radiation therapy simulators:
If a certain chapter is only applicable to ME equipment, or only applicable to ME systems, the title and content of the chapter will be explained: If not
In this case, the regulations apply to both ME equipment and ME systems:
201:1:2 Purpose
replace:
The purpose of this section is to establish specific requirements for basic safety and basic performance for ME equipment and ME systems for photography and perspective:
201:1:3 Parallel standards
Supplement:
This special standard refers to Chapter 2 of the general standard and 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 revised:
YY0709, IEC 60601-1-9, IEC 60601-1-10, IEC 60601-1-11 and IEC 60601-1-12 are not applicable:
Note: The operator of X-ray equipment is accustomed to the auditory signals required by this section, rather than the concept in YY0709: Therefore YY0709 is not applicable:
201:1:4 Specific standards
Supplement:
Special standards can modify, replace or delete requirements contained in general standards or parallel standards to apply to the ME equipment under consideration, or
Increase other basic safety and basic performance requirements:
Specific standard requirements take precedence over general standards:
In this section, GB 9706:1 is called the general standard: Parallel standards are indicated by their standard numbers:
The numbering of the 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
Standard 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:):
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB 9706.254-2020_English be delivered?Answer: Upon your order, we will start to translate GB 9706.254-2020_English as soon as possible, and keep you informed of the progress. The lead time is typically 4 ~ 7 working days. The lengthier the document the longer the lead time. Question 2: Can I share the purchased PDF of GB 9706.254-2020_English with my colleagues?Answer: Yes. The purchased PDF of GB 9706.254-2020_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.
|