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GB 9706.245-2020: Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographie X-ray equipment and mammographie stereotactic devices
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Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographie X-ray equipment and mammographie stereotactic devices
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GB 9706.245-2020
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Basic data | Standard ID | GB 9706.245-2020 (GB9706.245-2020) | | Description (Translated English) | Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographie X-ray equipment and mammographie stereotactic devices | | Sector / Industry | National Standard | | Classification of Chinese Standard | C43 | | Classification of International Standard | 11.040.50 | | Word Count Estimation | 40,463 | | Date of Issue | 2020-12-24 | | Date of Implementation | 2023-05-01 | | Older Standard (superseded by this standard) | GB 9706.24-2005 | | Quoted Standard | GB 9706.103-2020; YY 0505-2012; GB/T 24791.3-2009; YY/T 0063-2007; YY/T 0590.2-2010; IEC TR 60788-2004 | | Adopted Standard | IEC 60601-2-45-2015, 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 mammography equipment, including mammography tomosynthesis imaging equipment and mammography stereotaxic devices, also referred to as ME equipment hereinafter. This standard does not apply to: tomographic reconstruction other than breast tomosynthesis imaging; CT scanning equipment applicable to GB 9706.244-2020; diagnostic consoles; image archiving and communication systems (PACS); non-integrated fluorescent storage readers; hard copy cameras Films, intensifying screens and cassettes; computer-aided detection (CAD); performing biopsy devices and other biopsy tools; displaying the mode of operation of partial radiography (digital mammography with enhanced contrast). | GB 9706.245-2020: Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographie X-ray equipment and mammographie stereotactic devices
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Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographie X-ray equipment and mammographie stereotactic devices
ICS 11:040:50
C43
National Standards of People's Republic of China
Replace GB 9706:24-2005
Medical Electrical Equipment Part 2-45:
Mammography equipment and mammography stereo
Specific requirements for basic safety and basic performance of positioning devices
(IEC 60601-2-45:2015, MOD)
Released on 2020-12-24 Implemented on 2023-05-01
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 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 ME equipment identification, marking and documentation 5
201:8 Protection of ME equipment against electric shock risk 9
201:9 Protection of ME equipment and ME systems against mechanical hazards 11
201:10 Protection against unwanted or excessive radiation risks 13
201:11 Protection against over-temperature and other hazards 13
201:12 Accuracy of controllers and instruments and protection against dangerous outputs 13
201:13 Dangerous conditions and fault states of ME equipment 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 systems 14
202 Electromagnetic compatibility requirements and tests 14
202:101 Basic performance immunity test 14
203 Radiation protection of diagnostic X-ray equipment 14
203:4 General requirements 15
203:5 Marking, marking and documentation of ME equipment 16
203:6 Radiation Management 16
203:7 Radiation quality 27
203:8 Limitation and indication of X-ray beam range and the relationship between X-ray field and image receiving area 28
203:9 Focal distance 31
203:10 Attenuation of X-ray beam between patient and X-ray image receiver 31
203:11 Protection from residual radiation 31
203:13 Protection against stray radiation 32
Appendix 33
Appendix AA (informative appendix) special guide and principle explanation 34
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 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 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: 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 2-45 of GB 9706:
This section was drafted in accordance with the rules given in GB/T 1:1-2009:
This part replaces GB 9706:24-2005 "Medical electrical equipment Part 2-45: Mammography equipment and mammography stand
Special requirements for the safety of body positioning devices:
Compared with GB 9706:24-2005, the main technical changes in this part are as follows:
increased:
---The scope of application clarifies the mammography equipment including mammography equipment and mammography stereotaxic device
Equipment and including mammography equipment using integrated digital X-ray image receiver or integrated fluorescence storage subsystem
(See:201:1:1);
---Basic performance requirements (see table:201:101);
---Added the apparent resistance of the power supply network, average gland dose, defect detector unit, raw data, unprocessed data, comparison
Degree to noise ratio (see:201:3);
---Automatic exposure control (AEC) repeatability (see 203:6:5:3:2:);
---Automatic exposure control (AEC) thickness response (see 203:6:5:3:
---Imaging performance (see 203:6:7);
---The correlation coefficient of the minimum air kerma rate in different target materials and filtration combinations is given (see 203:6:7:104:1);
---Maximum loading time requirements under a specific mode (see 203:6:7:104: 2):
edited:
---Test method for linearity of air kerma kinetic energy at the interval of loading factors (see 203:6:3:1:2, GB 9706:24-2005
50:105:4):
This part uses the redrafting method to modify and adopt IEC 60601-2-45:2015 "Medical Electrical Equipment Part 2-45: Mammary X-ray
Special requirements for basic safety and basic performance of photographic equipment and mammography stereotaxic devices:"
The technical differences between this part and IEC 60601-2-45:2015 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 60601-1-2:2014 with YY0505-2012 which is equivalent to adopting international standards (see:201:1:
Text);
● Replace IEC 60601-1-3:2013 with GB 9706:103-2020 which is modified to adopt international standards (see:201:1:3 and related
Customs provisions);
● Removed IEC 60613:2010:
This section has made the following editorial changes:
---All terms are represented in bold;
--- The original text of the international standard in:201:7:9:2:1 was "Meet local regulations", and was revised to "Comply with Chinese radiation protection regulations" in the standard conversion
Requirements";
---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:
The previous versions of the standards replaced by this part are as follows:
---GB 9706:24-2005:
Medical Electrical Equipment Part 2-45:
Mammography equipment and mammography stereo
Specific requirements for basic safety and basic performance of positioning devices
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 mammography equipment including mammography equipment and mammography stereotaxic equipment
Safety and basic performance, hereinafter also referred to as ME equipment:
Note 1: This includes mammography equipment that uses an integrated digital X-ray image receiver or an integrated fluorescence storage subsystem:
This section does not apply to:
---Tomographic reconstruction outside the tomosynthesis of the breast;
--- CT scanning equipment applicable to GB 9706:244-2020;
---Diagnostic console;
---Picture Archiving and Communication System (PACS);
---Non-integrated fluorescent storage reader;
---Hard copy camera;
---Film, intensifying screen and cassette;
---Computer Aided Inspection (CAD);
---Perform biopsy devices and other biopsy tools;
---Display the operation mode of partial contrast (digital mammography with enhanced contrast):
If a chapter or article is clearly applicable only to ME equipment or only to ME systems, then the title and content of the chapter or article will be written
Bright: If not stated, then the relevant chapters or clauses apply to both ME equipment and ME systems:
Note 2: GB 9706:3-2000 and GB 9706:14-1997 are not part of the standard system of mammography equipment and mammography stereotaxic devices:
section:
201:1:2 Purpose
replace:
The purpose of this part is to establish basic safety and basic performance specifications for mammography equipment and mammography stereotaxic devices:
Use requirements; in order to ensure safety, it specifies the methods used to prove compliance with these requirements and provides guidance for risk management:
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:
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