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YY/T 1894-2023: Methods on verifying the reliability index of magnetic resonance equipment for medical diagnosis
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1894-2023 | English | 239 |
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Methods on verifying the reliability index of magnetic resonance equipment for medical diagnosis
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YY/T 1894-2023
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PDF similar to YY/T 1894-2023
Standard similar to YY/T 1894-2023 YY/T 1933 YY/T 1712 YY/T 1519 YY 9706.231 Basic data | Standard ID | YY/T 1894-2023 (YY/T1894-2023) | | Description (Translated English) | Methods on verifying the reliability index of magnetic resonance equipment for medical diagnosis | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C39 | | Classification of International Standard | 11.040.50 | | Word Count Estimation | 11,167 | | Date of Issue | 2023-06-20 | | Date of Implementation | 2024-07-01 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the method for verification of reliability indicators of medical magnetic resonance equipment. This standard applies to medical magnetic resonance equipment. This standard does not apply to the software part of medical magnetic resonance equipment. | YY/T 1894-2023: Methods on verifying the reliability index of magnetic resonance equipment for medical diagnosis
---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.
ICS 11.040.50
CCSC39
Pharmaceutical Industry Standards of the People's Republic of China
Verification method for reliability index of medical magnetic resonance equipment
Published on 2023-06-20
2024-07-01 Implementation
Released by the State Drug Administration
Table of contents
PrefaceⅠ
1 Scope 1
2 Normative reference documents 1
3 Terms and Definitions 1
4 General rules 1
5 Quantitative verification method for reliability of medical magnetic resonance equipment 3
Appendix A (informative) MTBF acquisition method of main components 6
Reference 7
Foreword
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents"
Drafting.
Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents.
This document is proposed by the National Medical Products Administration.
This document is sponsored by the National Medical Electrical Appliances Standardization Technical Committee Medical Electronic Instruments Standardization Sub-Technical Committee (SAC/TC10/SC5)
Return to home.
This document was drafted by. Shanghai Medical Device Inspection and Research Institute, Siemens (Shenzhen) Magnetic Resonance Co., Ltd., Shanghai United Imaging Medical Technology
Co., Ltd., Hangwei General Electric Medical Systems Co., Ltd., and Philips (China) Investment Co., Ltd.
The main drafters of this document. Yu Hongyi, Wang Jun, Jia Dongfang, Wang Kun, Chen Dayu, Hu Sheng, Yang Yu, Xu Luqin, Xing Xiaocong, and Ma Gang.
Verification method for reliability index of medical magnetic resonance equipment
1 Scope
This document describes a method for verification of reliability indicators for medical magnetic resonance equipment.
This document applies to medical magnetic resonance equipment.
This document does not apply to the software portion of medical magnetic resonance equipment.
2 Normative reference documents
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations
For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to
this document.
YY/T 1837 General requirements for reliability of medical electrical equipment
3 Terms and definitions
The terms and definitions defined in YY/T 1837 apply to this document.
4 General principles
4.1 Goals of reliability index verification of medical magnetic resonance equipment
Verify whether the magnetic resonance equipment meets the established reliability requirements by using methods such as reliability data analysis, reliability testing, and reliability prediction.
Requirements for quantitative indicators.
The goal of carrying out the verification of reliability indicators of medical magnetic resonance equipment is to analyze the basic functions and reliability of medical magnetic resonance equipment.
Analyze, determine the quantitative reliability requirements of medical magnetic resonance, and be able to evaluate the lifespan and expected mean time between failures of medical magnetic resonance components and complete machines.
4.2 Basic principles for verification of reliability indicators of medical magnetic resonance equipment
The basic principles are as follows.
---Due to the characteristics of the complete medical magnetic resonance machine, such as its large size, many components and uneven distribution, strong magnetic field, and ultra-low temperature, it is currently impossible to inspect the complete machine.
Conduct effective accelerated life tests so that the reliability indicators of the entire machine can be assigned to each key component;
---When determining the fault of each key component, it should be based on whether it affects the basic functions of the entire system. For example, the ambient light is not in contact.
It is faulty and cannot emit light normally. Such faults should not be regarded as a criterion for complete machine failure;
---For the verification of reliability indicators of components, for mature and improved products, based on the components or technologies shared by the products before improvement, adopt
Use reliability data for analysis and statistics; for newly developed products, life and accelerated life test methods can be used.
verify.
4.3 Principles for evaluation of reliability index verification results of medical magnetic resonance equipment
A comprehensive assessment of the verification of reliability indicators of medical magnetic resonance equipment includes the following aspects.
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