|
US$1389.00 · In stock
Delivery: <= 9 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 0482-2022: (Medical Magnetic Resonance Imaging Equipment - Determination of Main Image Quality Parameters)
Status: Valid YY/T 0482: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0482-2022 | English | 1389 |
Add to Cart
|
9 days [Need to translate]
|
(Medical Magnetic Resonance Imaging Equipment - Determination of Main Image Quality Parameters)
| Valid |
YY/T 0482-2022
|
| YY/T 0482-2010 | English | RFQ |
ASK
|
8 days [Need to translate]
|
Magnetic resonance equipment for medical imaging. Part 1: Determination of essential image quality parameters
| Obsolete |
YY/T 0482-2010
|
| YY/T 0482-2004 | English | 479 |
Add to Cart
|
4 days [Need to translate]
|
Technical requirements and test methods for magnetic resonance equipment for medical diagnosis
| Obsolete |
YY/T 0482-2004
|
PDF similar to YY/T 0482-2022
Basic data | Standard ID | YY/T 0482-2022 (YY/T0482-2022) | | Description (Translated English) | (Medical Magnetic Resonance Imaging Equipment - Determination of Main Image Quality Parameters) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C39 | | Word Count Estimation | 76,763 | | Issuing agency(ies) | State Drug Administration | YY/T 0482-2010: Magnetic resonance equipment for medical imaging. Part 1: Determination of essential image quality parameters
---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.
Magnetic resonance equipment for medical imaging.Part 1. Determination of essential image quality parameters
ICS 11.040.50
C39
People's Republic of China pharmaceutical industry standards
Replacing YY/T 0482-2004
MRI medical imaging equipment
Determination of the main parameters of the image quality
Part 1. Determinationofessentialimagequalityparameters
(IEC 62464-1.2007, MOD)
Issued on. 2010-12-27
2012-06-01 implementation
State Food and Drug Administration issued
Table of Contents
Introduction Ⅲ
1 Scope 1
2 Normative references 2
3 Terms, definitions and symbols 2
4 Determination of the main parameters of the image program 11
4.1 General measurement procedure requires 11
4.2 SNR 11
4.3 Uniformity 13
4.4 two-dimensional scanning of thickness 16
4.5 dimensional geometric distortion 19
4.6 Spatial resolution 23
4.7 Ghost 25
5 Stability Test 28
5.1 Purpose and Principle 28
5.2 Testing requirements of the mold 28
28 5.3 scan feature
5.4 Measurement procedure 28
5.5 data analysis, results reporting and tolerance 29
Appendix A (normative) an alternative method 30
Annex B (informative) Basic principles 39
References 51
Index 52
Figure 1 homogeneity test mold was placed in the RF coil 14
2 on the surface of the coil mold test position 14
Figure 3 swash plate method in signal intensity profile 16
Figure 4 Test mold rotation correction 18
Figure 5 specification for testing mold spherical region of the body, for example, large bottles made of polypropylene (Posi Pei PMMA) cylinder configuration,
Its inner wall perimeter 20 as a region of interest
6 specification for testing mold spherical region of the body, for example, distributed by a number of regions of interest in the composition of the perimeter of the vial 20
Figure 7 two lines through the center of the test mold 21
8 Determination of radius 21
9 cyclicals like 23
10 cyclical position like images and regions of interest 24
11 die as well as test signals, ghosting and noise measurements region of interest 26
Figure A.1 wedge test mold 33
Figure A.2 wedge test mold measuring thickness and cross-sectional slice 34
Diagram B.1 relaxation times T1 and T2 and CuSO4 · 5H2O concentration of 40
Figure B.2 center error 46
Conductive and dielectric properties Table B.1 test mold 41
Table B.2 company bandwidth is between 43
Table B.3 Gd [TMHD] relaxation fitting parameters specific gravity concentration ≤ 0.4% 44
Foreword
All technical contents of this standard are recommended.
This revised standard adopts the International Electrotechnical Commission IEC 62464-1.2007 "medical imaging magnetic resonance apparatus main image quality parameters
Determination. "
This standard and IEC 62464-1.2007 The main differences are as follows.
--- Scanning parameters specified in this standard as "body coil Perspective 440mm (or the maximum allowed field of vision equipment)", IEC 62464-1.
2007 standard "body coil Perspective 440mm".
To IEC 62464-1.2007, this standard made the following editorial changes.
--- Remove the IEC 62464-1.2007 standard covers, foreword and introduction;
--- For the international standard quoted in the standard, if China has been transposed into national standards, will be replaced by a reference to our standards;
--- According to Chinese layout characteristics of IEC 62464-1.2007 standard terms in capital letters, bold font Chinese
FIG.
Since the implementation of this standard instead of YY/T 0482-2004, while YY/T 0482-2004 abolished.
The main difference compared with the standard YY/T 0482-2004 as follows.
--- Remove the static magnetic field strength (resonant frequency) deviation requirements;
--- Deletion of the requirement of the stability of the magnetic field;
--- Remove the magnetic field uniformity requirement.
Appendix A of this standard is a normative appendix, Appendix B is an informative annex.
This standard by the National Standardization Technical Committee on Medical Electrical Medical Electronic Instrument Standardization Technical Committee.
This standard was drafted. the Shanghai Medical Device Testing, Siemens Mindit magnetic resonance (Shenzhen) Co., Ltd., Hang Wei GE Medical
Therapy Systems Limited.
The main drafters of this standard. Yu and Ni Cheng, Zhu Hongyi.
This standard replaces the standards previously issued as follows.
--- YY/T 0482-2004.
MRI medical imaging equipment
Determination of the main parameters of the image quality
1 Scope
The standard provides for the determination of many of the major medical equipment MRI image quality parameter measurement procedure. The standard test set forth in the
Procedures apply to the amount of.
--- Quality evaluation in the acceptance tests;
--- When stability tests for quality assurance.
In addition, as specified in this standard measurement procedure for type testing is also helpful, although it is not the purpose of this standard.
This standard does not apply to.
--- Performance level is determined at the time of acceptance tests and stability tests;
Image Quality Assessment --- more than 4T high-field magnetic resonance apparatus, unless otherwise noted;
--- By MRI compatibility issues that affect image quality;
--- Special diagnostic procedures, such as blood flow imaging, perfusion, diffusion, radiation therapy and image-guided therapy applications;
--- Type testing.
Scope of this standard is limited to measuring image quality characteristics of the test mold, rather than the patient's images.
In this standard measurement procedures for.
a) the manufacturer can declare compliance with this standard methods described in acceptance tests and stability tests;
b) laboratory, according to the standard method described in Claim performance magnetic resonance apparatus;
c) authorities, can be based on this standard, and
d) the responsibility of institutions willing to perform acceptance tests and stability tests described in this standard methods.
The main image quality parameters and measurement methods defined in this standard.
--- SNR,
--- Uniformity,
--- Sheet thickness and profile,
--- Geometric distortion,
--- Spatial resolution, and
--- Ghosting.
This standard describes the preferred measurement procedure in Appendix A also describes an alternative method. Alternative methods alternative to the preferred test method.
If necessary, other methods not described in this standard may also be used, as long as these other methods test methods described in this standard verified
And archiving. Verify that other test methods, requirements analysis and sensitivity analysis on the same test parameter of interest to other unrelated parameters
Test is not sensitive, and should be declared a similar or better sensitivity to the same parameter of interest, and a statement similar to, or better,
Anti-independent parameters robust levels. All methods should be quantitative results.
The principles set forth preferred and alternative methods and their shortcomings in Appendix B statement.
This standard also proposed for the main image quality parameter relates to a magnetic resonance device in terms of the stability test of the quality assurance program
begging. In the current automatic program effective use, there is no optimum stability test method applicability to offer. There is no priority
Methods, test methods in Appendix A only given by way of example as recommendations. If necessary, you can use this standard does not
Additional stability test methods stated. Quality assurance procedures required by the responsible authority will change, it will encourage the responsible authorities to determine the
To test range, the test of the quality of data and analysis of sensitivity. This standard can focus on repeat, to facilitate trend analysis from
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0482-2022_English be delivered?Answer: Upon your order, we will start to translate YY/T 0482-2022_English as soon as possible, and keep you informed of the progress. The lead time is typically 6 ~ 9 working days. The lengthier the document the longer the lead time. Question 2: Can I share the purchased PDF of YY/T 0482-2022_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 0482-2022_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. Question 5: Should I purchase the latest version YY/T 0482-2022?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0482-2022 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.
|