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YY/T 0773-2023: General technical requirements for ophthalmic ultrasound B-mode scan
Status: Valid YY/T 0773: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0773-2023 | English | 279 |
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General technical requirements for ophthalmic ultrasound B-mode scan
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YY/T 0773-2023
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| YY 0773-2010 | English | 559 |
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General technical requirements for ophthalmic ultrasound B-mode scan
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PDF similar to YY/T 0773-2023
Standard similar to YY/T 0773-2023 YY 0789 YY/T 0767 YY 0844 YY/T 0774 Basic data | Standard ID | YY/T 0773-2023 (YY/T0773-2023) | | Description (Translated English) | General technical requirements for ophthalmic ultrasound B-mode scan | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C41 | | Classification of International Standard | 11.040.50; 11.040.70 | | Word Count Estimation | 14,155 | | Date of Issue | 2023-09-05 | | Date of Implementation | 2024-09-15 | | Older Standard (superseded by this standard) | YY/T 0773-2010; YY/T 0849-2011 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the requirements and test methods for ophthalmic B-type ultrasonic diagnostic instruments. This standard applies to ophthalmic B-type ultrasonic diagnostic instruments, whose nominal ultrasonic frequency range is usually 10MHz ~ 50MHz. | YY/T 0773-2023: General technical requirements for ophthalmic ultrasound B-mode scan---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;11.040.70
CCSC41
Pharmaceutical Industry Standards of the People's Republic of China
Replace YY/T 0773-2010, YY/T 0849-2011
General technical conditions for ophthalmic B-mode ultrasonic diagnostic instruments
Published on 2023-09-05
Implemented on 2024-09-15
Released by the State Drug Administration
Table of contents
Preface III
1 Scope 1
2 Normative reference documents 1
3 Terms and Definitions 1
4 Requirements 1
5 Test method 3
Appendix A (informative) Ultrasonic tissue-mimetic phantom and specimen 5
Appendix B (informative) The relationship between the sound speed of distilled water and temperature 8
Reference 9
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.
This document replaces YY/T 0773-2010 "General Technical Conditions for Ophthalmic B-type Ultrasound Diagnostic Instruments" and YY/T 0849-2011 "Ophthalmic High-Tech
Frequency Ultrasound Diagnostic Instrument". This document is based on YY/T 0773-2010 and integrates the contents of YY/T 0849-2011.With YY/T 0773-
Compared with.2010, in addition to structural adjustments and editorial changes, the main technical changes are as follows.
a) “Composition and basic parameters” are deleted (see Chapter 3 of YY/T 0773-2010);
b) “Working conditions” is deleted (see 4.1 of YY/T 0773-2010);
c) "Performance" has been changed (see 4.1, 4.2 of YY/T 0773-2010);
d) Added “information disclosure” (see 4.3);
e) “Logo and instructions for use” are deleted (see Chapter 6 of YY/T 0773-2010);
f) The appendix "Ultrasonic tissue-mimetic phantom and specimens" has been changed (see Appendix A, Appendix A of YY/T 0773-2010);
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 under the jurisdiction of the Medical Ultrasound Equipment Sub-Technical Committee (SAC/TC10/SC2) of the National Technical Committee for Standardization of Medical Electrical Appliances.
This document was drafted by. Hubei Medical Device Quality Supervision and Inspection Institute, Tianjin Maida Medical Technology Co., Ltd.
The main drafters of this document. Jiang Shilin, Yang Jun, Wang Yanqun, Zhang Yusheng, Wang Zhijian, Lin Sen, and Wu Chengzhi.
The previous versions of this document and the documents it replaces are as follows.
---First released in.2010 as YY 0773-2010;
---First released in.2011 as YY 0849-2011;
---This is the first revision.
General technical conditions for ophthalmic B-mode ultrasonic diagnostic instruments
1 Scope
This document specifies the requirements and test methods for ophthalmic B-mode ultrasonic diagnostic instruments.
This document applies to ophthalmic B-type ultrasonic diagnostic instruments (hereinafter referred to as diagnostic instruments), whose nominal ultrasonic frequency range is usually 10MHz~
50MHz.
UBM).
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.
GB 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and basic performance
GB 9706.237 Medical electrical equipment Part 2-37.Ultrasonic diagnostic and monitoring equipment for basic safety and basic performance
Require
GB 10152 Type B ultrasonic diagnostic equipment
GB/T 14710 Environmental requirements and test methods for medical electrical appliances
YY/T 1420 Environmental requirements and test methods for medical ultrasound equipment
3 Terms and definitions
The terms and definitions defined in GB 10152 apply to this document.
4 requirements
4.1 Performance
4.1.1 B-type scanning performance
The diagnostic instrument B-scan performance requirements are shown in Table 1.
Table 1 Type B performance requirements
Performance
nominal frequency
10MHz≤f≤13MHz 13MHz< f≤25MHz 25MHz< f≤40MHz f >40MHz
Detection depth
mm
≥50 ≥20 ≥6 ≥5
Axial resolution
mm
≤0.2 ≤0.1 ≤0.1 ≤0.05
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