YY/T 0773-2023 English PDF

US$279.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 0773-2023: General technical requirements for ophthalmic ultrasound B-mode scan
Status: Valid

YY/T 0773: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0773-2023	279	Add to Cart	3 days	General technical requirements for ophthalmic ultrasound B-mode scan	Valid
YY 0773-2010	559	Add to Cart	3 days	General technical requirements for ophthalmic ultrasound B-mode scan	Obsolete

Similar standards

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Older Standard (superseded by this standard): YY/T 0773-2010; YY/T 0849-2011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 ......

Image     

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 0773-2023_English be delivered?

Answer: Upon your order, we will start to translate YY/T 0773-2023_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 0773-2023_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 0773-2023_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+ countries

Question 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 Sales@ChineseStandard.net. 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 0773-2023?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0773-2023 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.