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YY/T 1949-2024 English PDF

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YY/T 1949-2024: Artificial intelligence medical device - Specific requirement for datasets: color fundus images of diabetic retinopathy
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1949-2024	519	Add to Cart	5 days	Artificial intelligence medical device - Specific requirement for datasets: color fundus images of diabetic retinopathy	Valid

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Basic data

Standard ID: YY/T 1949-2024 (YY/T1949-2024)
Description (Translated English): Artificial intelligence medical device - Specific requirement for datasets: color fundus images of diabetic retinopathy
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C30
Classification of International Standard: 11.040.99
Word Count Estimation: 26,227
Date of Issue: 2024-09-29
Date of Implementation: 2025-10-15
Issuing agency(ies): State Drug Administration
Summary: This standard specifies the special requirements for the fundus color photo dataset of diabetic retinopathy (hereinafter referred to as "diabetic retinopathy") for artificial intelligence medical devices, and specifies the corresponding test methods. This standard is applicable to the data sets used in the research and development, production, quality control and other links of artificial intelligence medical devices that post-process diabetic retinopathy fundus color photos.

YY/T 1949-2024: Artificial intelligence medical device - Specific requirement for datasets: color fundus images of diabetic retinopathy

---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 11.040.99 CCSC30 Pharmaceutical Industry Standards of the People's Republic of China Special requirements for AI medical device datasets. Diabetic retinopathy fundus color photos Released on 2024-09-29 Implementation on October 15, 2025 The State Drug Administration issued

Preface III Introduction IV 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Dataset Description Requirements 1 5 Dataset quality requirements 5 6 Dataset Quality Compliance Evaluation 7 Appendix A (Normative) Data Collection Requirements 10 Appendix B (Informative) Data Annotation Process Example 13 Appendix C (Informative) Metadata Examples 17 References 19

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents" Drafting. Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This standard is proposed by the State Food and Drug Administration. This standard is under the jurisdiction of the technical authority responsible for standardization of artificial intelligence medical devices. This document was drafted by. Beijing Tongren Hospital Affiliated to Capital Medical University, National Health Commission Capacity Building and Continuing Education Center, Tsinghua University Shenzhen International Graduate School, China Food and Drug Inspection Institute, National Medical Products Administration Medical Device Technology Review Center, Zhongshan Eye Center of Sun Yat-sen University, the Second Affiliated Hospital of Zhejiang University School of Medicine, Peking Union Medical College Hospital of Chinese Academy of Medical Sciences, Beijing Hospital, Harbin The Second Affiliated Hospital of Binzhou Medical University, Beijing Eagle Eye Technology Development Co., Ltd., Yiwei Technology (Beijing) Co., Ltd., Beijing Eye and Optometry Co., Ltd. learn. The main drafters of this document are. Wei Wenbin, Yang Aiping, Dong Li, Shao Lei, Ma Lan, Li Jingli, Ma Zhaoyi, Liu Xiaoyin, Lin Haotian, Ye Juan, Chen Youxin, Dai Hong, Yuan Huiping, Song Chao, Yu Chen, Yu Weihong, Zhao Jing, Jin Kai, Lin Duoru, Gao Lin, Jiang Bo, Zhang Chuan, Li Fang, Meng Xiangfeng, Wang Hao, Hao Ye, Tang Chao, Ling Saiguang and Bai Yujing.

Introduction

The diabetic retinopathy fundus color photo dataset is used for the research and development of artificial intelligence medical devices such as diabetic retinopathy auxiliary diagnosis software, Resources commonly used in training, testing, quality control and other links have an important impact on product quality. This document is based on reference YY/T 1833.2-2022. Based on this, the special requirements for the color fundus photo dataset of diabetic retinopathy are proposed to guide the quality evaluation of such datasets. It is of reference significance to establish special evaluation criteria for other datasets. Special requirements for AI medical device datasets. Diabetic retinopathy fundus color photos

1 Scope

This document specifies the specialized requirements for the diabetic retinopathy (DR) fundus color photo dataset for artificial intelligence medical devices. The corresponding test methods are described. This document is applicable to the research and development, production, quality control and other links of artificial intelligence medical devices for post-processing of diabetic retinopathy fundus color photos. According to the collection.

2 Normative references

The contents of the following documents constitute the essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. YY/T 1833.1 Quality requirements and evaluation of artificial intelligence medical devices Part 1.Terminology YY/T 1833.2-2022 Quality requirements and evaluation of artificial intelligence medical devices Part 2.General requirements for data sets YY/T 0634 Ophthalmic instruments-Fundus cameras WS/T 305 Metadata Standard for Health Information Datasets

3 Terms and definitions

The terms and definitions defined in YY/T 1833.1, YY/T 1833.2-2022 and the following apply to this document. 3.1 diabetic retinopathy Diabetes causes damage to retinal microvessels, leading to a series of fundus lesions. 3.2 Digital color fundus photographs obtained using a fundus camera.

4 Dataset Description Requirements

4.1 Dataset Description 4.1.1 Overall description of the dataset 4.1.1.1 Dataset Type The dataset description should comply with the requirements of 4.1.1.1 in YY/T 1833.2-2022. 4.1.1.2 Dataset form The dataset description should comply with the requirements of 4.1.1.2 in YY/T 1833.2-2022. ......

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Question 1: How long will the true-PDF of YY/T 1949-2024_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1949-2024_English as soon as possible, and keep you informed of the progress. The lead time is typically 3 ~ 5 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 1949-2024_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1949-2024_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.