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www.ChineseStandard.net Database: 189760 (25 Oct 2025)

YY/T 1930-2024 English PDF

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YY/T 1930-2024: Medical device clinical evaluation - Terms and definitions
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YY/T 1930-2024English359 Add to Cart 4 days [Need to translate] Medical device clinical evaluation - Terms and definitions Valid YY/T 1930-2024

PDF similar to YY/T 1930-2024


Standard similar to YY/T 1930-2024

YY/T 1943   YY/T 1942   YY/T 1897   YY/T 1940   YY/T 1939   

Basic data

Standard ID YY/T 1930-2024 (YY/T1930-2024)
Description (Translated English) Medical device clinical evaluation - Terms and definitions
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 11.40
Word Count Estimation 18,177
Date of Issue 2024-09-29
Date of Implementation 2025-10-15
Issuing agency(ies) State Drug Administration
Summary This standard specifies the terms and definitions related to the clinical evaluation of medical devices, including the terms and definitions in the design, implementation, record and report of clinical trials of medical devices. This standard applies to the clinical evaluation of medical devices. This standard does not apply to in vitro diagnostic reagents.

YY/T 1930-2024: Medical device clinical evaluation - Terms and definitions

---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 11.40 CCSC30 Pharmaceutical Industry Standards of the People's Republic of China Medical Device Clinical Evaluation Terms and Definitions Released on 2024-09-29 Implementation on October 15, 2025 The State Drug Administration issued

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 institution does not bear responsibility for identifying patents. This document is proposed by the State Food and Drug Administration. This document is under the jurisdiction of the National Medical Device Clinical Evaluation Standardization Technical Authority. This document was drafted by. Medical Device Technical Review Center of the State Food and Drug Administration. The main drafters of this document. Liu Yinghui, Liu Lu, Cheng Weilu and Cui Xinyue. Medical Device Clinical Evaluation Terms and Definitions

1 Scope

This document defines the terms and definitions involved in the clinical evaluation of medical devices, including the design, implementation, recording and reporting of clinical trials of medical devices. terms and definitions used in reporting, etc. This document applies to the clinical evaluation of medical devices. This document does not apply to in vitro diagnostic reagents.

2 Normative references

This document has no normative references.

3 Terms and definitions

3.1 Clinical evaluation 3.1.1 Safety When the product is used within its intended scope, the risks are acceptable compared with the benefits. 3.1.2 Adverse event; AE < Clinical Evaluation> Medical events that are adverse to patients/subjects, users, or other persons. NOTE. Adverse events include unfavorable medical occurrences that may be associated with a medical device in clinical experience. 3.1.3 Equivalent device A situation where a medical device of the same type is a medical device that is equivalent to the medical device undergoing clinical evaluation. Note. Equivalent devices have the same scope of application as the declared product, and the similarity of technical features and/or biological characteristics makes the safety and clinical performance of the two devices comparable. and/or medical devices for which there is no clinically significant difference in effectiveness. 3.1.4 Comparative device A medical device selected by the registrant to have its clinical data used to support the clinical evaluation of the product being applied for. 3.1.5 Risk Management Apply management policies, processes and practices to analyze, assess, control and monitor risks. 3.1.6 Conformity assessment The applicant for registration shall systematically examine the evidence generated and its process in accordance with the requirements of the regulatory agency to determine whether the medical device complies with the safety Basic principles of safety and performance.

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