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Clinical investigation of in vitro diagnostic reagents - Terms and definitions
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YY/T 1956-2025
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Basic data
| Standard ID | YY/T 1956-2025 (YY/T1956-2025) |
| Description (Translated English) | Clinical investigation of in vitro diagnostic reagents - 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 | 14,130 |
| Date of Issue | 2025-02-26 |
| Date of Implementation | 2026-03-01 |
| Issuing agency(ies) | State Drug Administration |
| Summary | This standard specifies the terms and definitions involved in the clinical trials of in vitro diagnostic reagents, including the terms and definitions used in the design, implementation, recording and reporting of clinical trials of in vitro diagnostic reagents. The in vitro diagnostic reagents referred to in this standard are in vitro diagnostic reagents managed as medical devices. This standard is applicable to clinical trials of in vitro diagnostic reagents. |
YY/T 1956-2025: Clinical investigation of in vitro diagnostic reagents - 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
Terms and definitions for clinical trials of in vitro diagnostic reagents
Released on 2025-02-26
2026-03-01 Implementation
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. Lv Yunfeng, He Jingyun and Li Ran.
Terms and definitions for clinical trials of in vitro diagnostic reagents
1 Scope
This document defines the terms and definitions involved in clinical trials of in vitro diagnostic reagents, including the design, implementation,
Terms and definitions used in the process of recording and reporting. In vitro diagnostic reagents referred to in this document are in vitro diagnostic reagents managed in accordance with medical devices.
Reagents.
This document applies to clinical trials of in vitro diagnostic reagents.
2 Normative references
This document has no normative references.
3 Terms and definitions
3.1
Safety
When the product is used within its intended scope, the risks are acceptable compared with the benefits.
3.2
Case report form casereportform; CRF
A document designed in accordance with the clinical trial protocol for in vitro diagnostic reagents to record the complete data of each subject obtained during the trial.
Department information and data.
3.3
Adverse event; AE
Adverse medical events occurring during clinical trials of in vitro diagnostic reagents, regardless of whether they are related to the in vitro diagnostic reagents.
NOTE 1 Adverse events may result from, for example, inadequate instructions for use, deployment, installation, operation or any malfunction of the in vitro diagnostic reagent.
Sufficient or inappropriate.
NOTE 2 This definition includes equipment failure or reagent failure that has not resulted in death or serious injury but could result in death or serious injury.
Note 3.This definition is not used to determine whether an event should be reported to a regulatory authority.
Note 4.False-negative or false-positive results are not considered adverse events, but in interventional studies, inappropriate patient decisions based on these false-negative or false-positive results may be
Except as decided by the management.
3.4
Recognized measurement procedures that provide measurement results suitable for evaluating the validity of measurement values obtained by other measurement methods of similar quantities
Assignment of values to measurements, calibration or reference materials.
3.5
Comparator
In vitro diagnostic reagents are in vitro diagnostic reagents that have been marketed in the People’s Republic of China and used as controls in clinical trials.
3.6
protocol deviation
Intentional or unintentional failure to comply with the requirements of the in vitro diagnostic reagent clinical trial protocol.
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