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YY/T 1754.4-2024: Preclinical animal study of medical devices - Part 4: Acute trauma model for evaluating the healing promoting performance of dressing
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Preclinical animal study of medical devices - Part 4: Acute trauma model for evaluating the healing promoting performance of dressing
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YY/T 1754.4-2024
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Basic data | Standard ID | YY/T 1754.4-2024 (YY/T1754.4-2024) | | Description (Translated English) | Preclinical animal study of medical devices - Part 4: Acute trauma model for evaluating the healing promoting performance of dressing | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.040.01 | | Word Count Estimation | 10,117 | | Date of Issue | 2024-07-08 | | Date of Implementation | 2025-07-20 | | Issuing agency(ies) | State Drug Administration | YY/T 1754.4-2024: Preclinical animal study of medical devices - Part 4: Acute trauma model for evaluating the healing promoting performance of dressing
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ICS 11.040.01
CCSC30
Pharmaceutical Industry Standards of the People's Republic of China
Medical Device Preclinical Animal Research
Part 4.Evaluation of healing-promoting dressings
Acute trauma model
Released on 2024-07-08
2025-07-20 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.
This document is part 4 of YY/T 1754 “Preclinical Animal Studies of Medical Devices”. YY/T 1754 has been published in the following parts.
--- Part 1.General requirements;
--- Part 2.Inducing diabetic rat skin defect model;
--- Part 3.Animal abdominal wall incisional hernia model for evaluating the histological response and biomechanical properties of the patch;
--- Part 4.Acute wound model for evaluating dressings promoting healing.
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 document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the National Technical Committee for Biological Evaluation of Medical Devices (SAC/TC248).
This document was drafted by. Shandong Medical Device and Drug Packaging Inspection Institute, Shenzhen Drug Inspection Institute (Shenzhen Medical Device
Medical Device Testing Center), Jiangsu Kebiao Medical Testing Co., Ltd., and Saikesaisi Biotechnology Co., Ltd.
The main drafters of this document are. Liu Chenghu, Lin Zhenhua, Wang Shuhan, Zhang Qi, Xia Yiran, Zang Deyue, Zhou Yangfei, Liu Changfeng and Wei Zhenxi.
Introduction
YY/T 1754 aims to establish specific test methods for preclinical animal research of medical devices and is intended to consist of four parts.
--- Part 1.General requirements. The purpose is to provide general requirements for preclinical animal studies of medical devices.
--- Part 2.Induced diabetic rat skin defect model. The purpose is to provide the construction of the diabetic rat skin defect model.
Build method.
--- Part 3.Animal abdominal wall incisional hernia model for evaluating the histological response and biomechanical properties of the patch.
Testing and evaluation methods for the histological response and biomechanical properties of intraperitoneal patches.
--- Part 4.Acute wound model for evaluating wound healing performance of dressings.
Testing and evaluation methods for acute trauma models.
Medical Device Preclinical Animal Research
Part 4.Evaluation of healing-promoting dressings
Acute trauma model
1 Scope
This document describes the preparation of a porcine dorsal full-thickness acute wound model for experimental use.
This document is applicable to the testing and evaluation of the healing performance of wound dressings.
2 Normative references
The contents of the following documents constitute 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.
GB/T 16886.2 Biological evaluation of medical devices Part 2.Animal welfare requirements
3 Terms and definitions
The terms and definitions defined in GB/T 16886.2 apply to this document.
4 Animal selection
It is advisable to use healthy, non-pregnant, adult miniature pigs with an initial weight of 25kg to 30kg, regardless of gender.
The suitability of the experiment should be explained. The experimental animals should be of qualified quality and their skin should be intact.
The number of animals should be selected in combination with the purpose of the experiment, design type, evaluation index and
The accuracy of the evaluation method and other statistical factors should be considered comprehensively to determine the result.
It is generally recommended that the sample size of the test samples and control samples that complete the effective test at the final observation point should be no less than 10 each, so the number of animals
There should be no less than 4.
5 Main instruments and equipment
Commonly used surgical instruments, animal anesthesia monitoring equipment, pathological examination equipment, etc.
6 Surgical Procedure
6.1 Selection of control samples
It is advisable to select similar domestically marketed products with similar materials, structural design, and working principles as control samples.
For products, reasonable reasons and evidence for the selection of control samples should be provided.
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