YY/T 1679-2021Tissue engineering medical device products-Bone-Standard guide for pre-clinical in vivo evaluation in critical size segmental bone defects (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

Introduction

This standard is a general guideline for evaluating bone tissue engineering medical products (TEMPs)

Pieces. The drafting of this standard refers to ASTM F2721-09(14) (Standardguideforpre-clinicalinvivoevaluationin criticalsizesegmentalbonedefects). Bone tissue engineering medical products refer to the ability to repair bone defects or rebuild bone tissue in the body The products, including natural biological materials, synthetic biological materials (biocompatible and biodegradable) or composite materials, may contain fine Cells or biologically active substances (such as growth factors, synthetic polypeptides, plasmids or cDNA, etc.). Part of the critical size bone defect described in this standard Damage model refers to the smallest bone defect in the body that cannot be repaired by itself during the life of the animal without treatment. Therefore, this model is Test and evaluate the ability of bone tissue engineering medical products to induce or promote bone growth.

The purpose of this standard is to provide a series of in vivo animal models for clinical repair or regeneration of bone tissue engineering medical products (TEMPs) preclinical research. Before using the in vivo model evaluation described in this standard, appropriate national standards or industry standards should be used Evaluation of cytotoxicity and biocompatibility of materials or (and) TEMPs.

This standard includes descriptions of animal models, surgical observations, tissue processing, and qualitative and quantitative analysis of tissue specimens.

The standard contains descriptions and principles of various animal models, including rats, rabbits, dogs, goats, and sheep. Based on imaging, organization The results obtained from the analysis of science and mechanics are briefly described, which is of reference value. Users need to consider more when designing specific test methods. Many factors.

This standard does not include testing of raw materials, preparation of biological materials, sterilization, and packaging of final products.

Any method in this standard may produce results that are inconsistent with actual clinical manifestations in specific applications. Therefore, it is not ruled out.

His available testing methods are used for preclinical evaluation. The material needs to be suitable for its intended purpose. Of course, according to the characteristics of the material, additional production Physical testing and evaluation are also necessary.

The values mentioned in this standard are all international standard units, and other measurement units are not included in this document.

This standard is not intended to solve all safety issues, but also related to its use. The user of the standard is responsible for ensuring the safety and determination of the experiment The applicability of the rules. The results of animal models may not necessarily predict the results of humans, so the potential application conditions of humans need to be interpreted carefully.

1 Scope

This standard specifies the general rules for the evaluation of the critical size bone defect in vivo for the expected repair or regeneration of bone tissue implant bone formation activity; for bone defects The preparation of animal models of injury, the location and scope of bone defect, the type of defect, the preparation and evaluation of implants provide relevant parameters.

This standard applies to the preparation of partial critical size bone defect models, and the rational use of critical size bone defect models to induce or Testing and evaluation of bone tissue engineering medical products that promote bone growth.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document. For undated reference documents, the latest version (including all amendments) is applicable to this document.

GB 14925 Laboratory Animal Environment and Facilities

GB/T 16886.1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing in the Process of Risk Management The Pharmacopoeia of the People's Republic of China (2015 Edition) Four

3 Terms and definitions

The following terms and definitions apply to this document.