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YY/T 1575-2017 English PDF

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YY/T 1575-2017: Tissue engineering medical device products - Standard guide for in vivo assessment of implantable devices intended to repair or regenerate bone defect
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YY/T 1575-2017English359 Add to Cart 4 days [Need to translate] Tissue engineering medical device products - Standard guide for in vivo assessment of implantable devices intended to repair or regenerate bone defect Valid YY/T 1575-2017

PDF similar to YY/T 1575-2017


Standard similar to YY/T 1575-2017

YY/T 1680   YY/T 1561   YY/T 1571   YY/T 1570   

Basic data

Standard ID YY/T 1575-2017 (YY/T1575-2017)
Description (Translated English) Tissue engineering medical device products - Standard guide for in vivo assessment of implantable devices intended to repair or regenerate bone defect
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C45
Classification of International Standard 11.040.40
Word Count Estimation 18,135
Date of Issue 2017-08-18
Date of Implementation 2018-09-01
Regulation (derived from) China Food & Drug Administration Announcement 2017 No. 99
Issuing agency(ies) State Food and Drug Administration

YY/T 1575-2017: Tissue engineering medical device products - Standard guide for in vivo assessment of implantable devices intended to repair or regenerate bone defect


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Tissue engineering medical device products-Standard guide for in vivo assessment of implantable devices intended to repair or regenerate bone defect ICS 11.040.40 C45 People's Republic of China pharmaceutical industry standards Tissue Engineering Medical Devices Product Repair and Replacement Bone Guidelines for in vivo evaluation of tissue implant osteogenesis activity 2017-08-18 Posted 2018-09-01 implementation State Food and Drug Administration released Directory Foreword Ⅲ 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Meaning and purpose 3 5 animal model 3 6 different animal critical bone defects and the scope of 6 7 defect type 7 8 Test Procedure 7 9 Results and Evaluation 9 10 Analysis 10 References 11

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of this document may be patentable. The issuing agencies of this document do not bear the responsibility of identifying these patents. This standard proposed by the State Food and Drug Administration. This standard by the National Surgical Implants and Orthopedic Instruments Standardization Technical Committee Organization Engineering Medical Devices Products Technical Committee (SAC/TC110/SC3) centralized. This standard drafting unit. Southern Medical University, China Institute of Food and Drug Control. The main drafters of this standard. Ouyang Jun, Liao Hua. Tissue Engineering Medical Devices Product Repair and Replacement Bone Guidelines for in vivo evaluation of tissue implant osteogenesis activity

1 Scope

This standard specifies the general principles of in vivo evaluation of implant bone formation activity for repair and replacement of bone tissue defects. Implants in this standard may be From natural or synthetic biological materials (biodegradable), or composite thereof. This standard describes the rat, rabbit, dog, pig, sheep and other species of animal models and the corresponding test procedures, as well as morphology, tissue biology Chemical and biomechanical analysis of the results of determination and evaluation methods. This standard applies to the repair and replacement of bone defect implants.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version applies to this article Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management processes (ISO 10993-1. 2009, IDT) ISO 12891 surgical implant removal and analysis (Retrievalandanalysisofsurgicalimplants)

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Bone defect bonedefect Congenital or acquired disease and trauma and other causes of complete bone loss. 3.2 Critical bone defect bonecritical-sizedefect The smallest bone defect in animals that can not be repaired by themselves for life. 3.3 Cochlear bone endochondralossification Mesenchymal cells evolved into cartilage, that is, the prototype of cartilage, cartilage primordia, the central chondrocyte hypertrophy, stromal calcification, perichondrial vascular Invade the chondrocyte capsule, by the osteoblast osteogenic activity and osteogenesis, the formation of the original ossification center, later also appeared in the backbone of the secondary bone Center, ossification center is expanding, and finally all ossification to complete the development of the skeleton. Torso, limbs, skull base bone for the formation of cartilage. 3.4 Membrane bony intramembranousossification Mesenchymal cells evolve into fibrous membranes, and then one or more ossification center appears in the membrane, and then gradually expanded to complete the development of bone. Facial bone And the cranial bone to membranous bone formation. 3.5 Bone repair bonerepair The damaged bone or its substitutes pass through the healing process of cell proliferation and new extracellular matrix synthesis.

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