HOME   Cart(1)   Quotation   About-Us Policy PDFs Standard-List
www.ChineseStandard.net Database: 189760 (18 Oct 2025)

YY/T 1951-2024 English PDF

US$359.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1951-2024: Tissue engineering medical device products - Generic requirement for bio-derived peripheral nerve repair implant
Status: Valid
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 1951-2024English359 Add to Cart 4 days [Need to translate] Tissue engineering medical device products - Generic requirement for bio-derived peripheral nerve repair implant Valid YY/T 1951-2024

PDF similar to YY/T 1951-2024


Standard similar to YY/T 1951-2024

YY/T 1680   YY/T 1561   YY/T 1571   YY/T 1925   YY/T 1839   

Basic data

Standard ID YY/T 1951-2024 (YY/T1951-2024)
Description (Translated English) Tissue engineering medical device products - Generic requirement for bio-derived peripheral nerve repair implant
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C45
Classification of International Standard 11.040.40
Word Count Estimation 18,156
Date of Issue 2024-09-29
Date of Implementation 2025-10-15
Issuing agency(ies) State Drug Administration
Summary This standard specifies the general requirements for performance indicators, packaging labels, storage, transportation, etc. of biogenic peripheral nerve implants for nerve repair, and specifies the corresponding test methods. This standard applies to biogenic peripheral nerve repair implants. This standard does not apply to non-biogenic peripheral nerve implants.

YY/T 1951-2024: Tissue engineering medical device products - Generic requirement for bio-derived peripheral nerve repair implant


---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 11.040.40 CCSC45 Pharmaceutical Industry Standards of the People's Republic of China Biogenicity of Tissue Engineering Medical Devices General requirements for peripheral nerve repair implants Released on 2024-09-29 Implementation on October 15, 2025 The State Drug Administration issued

Table of Contents

Preface III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 2 4 Performance requirements 2 4.1 Composition and structure 2 4.2 Physical properties 2 4.3 Chemical properties 3 4.4 Biological properties 5 4.5 Biological evaluation 5 5 Inspection methods 6 5.1 Composition and structure 6 5.2 Physical properties 6 5.3 Chemical properties 7 5.4 Biological properties 8 5.5 Biological evaluation 9 6 Raw material safety requirements 9 6.1 Materials of animal origin 9 6.2 Allogeneic materials 9 7 Logo 9 7.1 Packaging Marking 9 7.2 Storage and transportation signs 10 8 Packaging, transportation and storage 10 Reference 11

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 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 organized by the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices, Technical Committee for Engineering Medical Device Products (SAC/TC110/SC3) is responsible for this matter. This document was drafted by. China Food and Drug Administration, Nantong University, the First Affiliated Hospital of Sun Yat-sen University, Nankai University, People's Liberation Army General Hospital, Sichuan University, Tianjin Medical Device Quality Supervision and Inspection Center, Jiangsu Yitong Biotechnology Co., Ltd., Guangzhou Zhongda Medical Devices Co., Ltd., Beijing Huifukang Medical Technology Co., Ltd., Shandong Junxiu Biotechnology Co., Ltd., Tianxinfu (Beijing) Medical Medical Equipment Co., Ltd. The main drafters of this document are. Shao Anliang, Xu Liming, Yang Yumin, Zhu Qingtang, Zhu Meifeng, Peng Jiang, Ao Qiang, Li Libin, Zhang Tian, Yang Yuexiong, Cheng Huijing, Gao Xiuwei, Li Xiaojing, Zhao Danmei, Li Chongchong, Zhao Yahong, Zheng Canbin, Dong Xianhao, Wang Yu, Cheng Junqiu, Li Jia, Zhao Minjian, Zhang Yang, Wang Chao, Ren Xiaomin, and Zhang Wei. Biogenicity of Tissue Engineering Medical Devices General requirements for peripheral nerve repair implants

1 Scope

This document specifies the performance indicators, packaging labels, storage, transportation, etc. of bioderived peripheral nerve implants used for peripheral nerve repair. General requirements and corresponding test methods are described. This document applies to bioderived peripheral nerve repair implants. This document does not apply to peripheral nerve implants of non-biological origin. Note. Peripheral nerve repair implants mainly include. peripheral nerve implants used to repair peripheral nerve defects of varying degrees; Provide a nerve growth microenvironment for the spontaneous repair of damaged or ruptured peripheral nerves, and guide the selective growth (chemotaxis-induced) of nerve fibers Nerve sleeve; peripheral nerve implant used to prevent local adhesion of peripheral nerve injury or prevent neuroma formation.

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 191 Pictorial markings for packaging, storage and transportation GB/T 14233.1 Inspection methods for medical infusion, blood transfusion and injection equipment Part 1.Chemical analysis methods GB/T 16886.1 Biological evaluation of medical devices Part 1.Evaluation and testing in the risk management process GB/T 16886.3 Biological evaluation of medical devices Part 3.Tests for genotoxicity, carcinogenicity and reproductive toxicity GB/T 16886.5 Biological evaluation of medical devices Part 5.In vitro cytotoxicity test GB/T 16886.6 Biological evaluation of medical devices Part 6.Local reaction test after implantation GB/T 16886.7 Biological evaluation of medical devices Part 7.Ethylene oxide sterilization residues GB/T 16886.10 Biological evaluation of medical devices Part 10.Irritation and skin sensitization tests GB/T 16886.12 Biological evaluation of medical devices Part 12.Sample preparation and reference materials GB/T 16886.20 Biological evaluation of medical devices Part 20.Principles and methods of immunotoxicology testing of medical devices GB/T 36988 Guidelines for the operation of human tissues for tissue engineering SN/T 2843 Determination of rubber content in raw silk YY 0167 Non-absorbable surgical suture YY/T 0313 Requirements for packaging of medical polymer products and information provided by manufacturers YY/T 0513.1 Allogeneic repair materials Part 1.Basic requirements for tissue banks YY/T 0771.1 Medical devices of animal origin Part 1.Application of risk management YY/T 0771.2 Medical devices of animal origin Part 2.Control of sources, collection and disposal YY/T 0771.3 Medical devices of animal origin Part 3.Removal and inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents confirm YY/T 1453 Characterization method of type I collagen in tissue engineering medical devices YY/T 1561 Detection of residual α-Gal antigen in animal-derived scaffold materials of tissue engineering medical devices YY/T 1699 Chitosan for tissue engineering medical devices

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1951-2024_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1951-2024_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 1951-2024_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1951-2024_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.