YY/T 1951-2024 Active Industry standards-Medicine

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

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

Publish Date: 2024-09-29 Implement Date: 2025-10-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1951-2024
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices
ICS Name: Surgical implants, prostheses, and orthoses
Publish Date: 2024-09-29
Implement Date: 2025-10-15
Pages: 20 pages

Scope

This document specifies the performance indicators, packaging markings, and general requirements for storage and transportation of bio-based peripheral nerve implants used in peripheral nerve repair, and describes the corresponding testing methods. This document is applicable to bio-based peripheral nerve repair implants.
This document is not applicable to non-bio-based peripheral nerve implants.
Note: Peripheral nerve repair implants mainly include: peripheral nerve implants used for repairing peripheral nerve defects of different degrees; peripheral nerve suture tubes used to provide a microenvironment for nerve growth and guide the selective growth of nerve fibers (chemotactic induction) by the small-gap suture method; and peripheral nerve implants used to prevent adhesions or the formation of neuromas at the site of peripheral nerve injury.

Development Information

Word Count: 26 Thousand words Pages: 20 pages

Referenced Standards

GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 191-2008 Packaging—Pictorial marking for handling of goods GB/T 14233.1-1998 Infusion,transfusion,injection equipment for medical use—Part 1:Chemical analysis methods GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity GB/T 16886.3-2008 Biological evaluation of medical devices—Part 3:Tests for genotoxicity,carcinogenicity and reproductive toxicity GB/T 16886.3-2019 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity GB/T 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity GB/T 16886.5-2017 Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.6-2015 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals GB/T 16886.10-2000 Biological evaluation of medical devices—Part 10:Tests for irritation and sensitization GB/T 16886.10-2005 Biological evaluation of medical devices—Part 10:Tests for irritation and delayed-type hypersensitivity GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization GB/T 16886.12-2000 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2005 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2023 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.20-2015 Biological evaluation of medical devices—Part 20:Principles and methods for immunotoxicology testing of medical devices GB/T 36988-2018 Guidance for good tissue practice of human origin for tissue engineered medical products SN/T 2843 YY 0167-2005 Non-absorbable surglcal suture YY 0167-2020 Non-absorbable surgical suture YY 0167-1998 Non-absorbable Surgical Suture YY/T 0313-1998 Package,lable,transport and storage for medical polymer products YY/T 0313-2014 Medical polymer products—Requirement for package and information supplied by manufacturer YY/T 0513.1-2019 Allogeneic grafts—Part 1:The basic requirements for tissue bank YY/T 0771.1-2020 Medical devices utilizing animal tissues and their derivatives—Part 1:Application of risk management YY/T 0771.2-2020 Medical devices utilizing animal tissues and their derivatives—Part 2:Controls on sourcing,collection and handling YY/T 0771.3-2009 Animal-derived medical devices - Part 3: Verification of removal and inactivation of viruses and transmissible spongiform encephalopathy (TSE) factors YY/T 1453-2016 Tissue engineering medical device products—Methods for determination of type Ⅰ collagen YY/T 1561-2017 Tissue engineering medical device products—Remnant α-Gal antigen determination in scaffold materials utilizing animal tissues and their derivatives YY/T 1699-2020 Tissue engineering medical device products—Chitosan YY/T 1670.1-2019 Evaluation of neurotoxicity of medical devices—Part 1:Standard guide for selecting tests to evaluate potential neurotoxicity YY/T 1810-2022 Tissue-engineered medical products—Quantification of sulfated glycosaminoglycans (sGAG) for evaluation of chondrogenesis YY/T 1876-2023 Tissue engineered medical products—Quantification of remnant DNA in biological materials utilizing animal tissues and their derivatives:Fluorescence method 中华人民共和国药典 GB/T 191-2025 Graphical symbols marking for handling and storage of packages

Related Standards

Contact Us