YY/T 0965-2025 Pending Industry standards-Medicine

YY/T 0965-2025 Implants for sports medicine—Particular requirements of artificial ligaments

YY/T 0965-2025 Implants for sports medicine—Particular requirements of artificial ligaments

Publish Date: 2025-09-15 Implement Date: 2026-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: YY/T 0965-2025

Standard Type: Industry standards

Standard Status: Pending

is_force_gb: no

CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2025-09-15

Implement Date: 2026-10-01

Pages: 28 pages

Scope

This document specifies the expected performance, design attributes, materials, design evaluation, pre-clinical evaluation, post-market tracking, manufacturing, sterilization, and packaging requirements for sports medicine implantable devices (artificial ligaments) intended for clinical use, and describes the corresponding test methods.
This document applies to textile-type artificial ligaments. Other types of artificial ligaments may refer to this document for guidance.

Development Information

Word Count: 38 Thousand words Pages: 28 pages

Replace the following standards

YY/T 0965-2014 Implants for surgery—Artificial ligaments

Referenced Standards

GB/T 3923.1-2013 Textiles—Tensile properties of fabrics—Part 1:Determination of maximum force and elongation at maximum force using the strip method 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 YY/T 0640-2016 Non-active surgical implants—General requirements 中华人民共和国药典　2020年版　四部

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