GB/T 12417.2-2025 Active National standards

GB/T 12417.2-2025 Non-active surgical implants—Osteosynthesis and joint replacement implants—Part 2:Particular requirements for joint replacement implants

GB/T 12417.2-2025 Non-active surgical implants—Osteosynthesis and joint replacement implants—Part 2:Particular requirements for joint replacement implants

Publish Date: 2025-02-28 Implement Date: 2026-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 12417.2-2025

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Orthopaedic surgery, orthopaedic instruments

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2025-02-28

Implement Date: 2026-03-01

Pages: 24 pages

Scope

This document specifies the special requirements for total and partial joint replacement implants, artificial ligaments, and bone cement (hereinafter referred to as implants). This document specifies the requirements for expected performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information provided by the manufacturer. In this document, artificial ligaments and related fixation devices are included in the term "implants", which are also referred to as implants hereinafter.
This document applies to total and partial joint replacement implants, artificial ligaments, and bone cement.
Note: Some tests to verify compliance with this document are included in the third-level standards or their referenced documents.

Development Information

Word Count: 27 Thousand words Pages: 24 pages

Replace the following standards

GB/T 12417.2-2008 Non-active surgical implants—Osteosynthesis and joint replacement implants—Part 2:Particular requirements for joint replacement implants

Referenced Standards

GB/T 3505-2000 Geometrical product specifications (GPS)—Surface texture:Profile method—Terms, definitions and surface texture parameters GB/T 3505-2009 Geometrical Product Specifications (GPS)—Surface texture:Profile method—Terms,definitions and surface texture parameters YY/T 0640-2016 Non-active surgical implants—General requirements YY/T 0651.1-2008 Implant for surgery—Wear of total hip-joint prostheses—Part 1:Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test YY/T 0651.1-2016 Implants for surgery—Wear of total hip-joint prostheses—Part 1:Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test YY/T 0651.2-2008 Implant for surgery—Wear of total hip-joint prostheses—Part 2:Methods of measurement YY/T 0651.2-2020 Implants for surgery—Wear of total hip-joint prostheses—Part 2:Methods of measurement YY/T 0809.4-2010 Implants for surgery—Partial and total hip joint prostheses—Part 4:Determination of endurance properties of stemmed femoral components YY/T 0809.4-2018 Implants for surgery—Partial and total hip joint prostheses—Part 4:Determination of endurance properties and performance of stemmed femoral components YY/T 0810.1-2010 Implants for surgery—Total knee-joint prostheses—Part 1:Determination of endurance properties of knee tibial trays YY/T 0810.1-2024 Joint replacements—Total knee-joint prostheses—Part 1:Determination of endurance properties of knee tibial trays YY/T 1426.1-2016 Implants for surgery—Wear of total knee-joint prostheses—Part 1:Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test YY/T 1426.2-2016 Implants for surgery—Wear of total knee-joint prostheses—Part 2:Methods of measurement YY/T 1426.3-2017 Implants for surgery—Wear of total knee joint prostheses—Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test

Adopt standards

ISO 21534:2007

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