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

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Scope

This document specifies particular requirements for total and partial joint replacement implants,
artificial ligaments, and bone cement (hereinafter referred to as the “implants”). This document
specifies requirements regarding intended performance, design attributes, materials, design
evaluation, manufacturing, sterilization, packaging, and information supplied by the
manufacturer. In this document, artificial ligaments and related fixation devices are included
within the term “implants”, hereinafter also referred to as the “implants”.
This document is applicable to total and partial joint replacement implants, artificial ligaments,
and bone cement.
NOTE. Some tests required to demonstrate compliance with this document are included in the
Level 3 standard or its references.

Basic Data

Standard ID	GB/T 12417.2-2025 (GB/T12417.2-2025)
Description (Translated English)	Non-active surgical implants - Osteosynthesis and joint replacement implants - Part 2: Particular requirements for joint replacement implants
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C35
Classification of International Standard	11.040.40
Word Count Estimation	22,258
Date of Issue	2025-02-28
Date of Implementation	2026-03-01
Issuing agency(ies)	State Administration for Market Regulation, China National Standardization Administration