This document specifies particular requirements for non-active surgical implants for osteosynthesis (hereinafter referred to as the “implants”). This document provides particular requirements regarding intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information supplied by the manufacturer.
Basic Data
Standard ID
GB/T 12417.1-2024 (GB/T12417.1-2024)
Description (Translated English)
Non-active surgical implants - Osteosynthesis and joint replacement implants - Part 1: Particular requirements for osteosynthesis implants
Sector / Industry
National Standard (Recommended)
Classification of Chinese Standard
C35
Classification of International Standard
11.040.40
Word Count Estimation
22,237
Date of Issue
2024-12-31
Date of Implementation
2026-01-01
Older Standard (superseded by this standard)
GB/T 12417.1-2008
Issuing agency(ies)
State Administration for Market Regulation, China National Standardization Administration
