Standard No.:	GB/T 12417.2-2008
English Name:	Non-active surgical implants - Osteosynthesis and joint replacement implants - Part 2: Particular requirements for joint replacement implants
Chinese Name:	无源外科植入物 骨接合与关节置换植入物 第2部分：关节置换植入物特殊要求
Chinese Classification:	C35    Orthopedic devices
Professional Classification:	GB    National Standard
ICS Classification:	11.040.40 11.040.40    Implants for surgery, prosthetics and orthotics 11.040.40
Source Content Issued by:	AQSIQ; SAC
Issued on:	1990-7-17
Implemented on:	1991-2-1
Status:	to be superseded
Superseded by:	GB/T 12417.2-2025 Non-active surgical implants―Osteosynthesis and joint replacement implants―Part 2: Particular requirements for joint replacement implants
Superseded on:	2026-3-1
Abolished on:	2026-03-01
Superseding:	GB 12417-1990 The general technological conditions of surgical metal implant
Target Language:	English
File Format:	PDF
Word Count:	6000 words
Translation Price(USD):	140.0
Delivery:	via email in 1~3 business day

GB/T 12417的本部分规定了对全关节和部分关节置换植入物、人工韧带和骨水泥的特殊要求。在本部分中，人工韧带及相关的固定装置是包含在植入物这一术语之中的，以下亦称为植入物。
本部分规定了对预期性能、设计属性、材料、设计评估、制造、灭菌、包装和制造商提供的信息的要求。
一些要求证实与本部分相符合的试验，包含在三级标准或其引用文件中。