GB/T 12417.1-2008 in English

SUPERSEDED

Non-active surgical implants - Osteosynthesis and joint replacement implants - Part 1: Particular requirements for osteosynthesis implants

Issued on:1990-07-17
Implemented on:1991-02-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $120.00
$117.00

Standard No:	GB/T 12417.1-2008
Document status:	SUPERSEDED
Superseded by:	GB/T 12417.1-2024 Non-active surgical implants—Osteosynthesis and joint replacement implants—Part 1：Particular requirements for osteosynthesis implants
Superseded on:	2026-01-01
Title in English:	Non-active surgical implants - Osteosynthesis and joint replacement implants - Part 1: Particular requirements for osteosynthesis implants
Title in Chinese:	无源外科植入物骨接合与关节置换植入物第1部分：骨接合植入物特殊要求
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	1990-07-17
Implemented on:	1991-02-01
ICS Classification:	11.040.40-Implants for surgery, prosthetics and orthotics
Chinese Classification:	C35-Orthopedic devices
Professional Classification:	GB-National Standard
Related Keywords:	osteosynthesis implants scopethis part non-active surgical implants passive surgical implants joint replacement implants particular requirements
Related Topics:	bone join Surgical Implantation Standards iso14602 bone engaging implants Implantation program Implantation program plant part plant energy Passive Surgical Implants plant energy plant characteristics Passive Surgical Implants Direct Implantable In Vivo Analysis implant aging Implantable wireless charging Phytochemistry \| Western Plant Resources GB/T 12417.1 GB/T 12417.1-2008 implant shock surgical implant surgical implant Plant-Animal Mutualism Cases Suitable for powder metallurgy orthopedic implants xenograft implant drug release Implant packaging requirements surgical implant polymer

《GB/T 12417.1-2008无源外科植入物骨接合与关节置换植入物第1部分：骨接合植入物特殊要求》由TC110（全国外科植入物和矫形器械标准化技术委员会）归口，TC110SC1（全国外科植入物和矫形器械标准化技术委员会骨科植入物分会）执行，主管部门为国家药品监督管理局。
GB/T 12417的本部分规定了骨接合用无源外科植入物的特殊要求。
除ISO 14630规定的条款要求外，本部分对植入物的预期性能、设计属性、材料、设计评价、制造、灭菌、包装和制造商提供的信息又做出了特殊要求。

Scope

This part of GB/T 12417 specifies the special requirements for passive surgical implants for bone joints (hereinafter referred to as implants). In addition to the requirements stipulated in ISO 14630, this part makes special requirements for the expected performance of implants, design properties, materials, design evaluation, manufacturing, sterilization, packaging and information provided by the manufacturer.

More samples: GB 50021-2001(2009) DL/T 5154-2012 QC/T 942-2021

Sample only — not a preview of GB/T 12417.1-2008

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