GB/T 12417.1-2008: Non-active surgical implants -- Osteosynthesis and joint replacement implants -- Part 1: Particular requirements for osteosynthesis implants

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Scope

This part of GB/T 12417 specifies the special requirements for passive surgical implants for bone joining (hereinafter referred to as implants).
In addition to the provisions of the ISO 14630 provisions, this section on the expected performance of the implant, design properties, materials, design evaluation, manufacturing, extinction
The information provided by the bacteria, packaging and manufacturer has made special requirements.

Basic Data

Standard ID	GB/T 12417.1-2008 (GB/T12417.1-2008)
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	11,161
Date of Issue	2008-12-15
Date of Implementation	2010-02-01
Older Standard (superseded by this standard)	GB 12417-1990
Quoted Standard	ISO 14630-1997
Adopted Standard	ISO 14602-1998, IDT
Regulation (derived from)	National Standard Approval Announcement 2008 No.21 (Total No.134)
Issuing agency(ies)	General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary	This standard specifies the special requirements of osteosynthesis with active surgical implants (hereinafter referred to as the implant) is. In addition to the terms of the requirements specified in ISO 14630, the expected performance of this part of the implant, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and manufacturer's information and make a special request.