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

Standard No.

GB/T 12417.1-2008

Language

Chinese, Available in English version

Release Date

2008

Published By

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China

Latest

GB/T 12417.1-2008

Replace

GB 12417-1990

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.

GB/T 12417.1-2008 Referenced Document

• ISO 14630:1997 Non-active surgical implants - General requirements

GB/T 12417.1-2008 history

• 2008 GB/T 12417.1-2008 Non-active surgical implants.Osteosynthesis and joint replacement implants.Part 1:Particular requirements for osteosynthesis implants
• 1990 GB 12417-1990 The gereral technological conditions of surgical metal implant

GB/T 12417.1-2008 Non-active surgical implants.Osteosynthesis and joint replacement implants.Part 1:Particular requirements for osteosynthesis implants has been changed from GB 12417-1990 The gereral technological conditions of surgical metal implant.

GB/T 12417.1-2008 -All Parts