GB/T 12417.2-2008
Non-active surgical implants.Osteosynthesis and joint replacement implants.Part 2:Particular requirements for joint replacement implants (English Version)

Standard No.

GB/T 12417.2-2008

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 12417.2-2008

Replace

GB 12417-1990

Scope

This part of GB/T 12417 specifies the special requirements for total joint and partial joint replacement implants, artificial ligaments and bone cement (hereinafter referred to as implants). In this section, artificial ligaments and related fixation devices are included in the term implant, hereinafter also referred to as implant. This standard specifies requirements for expected performance, design properties, materials, design evaluation, fabrication, sterilization, packaging, and information provided by the manufacturer. Some tests required to demonstrate compliance with this standard are included in the tertiary standard or its references.

GB/T 12417.2-2008 Referenced Document

• ISO 14630:1997 Non-active surgical implants - General requirements
• ISO 7206-2 Implants for surgery — Partial and total hip joint prostheses — Part 2: Articulating surfaces made of metallic, ceramic and plastics materials AMENDMENT 1*， 2011-01-01 Update

GB/T 12417.2-2008 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 12417.2-2008 Non-active surgical implants.Osteosynthesis and joint replacement implants.Part 2:Particular requirements for joint replacement implants has been changed from GB 12417-1990 The gereral technological conditions of surgical metal implant.

GB/T 12417.2-2008 -All Parts