GB/T 12417.2-2008 Replaced National standards

GB/T 12417.2-2008 Non-active surgical implants—Osteosynthesis and joint replacement implants—Part 2:Particular requirements for joint replacement implants

Publish Date: 2008-12-15 Implement Date: 2010-02-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 12417.2-2008

Standard Type: National standards

Standard Status: Replaced

is_force_gb: no

CCS Name: Orthopaedic surgery, orthopaedic instruments

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2008-12-15

Implement Date: 2010-02-01

Pages: 16 pages

Scope

This part of GB/T 12417 specifies the special requirements for total and partial joint replacement implants, artificial ligaments, and bone cement (hereinafter referred to as implants). In this part, artificial ligaments and related fixation devices are included in the term "implants", which are also referred to as implants hereinafter.
This part specifies the requirements for expected performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information provided by the manufacturer.
Some tests to verify compliance with this part are included in the third-level standards or their referenced documents.