GB/T 12417.1-2008 Active National standards

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

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

Standard Type: National standards

Standard Status: Active

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: 10 pages

Scope

This part of GB/T 12417 specifies the special requirements for passive surgical implants (hereinafter referred to as implants) used for bone fixation.
In addition to the requirements of ISO 14630, this part also sets forth special requirements for the expected performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information provided by the manufacturer of implants.

Development Information

Word Count: 14 Thousand words Pages: 10 pages

Same series standard

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

Replace the following standards

GB 12417-1990 The general technological conditions of surgical metal implant

Superseded by the following standards

GB/T 12417.1-2024 Non-active surgical implants—Osteosynthesis and joint replacement implants—Part 1:Particular requirements for osteosynthesis implants

Referenced Standards

ISO 14630:1997

Adopt standards

ISO 14602:1998

Related Standards

GB 12264-1990 Replaced

GB 12264-1990 Artificial heart-lung machine Silicon rubber pump tube

Publish Date: 1990-01-08

GB 12279-1990 Replaced

GB 12279-1990 Cardiac valve prostheses general technical specification

Publish Date: 1990-03-26

GB 12417-1990 Replaced

GB 12417-1990 The general technological conditions of surgical metal implant

Publish Date: 1990-07-17

GB/T 13461-1992 Replaced

GB/T 13461-1992 Synthetic resin blow knee prostheses

Publish Date: 1992-06-01

GB/T 14191-1993 Replaced

GB/T 14191-1993 Terminology for prosthetics and orthotics

Publish Date: 1993-02-25

GB 14722-1993 Replaced

GB 14722-1993 Endoskeletal above knee prosthesis

Publish Date: 1993-12-04