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

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Scope

This part of GB/T 12417 specifies implants, artificial ligaments and bone cement for whole joints and partial joints (hereinafter referred to as implants).
Special requirements for entry. In this section, artificial ligaments and related fixation devices are included in the term implant, the following
Called an implant.
This section specifies information for expected performance, design properties, materials, design evaluation, manufacturing, sterilization, packaging, and manufacturer.
Claim.
Some tests that require confirmation of this part are included in the Level 3 standard or its reference documents.

Basic Data

Standard ID	GB/T 12417.2-2008 (GB/T12417.2-2008)
Description (Translated English)	Non-active surgical implants -- Osteosynthesis and joint replacement implants -- Part 2: Particular requirements for joint replacement implants
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C35
Classification of International Standard	11.040.40
Word Count Estimation	13,167
Date of Issue	2008-12-15
Date of Implementation	2010-02-01
Older Standard (superseded by this standard)	GB 12417-1990
Adopted Standard	ISO 21534-2002, 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 provides for full and partial joint replacement joint implants, artificial ligaments and bone cement (hereinafter referred to as the implant) special requirements. In this section, artificial ligaments and associated fixing means is included in this term into the implant, hereinafter also referred to as the implant. This section provides for the expected performance, requested information packaging and manufacturer, sterilization, manufacturing, design attributes, materials, design evaluation. Some of the requirements of this section consistent with the confirmed test. Contained in the three standards or references file.