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GB/T 12417.2-2025 English PDF

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GB/T 12417.2-2025: Non-active surgical implants - Osteosynthesis and joint replacement implants - Part 2: Particular requirements for joint replacement implants
Status: Valid

GB/T 12417.2: Evolution and historical versions

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GB/T 12417.2-2025English439 Add to Cart 4 days [Need to translate] Non-active surgical implants - Osteosynthesis and joint replacement implants - Part 2: Particular requirements for joint replacement implants Valid GB/T 12417.2-2025
GB/T 12417.2-2008English150 Add to Cart 0--9 seconds. Auto-delivery Non-active surgical implants -- Osteosynthesis and joint replacement implants -- Part 2: Particular requirements for joint replacement implants Valid GB/T 12417.2-2008

PDF similar to GB/T 12417.2-2025


Standard similar to GB/T 12417.2-2025

GB/T 19701.1   GB/T 19701.2   GB 16174.2   GB/T 12417.1   

Basic data

Standard ID GB/T 12417.2-2025 (GB/T12417.2-2025)
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 22,286
Date of Issue 2025-02-28
Date of Implementation 2026-03-01
Issuing agency(ies) State Administration for Market Regulation, China National Standardization Administration

GB/T 12417.2-2025: Non-active surgical implants - Osteosynthesis and joint replacement implants - Part 2: Particular requirements for joint replacement implants


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GB/T 12417.2-2025 English version. Non-active surgical implants - Osteosynthesis and joint replacement implants - Part 2.Particular requirements for joint replacement implants ICS 11.040.40 CCSC35 National Standard of the People's Republic of China Replaces GB/T 12417.2-2008 Passive surgical implants for bone joining and joint replacement Implantable devices Part 2.Joint replacement implants Special requirements for equipment Part 2.Particularrequirementsforjointreplacementimplants (ISO 21534.2007,Non-activesurgicalimplants-Jointreplacementimplants- Particular requirements, MOD) Published on February 28, 2025, implemented on March 1, 2026 State Administration for Market Regulation The National Standardization Administration issued

Table of Contents

Preface III Introduction V 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Expected Performance 2 5 Design attributes 2 6 Materials 3 7 Design Evaluation 3 8 Manufacturing and Inspection 4 9 Sterilization 4 10 Packaging 5 11 Information provided by the manufacturer 5 Appendix A (informative) Approved materials for the manufacture of implants 7 Appendix B (informative) Approved and unapproved materials for implant articular surfaces 9 Appendix C (informative) Approved and unapproved metal combinations for non-articular contact surfaces of implants 10 Reference 11

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents" Drafting. This document is part 2 of GB/T 12417 "Passive surgical implants for osteosynthesis and joint replacement implants". The following parts have been published. --- Part 1.Particular requirements for bone-jointing implant devices; --- Part 2.Particular requirements for implantable devices for joint replacement. This document replaces GB/T 12417.2-2008 "Passive surgical implants for osteosynthesis and joint replacement implants Part 2.Joint Compared with GB/T 12417.2-2008, in addition to structural adjustments and editorial changes, the main technical changes are as follows. --- Added the terms and definitions of "center of sphere" and "radial deviation of sphericity" (see 3.3, 3.4); --- Deleted the wear of "ligament" [see Chapter 4 d) and 7.2c) of the.2008 edition]; --- Added the content "The evaluation should be carried out using components that fully represent the final implant state" in "Design evaluation" (see 7.1), and added The content of "biocompatibility of unused materials" (see 7.2.1a)) and the content of "post-marketing follow-up" (see 7.4); --- Changed the design evaluation requirements, "surface roughness measurement" was changed to "measured according to one of the methods given in GB/T 3505" (see 7.2.2, 7.2.1 of the.2008 edition), "sphericity measurement" is changed to "measured by a method that has been proven to be accurate and repeatable" (see 7.2.3, 7.2.2 of the.2008 edition); --- Added the content of "degreasing (if necessary)" of plastic surface in "manufacturing and inspection" (see 8.3, 8.2 of the.2008 edition), added Ceramic surfaces should be cleaned, degreased, rinsed and dried (see 8.4, 8.3 of the.2008 edition); --- Added the content "If the radiation is intended to improve the mechanical properties of the material while sterilizing" in "Sterilization" (see 9.1,.2008 edition 9.1) Added the expiration date (see 9.2); --- Added the content of "Re-sterilization of zirconia ceramics" in "Information provided by the manufacturer" (see 11.7), and added "Use or not use The contents of the labeling of cemented implants are as follows (see 11.8). This document is modified to adopt ISO 21534.2007 “Particular requirements for passive surgical implants for joint replacement devices”. The technical differences between this document and ISO 21534.2007 and their reasons are as follows. --- ISO 4287 (see 7.2.2) has been replaced by the normative reference GB/T 3505 to adapt to my country's technical conditions and improve operability. Sexuality; --- Replaced ISO 14630.2008 with the normative reference YY/T 0640-2016 (see Chapter 3, Chapter 4, 5.1, 6.1, 7.1, 7.2.1, 8.1, 9.1, Chapter 10, 11.1), to adapt to my country's technical conditions and improve operability; --- Replaced ISO 14242-1 (see 7.2.1) with the normative reference YY/T 0651.1 to adapt to my country's technical conditions and improve Operability; --- Replaced ISO 14242-2 (see 5.1, 7.2.1) with the normative reference YY/T 0651.2 to adapt to my country's technical conditions and provide High operability; --- ISO 7206-4 (see 7.2.1) has been replaced by the normative reference YY/T 0809.4 to adapt to my country's technical conditions and improve the reliability of the product. Operability; --- Replaced ISO 14879-1 (see 7.2.1) with the normative reference YY/T 0810.1 to adapt to my country's technical conditions and improve Operability; --- ISO 14243-2 (see 5.1) has been replaced by the normative reference YY/T 1426.2 to adapt to my country's technical conditions and improve the reliability of the product. Operability; --- ISO 14243-3 (see 5.1) has been replaced by the normative reference YY/T 1426.3 to adapt to my country's technical conditions and improve the reliability of the product. Operability; --- Deleted the normative reference to ISO 7206-8 (see 7.2.1 of ISO 21534.2007). The following editorial changes were made to this document. --- In order to coordinate with the existing standards, the name of the standard is changed to "Passive surgical implants for bone joining and joint replacement implants Part 2 Part 1.Special requirements for joint replacement implant devices. --- Added a number of standards involved (see Appendix A); --- Deleted the informative reference ISO 5832-8 (see Annex A, Annex B and Annex C of ISO 21534.2007). Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed by the State Food and Drug Administration. This document is under the jurisdiction of the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices (SAC/TC110). This document was drafted by. Tianjin Medical Device Quality Supervision and Inspection Center, State Drug Administration Medical Device Technical Review and Inspection Greater Bay Area Center, Beijing Ruilangtai Medical Equipment Co., Ltd., Beijing Aikang Yicheng Medical Equipment Co., Ltd., Suzhou Micro-Invasive Joint Medical Technology Co., Ltd., Suzhou Aide Technology Development Co., Ltd. The main drafters of this document are. Li Na, Dong Shuangpeng, Luo Yang, Li Wenjiao, Ding Jinju, Han Dan, Cheng Buyuan, Jiang Jiyu, Li Xinyu, Chen Bo, Yu Tianbai, Li Xuan, Shang Yaguang. The previous versions of this document and the documents it replaces are as follows. ---First published in.2008 as GB/T 12417.2-2008; ---This is the first revision.

Introduction

The standards for passive surgical implants and related devices are divided into three levels (the first level standard is the most basic requirement and the highest level), as follows shown. ---Level 1.General requirements for passive surgical implants, including requirements applicable to all passive surgical implants, and also indicates There are some additional requirements in the secondary and tertiary standards. ---Level 2.Special requirements for various types of passive surgical implants. ---Level 3.Special requirements for various passive surgical implants, applicable to a specific implant in a certain type of passive surgical implant Such as knee prosthesis and hip prosthesis. GB/T 12417 "Passive surgical implants for osteosynthesis and joint replacement implants" is a secondary standard and is intended to consist of two parts. --- Part 1.Particular requirements for bone-jointing implants. The purpose is to standardize the requirements for bone-jointing implants in passive surgical implants. Special requirements for machinery. --- Part 2.Particular requirements for joint replacement implants. The purpose is to standardize the passive surgical implants suitable for joint replacement implants. Special requirements for devices. To understand all the requirements for a particular implant, start with the lowest level standard currently in force. Passive surgical implants for bone joining and joint replacement Implantable devices Part 2.Joint replacement implants Special requirements for equipment

1 Scope

This document specifies the specific requirements for total and partial joint replacement implants, artificial ligaments and bone cement (hereinafter referred to as implants). This document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information provided by the manufacturer. In this document, artificial ligaments and related fixation devices are included in the term implants, hereinafter also referred to as implants. This document applies to total and partial joint replacement implants, artificial ligaments and bone cements. NOTE Some tests required to demonstrate compliance with this document are contained in the Class III standards or their referenced documents.

2 Normative references

The contents of the following documents constitute essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. GB/T 3505 Product Geometry Specification (GPS) Surface Structure Profile Method Terminology, Definitions and Surface Structure Parameters (GB/T 3505-2009, ISO 4287.1997, IDT) YY/T 0640-2016 General requirements for passive surgical implants YY/T 0651.1 Implants for surgery - Wear of total hip prostheses - Part 1.Load and displacement parameters of wear testing machines and Relevant test environment conditions YY/T 0651.2 Implants for surgery - Wear of total hip prostheses - Part 2.Measurement methods YY/T 0809.4 Implants for surgery - Parts and total hip prostheses - Part 4.Fatigue performance test and performance test of stemmed femoral components Can request YY/T 0810.1 Joint replacement implants Total knee prosthesis Part 1.Determination of fatigue properties of tibial tray YY/T 1426.1 Implants for surgery - Wear of total knee prostheses - Part 1.Load and wear test of load-controlled wear testing machines Displacement parameters and related test environment conditions YY/T 1426.2 Implants for surgery - Wear of total knee prostheses - Part 2.Measurement methods YY/T 1426.3 Implants for surgery - Wear of total knee prostheses - Part 3.Load and load characteristics of a displacement-controlled wear test machine Displacement parameters and related test environment conditions

3 Terms and definitions

The terms and definitions defined in YY/T 0640-2016 and the following apply to this document. 3.1 Artificial ligamentartificialligament Implants used to augment or replace natural ligaments in the human body, including necessary fixation devices.

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