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GB/T 12417.1-2024: Non-active surgical implants - Osteosynthesis and joint replacement implants - Part 1: Particular requirements for osteosynthesis implants
Status: Valid GB/T 12417.1: Evolution and historical versions
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| GB/T 12417.1-2024 | English | 439 |
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Non-active surgical implants - Osteosynthesis and joint replacement implants - Part 1: Particular requirements for osteosynthesis implants
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GB/T 12417.1-2024
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| GB/T 12417.1-2008 | English | 130 |
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Non-active surgical implants -- Osteosynthesis and joint replacement implants -- Part 1: Particular requirements for osteosynthesis implants
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GB/T 12417.1-2008
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| GB 12417-1990 | English | 319 |
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The gereral technological conditions of surgical metal implant
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GB 12417-1990
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PDF similar to GB/T 12417.1-2024
Basic data | Standard ID | GB/T 12417.1-2024 (GB/T12417.1-2024) | | Description (Translated English) | Non-active surgical implants - Osteosynthesis and joint replacement implants - Part 1: Particular requirements for osteosynthesis implants | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 22,217 | | Date of Issue | 2024-12-31 | | Date of Implementation | 2026-01-01 | | Older Standard (superseded by this standard) | GB/T 12417.1-2008 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 12417.1-2024: Non-active surgical implants - Osteosynthesis and joint replacement implants - Part 1: Particular requirements for osteosynthesis implants
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ICS 11.040.40
CCSC35
National Standard of the People's Republic of China
Replaces GB/T 12417.1-2008
Passive surgical implants for bone joining and joints
Replacement implants. Part 1.Osseous anastomosis
Special requirements for implantable devices
Published on 2024-12-31, implemented on 2026-01-01
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 1
5 Design attributes 2
6 Materials 3
7 Design Evaluation 3
8 Manufacturing 4
9 Sterilization 4
10 Packaging 4
11 Information provided by the manufacturer 4
Appendix A (Informative) Correspondence between this document and the clauses of YY/T 0340-2009 5
Appendix B (Informative) Standards for bone bonding implants and related surgical instruments that have been proven to be acceptable in clinical use 6
Appendix C (Informative) Standards for materials that have been proven acceptable for clinical use 9
Appendix D (Informative) Related standards for testing and design evaluation 11
Reference 13
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 1 of GB/T 12417 "Passive surgical implants for osteosynthesis and joint replacement implants".
The following parts have been published.
--- Part 1.Particular requirements for implant devices for bone bonding;
--- Part 2.Particular requirements for joint replacement implants.
This document replaces GB/T 12417.1-2008 "Passive surgical implants for bone joining and joint replacement implants Part 1.Bone joining
Compared with GB/T 12417.1-2008, in addition to structural adjustments and editorial changes, the main technical changes are as follows.
--- Changed the requirements for "functional characteristics", deleted "limit or control movement", and added "correct or control force line" (see 4.3,.2008
Version 4.1);
--- Changed the requirements for "Intended Conditions of Use" and added "Surgical Techniques" and "Postoperative Rehabilitation" (see 4.4, 4.3 of the.2008 Edition);
--- Changed the requirements of “Design attributes” and added “c) To reduce usage errors, implant designers should consider the required surgical skills and
Proper care and handling of implants, provided that they do not interfere with their intended use and function." (See Chapter 5,.2008 edition)
Chapter 5);
--- Changed the requirements for “preclinical evaluation” and added “c) if appropriately validated, biological, physical or modeling studies may be used to
Demonstrate that the expected performance of the implant has been achieved. " (See 7.2, 7.2 of the.2008 edition);
--- Changed "Information provided by the manufacturer" and added "labeling", "combination restrictions" and "special purpose marking" requirements (see Section 11
Chapter 11 of the.2008 edition).
This document is modified to adopt ISO 14602.2010 “Particular requirements for passive surgical implants for osteosynthesis”.
The technical differences between this document and ISO 14602.2010 and their reasons are as follows.
--- Replaced ISO 14630.2008 (see Chapters 4 to 11) with the normative reference YY/T 0640-2016 to adapt to our
The country's technical conditions improve operability.
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 1
Division. Special requirements for bone-joining implant devices;
--- ISO 14283.2004 (see Appendix A) has been replaced with the informative reference YY/T 0340-2009 to adapt to my country's technology
Conditions, improve operability;
--- Added the correspondence with the clauses of YY/T 0340-2009 (see Appendix A);
--- Added and updated a number of related standards (see Appendix B, Appendix C, Appendix D).
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, National Medical Products Administration Medical Device Technical Review and Inspection
Greater Bay Area Center, Xi'an Jiaotong University, Beijing Natong Technology Group Co., Ltd., Beijing Deyi Damei Medical Technology Co., Ltd., Tianjin
Tianjin Hospital.
The main drafters of this document are. Yuan Bo, Dong Shuangpeng, Zhang Na, Wang Tao, Ding Jinju, Gao Jintao, Wang Ling, Dong Enchun, Zhao Wenwen, Li Renyao,
Kong Qingjun, Wei Ning, Ma Xinlong, and Yang Qiang.
The previous versions of this document and the documents it replaces are as follows.
---First published in.2008 as GB/T 12417.1-2008;
---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 bonding are used in trauma treatment or corrective surgery to stabilize broken bones and their structures and achieve bone healing.
The implant is removed or left in the body when the intended function is completed.
This document provides the basic principles of YY/T 0340-2009, which is applicable to passive surgical implants for bone fusion. Appendix A
The corresponding relationship between this document and the provisions of YY/T 0340-2009 is given. This document may have an impact on manufacturers’ compliance with the requirements of other regulatory agencies.
It also helps to a certain extent.
Passive surgical implants for bone joining and joints
Replacement implants. Part 1.Osseous anastomosis
Special requirements for implantable devices
1 Scope
This document specifies the specific requirements for passive surgical implants for bone joining (hereinafter referred to as implants).
This document gives specific information on intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and manufacturer-supplied information.
Require.
2 Normative references
The contents of the following documents constitute the 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.
YY/T 0640-2016 General requirements for passive surgical implants (ISO 14630.2012, IDT)
3 Terms and definitions
The terms and definitions defined in YY/T 0640-2016 and the following apply to this document.
3.1
Passive surgical implants used to provide support to bone, cartilage, tendon or ligament structures.
4 Expected Performance
4.1 General
The expected performance should comply with the requirements of Chapter 4 of YY/T 0640-2016, and the requirements of 4.2 to 4.4 should also be considered.
Note. Due to the diversity of anatomy, fracture sites and applications, it is necessary for osteosynthesis implants to have a certain degree of versatility; the size of the implants is determined by anatomical reasons.
There are certain limitations; bone quality, bone structure and other defects may also affect the performance of the implant.
4.2 Intended Purpose
The purpose is bone joining, including the following application areas. When describing and documenting the expected performance of implants used in bone joining, the expected
Typical application areas include.
a) Fracture treatment;
b) cancer treatment;
c) stabilization of the osteotomy;
d) stabilization of arthrodesis;
e) bone lengthening, shortening or articulation;
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