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YY/T 1982-2025: Implants for surgery - Test method for morphological characteristics of porous structures
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Implants for surgery - Test method for morphological characteristics of porous structures
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Standard similar to YY/T 1982-2025 YY/T 1860.1 | YY/T 1748 | YY/T 1653 | YY/T 1924 | YY/T 1988 | Basic data | Standard ID | YY/T 1982-2025 (YY/T1982-2025) | | Description (Translated English) | Implants for surgery - Test method for morphological characteristics of porous structures | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 18,116 | | Date of Issue | 2025-06-18 | | Date of Implementation | 2026-07-01 | | Issuing agency(ies) | National Medical Products Administration | | Summary | This standard specifies the test methods for the morphological characteristics of porous structures in surgical implants. Morphological characteristic parameters include porosity, pore diameter, wire diameter, internal connectivity, pore gradient, porous structure thickness, and internal structural defects. This document applies to porous structures in surgical implants. This document applies to materials including: metals such as titanium, tantalum, magnesium, and their alloys; ceramics such as hydroxyapatite and ��-tricalcium phosphate; polymers (degradable and non-degradable) such as polyethylene, polyetheretherketone, polylactic acid, or polycaprolactone; and composite materials. | YY/T 1982-2025: Implants for surgery - Test method for morphological characteristics of porous structures
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Pharmaceutical Industry Standards of the People's Republic of China
ICS 11.040.40CCS C 35
Morphological characteristics of porous structures in surgical implants
Test methods
Implants for surgery-Test method for morphological characteristics of
porous structures
Released on June 18, 2025
Implemented 2026-07-01
National Medical Products Administration issued
Table of contents
Foreword ... III
IntroductionIV
1.Scope...1
2 Normative references...1
3.Terms and Definitions...1
4.Overview of Test Methods...3
5.Instruments and Equipment...3
6 Test samples...4
7.Test Methods4
8 Report...9
Appendix A (Normative) X-ray CT Method...10
Appendix B (Normative) Mercury Porosimetry...11
Appendix C (Informative) Sampling Principles of X-ray CT Method...12
References...13
Foreword
This document conforms to GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents".
Drafting is scheduled.
Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents.
This document was proposed by the National Medical Products Administration.
This document is under the jurisdiction of the National Technical Committee on Standardization of Surgical Implants and Orthopedic Devices (SAC/TC 110).
This document was drafted by. Tianjin Medical Device Quality Supervision and Inspection Center, Xi'an Jiaotong University, and the National Medical Products Administration.
Medical Device Technical Review and Inspection Center (Greater Bay Area Branch), Sichuan University, Beijing Institute for Medical Device Testing (Beijing Institute of Medical Biological Protective Equipment Testing)
Research Center), Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University, Shanghai Jiao Tong University Analytical and Testing Center, Tongguang
(Kunshan) Biotechnology Co., Ltd., Suzhou Ding'an Technology Co., Ltd., and Changzhou Jishuo Medical Device Co., Ltd.
The main drafters of this document are. Zhang Chen, Ma Hui, Zhang Haocheng, Wang Ling, Dong Enchun, Liu Jiayin, Liu Bin, Ding Jinju, Zhu Xiangdong, and Li Xiangfeng.
Xiao Yumei, Chen Yanmei, Wang Jianjun, Wang Jinwu, Tao Hairong, Xu Yuanjing, Zhang Changru, Zhu Yanhua, Zheng Wei, Chen Feihao, Li Yadong, Li Yajun
Jiang Xiaofeng and Sun Qian.
Introduction
This document aims to develop a comprehensive and scientific experimental method for evaluating the structural morphology characteristics of porous components in surgical implants.
Establish standardized and unified test content and procedures to ensure that the test process is based on evidence, the results are accurately evaluated, and the same test can be performed in different enterprises.
A comparative analysis of the morphological characteristics of porous structures manufactured by the process.
Morphological characteristics of porous structures in surgical implants
Test methods
1 Scope
This document describes experimental methods for characterizing the porous structure morphology of surgical implants. Morphological parameters include porosity, pore size, and wire diameter.
Internal connectivity, pore gradient, porous structure thickness, and internal structural defects.
This document applies to porous structures in surgical implants.
The materials to which this document applies may include.
--Metals, such as titanium, tantalum, magnesium, and their alloys;
--Ceramics, such as hydroxyapatite, β-tricalcium phosphate, etc.;
--Polymer materials (degradable and non-degradable), such as polyethylene, polyetheretherketone, polylactic acid, or polycaprolactone;
--Composite materials.
Its manufacturing technology may include, but is not limited to.
--Additive manufacturing;
--Adding foaming agent;
--Template method;
--Gas-based pore formation method;
--Vacuum-phase deposition, etc.
This document does not apply to various porous coatings attached to non-porous substrates as specified in YY/T 0988.14, such as plasma-sprayed pure coatings.
Titanium coating, plasma-sprayed hydroxyapatite coating, sintered coating formed by thermal polymerization of individual entities (powder particles, metal wires, meshes, beads, etc.)
Coatings, etc.
Note. Users of this document may select appropriate test items based on the test samples and manufacturing technology.
2 Normative references
The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are listed below.
For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.
This document.
GB/T 21650.1 Determination of pore size distribution and porosity of stationary materials by mercury porosimetry and gas adsorption methods – Part 1.Mercury porosimetry
GB/T 36984-2018 X-ray CT inspection method for porous metallic materials used in surgical implants
GB/T 41672-2022 Surgical Implants - Bone-Inducing Calcium Phosphate Bioceramics
YY/T 0988.14 Surgical implant coatings - Part 14.Stereometric evaluation method for porous coatings
ISO 13383-1 Fine ceramics (advanced ceramics, advanced process ceramics) Microstructural characteristics - Part 1.Grain size and particle size
Determination of distribution [Fine ceramics (advanced ceramics, advanced technical ceramics)-Microstructural character⁃
ization-Part 1.Determination of grain size and size distribution]
3 Terms and Definitions
The following terms and definitions apply to this document.
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