ICS11.040.40

CCSC35

中華人民共和國醫(yī)藥行業(yè)標(biāo)準(zhǔn)

YY/T1982—2025

外科植入物多孔結(jié)構(gòu)形貌特征

試驗方法

Implantsforsurgery—Testmethodformorphologicalcharacteristicsof

porousstructures

2025?06?18發(fā)布2026?07?01實施

國家藥品監(jiān)督管理局發(fā)布

YY/T1982—2025

目次

前言··························································································································Ⅲ

引言··························································································································Ⅳ

1范圍·······················································································································1

2規(guī)范性引用文件········································································································1

3術(shù)語和定義··············································································································1

4試驗方法概述···········································································································3

5儀器設(shè)備·················································································································3

6試驗樣品·················································································································4

7試驗方法·················································································································4

8報告·······················································································································9

附錄A（規(guī)范性）X射線CT法······················································································10

附錄B（規(guī)范性）壓汞法·······························································································11

附錄C（資料性）X射線CT法采樣原則··········································································12

參考文獻(xiàn)····················································································································13

Ⅰ

YY/T1982—2025

前言

本文件按照GB/T1.1—2020《標(biāo)準(zhǔn)化工作導(dǎo)則第1部分：標(biāo)準(zhǔn)化文件的結(jié)構(gòu)和起草規(guī)則》的規(guī)

定起草。

請注意本文件的某些內(nèi)容可能涉及專利。本文件的發(fā)布機構(gòu)不承擔(dān)識別專利的責(zé)任。

本文件由國家藥品監(jiān)督管理局提出。

本文件由全國外科植入物和矯形器械標(biāo)準(zhǔn)化技術(shù)委員會（SAC/TC110）歸口。

本文件起草單位：天津市醫(yī)療器械質(zhì)量監(jiān)督檢驗中心、西安交通大學(xué)、國家藥品監(jiān)督管理局醫(yī)療器

械技術(shù)審評檢查大灣區(qū)分中心、四川大學(xué)、北京市醫(yī)療器械檢驗研究院（北京市醫(yī)用生物防護(hù)裝備檢驗

研究中心）、上海交通大學(xué)醫(yī)學(xué)院附屬第九人民醫(yī)院、上海交通大學(xué)、上海交通大學(xué)分析測試中心、同光

（昆山）生物科技有限公司、蘇州鼎安科技有限公司、常州集碩醫(yī)療器械有限公司。

本文件主要起草人：張晨、馬會、張皓成、王玲、董恩純、劉佳音、劉斌、丁金聚、朱向東、李向鋒、

肖玉梅、陳艷梅、王建軍、王金武、陶海榮、許苑晶、張昌入、朱燕華、鄭煒、陳飛浩、李亞東、李亞軍、

蔣曉豐、孫倩。

Ⅲ

YY/T1982—2025

引言

本文件旨在針對外科植入物中多孔部分的結(jié)構(gòu)形貌特征的評價制定一套全面、科學(xué)的試驗方法，

形成規(guī)范且統(tǒng)一的試驗內(nèi)容和試驗過程，保證試驗過程有據(jù)可依，結(jié)果評價準(zhǔn)確，實現(xiàn)不同企業(yè)同種工

藝制造的多孔結(jié)構(gòu)形貌特征之間的等同比較。

Ⅳ

YY/T1982—2025

外科植入物多孔結(jié)構(gòu)形貌特征

試驗方法

1范圍

本文件描述了外科植入物多孔結(jié)構(gòu)形貌特征的試驗方法，形貌特征參數(shù)包括孔隙率、孔徑、絲徑、

內(nèi)部連通性、孔隙漸變梯度、多孔結(jié)構(gòu)厚度和內(nèi)部結(jié)構(gòu)缺陷。

本文件適用于外科植入物中的多孔結(jié)構(gòu)。

本文件適用的材料可包括：

——金屬，例如鈦、鉭、鎂等及其合金材料；

——陶瓷，例如羥基磷灰石、β?磷酸三鈣等；

——高分子材料（可降解、不可降解），例如聚乙烯、聚醚醚酮、聚乳酸或聚己內(nèi)酯等；

——復(fù)合材料。

其制造技術(shù)可包括但不限于：

——增材制造；

——添加發(fā)泡劑法；

——模板法；

——氣體造孔法；

——氣相沉積法等。

本文件不適用于YY/T0988.14中規(guī)定的附著于無孔基體上的各種多孔涂層，例如等離子噴涂純

鈦涂層、等離子噴涂羥基磷灰石涂層、由單個實體（粉末顆粒、金屬絲、網(wǎng)、珠等）通過熱聚合形成的燒結(jié)

涂層等。

注：本文件的使用者可根據(jù)試驗樣品及制造技術(shù)選擇適合的試驗項目。

2規(guī)范性引用文件

下列文件中的內(nèi)容通過文中的規(guī)范性引用而構(gòu)成本文件必不可少的條款。其中，注日期的引用文

件，僅該日期對應(yīng)的版本適用于本文件；不注日期的引用文件，其最新版本（包括所有的修改單）適用于

本文件。

GB/T21650.1壓汞法和氣體吸附法測定固定材料孔徑分布和孔隙度第1部分：壓汞法

GB/T36984—2018外科植入物用多孔金屬材料X射線CT檢測方法

GB/T41672—2022外科植入物骨誘導(dǎo)磷酸鈣生物陶瓷

YY/T0988.14外科植入物涂層第14部分：多孔涂層體視學(xué)評價方法

ISO13383?1精細(xì)陶瓷（高級陶瓷、高級工藝陶瓷）顯微結(jié)構(gòu)特征第1部分：晶粒尺寸和粒度

分布的測定［Fineceramics（advancedceramics，advanced