GB/T 18457-2024制造醫(yī)療器械用不銹鋼針管要求和試驗(yàn)方法

ICS

11.040.20

CCS

C31

中華人民共和國(guó)國(guó)家標(biāo)準(zhǔn)

GB/T18457—2024

代替GB/T18457—2015

制造醫(yī)療器械用不銹鋼針管

要求和試驗(yàn)方法

Stainlesssteelneedletubingforthemanufactureofmedicaldevices—

Requirementsandtestmethods

（ISO9626:2016，MOD）

2024-08-23發(fā)布2025-09-01實(shí)施

國(guó)家市場(chǎng)監(jiān)督管理總局發(fā)布

國(guó)家標(biāo)準(zhǔn)化管理委員會(huì)

GB/T18457—2024

目次

前言

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Ⅲ

1

范圍

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2

規(guī)范性引用文件

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3

術(shù)語(yǔ)和定義

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4

材料

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5

要求和試驗(yàn)方法

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2

5.1

通則

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5.2

表面粗糙度和外觀

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5.3

清潔度

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5.4

酸堿度限值

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5.5

尺寸標(biāo)識(shí)

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5.6

尺寸

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5.7

剛性

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5.8

韌性

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6

5.9

耐腐蝕性

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6

附錄A（資料性）不銹鋼牌號(hào)

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附錄B（規(guī)范性）檢驗(yàn)液制備方法

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B.1

原理

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B.2

儀器和試劑

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B.3

制備程序

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附錄C（規(guī)范性）針管剛性試驗(yàn)方法

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C.1

原理

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C.2

儀器

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C.3

試驗(yàn)程序

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C.4

試驗(yàn)報(bào)告

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10

附錄D（規(guī)范性）針管韌性試驗(yàn)方法

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D.1

原理

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D.2

儀器

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D.3

步驟

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D.4

試驗(yàn)報(bào)告

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12

附錄E（規(guī)范性）針管耐腐蝕試驗(yàn)方法

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14

E.1

原理

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E.2

試劑和儀器

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Ⅰ

GB/T18457—2024

E.3

實(shí)驗(yàn)程序

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14

E.4

試驗(yàn)報(bào)告

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14

參考文獻(xiàn)

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Ⅱ

GB/T18457—2024

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。

本文件代替GB/T18457—2015《制造醫(yī)療器械用不銹鋼針管》，與GB/T18457—2015相比，除

結(jié)構(gòu)調(diào)整和編輯性改動(dòng)外，主要技術(shù)變化如下：

a）更改了范圍，增加了0.18mm（34G）尺寸（見第1章，2015年版的第1章）；

b）增加了術(shù)語(yǔ)和定義（見第3章）；

c）更改了所用材料的要求（見第4章，2015年版的第4章）;

d）增加了部分規(guī)格的超薄壁、極薄壁的尺寸要求（見第5章）；

e）增加了0.18mm針管標(biāo)稱外徑的具體尺寸要求（見表1）；

f）更改了尺寸標(biāo)識(shí)的要求（見5.5，2015年版的第5章）；

g）更改了針管尺寸和剛性參數(shù)表（見5.7，2015年版的第9章）；

h）更改了檢驗(yàn)液制備方法的相關(guān)要求（見附錄B，2015年版的附錄B）；

i）刪除了“針管酸堿度試驗(yàn)方法”（見2015年版的附錄C）；

j）更改了針管剛性試驗(yàn)方法及要求（見附錄C，2015年版的附錄D）；

k）更改了針管韌性試驗(yàn)方法及要求（見附錄D，2015年版的附錄E）；

l）更改了針管耐腐蝕性試驗(yàn)報(bào)告的要求（見E.4，2015年版的F.4）。

本文件修改采用ISO9626：2016《制造醫(yī)療器械用不銹鋼針管技術(shù)要求和試驗(yàn)方法》。

本文件與ISO9626：2016相比做了下述結(jié)構(gòu)調(diào)整：

—?jiǎng)h除了ISO9626：2016的5.7，后續(xù)條號(hào)順序前移；

—增加了附錄A；

—附錄B對(duì)應(yīng)ISO9626：2016的附錄A；

—附錄C對(duì)應(yīng)ISO9626：2016的附錄B；

—附錄D對(duì)應(yīng)ISO9626：2016的附錄C；

—附錄E對(duì)應(yīng)ISO9626：2016的附錄D；

—?jiǎng)h除了ISO9626：2016的附錄E。

本文件與ISO9626：2016的技術(shù)差異及其原因如下：

—更改了材料的要求,以符合國(guó)內(nèi)技術(shù)條件

（見第4章，ISO9626：2016的第4章）；

—?jiǎng)h除了ISO9626:2016中5.7“樣本量”的要求，避免與5.1總則產(chǎn)生歧義。

；

—用規(guī)范性引用的GB/T6682替換了ISO3696（見B.2.1），以適應(yīng)我國(guó)國(guó)情；

—更改了韌性要求，以符合國(guó)內(nèi)技術(shù)要求（見附錄D，ISO9626：2016的附錄C）。

本文件做了下列編輯性改動(dòng)：

—?jiǎng)h除了ISO9626:2016第4章中的注；

—增加了“不銹鋼牌號(hào)”（見附錄A）；

—?jiǎng)h除了ISO9626:2016資料性附錄E“針管剛度試驗(yàn)方法的基本原理”。

請(qǐng)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(jī)構(gòu)不承擔(dān)識(shí)別專利的責(zé)任。

本文件由國(guó)家藥品監(jiān)督管理局提出。

本文件由全國(guó)醫(yī)用注射器（針）標(biāo)準(zhǔn)化技術(shù)委員會(huì)（SAC/TC95）歸口。

本文件起草單位：浙江康德萊醫(yī)療器械股份有限公司、上海市醫(yī)療器械檢驗(yàn)研究院、山東威高集團(tuán)

醫(yī)用高分子制品股份有限公司、上海埃斯埃醫(yī)療技術(shù)有限公司、江西三鑫醫(yī)療科技股份有限公司、貝朗

醫(yī)療（上海）國(guó)際貿(mào)易有限公司。

Ⅲ

GB/T18457—2024

本文件主要起草人：張謙、陸離原、花松鶴、叢日楠、李璐、孫洪榮、劉勉、王甘英、常明。

本文件及其所代替文件的歷次版本發(fā)布情況為：

—2001年首次發(fā)布為GB18457—2001，2015年第一次修訂；

—本次為第二次修訂。

Ⅳ

GB/T18457—2024

制造醫(yī)療器械用不銹鋼針管

要求和試驗(yàn)方法

1范圍

本文件規(guī)定了公稱尺寸從0.18mm（34G）到3.4mm（10G）不銹鋼針管（以下簡(jiǎn)稱針管）的要

求，描述了試驗(yàn)方法。

本文件適用于制造人體用皮下注射針和其他醫(yī)療器械的硬直針管。

本文件不適用于易彎式針管，因其力學(xué)性能不同于本文件規(guī)定的硬直針管，但鼓勵(lì)易彎式針管的制

造商和購(gòu)買方選用本文件中的規(guī)定尺寸。

注：當(dāng)針管被整