GB/T 18457-2024 制造医疗器械用不锈钢针管 要求和试验方法

ICS

11.040.20

CCS

C31

中华人民共和国国家标准

GB/T18457—2024

代替GB/T18457—2015

制造医疗器械用不锈钢针管

要求和试验方法

Stainlesssteelneedletubingforthemanufactureofmedicaldevices—

Requirementsandtestmethods

（ISO9626:2016，MOD）

2024-08-23发布2025-09-01实施

国家市场监督管理总局发布

国家标准化管理委员会

GB/T18457—2024

目次

前言

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Ⅲ

1

范围

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1

2

规范性引用文件

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1

3

术语和定义

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1

4

材料

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1

5

要求和试验方法

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2

5.1

通则

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2

5.2

表面粗糙度和外观

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2

5.3

清洁度

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2

5.4

酸碱度限值

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2

5.5

尺寸标识

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2

5.6

尺寸

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2

5.7

刚性

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5

5.8

韧性

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6

5.9

耐腐蚀性

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6

附录A（资料性）不锈钢牌号

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7

附录B（规范性）检验液制备方法

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9

B.1

原理

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9

B.2

仪器和试剂

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9

B.3

制备程序

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9

附录C（规范性）针管刚性试验方法

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10

C.1

原理

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10

C.2

仪器

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10

C.3

试验程序

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10

C.4

试验报告

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10

附录D（规范性）针管韧性试验方法

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12

D.1

原理

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12

D.2

仪器

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12

D.3

步骤

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D.4

试验报告

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12

附录E（规范性）针管耐腐蚀试验方法

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14

E.1

原理

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14

E.2

试剂和仪器

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14

Ⅰ

GB/T18457—2024

E.3

实验程序

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14

E.4

试验报告

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14

参考文献

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15

Ⅱ

GB/T18457—2024

前言

本文件按照GB/T1.1—2020《标准化工作导则第1部分：标准化文件的结构和起草规则》的规

定起草。

本文件代替GB/T18457—2015《制造医疗器械用不锈钢针管》，与GB/T18457—2015相比，除

结构调整和编辑性改动外，主要技术变化如下：

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

b）增加了术语和定义（见第3章）；

c）更改了所用材料的要求（见第4章，2015年版的第4章）;

d）增加了部分规格的超薄壁、极薄壁的尺寸要求（见第5章）；

e）增加了0.18mm针管标称外径的具体尺寸要求（见表1）；

f）更改了尺寸标识的要求（见5.5，2015年版的第5章）；

g）更改了针管尺寸和刚性参数表（见5.7，2015年版的第9章）；

h）更改了检验液制备方法的相关要求（见附录B，2015年版的附录B）；

i）删除了“针管酸碱度试验方法”（见2015年版的附录C）；

j）更改了针管刚性试验方法及要求（见附录C，2015年版的附录D）；

k）更改了针管韧性试验方法及要求（见附录D，2015年版的附录E）；

l）更改了针管耐腐蚀性试验报告的要求（见E.4，2015年版的F.4）。

本文件修改采用ISO9626：2016《制造医疗器械用不锈钢针管技术要求和试验方法》。

本文件与ISO9626：2016相比做了下述结构调整：

—删除了ISO9626：2016的5.7，后续条号顺序前移；

—增加了附录A；

—附录B对应ISO9626：2016的附录A；

—附录C对应ISO9626：2016的附录B；

—附录D对应ISO9626：2016的附录C；

—附录E对应ISO9626：2016的附录D；

—删除了ISO9626：2016的附录E。

本文件与ISO9626：2016的技术差异及其原因如下：

—更改了材料的要求,以符合国内技术条件

（见第4章，ISO9626：2016的第4章）；

—删除了ISO9626:2016中5.7“样本量”的要求，避免与5.1总则产生歧义。

；

—用规范性引用的GB/T6682替换了ISO3696（见B.2.1），以适应我国国情；

—更改了韧性要求，以符合国内技术要求（见附录D，ISO9626：2016的附录C）。

本文件做了下列编辑性改动：

—删除了ISO9626:2016第4章中的注；

—增加了“不锈钢牌号”（见附录A）；

—删除了ISO9626:2016资料性附录E“针管刚度试验方法的基本原理”。

请注意本文件的某些内容可能涉及专利。本文件的发布机构不承担识别专利的责任。

本文件由国家药品监督管理局提出。

本文件由全国医用注射器（针）标准化技术委员会（SAC/TC95）归口。

本文件起草单位：浙江康德莱医疗器械股份有限公司、上海市医疗器械检验研究院、山东威高集团

医用高分子制品股份有限公司、上海埃斯埃医疗技术有限公司、江西三鑫医疗科技股份有限公司、贝朗

医疗（上海）国际贸易有限公司。

Ⅲ

GB/T18457—2024

本文件主要起草人：张谦、陆离原、花松鹤、丛日楠、李璐、孙洪荣、刘勉、王甘英、常明。

本文件及其所代替文件的历次版本发布情况为：

—2001年首次发布为GB18457—2001，2015年第一次修订；

—本次为第二次修订。

Ⅳ

GB/T18457—2024

制造医疗器械用不锈钢针管

要求和试验方法

1范围

本文件规定了公称尺寸从0.18mm（34G）到3.4mm（10G）不锈钢针管（以下简称针管）的要

求，描述了试验方法。

本文件适用于制造人体用皮下注射针和其他医疗器械的硬直针管。

本文件不适用于易弯式针管，因其力学性能不同于本文件规定的硬直针管，但鼓励易弯式针管的制

造商和购买方选用本文件中的规定尺寸。

注：当针管被整合到即用型设备时，在针管上可能需要做额外的性能试验。

2规范性引用文件

下列文件中的内容通过文中的规范性引用而构成本文件必不可少的条款。其中，注日期的引用文

件，仅该日期对应的版本适用于本文件；不注日期的引用文件，其最新版本（包括所有的修改单）适用

于本文件。

GB/T6682分析实验室用水规格和试验方法（GB/T6682—2008，ISO3696:1987，MOD）

ISO15510：2014不锈钢化学成分（Stainlesssteels—Chemicalcomposition）

3术语和定义

下列术语和定义适用于本文件。

3.1

公称尺寸designatedmetricsize

表1中定义的针管外径。

注：单位以毫米（mm）表示。

3.2

规格Gauge

英制（伯明翰）尺寸。

注：特定规格尺寸对应于规定外径限值的指定公称尺寸。

3.3

壁厚wallthickness

针管的内外径之间的材料厚度。

注：壁厚类型表示为RW=正常壁，TW=薄壁，ETW=超薄壁，UTW=极薄壁，见表1。

4材料

针管应采用符合ISO15510：2014中的X2CrNi18﹘9、X5CrNi18﹘10、X6CrNiNb18﹘10、X5CrNiMo

17﹘12﹘2、X6CrNiMoTi17﹘12﹘2、X6CrNiMoNb17﹘12﹘2等奥氏体不锈钢制成，或与上述钢材相当的其

他奥氏体不锈钢制成。附录A给出了相当的不锈钢牌号、化学成分对照表。

1

GB/T18457—2024

5要求和试验方法

5.1通则

应根据特定用途和预期用途采用风险评估的方法来选择针管。

5.2表面粗糙度和外观

用正常视力或矫正视力观察时，针管的外表面应光滑无缺陷，针管应笔直且呈规则圆形。

根据医疗器械的最终功能，表面粗糙度要求可能有所不同；在这种情况下，医疗器械制造商宜制定

具体的表面粗糙度要求。

5.3清洁度

用正常视力或矫正视力观察时，针管表面应无金属屑和加工过程中产生的杂质。

根据医疗器械的最终功能，清洁度要求可能有所不同；在这种情况下，医疗器械制造商宜制定具体

的清洁度要求。

5.4酸碱度限值

按附录B制备检验液，用pH计测定，检验液与空白对照液的pH值之差应≤1.0。

5.5尺寸标识

针管尺寸应由标称外径，即单位为毫米（即公称尺寸）、相应的规格（如G31或31G）和壁厚类型，来标

识。

示例：0.25mm（31G）ETW。

5.6尺寸

针管尺寸应符合表1规定。

表1针管尺寸

公称尺寸最小外径（OD）最大外径（OD）最小内径（ID）

规格（G）壁厚类型

mmmmmmmm

RW0.064

0.18340.1780.191TW0.091

ETW0.105

RW0.089

0.2330.2030.216TW0.105

ETW0.125

RW0.089

TW0.105

0.23320.2290.241

ETW0.125

UTW0.146

RW0.114

0.25310.2540.267

TW0.125

2

GB/T18457—2024

表1针管尺寸（续）

公称尺寸

最小外径（OD）最大外径（OD）最小内径（ID）

规格（G）壁厚类型

mmmmmmmm

ETW0.146

0.25310.2540.267

UTW