GB/T 18457-2024制造醫療器械用不銹鋼針管要求和試驗方法

ICS

11.040.20

CCS

C31

中華人民共和國國家標準

GB/T18457—2024

代替GB/T18457—2015

制造醫療器械用不銹鋼針管

要求和試驗方法

Stainlesssteelneedletubingforthemanufactureofmedicaldevices—

Requirementsandtestmethods

（ISO9626:2016，MOD）

2024-08-23發布2025-09-01實施

國家市場監督管理總局發布

國家標準化管理委員會

GB/T18457—2024

目次

前言

·····································································································

Ⅲ

1

范圍

··································································································

1

2

規范性引用文件

······················································································

1

3

術語和定義

···························································································

1

4

材料

··································································································

1

5

要求和試驗方法

······················································································

2

5.1

通則

······························································································

2

5.2

表面粗糙度和外觀

···············································································

2

5.3

清潔度

···························································································

2

5.4

酸堿度限值

······················································································

2

5.5

尺寸標識

·························································································

2

5.6

尺寸

······························································································

2

5.7

剛性

······························································································

5

5.8

韌性

······························································································

6

5.9

耐腐蝕性

·························································································

6

附錄A（資料性）不銹鋼牌號

········································································

7

附錄B（規范性）檢驗液制備方法

····································································

9

B.1

原理

·····························································································

9

B.2

儀器和試劑

······················································································

9

B.3

制備程序

························································································

9

附錄C（規范性）針管剛性試驗方法

································································

10

C.1

原理

····························································································

10

C.2

儀器

····························································································

10

C.3

試驗程序

·······················································································

10

C.4

試驗報告

·······················································································

10

附錄D（規范性）針管韌性試驗方法

································································

12

D.1

原理

····························································································

12

D.2

儀器

····························································································

12

D.3

步驟

····························································································

12

D.4

試驗報告

·······················································································

12

附錄E（規范性）針管耐腐蝕試驗方法

······························································

14

E.1

原理

····························································································

14

E.2

試劑和儀器

·····················································································

14

Ⅰ

GB/T18457—2024

E.3

實驗程序

·······················································································

14

E.4

試驗報告

·······················································································

14

參考文獻

································································································

15

Ⅱ

GB/T18457—2024

前言

本文件按照GB/T1.1—2020《標準化工作導則第1部分：標準化文件的結構和起草規則》的規

定起草。

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

結構調整和編輯性改動外，主要技術變化如下：

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）增加了術語和定義（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針管標稱外徑的具體尺寸要求（見表1）；

f）更改了尺寸標識的要求（見5.5，2015年版的第5章）；

g）更改了針管尺寸和剛性參數表（見5.7，2015年版的第9章）；

h）更改了檢驗液制備方法的相關要求（見附錄B，2015年版的附錄B）；

i）刪除了“針管酸堿度試驗方法”（見2015年版的附錄C）；

j）更改了針管剛性試驗方法及要求（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報告的要求（見E.4，2015年版的F.4）。

本文件修改采用ISO9626：2016《制造醫療器械用不銹鋼針管技術要求和試驗方法》。

本文件與ISO9626：2016相比做了下述結構調整：

—刪除了ISO9626：2016的5.7，后續條號順序前移；

—增加了附錄A；

—附錄B對應ISO9626：2016的附錄A；

—附錄C對應ISO9626：2016的附錄B；

—附錄D對應ISO9626：2016的附錄C；

—附錄E對應ISO9626：2016的附錄D；

—刪除了ISO9626：2016的附錄E。

本文件與ISO9626：2016的技術差異及其原因如下：

—更改了材料的要求,以符合國內技術條件

（見第4章，ISO9626：2016的第4章）；

—刪除了ISO9626:2016中5.7“樣本量”的要求，避免與5.1總則產生歧義。

；

—用規范性引用的GB/T6682替換了ISO3696（見B.2.1），以適應我國國情；

—更改了韌性要求，以符合國內技術要求（見附錄D，ISO9626：2016的附錄C）。

本文件做了下列編輯性改動：

—刪除了ISO9626:2016第4章中的注；

—增加了“不銹鋼牌號”（見附錄A）；

—刪除了ISO9626:2016資料性附錄E“針管剛度試驗方法的基本原理”。

請注意本文件的某些內容可能涉及專利。本文件的發布機構不承擔識別專利的責任。

本文件由國家藥品監督管理局提出。

本文件由全國醫用注射器（針）標準化技術委員會（SAC/TC95）歸口。

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

醫用高分子制品股份有限公司、上海埃斯埃醫療技術有限公司、江西三鑫醫療科技股份有限公司、貝朗

醫療（上海）國際貿易有限公司。

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布情況為：

—2001年首次發布為GB18457—2001，2015年第一次修訂；

—本次為第二次修訂。

Ⅳ

GB/T18457—2024

制造醫療器械用不銹鋼針管

要求和試驗方法

1范圍

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

求，描述了試驗方法。

本文件適用于制造人體用皮下注射針和其他醫療器械的硬直針管。

本文件不適用于易彎式針管，因其力學性能不同于本文件規定的硬直針管，但鼓勵易彎式針管的制

造商和購買方選用本文件中的規定尺寸。

注：當針管被整