GB/T 36917.2-2024 牙科学 技工室用刃具 第2部分：技工室用硬质合金刃具

ICS

11.060.20

CCS

C33

中华人民共和国国家标准

GB/T36917.2—2024

代替GB/T36917.2—2018

牙科学技工室用刃具

第2部分：技工室用硬质合金刃具

Dentistry—Laboratorycutters—Part2：Carbidelaboratorycutters

（ISO7787-2：2020，MOD）

2024-09-29发布2025-10-01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/T36917.2—2024

目次

前言

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

Ⅲ

引言

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

Ⅴ

1

范围

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

1

2

规范性引用文件

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

1

3

术语和定义

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

1

4

符号

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

1

5

分类

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

1

6

要求

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

2

6.1

材料

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

2

6.2

形状

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

2

6.3

尺寸

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

2

6.4

刃具切削刃

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

6

6.5

径向跳动

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

6

7

抽样

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

6

8

试验方法

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

6

8.1

形状

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

6

8.2

尺寸

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

7

8.3

刃具切削刃

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

7

8.4

径向跳动

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

7

8.5

判定

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

7

9

标示

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

7

9.1

标号

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

7

9.2

刃具切削刃标示

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

7

10

器械标识

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

7

11

包装标签

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

7

12

包装

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

8

附录A（资料性）

刃具切削刃标示和切削刃数目

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

9

Ⅰ

GB/T36917.2—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。

本文件是GB/T36917的第2部分。GB/T36917已经发布了以下部分：

—第1部分：技工室用钢质刃具；

—第2部分：技工室用硬质合金刃具；

—第3部分：铣床用硬质合金刃具；

—第4部分：技工室用微型硬质合金刃具。

本文件代替GB/T36917.2—2018《牙科学技工室用刃具第2部分：技工室用硬质合金刃

具》，与GB/T36917.2—2018相比，除结构性调整和编辑性改动外，主要技术变化如下：

a）更改了范围（见第1章，2018年版的第1章）；

b）增加了“术语和定义”一章（见第3章）；

c）更改了分类，增加了第三类适宜材料（见第5章，2018年版的第3章）；

d）更改了杆材料的要求，增加了类型选择及其处理方法由制造商决定（见6.1.2，2018年版的

5.1.2）；

e）增加了杆长度的规定（见6.3.2）；

f）增加了“抽样”一章（见第7章）；

g）增加了标号相关规定（见9.1），更改了标示规定，增加了颜色标注相关规定（见9.2，2018年版

的第8章）；

h）更改了器械标识中颜色标识的相关规定（见第10章，2018年版的第9章）；

i）更改了包装标签的相关规定，增加了用于包装标签的图形符号规定（见第11章，2018年版的

第10章）；

j）增加了刃具切削刃标示和切削刃数目（见附录A）；

k）更改了表12中切削刃数目，删除了表12中关于左右及公称直径的表注（见表A.1，2018年版的

表12）。

本文件修改采用ISO7787﹘2：2020《牙科学技工室用刃具第2部分：技工室用硬质合金刃具》。

本文件与ISO7787﹘2：2020的技术差异及其原因如下：

—用规范性引用的GB/T9937替换了ISO1942，以适应我国的技术条件，提高可操作性（见

第3章）；

—用规范性引用的YY/T0967替换了ISO1797，以适应我国的技术条件，提高可操作性（见

第5章、6.3.2、第11章）；

—用规范性引用的YY/T0874替换了ISO8325，以适应我国的技术条件，提高可操作性（见8.1、

8.2、8.4）；

—用规范性引用的YY/T1011替换了ISO2157，以适应我国的技术条件，提高可操作性（见

9.1）；

—用规范性引用的YY/T0466.1替换了ISO15223﹘1，以适应我国的技术条件，提高可操作性（见

第11章）；

—增加了切削刃数目的要求，将“刃具切削刃的选择由制造商规定”更改为“刃具切削刃的选择

和数目由制造商规定”，以提高可操作性（见6.4）；

—将包装标签a）中“制造商或其授权代理商的名称和/或商标和地址”更改为“制造商的名称和/

或商标和地址”，以提高可操作性（见第11章）。

Ⅲ

GB/T36917.2—2024

本文件做了下列编辑性改动：

—增加了本文件适用界限的陈述，删除了范围项下的注；

—删除了ISO7787﹘2：2020第3章中对ISO和IEC术语数据库的介绍内容；

—将6.3的标题由“尺寸和切削刃数目”更改为“尺寸”；

—将8.2的标题由“尺寸和切削刃数目”更改为“尺寸”，将8.2中“通过目测确定切削刃数目”

移至8.3。

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。

本文件由全国口腔材料和器械设备标准化技术委员会（SAC/TC99）归口。

本文件起草单位：浙江新亚医疗科技股份有限公司、宁波信远齿科器械有限公司、广东省医疗器械

质量监督检验所。

本文件主要起草人：陈贤明、方旻、徐苏华、许慧、伍倚明、张力扬、曾志雄、阮志孟。

本文件及其所代替文件的历次版本发布情况为：

—2018年首次发布为GB/T36917.2—2018；

—本次为第一次修订。

Ⅳ

GB/T36917.2—2024

引言

牙科技工室用刃具在尺寸上和其他方面上的各种要求，对确保技工室器械的互换性和安全使用是非

常重要的。

按照技工室用刃具在材料、连接设备、尺寸等方面的不同，将GB/T36917分为以下四个部分。

—第1部分：技工室用钢质刃具。目的在于规范钢质刃具的尺寸和其他方面的各种要求。

—第2部分：技工室用硬质合金刃具。目的在于规范硬质合金刃具在尺寸和其他方面的各种

要求。

—第3部分：铣床用硬质合金刃具。目的在于规范铣床用硬质合金刃具在尺寸和其他方面的各种

要求。

—第4部分：技工室用微型硬质合金刃具。目的在于规范微型硬质合金刃具在尺寸和其他方面的

各种要求。