標(biāo)準(zhǔn)解讀
《GB/T 36917.2-2024 牙科學(xué) 技工室用刃具 第2部分:技工室用硬質(zhì)合金刃具》相較于《GB/T 36917.2-2018 牙科學(xué) 技工室用刃具 第2部分:技工室用硬質(zhì)合金刃具》,在多個方面進(jìn)行了更新和調(diào)整。主要變化包括但不限于以下幾個方面:
-
術(shù)語與定義:新版本對某些專業(yè)術(shù)語進(jìn)行了修訂或新增,以更準(zhǔn)確地反映當(dāng)前行業(yè)內(nèi)的通用語言和技術(shù)發(fā)展情況。
-
材料要求:對于硬質(zhì)合金材料的性能指標(biāo)提出了更加嚴(yán)格的要求,比如硬度、耐磨性等關(guān)鍵參數(shù)可能有所提高,旨在確保刃具使用壽命更長、加工精度更高。
-
尺寸公差:針對不同類型的刃具,其幾何形狀及尺寸公差范圍可能有所調(diào)整,這有助于提升產(chǎn)品的互換性和適用性。
-
表面處理:增加了關(guān)于刃具表面涂層或處理方法的新規(guī)定,強調(diào)了改善耐腐蝕性、減少摩擦等方面的重要性。
-
測試方法:改進(jìn)和完善了部分檢測項目的試驗條件及操作步驟,使得測試結(jié)果更加可靠且具有可比性。
-
包裝運輸:細(xì)化了產(chǎn)品包裝標(biāo)識信息以及運輸過程中的保護(hù)措施建議,力求降低物流環(huán)節(jié)中可能對產(chǎn)品質(zhì)量造成的影響。
如需獲取更多詳盡信息,請直接參考下方經(jīng)官方授權(quán)發(fā)布的權(quán)威標(biāo)準(zhǔn)文檔。
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- 2024-09-29 頒布
- 2025-10-01 實施
文檔簡介
ICS
11.060.20
CCS
C33
中華人民共和國國家標(biāo)準(zhǔn)
GB/T36917.2—2024
代替GB/T36917.2—2018
牙科學(xué)技工室用刃具
第2部分:技工室用硬質(zhì)合金刃具
Dentistry—Laboratorycutters—Part2:Carbidelaboratorycutters
(ISO7787-2:2020,MOD)
2024-09-29發(fā)布2025-10-01實施
國家市場監(jiān)督管理總局發(fā)布
國家標(biāo)準(zhǔn)化管理委員會
GB/T36917.2—2024
目次
前言
·····································································································
Ⅲ
引言
·····································································································
Ⅴ
1
范圍
··································································································
1
2
規(guī)范性引用文件
······················································································
1
3
術(shù)語和定義
···························································································
1
4
符號
··································································································
1
5
分類
··································································································
1
6
要求
··································································································
2
6.1
材料
······························································································
2
6.2
形狀
······························································································
2
6.3
尺寸
······························································································
2
6.4
刃具切削刃
······················································································
6
6.5
徑向跳動
·························································································
6
7
抽樣
··································································································
6
8
試驗方法
······························································································
6
8.1
形狀
······························································································
6
8.2
尺寸
······························································································
7
8.3
刃具切削刃
······················································································
7
8.4
徑向跳動
·························································································
7
8.5
判定
······························································································
7
9
標(biāo)示
··································································································
7
9.1
標(biāo)號
······························································································
7
9.2
刃具切削刃標(biāo)示
·················································································
7
10
器械標(biāo)識
····························································································
7
11
包裝標(biāo)簽
····························································································
7
12
包裝
·································································································
8
附錄A(資料性)
刃具切削刃標(biāo)示和切削刃數(shù)目
·····················································
9
Ⅰ
GB/T36917.2—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。
本文件是GB/T36917的第2部分。GB/T36917已經(jīng)發(fā)布了以下部分:
—第1部分:技工室用鋼質(zhì)刃具;
—第2部分:技工室用硬質(zhì)合金刃具;
—第3部分:銑床用硬質(zhì)合金刃具;
—第4部分:技工室用微型硬質(zhì)合金刃具。
本文件代替GB/T36917.2—2018《牙科學(xué)技工室用刃具第2部分:技工室用硬質(zhì)合金刃
具》,與GB/T36917.2—2018相比,除結(jié)構(gòu)性調(diào)整和編輯性改動外,主要技術(shù)變化如下:
a)更改了范圍(見第1章,2018年版的第1章);
b)增加了“術(shù)語和定義”一章(見第3章);
c)更改了分類,增加了第三類適宜材料(見第5章,2018年版的第3章);
d)更改了桿材料的要求,增加了類型選擇及其處理方法由制造商決定(見6.1.2,2018年版的
5.1.2);
e)增加了桿長度的規(guī)定(見6.3.2);
f)增加了“抽樣”一章(見第7章);
g)增加了標(biāo)號相關(guān)規(guī)定(見9.1),更改了標(biāo)示規(guī)定,增加了顏色標(biāo)注相關(guān)規(guī)定(見9.2,2018年版
的第8章);
h)更改了器械標(biāo)識中顏色標(biāo)識的相關(guān)規(guī)定(見第10章,2018年版的第9章);
i)更改了包裝標(biāo)簽的相關(guān)規(guī)定,增加了用于包裝標(biāo)簽的圖形符號規(guī)定(見第11章,2018年版的
第10章);
j)增加了刃具切削刃標(biāo)示和切削刃數(shù)目(見附錄A);
k)更改了表12中切削刃數(shù)目,刪除了表12中關(guān)于左右及公稱直徑的表注(見表A.1,2018年版的
表12)。
本文件修改采用ISO7787?2:2020《牙科學(xué)技工室用刃具第2部分:技工室用硬質(zhì)合金刃具》。
本文件與ISO7787?2:2020的技術(shù)差異及其原因如下:
—用規(guī)范性引用的GB/T9937替換了ISO1942,以適應(yīng)我國的技術(shù)條件,提高可操作性(見
第3章);
—用規(guī)范性引用的YY/T0967替換了ISO1797,以適應(yīng)我國的技術(shù)條件,提高可操作性(見
第5章、6.3.2、第11章);
—用規(guī)范性引用的YY/T0874替換了ISO8325,以適應(yīng)我國的技術(shù)條件,提高可操作性(見8.1、
8.2、8.4);
—用規(guī)范性引用的YY/T1011替換了ISO2157,以適應(yīng)我國的技術(shù)條件,提高可操作性(見
9.1);
—用規(guī)范性引用的YY/T0466.1替換了ISO15223?1,以適應(yīng)我國的技術(shù)條件,提高可操作性(見
第11章);
—增加了切削刃數(shù)目的要求,將“刃具切削刃的選擇由制造商規(guī)定”更改為“刃具切削刃的選擇
和數(shù)目由制造商規(guī)定”,以提高可操作性(見6.4);
—將包裝標(biāo)簽a)中“制造商或其授權(quán)代理商的名稱和/或商標(biāo)和地址”更改為“制造商的名稱和/
或商標(biāo)和地址”,以提高可操作性(見第11章)。
Ⅲ
GB/T36917.2—2024
本文件做了下列編輯性改動:
—增加了本文件適用界限的陳述,刪除了范圍項下的注;
—刪除了ISO7787?2:2020第3章中對ISO和IEC術(shù)語數(shù)據(jù)庫的介紹內(nèi)容;
—將6.3的標(biāo)題由“尺寸和切削刃數(shù)目”更改為“尺寸”;
—將8.2的標(biāo)題由“尺寸和切削刃數(shù)目”更改為“尺寸”,將8.2中“通過目測確定切削刃數(shù)目”
移至8.3。
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。
本文件由全國口腔材料和器械設(shè)備標(biāo)準(zhǔn)化技術(shù)委員會(SAC/TC99)歸口。
本文件起草單位:浙江新亞醫(yī)療科技股份有限公司、寧波信遠(yuǎn)齒科器械有限公司、廣東省醫(yī)療器械
質(zhì)量監(jiān)督檢驗所。
本文件主要起草人:陳賢明、方旻、徐蘇華、許慧、伍倚明、張力揚、曾志雄、阮志孟。
本文件及其所代替文件的歷次版本發(fā)布情況為:
—2018年首次發(fā)布為GB/T36917.2—2018;
—本次為第一次修訂。
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種要求,對確保技工室器械的互換性和安全使用是非
常重要的。
按照技工室用刃具在材料、連接設(shè)備、尺寸等方面的不同,將GB/T36917分為以下四個部分。
—第1部分:技工室用鋼質(zhì)刃具。目的在于規(guī)范鋼質(zhì)刃具的尺寸和其他方面的各種要求。
—第2部分:技工室用硬質(zhì)合金刃具。目的在于規(guī)范硬質(zhì)合金刃具在尺寸和其他方面的各種
要求。
—第3部分:銑床用硬質(zhì)合金刃具。目的在于規(guī)范銑床用硬質(zhì)合金刃具在尺寸和其他方面的各種
要求。
—第4部分:技工室用微型硬質(zhì)合金刃具。目的在于規(guī)范微型硬質(zhì)合金刃具在尺寸和其他方面的
各種要求。
Ⅴ
GB/T36917.2—2024
牙科學(xué)技工室用刃具
第2部分:技工室用硬質(zhì)合金刃具
1范圍
本文件規(guī)定了11種常用的硬質(zhì)合金刃具的尺寸以及其他要求,這11種硬質(zhì)合金刃具是牙科技工室
最主要使用的刃具。
本文件適用于牙科技工室用硬質(zhì)合金刃具。
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