標(biāo)準(zhǔn)解讀

《GB/T 44466-2024 牙科學(xué) 醫(yī)師椅》這一標(biāo)準(zhǔn)主要針對(duì)牙科診療過程中使用的醫(yī)師椅,從設(shè)計(jì)、制造到性能測試等多個(gè)方面提出了具體的要求。該標(biāo)準(zhǔn)涵蓋了醫(yī)師椅的基本結(jié)構(gòu)與尺寸、安全要求、舒適性考量以及環(huán)境適應(yīng)性等方面的內(nèi)容。

在基本結(jié)構(gòu)與尺寸部分,規(guī)定了醫(yī)師椅應(yīng)當(dāng)具備的最小座位寬度和深度,以確保不同體型的醫(yī)生能夠舒適地坐下;同時(shí)對(duì)座椅高度調(diào)節(jié)范圍進(jìn)行了限定,保證使用者可以根據(jù)自身需要調(diào)整至最合適的工作高度。此外,還詳細(xì)描述了扶手、腳踏板等輔助設(shè)施的設(shè)計(jì)原則。

安全要求方面,強(qiáng)調(diào)了產(chǎn)品必須通過一系列嚴(yán)格的安全性檢測,包括但不限于穩(wěn)定性測試、耐久度評(píng)估及電氣安全檢驗(yàn)等,旨在防止因設(shè)備故障而引發(fā)的人身傷害事故。特別指出,在使用電動(dòng)或氣動(dòng)驅(qū)動(dòng)系統(tǒng)時(shí),需采取有效措施避免過熱、漏電等問題的發(fā)生。

對(duì)于舒適性的考量,則更多關(guān)注于如何通過合理的設(shè)計(jì)來減輕長時(shí)間坐姿工作給醫(yī)護(hù)人員帶來的身體負(fù)擔(dān)。比如推薦采用具有良好透氣性和支撐力的材料制作座墊與靠背,并建議提供多檔位可調(diào)的腰部支撐功能,以便更好地貼合人體曲線,緩解腰背疼痛。

環(huán)境適應(yīng)性條款則涉及到產(chǎn)品的清潔維護(hù)便捷性、抗腐蝕能力以及噪音控制水平等內(nèi)容,要求制造商在選材用料上充分考慮到實(shí)際應(yīng)用場景下的特殊需求,確保設(shè)備長期穩(wěn)定運(yùn)行的同時(shí),也能為患者創(chuàng)造一個(gè)安靜舒適的治療氛圍。


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文檔簡介

ICS

11.060.20

CCS

C33

中華人民共和國國家標(biāo)準(zhǔn)

GB/T44466—2024

牙科學(xué)醫(yī)師椅

Dentistry—Operator’sstool

(ISO7493:2006,MOD)

2024-09-29發(fā)布2025-10-01實(shí)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(huì)

GB/T44466—2024

目次

前言

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

引言

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

1

范圍

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

1

2

規(guī)范性引用文件

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

1

3

術(shù)語、定義和符號(hào)

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

1

3.1

術(shù)語和定義

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

1

3.2

符號(hào)

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

2

4

要求

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

4

4.1

通用要求

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

4

4.2

座位高度和調(diào)整范圍

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

4

4.3

牙科醫(yī)師椅的承載能力

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

4

4.4

牙科醫(yī)師椅的穩(wěn)定性

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

4

4.5

靠背偏移

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

4

4.6

扶手和軀干支撐部分

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

4

4.7

清洗和消毒

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

4

4.8

可燃性

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

4

5

取樣

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

4

6

試驗(yàn)方法

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

5

6.1

通則

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

5

6.2

目測

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

5

6.3

器具

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

5

6.4

座椅的承載能力

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

5

6.5

座椅的穩(wěn)定性

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

5

6.6

靠背偏移

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

5

6.7

扶手和軀干支撐部分

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

5

6.8

清洗和消毒

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

6

6.9

可燃性

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

6

7

制造商的使用說明

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

6

8

牙科醫(yī)師椅的標(biāo)記

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

6

9

牙科醫(yī)師椅的包裝

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

6

附錄A(資料性)

為牙科醫(yī)師椅制造商提出的設(shè)計(jì)建議

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

7

參考文獻(xiàn)

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

8

GB/T44466—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。

本文件修改采用ISO7493:2006《牙科學(xué)醫(yī)師椅》。

本文件與ISO7493:2006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

3.1);

—用規(guī)范性引用的GB17927.1替換了ISO8191?1,以適應(yīng)我國的技術(shù)條件,提高可操作性(見

6.9);

—用規(guī)范性引用的YY/T0628替換了ISO9687,以適應(yīng)我國的技術(shù)條件,提高可操作性(見第

8章);

—用規(guī)范性引用的YY/T1400替換了ISO21530,以適應(yīng)我國的技術(shù)條件,提高可操作性(見

6.8);

—更改了通用要求的試驗(yàn)方法,與試驗(yàn)方法6.2的規(guī)定保持一致,提高可操作性(見4.1);

—?jiǎng)h除了醫(yī)師椅的試驗(yàn)裝置,以適應(yīng)我國的技術(shù)條件,提高可操作性(見6.3.1)。

本文件做了下列編輯性改動(dòng):

—更改了通用要求的條款號(hào)(見4.1)。

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(huì)(SAC/TC99)歸口。

本文件起草單位:廣東省醫(yī)療器械質(zhì)量監(jiān)督檢驗(yàn)所、廣東福肯科技工業(yè)有限公司、通標(biāo)標(biāo)準(zhǔn)技術(shù)服

務(wù)有限公司深圳分公司、西諾醫(yī)療器械集團(tuán)有限公司、佛山市盛田醫(yī)療器械有限公司。

本文件主要起草人:伍倚明、張曉康、李蘭、李偉松、雷康寧、石輝、趙麗君、毛獻(xiàn)輝。

GB/T44466—2024

引言

本文件目的是確保牙科診所內(nèi)所使用的醫(yī)師椅的設(shè)計(jì)和功能達(dá)到安全和舒適有效的要求,最大限度

減輕牙科醫(yī)師在臨床操作過程中對(duì)肩部、脊椎以及肌肉所造成的疲勞不適。同時(shí),以便讓牙科醫(yī)師座椅

輕松自如地移動(dòng)。

GB/T44466—2024

牙科學(xué)醫(yī)師椅

1范圍

本文件規(guī)定了在牙科診所中使用的醫(yī)師椅的要求、制造商的使用說明書要求、標(biāo)記和包裝要求,描

述了在牙科診所中使用的醫(yī)師椅的試驗(yàn)方法,還對(duì)制造商提供了醫(yī)師椅和設(shè)計(jì)方面的建議(附錄A)。

注:為了使本文件能夠達(dá)到目的,術(shù)語“牙科醫(yī)師”包括牙科醫(yī)生、牙科助理醫(yī)師和牙科技師。

本文件適用于牙科診所中使用的醫(yī)師椅。

2規(guī)范性引用文件

下列文件中的內(nèi)容通過文中的規(guī)范性引用而構(gòu)成本文件必不可少的條款。其中,注日期的引用文

件,僅該日期對(duì)應(yīng)的版本適用于本文件;不注日期的引用文件,其最新版本(包括所有的修改單)適用

于本文件。

GB/T9937牙科學(xué)名詞術(shù)語(GB/T9937—2020,ISO1942:2009,MOD)

GB17927.1軟體家具床墊和沙發(fā)抗引燃特性的評(píng)定第1部分:陰燃的香煙

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