標(biāo)準(zhǔn)解讀

GB/T 44423-2024是一項(xiàng)針對(duì)近紅外腦功能康復(fù)評(píng)估設(shè)備制定的國(guó)家標(biāo)準(zhǔn)，旨在規(guī)范此類設(shè)備的設(shè)計(jì)、生產(chǎn)、性能及安全要求，確保其在醫(yī)療健康領(lǐng)域中的有效性和可靠性。該標(biāo)準(zhǔn)具體涵蓋了以下幾個(gè)關(guān)鍵方面：

  1. 范圍定義：明確了標(biāo)準(zhǔn)適用的近紅外腦功能康復(fù)評(píng)估設(shè)備類型，這類設(shè)備通常利用近紅外光譜技術(shù)，無(wú)創(chuàng)地監(jiān)測(cè)和評(píng)估大腦活動(dòng)，輔助理解腦功能狀態(tài)及康復(fù)進(jìn)展。

  2. 術(shù)語(yǔ)和定義：為確保標(biāo)準(zhǔn)的準(zhǔn)確理解和應(yīng)用，首先界定了相關(guān)專業(yè)術(shù)語(yǔ)，如“近紅外光譜成像”、“腦功能激活區(qū)域”等，為后續(xù)條款提供清晰的語(yǔ)境基礎(chǔ)。

  3. 基本要求：規(guī)定了設(shè)備應(yīng)滿足的基本條件，包括安全性、穩(wěn)定性、精確度及用戶友好性。強(qiáng)調(diào)設(shè)備需符合醫(yī)療器械相關(guān)的國(guó)家和國(guó)際安全標(biāo)準(zhǔn)，確?；颊吆筒僮髡叩陌踩?。

  4. 技術(shù)性能指標(biāo)：詳細(xì)列出了設(shè)備應(yīng)達(dá)到的技術(shù)性能要求，例如信號(hào)采集的靈敏度、空間分辨率、時(shí)間分辨率以及數(shù)據(jù)處理能力等，以保證評(píng)估結(jié)果的準(zhǔn)確性和可靠性。

  5. 測(cè)試方法：提供了對(duì)設(shè)備進(jìn)行性能驗(yàn)證和質(zhì)量控制的具體測(cè)試流程和方法，包括校準(zhǔn)方法、性能評(píng)估步驟及相應(yīng)的合格判定準(zhǔn)則，確保各廠家產(chǎn)品的一致性和可比性。

  6. 使用說(shuō)明與標(biāo)識(shí)：要求設(shè)備附帶詳細(xì)的使用說(shuō)明書，明確指示操作流程、維護(hù)保養(yǎng)、注意事項(xiàng)及可能的風(fēng)險(xiǎn)警告。同時(shí)，設(shè)備及包裝上需有合規(guī)的標(biāo)識(shí)信息，如生產(chǎn)日期、有效期、制造商信息等。

  7. 質(zhì)量管理體系：鼓勵(lì)生產(chǎn)商建立并執(zhí)行有效的質(zhì)量管理體系，以持續(xù)監(jiān)控和提升產(chǎn)品質(zhì)量，確保設(shè)備從設(shè)計(jì)、生產(chǎn)到售后服務(wù)的全鏈條管理符合標(biāo)準(zhǔn)要求。

  8. 信息安全與隱私保護(hù)：鑒于設(shè)備可能涉及收集和處理個(gè)人健康信息，標(biāo)準(zhǔn)還強(qiáng)調(diào)了數(shù)據(jù)加密、訪問(wèn)控制及隱私保護(hù)的重要性，要求設(shè)備具有相應(yīng)的安全措施來(lái)保障用戶數(shù)據(jù)安全。


如需獲取更多詳盡信息，請(qǐng)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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文檔簡(jiǎn)介

ICS

11.180.01

CCS

C45

中華人民共和國(guó)國(guó)家標(biāo)準(zhǔn)

GB/T44423—2024

近紅外腦功能康復(fù)評(píng)估設(shè)備通用要求

Generalrequirementsfornear-infraredbrainfunctionrehabilitationassessment

equipment

2024-08-23發(fā)布2024-12-01實(shí)施

國(guó)家市場(chǎng)監(jiān)督管理總局發(fā)布

國(guó)家標(biāo)準(zhǔn)化管理委員會(huì)

GB/T44423—2024

目次

前言

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

Ⅲ

1

范圍

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

1

2

規(guī)范性引用文件

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

1

3

術(shù)語(yǔ)和定義

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

1

4

分類

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

3

4.1

按結(jié)構(gòu)分類

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

3

4.2

按光源類型分類

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

3

5

組成

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

3

6

要求

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

4

6.1

外觀

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

4

6.2

基本功能

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

4

6.3

技術(shù)參數(shù)

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

4

6.4

軟件

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

5

6.5

連續(xù)工作時(shí)間

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

5

6.6

探頭外殼進(jìn)液防護(hù)等級(jí)

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

5

6.7

電源電壓適應(yīng)能力

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

5

6.8

安全性

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

5

6.9

電磁兼容性

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

5

6.10

環(huán)境適應(yīng)性

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

5

7

試驗(yàn)方法

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

6

7.1

試驗(yàn)條件

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

6

7.2

外觀

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

6

7.3

基本功能

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

6

7.4

技術(shù)參數(shù)

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

6

7.5

軟件

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

11

7.6

連續(xù)工作時(shí)間

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

11

7.7

探頭外殼進(jìn)液防護(hù)等級(jí)

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

11

7.8

電源電壓適應(yīng)能力

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

11

7.9

安全性

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

11

7.10

電磁兼容性

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

11

7.11

環(huán)境適應(yīng)性

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

11

8

檢驗(yàn)規(guī)則

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

11

8.1

出廠檢驗(yàn)

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

11

8.2

型式檢驗(yàn)

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

11

Ⅰ

GB/T44423—2024

9

標(biāo)志、使用說(shuō)明書

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

12

9.1

標(biāo)志

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

12

9.2

使用說(shuō)明書

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

12

10

包裝、運(yùn)輸、貯存

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

13

10.1

包裝

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

13

10.2

運(yùn)輸

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

13

10.3

貯存

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

13

附錄A（資料性）

計(jì)算腦區(qū)激活度的方法

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

14

A.1

濃度差計(jì)算法

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

14

A.2

一般線性模型計(jì)算法

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

14

A.3

小波幅值計(jì)算法

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

14

附錄B（資料性）

一種內(nèi)置有介質(zhì)濃度依賴的可變光吸收體的近紅外光散射體的實(shí)例參考

·······

16

Ⅱ

GB/T44423—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。

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。

本文件由中華人民共和國(guó)民政部提出。

本文件由全國(guó)殘疾人康復(fù)和專用設(shè)備標(biāo)準(zhǔn)化技術(shù)委員會(huì)（SAC/TC148）歸口。

本文件起草單位：國(guó)家康復(fù)輔具研究中心、丹陽(yáng)慧創(chuàng)醫(yī)療設(shè)備有限公司、北京航空航天大學(xué)、中山

大學(xué)附屬第三醫(yī)院、蘇州愛(ài)琴生物醫(yī)療電子有限公司、中關(guān)村醫(yī)療器械產(chǎn)業(yè)技術(shù)創(chuàng)新聯(lián)盟、北京社會(huì)管

理職業(yè)學(xué)院、浙江普可醫(yī)療科技有限公司、鄭州仁惠醫(yī)療科技股份有限公司、安徽哈工標(biāo)致醫(yī)療健康產(chǎn)

業(yè)有限公司。

本文件主要起草人：張騰宇、李增勇、汪待發(fā)、李文昊、付其軍、潘國(guó)新、張靜莎、徐功鋮、

李鑫、李岳、秦永清、珠淮、管世昌、肖洪波。

Ⅲ

GB/T44423—2024

近紅外腦功能康復(fù)評(píng)估設(shè)備通用要求

1范圍

本文件規(guī)定了近紅外腦功能康復(fù)評(píng)估設(shè)備（以下簡(jiǎn)稱“設(shè)備”）的分類、組成、要求，描述了相應(yīng)

的試驗(yàn)方法，并對(duì)檢驗(yàn)規(guī)則、標(biāo)志、使用說(shuō)明書、包裝、運(yùn)輸、貯存的內(nèi)容做出了規(guī)定。

本文件適用于利用近紅外光譜技術(shù)對(duì)腦功能損傷、發(fā)育障礙或病變導(dǎo)致的運(yùn)動(dòng)、認(rèn)知、精神障礙等

人群康復(fù)過(guò)程中腦功能狀況進(jìn)行評(píng)估所用設(shè)備的設(shè)計(jì)、生產(chǎn)、檢驗(yàn)、使用。

2規(guī)范性引用文件

下列文件中的內(nèi)容通過(guò)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/T191包裝儲(chǔ)運(yùn)圖示標(biāo)志

GB/T4208外殼防護(hù)等級(jí)（IP代碼）

GB7247.1激光產(chǎn)品的安全第1部分：設(shè)備分類、要求

GB9706.1醫(yī)用電氣設(shè)備第1部分：基本安全和基本性能的通用要求

GB9706.271—2022醫(yī)用電氣設(shè)備第2?71部分：功能性近紅外光譜(NIRS)設(shè)備的基本安全和

基本性能專用要求

G

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