ICS

11.180.01

CCS

C45

中華人民共和國國家標準

GB/T44423—2024

近紅外腦功能康復評估設備通用要求

Generalrequirementsfornear-infraredbrainfunctionrehabilitationassessment

equipment

2024-08-23發布2024-12-01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/T44423—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

分類

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

3

4.1

按結構分類

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

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

技術參數

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

4

6.4

軟件

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

5

6.5

連續工作時間

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

5

6.6

探頭外殼進液防護等級

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

5

6.7

電源電壓適應能力

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

5

6.8

安全性

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

5

6.9

電磁兼容性

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

5

6.10

環境適應性

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

5

7

試驗方法

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

6

7.1

試驗條件

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

6

7.2

外觀

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

6

7.3

基本功能

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

6

7.4

技術參數

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

6

7.5

軟件

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

11

7.6

連續工作時間

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

11

7.7

探頭外殼進液防護等級

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

11

7.8

電源電壓適應能力

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

11

7.9

安全性

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

11

7.10

電磁兼容性

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

11

7.11

環境適應性

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

11

8

檢驗規則

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

11

8.1

出廠檢驗

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

11

8.2

型式檢驗

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

11

Ⅰ

GB/T44423—2024

9

標志、使用說明書

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

12

9.1

標志

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

12

9.2

使用說明書

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

12

10

包裝、運輸、貯存

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

13

10.1

包裝

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

13

10.2

運輸

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

13

10.3

貯存

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

13

附錄A（資料性）

計算腦區激活度的方法

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

14

A.1

濃度差計算法

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

14

A.2

一般線性模型計算法

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

14

A.3

小波幅值計算法

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

14

附錄B（資料性）

一種內置有介質濃度依賴的可變光吸收體的近紅外光散射體的實例參考

·······

16

Ⅱ

GB/T44423—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。

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。

本文件由中華人民共和國民政部提出。

本文件由全國殘疾人康復和專用設備標準化技術委員會（SAC/TC148）歸口。

本文件起草單位：國家康復輔具研究中心、丹陽慧創醫療設備有限公司、北京航空航天大學、中山

大學附屬第三醫院、蘇州愛琴生物醫療電子有限公司、中關村醫療器械產業技術創新聯盟、北京社會管

理職業學院、浙江普可醫療科技有限公司、鄭州仁惠醫療科技股份有限公司、安徽哈工標致醫療健康產

業有限公司。

本文件主要起草人：張騰宇、李增勇、汪待發、李文昊、付其軍、潘國新、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

近紅外腦功能康復評估設備通用要求

1范圍

本文件規定了近紅外腦功能康復評估設備（以下簡稱“設備”）的分類、組成、要求，描述了相應

的試驗方法，并對檢驗規則、標志、使用說明書、包裝、運輸、貯存的內容做出了規定。

本文件適用于利用近紅外光譜技術對腦功能損傷、發育障礙或病變導致的運動、認知、精神障礙等

人群康復過程中腦功能狀況進行評估所用設備的設計、生產、檢驗、使用。

2規范性引用文件

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

件，僅該日期對應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。

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G