GB/T 44423-2024 近红外脑功能康复评估设备通用要求

ICS

11.180.01

CCS

C45

中华人民共和国国家标准

GB/T44423—2024

近红外脑功能康复评估设备通用要求

Generalrequirementsfornear-infraredbrainfunctionrehabilitationassessment

equipment

2024-08-23发布2024-12-01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/T44423—2024

目次

前言

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Ⅲ

1

范围

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2

规范性引用文件

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3

术语和定义

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4

分类

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4.1

按结构分类

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3

4.2

按光源类型分类

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5

组成

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6

要求

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6.1

外观

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4

6.2

基本功能

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4

6.3

技术参数

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4

6.4

软件

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6.5

连续工作时间

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6.6

探头外壳进液防护等级

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6.7

电源电压适应能力

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5

6.8

安全性

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5

6.9

电磁兼容性

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5

6.10

环境适应性

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7

试验方法

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6

7.1

试验条件

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6

7.2

外观

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6

7.3

基本功能

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6

7.4

技术参数

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6

7.5

软件

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11

7.6

连续工作时间

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11

7.7

探头外壳进液防护等级

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

11

7.8

电源电压适应能力

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11

7.9

安全性

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11

7.10

电磁兼容性

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11

7.11

环境适应性

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8

检验规则

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8.1

出厂检验

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8.2

型式检验

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Ⅰ

GB/T44423—2024

9

标志、使用说明书

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12

9.1

标志

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12

9.2

使用说明书

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12

10

包装、运输、贮存

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13

10.1

包装

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13

10.2

运输

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10.3

贮存

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13

附录A（资料性）

计算脑区激活度的方法

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14

A.1

浓度差计算法

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A.2

一般线性模型计算法

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14

A.3

小波幅值计算法

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14

附录B（资料性）

一种内置有介质浓度依赖的可变光吸收体的近红外光散射体的实例参考

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16

Ⅱ

GB/T44423—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。

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。

本文件由中华人民共和国民政部提出。

本文件由全国残疾人康复和专用设备标准化技术委员会（SAC/TC148）归口。

本文件起草单位：国家康复辅具研究中心、丹阳慧创医疗设备有限公司、北京航空航天大学、中山

大学附属第三医院、苏州爱琴生物医疗电子有限公司、中关村医疗器械产业技术创新联盟、北京社会管

理职业学院、浙江普可医疗科技有限公司、郑州仁惠医疗科技股份有限公司、安徽哈工标致医疗健康产

业有限公司。

本文件主要起草人：张腾宇、李增勇、汪待发、李文昊、付其军、潘国新、张静莎、徐功铖、

李鑫、李岳、秦永清、珠淮、管世昌、肖洪波。

Ⅲ

GB/T44423—2024

近红外脑功能康复评估设备通用要求

1范围

本文件规定了近红外脑功能康复评估设备（以下简称“设备”）的分类、组成、要求，描述了相应

的试验方法，并对检验规则、标志、使用说明书、包装、运输、贮存的内容做出了规定。

本文件适用于利用近红外光谱技术对脑功能损伤、发育障碍或病变导致的运动、认知、精神障碍等

人群康复过程中脑功能状况进行评估所用设备的设计、生产、检验、使用。

2规范性引用文件

下列文件中的内容通过文中的规范性引用而构成本文件必不可少的条款。其中，注日期的引用文

件，仅该日期对应的版本适用于本文件；不注日期的引用文件，其最新版本（包括所有的修改单）适用

于本文件。

GB/T191包装储运图示标志

GB/T4208外壳防护等级（IP代码）

GB7247.1激光产品的安全第1部分：设备分类、要求

GB9706.1医用电气设备第1部分：基本安全和基本性能的通用要求

GB9706.271—2022医用电气设备第2﹘71部分：功能性近红外光谱(NIRS)设备的基本安全和

基本性能专用要求

GB/T14710—2009医用电器环境要求及试验方法

GB/T25000.51—2016系统与软件工程系统与软件质量要求和评价（SQuaRE）第51部分：

就绪可用软件产品（RUSP）的质量要求和测试细则

YY9706.102医用电气设备第1﹘2部分：基本安全和基本性能的通用要求并列标准：电磁兼

容要求和试验

YY9706.257医用电气设备第2﹘57部分：治疗、诊断、监测和整形/医疗美容使用的非激光光

源设备基本安全和基本性能的专用要求

3术语和定义

下列术语和定义适用于本文件。

3.1

近红外脑功能康复评估设备near-infraredbrainfunctionrehabilitationassessmentequipment

通过近红外脑血氧采集系统获取大脑皮质表面区域脑血氧含量相对变化的分布情况，据此反映脑功

能康复状况的装置。

3.2

近红外脑血氧采集系统near-infraredbrainbloodoxygenacquisitionsystem

利用近红外光谱技术测量脑组织血红蛋白浓度变化量的装置。

注：其工作原理为通过发射光谱到脑组织中，并检测从脑组织中扩散反射的红外和可见光强度的变化，计算得到脑

组织血红蛋白浓度（氧合血红蛋白、脱氧血红蛋白、总血红蛋白）的变化量。

3.3

发射探头emitterprobe

近红外脑血氧采集系统的组成部分，用于发射光谱到活体组织，构成该系统的应用部分。

1