标准解读

GB/T 44423-2024是一项针对近红外脑功能康复评估设备制定的国家标准，旨在规范此类设备的设计、生产、性能及安全要求，确保其在医疗健康领域中的有效性和可靠性。该标准具体涵盖了以下几个关键方面：

  1. 范围定义：明确了标准适用的近红外脑功能康复评估设备类型，这类设备通常利用近红外光谱技术，无创地监测和评估大脑活动，辅助理解脑功能状态及康复进展。

  2. 术语和定义：为确保标准的准确理解和应用，首先界定了相关专业术语，如“近红外光谱成像”、“脑功能激活区域”等，为后续条款提供清晰的语境基础。

  3. 基本要求：规定了设备应满足的基本条件，包括安全性、稳定性、精确度及用户友好性。强调设备需符合医疗器械相关的国家和国际安全标准，确保患者和操作者的安全。

  4. 技术性能指标：详细列出了设备应达到的技术性能要求，例如信号采集的灵敏度、空间分辨率、时间分辨率以及数据处理能力等，以保证评估结果的准确性和可靠性。

  5. 测试方法：提供了对设备进行性能验证和质量控制的具体测试流程和方法，包括校准方法、性能评估步骤及相应的合格判定准则，确保各厂家产品的一致性和可比性。

  6. 使用说明与标识：要求设备附带详细的使用说明书，明确指示操作流程、维护保养、注意事项及可能的风险警告。同时，设备及包装上需有合规的标识信息，如生产日期、有效期、制造商信息等。

  7. 质量管理体系：鼓励生产商建立并执行有效的质量管理体系，以持续监控和提升产品质量，确保设备从设计、生产到售后服务的全链条管理符合标准要求。

  8. 信息安全与隐私保护：鉴于设备可能涉及收集和处理个人健康信息，标准还强调了数据加密、访问控制及隐私保护的重要性，要求设备具有相应的安全措施来保障用户数据安全。


如需获取更多详尽信息，请直接参考下方经官方授权发布的权威标准文档。

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文档简介

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

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

Ⅲ

1

范围

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

1

2

规范性引用文件

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

1

3

术语和定义

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

1

4

分类

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

3

4.1

按结构分类

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

3

4.2

按光源类型分类

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

3

5

组成

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

3

6

要求

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

4

6.1

外观

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

4

6.2

基本功能

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

4

6.3

技术参数

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

4

6.4

软件

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

5

6.5

连续工作时间

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

5

6.6

探头外壳进液防护等级

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

5

6.7

电源电压适应能力

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

5

6.8

安全性

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

5

6.9

电磁兼容性

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

5

6.10

环境适应性

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

5

7

试验方法

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

6

7.1

试验条件

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

6

7.2

外观

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

6

7.3

基本功能

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

6

7.4

技术参数

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

6

7.5

软件

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

11

7.6

连续工作时间

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

11

7.7

探头外壳进液防护等级

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

11

7.8

电源电压适应能力

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

11

7.9

安全性

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

11

7.10

电磁兼容性

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

11

7.11

环境适应性

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

11

8

检验规则

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

11

8.1

出厂检验

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

11

8.2

型式检验

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

11

Ⅰ

GB/T44423—2024

9

标志、使用说明书

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

12

9.1

标志

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

12

9.2

使用说明书

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

12

10

包装、运输、贮存

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

13

10.1

包装

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

13

10.2

运输

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

13

10.3

贮存

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

13

附录A（资料性）

计算脑区激活度的方法

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

14

A.1

浓度差计算法

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

14

A.2

一般线性模型计算法

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

14

A.3

小波幅值计算法

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

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

·······

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。

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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

G

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