医疗软件检测

T/SHDSGY 017-2023 智慧医疗软件系统技术规范

本文件规定了智慧医疗软件的系统架构、功能要求、设备要求以及测试方法。 本文件适用于智慧医疗软件系统

Technical specification of intelligent medical software system

BS PD CEN/TR 15640:2007 医疗信息学.确保病人安全的医疗软件的测量

This document considers the control measures required to ensure patient safety in respect to health software products. It does not apply to software

Health informatics — Measures for ensuring the patient safety of health software

KS X ISO TS 25238:2014 健康信息学.医疗软件引发的安全危害的分类

Health informatics — Classification of safety risks from health software

KS X ISO TS 25238:2017 健康信息学 医疗软件引发的安全危害的分类

Health informatics — Classification of safety risks from health software

BS PD IEC/TR 80002-3:2014 医疗器械软件. 医疗器械软件生命周期过程的流程参考模式 (IEC 62304)

Medical device software. Process reference model of medical device software life cycle processes (IEC 62304)

GOST R 55544-2013 医疗器械软件. 第1部分. ISO 14971医疗器械软件应用指南

Medical devices software. Part 1. Guidance on the application of ISO 14971 medical devices software

IEC TR 80002-3:2014 医疗器械软件. 第3部分: 医疗器械软件生命周期过程的流程参考模式(IEC 62304)

Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)

IEC/TR 80002-3-2014 医疗器械软件 - 第3部分:医疗器械软件生命周期过程的过程参考模型（Iec 62304）

Medical device software — Part 3: Process reference model of medical device software life cycle processes (IEC 62304)

ISO/TR 80002-2:2017 医疗器械软件第2部分:医疗器械质量体系软件的验证

Medical device software - Part 2: Validation of software for medical device quality systems

KS P ISO TR 80002-2:2021 医疗器械软件.第2部分:医疗器械质量体系软件的验证

Medical device software — Part 2: Validation of software for medical device quality systems

GOST R 58976-2020 医疗设备 软件 第2部分：医疗器械质量体系软件的验证

Medical devices. Software. Part 2. Validation of software for medical device quality systems

YY/T 1406.1-2016 医疗器械软件 第1部分:YY/T 0316应用于医疗器械软件的指南

本部分为YY/T 0316-2016《医疗器械风险管理对医疗器械的应用》中包含的要求应用于有关YY/T 0664-2008《医疗器械软件软件生存周期过程》中所指的医疗器械软件提供了指南，本部分并不增加或改变YY/T 0316-2016或YY/T 0664-2008的要求。 当软件作为医疗器械／系统

Medical device software.Part 1:Guidance on the application of ISO 14971 to medical device software

IEC TR 80002-1:2009 医疗器械软件.第1部分:ISO 14971在医疗器械软件中的应用指南

"This technical report provides guidance for the application of the requirements contained in ISO 14971:2007@ Medical devices?? Application of risk

Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software

IEC/TR 80002-1-2009 医疗器械软件第1部分:ISO 14971在医疗器械软件中的应用指南

Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software

YY/T 1406.1-2016/IEC/TR 80002-1 医疗器械软件 第1部分：YY/T 0316应用于医疗器械软件的指南

T/SHDSGY 017-2023 智慧医疗软件系统技术规范

本文件规定了智慧医疗软件的系统架构、功能要求、设备要求以及测试方法。 本文件适用于智慧医疗软件系统

Technical specification of intelligent medical software system

BS PD CEN/TR 15640:2007 医疗信息学.确保病人安全的医疗软件的测量

This document considers the control measures required to ensure patient safety in respect to health software products. It does not apply to software

Health informatics — Measures for ensuring the patient safety of health software

KS X ISO TS 25238:2014 健康信息学.医疗软件引发的安全危害的分类

Health informatics — Classification of safety risks from health software

KS X ISO TS 25238:2017 健康信息学 医疗软件引发的安全危害的分类

Health informatics — Classification of safety risks from health software

BS PD IEC/TR 80002-3:2014 医疗器械软件. 医疗器械软件生命周期过程的流程参考模式 (IEC 62304)

Medical device software. Process reference model of medical device software life cycle processes (IEC 62304)

GOST R 55544-2013 医疗器械软件. 第1部分. ISO 14971医疗器械软件应用指南

Medical devices software. Part 1. Guidance on the application of ISO 14971 medical devices software

IEC TR 80002-3:2014 医疗器械软件. 第3部分: 医疗器械软件生命周期过程的流程参考模式(IEC 62304)

Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)

IEC/TR 80002-3-2014 医疗器械软件 - 第3部分:医疗器械软件生命周期过程的过程参考模型（Iec 62304）

Medical device software — Part 3: Process reference model of medical device software life cycle processes (IEC 62304)

ISO/TR 80002-2:2017 医疗器械软件第2部分:医疗器械质量体系软件的验证

Medical device software - Part 2: Validation of software for medical device quality systems

KS P ISO TR 80002-2:2021 医疗器械软件.第2部分:医疗器械质量体系软件的验证

Medical device software — Part 2: Validation of software for medical device quality systems

GOST R 58976-2020 医疗设备 软件 第2部分：医疗器械质量体系软件的验证

Medical devices. Software. Part 2. Validation of software for medical device quality systems

YY/T 1406.1-2016 医疗器械软件 第1部分:YY/T 0316应用于医疗器械软件的指南

本部分为YY/T 0316-2016《医疗器械风险管理对医疗器械的应用》中包含的要求应用于有关YY/T 0664-2008《医疗器械软件软件生存周期过程》中所指的医疗器械软件提供了指南，本部分并不增加或改变YY/T 0316-2016或YY/T 0664-2008的要求。 当软件作为医疗器械／系统

Medical device software.Part 1:Guidance on the application of ISO 14971 to medical device software

IEC TR 80002-1:2009 医疗器械软件.第1部分:ISO 14971在医疗器械软件中的应用指南

"This technical report provides guidance for the application of the requirements contained in ISO 14971:2007@ Medical devices?? Application of risk

Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software

IEC/TR 80002-1-2009 医疗器械软件第1部分:ISO 14971在医疗器械软件中的应用指南

Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software

YY/T 1406.1-2016/IEC/TR 80002-1 医疗器械软件 第1部分：YY/T 0316应用于医疗器械软件的指南