【CODEX翻译】YY-T 1708.1-2020 医用诊断X射线影像设备连通性符合性 基本要求 第1部分：通用要求
Date：2022-03-14
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【CODEX】YY-T 1708.1-2020 医用诊断X射线影像设备连通性符合性 基本要求
第1部分：通用要求-英文版PDF
YY-T 1708.1-2020 医用诊断X射线影像设备连通性符合性 基本要求 第1部分：通用要求
Basic requirements of communication and comformance for medical diagnostic X-ray image equipment-Part 1：General requirements
1 范围
1 Scope
YY/T 1708的本部分规定了医用诊断X射线影像设备及其相关软件组件连通性符合性的术语和 定义、通用要求、试验方法。
本部分适用于具有可通过数字介质存储或通过网络传输健康数据功能的医用诊断X射线设备及 其相关软件组件。
本部分不适用于不具备数字介质存储功能和通过网络传输健康数据功能的医用诊断X射线设备 及其相关软件组件。
This part of YY/T 1708 specifies terms and definitions, general requirements and test methods for communication and conformance for medical diagnostic X-ray image equipment and related software components.
This part applies to medical diagnostic X-ray equipment and its related software components with the function of storing health data via digital media or transmitting health data over a network.
This part does not apply to medical diagnostic X-ray equipment and its related software components that do not have the function of digital media storage and the ability to transmit health data over a network.
2 规范性引用文件
2 Normative References
下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件，仅注日期的版本适用于本文件。凡是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。
The following documents are indispensable for the application of this document. For dated references, only the dated edition is applicable to this document. For undated references, the latest edition of the document (including any amendments) applies.
GB/T 10149医用X射线设备术语和符号
GB/T 10149 Terminology and symbol for medical X-ray equipment
GB/T 25000.1—2010软件工程软件产品质量要求与评价(SQuaRE) SQuaRE指南
GB/T 25000.1-2010 Software engineering-Software product Quality Requirements and Evaluation (SQuaRE) -Guide to SQuaRE
YY/T 0316—2016 医疗器械 风险管理对医疗器械的应用
YY/T 0316-2016 Medical devices-Application of risk management to medical devices
IECTR 80001-2-2:2012包含医疗设备的IT网络的风险管理应用第2-2部分医疗设备安全需求、风险和控制的披露和通报指南（Application of risk management for IT-networks incorporating medical devices—Part 2-2： Guidance for the disclosure and communication of medical device security needs，risks and controls)
IECTR 80001-2-2:2012 Application of risk management for IT-networks incorporating medical devices—Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
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