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【CODEX】YY-T 1708.1-2020 Basic requirements of communication and comformance for medical diagnostic X-ray image equipment-Part 1:General requirements
Date:2022-03-14
¥4269.60
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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 needsrisks 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




      CODEX北京科译翻译有限公司是一家专业提供生命科学翻译和本地化服务的公司,作为中国专业的生命科学翻译公司之一以及国内为数不多的通过国际ISO17100: 2015认证的医学翻译提供商,CODEX科译拥有更多的医学资深语言专家,能实现40多种语言对的互译,接受更高难度的医学领域的项目挑战,并在最短时间内适应以给出最合理的解决方案。保证最高质量,100%按时交付,高效、完善的售后保障是CODEX科译给客户的用心承诺。

CODEX is a leading provider of cross-border communications based in Beijing. With our exclusive database in life science, and ISO 17100:2015 certified, CODEX has the required expertise and experience in localization, documentation, and medical literature to deliver a full range of end-to-end content and consulting services in many languages. We closely work with clients to deliver solutions to the challenges of engaging markets, consumers, and regulatory and patent environments worldwide.


      以上是免费内容,查看更多可立即购买
【CODEX】YY-T 1708.1-2020 Basic requirements of communication and comformance for medical diagnostic X-ray image equipment-Part 1:General requirements
Date:2022-03-14
¥4269.60
Download

【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 needsrisks 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




      CODEX北京科译翻译有限公司是一家专业提供生命科学翻译和本地化服务的公司,作为中国专业的生命科学翻译公司之一以及国内为数不多的通过国际ISO17100: 2015认证的医学翻译提供商,CODEX科译拥有更多的医学资深语言专家,能实现40多种语言对的互译,接受更高难度的医学领域的项目挑战,并在最短时间内适应以给出最合理的解决方案。保证最高质量,100%按时交付,高效、完善的售后保障是CODEX科译给客户的用心承诺。

CODEX is a leading provider of cross-border communications based in Beijing. With our exclusive database in life science, and ISO 17100:2015 certified, CODEX has the required expertise and experience in localization, documentation, and medical literature to deliver a full range of end-to-end content and consulting services in many languages. We closely work with clients to deliver solutions to the challenges of engaging markets, consumers, and regulatory and patent environments worldwide.


      以上是免费内容,查看更多可立即购买
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Sixteen years of translation experience in medical and intellectual property fields
Sixteen years of translation experience in medical and intellectual property fields
Since the establishment, CODEX has been deeply engaged in medical translation. Quality translation and services are the driving force for our sustainable development.
Professional and Elite Team
Professional and Elite Team
The translation team consists of graduates returned from abroad, post-graduate students from the most prestigious universities, professional native-speaking translators and consultants in the medical industry.
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Authoritative Quality Certification
We provide services for many world-renowned pharmaceutical companies with ISO9001:2015 and ISO17100:2015 Quality Management System Certification.
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Strict Control Process
Codex has established a perfect translation quality assurance system and systematic operation process, strictly adopts the working procedure of  “firstly translation, secondly modification, thirdly proofreading and fourthly review”.
Excellent Staff Quality
Excellent Staff Quality
Being strictly examined and selected, every one of us is characterized with a strong sense of responsibility and proficiency in medical translation , and we strictly follow the confidential system.
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Client Support
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As one of the few medical translation suppliers in China that have been certified by ISO17100: 2015, we have been providing life sciences translation services, localization services and intellectual property translation services since our founding 16 years ago.
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