医用软件检测

DIN EN 62304:2007 医疗器械用软件.软件寿命过程

Medical device software - Software life-cycle processes (IEC 62304:2006); German version EN 62304:2006

NF C74-017*NF EN 62304:2006 医疗器械用软件.软件寿命过程

Medical device software - Software life-cycle processes.

BS EN 62304:2006 医疗器械软件.软件使用周期过程

This standard defines the life cycle requirements for MEDICAL DEVICE SOFTWARE. The set of PROCESSES, ACTIVITIES, and TASKS described in this standard

Medical device software - Software life-cycle processes

EN 62304:2006 医疗器械用软件.软件寿命过程:2006

Medical device software - Software life-cycle processes (Incorporating corrigendum November 2008)

KS P 1304-2010 医用气体软管组件

이 표준은 임상에서 사용하는 의료용 가스 공급설비에 사용하는 호스 어셈블리에 대하여 규정한

Hose assemblies for use with medical gas systems

ANSI/AAMI/IEC 62304,Ed.1:2006 医疗器械用软件.软件寿命循环过程

Defines the life-cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes

Medical device software - Software life-cycle processes

ANSI/AAMI/IEC 62304:2006 医疗器械用软件.软件生命周期过程

Defines the life-cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes

Medical device software - Software life-cycle processes

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

T/CQAE 11004-2018 医疗服务软件测试指南

本标准给出了医疗服务软件产品质量参考模型，规定了医疗服务软件产品的测试内容，以及质量评价准则。 本标准适用于： a)需方依此确定医疗服务软件质量需求和产品确认准则； b)供方依此及需方提出的要求确定质量保证准则； c)评价方依此及相关国家标准和用户要求，搭建测试环境、设计测试用例、执行测试和

YY/T 0799-2010 医用气体低压软管组件

1.1本标准规定了用于下列医用气体的低压软管组件的要求： 氧气；氧化亚氮（笑气）；医用空气；氦气；二氧化碳；氙气；上述气体的专用混合气；富氧空气；驱动手术器械用空气；驱动手术器械用氮气；真空。 其目的主要是确保气体专用性，防止不同气体传输系统间的交叉连接。这些软管组件预期用于最大工作压力小于

Low-pressure hose assemblies for use with medical gases

ISO 5359:2000 医用气体用低压软管组件

1 This International Standard specifies requirements for low-pressure hose assemblies intended for use with the following medical gases: — oxygen

Low-pressure hose assemblies for use with medical gases

KS P 1304-2021 医用气体系统用软管组件

Hose assemblies for use with medical gas 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

YY/T 0664-2008 医疗器械软件.软件生存周期过程

本标准适用于医疗器械软件的开发和维护。 当软件本身是医疗器械，或当软件是最终医疗器械的嵌入部分或组成部分时，本标准适用于该医疗器械软件的开发和维护。 本标准不覆盖医疗器械的确认和最终发行，即使当该医疗器械完全由软件组成时

Medical devices software.Software life cycle processes

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

ISO 5359:2008/Amd 1:2011 医用气体低压软管组件.修改件1

Low-pressure hose assemblies for use with medical gases; Amendment 1

NF S95-174/A1:2012 医用气体低压软管组件.修改件1

Low-pressure hose assemblies for use with medical gases - Amendment 1.

BS EN 62304:2006 医疗器械软件.软件使用周期过程

This standard defines the life cycle requirements for MEDICAL DEVICE SOFTWARE. The set of PROCESSES, ACTIVITIES, and TASKS described in this standard

Medical device software - Software life-cycle processes

KS P 1304-2010(2016 软管组件与医用气体系统使用

Hose assemblies for use with medical gas systems

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

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

DIN EN 62304:2016 医疗器械用软件.软件寿命过程(IEC 62304-2006+A1-2015).德文版本EN 62304-2006+Cor.-2008+A1-2015

Medical device software - Software life-cycle processes (IEC 62304:2006 + A1:2015); German version EN 62304:2006 + Cor.:2008 + A1:2015

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

BS EN ISO 5359:2008 医疗气体设备用低压软管组件

1.1 This International Standard specifies requirements for low-pressure hose assemblies intended for use with the following medical gases: -oxygen

Low-pressure hose assemblies for use with medical gases

JIS T 7111:1993 医疗气体系统使用的软管组件

Hose assemblies for use with medical gas systems

JIS T 7111:2006 医疗气体系统使用的软管组件

この規格は，次の医療ガスを1400kPa未満で使用するときに用いるホースアセンブリのホース，及びホース両端に備えるコネクタとして，各ガスとの交差接続を確実に防ぐねじ式ガス別特定のNISTコネクタ及びDISSコネクタについて規定する

Hose assemblies for use with medical gas systems

CSA Z5359-04-CAN/CSA-2004 医疗气体用的低压软管组件.第1版.

This part of IS0 10079 specifies minimum safety and performance requirements for medical and surgical suction equipment (see Figure 1) for health

Low-pressure hose assemblies for use with medical gases First Edition;

GOST 31517-2012 医用气体低压软管组件.技术要求和试验方法

Low-pressure hose assemblies for use with medical gases. Technical requirements and test methods

prEN 739-1992 医用供气系统的低压软连接组件(软管组件)

Low pressure flexible connecting assemblies (hose assemblies) for use with medical gas supply systems

BS EN 739:1998 医疗用气体设备的低压软管组件

1 This European Standard specifies requirements for low-pressure hose assemblies intended for use with the following medical gases: —oxygen; —nitrous

Low-pressure hose assemblies for use with medical gases