首页 馆藏资源 舆情信息 标准服务 科研活动 关于我们
现行 IEC TR 62366-2:2016
到馆阅读
收藏跟踪
购买正版
Medical devices - Part 2: Guidance on the application of usability engineering to medical devices 医疗器械.第2部分:医疗器械可用性工程应用指南
发布日期: 2016-04-27
IEC TR 62366-2:20 16(E)是一份技术报告,包含背景信息并提供指导,解决经验表明对实施IEC 62366-1:20 15中定义的可用性工程(人为因素工程)流程和支持安全性以外的目标的人员有帮助的特定领域。本技术报告不打算用于监管目的。它不包含任何要求,仅提供指导和教程信息。 本出版物应与IEC 62366-1:20 15一起阅读。
IEC TR 62366-2:2016(E), which is a Technical Report, contains background information and provides guidance that addresses specific areas that experience suggests can be helpful for those implementing a USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS both as defined in IEC 62366-1:2015 and as supporting goals other than SAFETY. This technical report is not intended to be used for regulatory purposes. It contains no requirements and only provides guidance and tutorial information.

This publication is to be read in conjunction with IEC 62366-1:2015.
分类信息
关联关系
研制信息
归口单位: TC 62/SC 62A
相似标准/计划/法规
现行
IEC/TR 62366-2-2016
Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
医疗器械 - 第2部分:医疗器械可用性工程应用指南
2016-04-28
现行
KS P IEC TR 62366-2
의료기기 — 제2부: 의료기기의 사용성 공학 적용에 관한 지침
医疗器械第2部分:可用性工程在医疗器械中的应用指导
2020-12-30
现行
AAMI/IEC TIR62366-2-2016
Medical Devices Part 2: Guidance on the Application of Usability Engineering to Medical Devices
医疗器械第2部分:可用性工程在医疗器械中的应用指南
2016-07-24
现行
ISO TR 80001-2-6-2014
Application of risk management for IT-networks incorporating medical devices -- Part 2-6: Application guidance -- Guidance for responsibility agreements
医疗器械IT网络风险管理的应用第2-6部分:应用指南责任协议指南
2014-11-20
现行
ISO/TR 80001-2-6-2014
Application of risk management for IT-networks incorporating medical devices — Part 2-6: Application guidance — Guidance for responsibility agreements
包含医疗器械的IT网络的风险管理应用 - 第2-6部分:应用指南 - 责任协议指导
2014-11-20
现行
IEC TR 80001-2-5-2014
Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
包含医疗设备的IT网络的风险管理应用第2-5部分:应用指南分布式报警系统指南
2014-12-16
现行
IEC/TR 80001-2-5-2014
Application of risk management for IT-networks incorporating medical devices — Part 2-5: Application guidance — Guidance for distributed alarm systems
包含医疗器械的IT网络的风险管理应用 - 第2-5部分:应用指南 - 分布式报警系统的指导
2014-12-17
现行
AAMI/IEC TIR80001-2-5-2014
Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
包含医疗设备的IT网络的风险管理应用第2-5部分:应用指南分布式报警系统指南
2014-12-24
现行
IEC/TR 80001-2-2-2012
Application of risk management for IT-networks incorporating medical devices — Part 2-2: Guidance for the communication of medical device security needs, risks and controls
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、风险和控制沟通指南
2012-07-13
现行
IEC TR 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
包含医疗器械的IT网络的风险管理应用第2-2部分:医疗器械安全需求、风险和控制的披露和沟通指南
2012-07-10
现行
KS X IEC TR 80001-2-2(2020 Confirm)
의료기기가 통합된 IT네트워크에 대한 위험 관리의 적용 — 제2-2부: 의료기기의 보안 요구사항, 위험, 통제에 대한 공개 및 통신을 위한 지침
医疗器械网络风险管理应用 - 第2-2部分:医疗器械安全需求披露与沟通的指导意见 风险与控制
2015-08-05
现行
KS X IEC TR 80001-2-4(2020 Confirm)
의료기기가 통합된 IT네트워크에 대한 위험 관리의 적용 — 제2-4부: 적용지침 — 의료서비스기관에 대한 일반 구현 지침
医疗器械网络风险管理应用 - 第2-4部分:应用指南 - 医疗保健服务组织总体实施指南
2015-08-05
现行
IEC/TR 80001-2-3-2012
Application of risk management for IT-networks incorporating medical devices — Part 2-3: Guidance for wireless networks
包含医疗设备的IT网络的风险管理应用第2-3部分:无线网络指南
2012-07-13
现行
KS X IEC TR 80001-2-3(2020 Confirm)
의료기기가 통합된 IT네트워크에 대한 위험 관리의 적용 — 제2-3부: 무선 네트워크에 대한 지침
适用于融合医疗器械的网络风险管理 - 第2-3部分:无线网络指导
2015-08-05
现行
AAMI/IEC TIR80001-2-3-2012
Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
包含医疗设备的IT网络的风险管理应用.第2-3部分:无线网络指南
2012-09-02
现行
GOST R 56840-2015
Информатизация здоровья. Менеджмент рисков в информационно-вычислительных сетях с медицинскими приборами. Часть 2-3. Руководство по беспроводным сетям
风险管理对包含医疗器械的IT网络的应用 第2-3部分 无线网络指导
现行
IEC/TR 80001-2-8-2016
Application of risk management for IT-networks incorporating medical devices — Part 2-8: Application guidance — Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2
风险管理应用于包含医疗设备的网络 - 第2-8部分:应用指南 - 建立Iec 80001-2-2中确定的安全功能标准的指导
2016-05-19
现行
AAMI/IEC TIR80001-2-8-2016
Application of risk management for IT networks incorporating medical devices - Part 2-8: Application guidance Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2
包含医疗设备的IT网络风险管理的应用第2-8部分:IEC 80001-2-2中确定的安全能力建立标准的应用指南
2016-11-18
现行
IEC TR 80001-2-8-2016
Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2
包含医疗设备的IT网络的风险管理应用第2-8部分:应用指南IEC TR 80001-2-2中确定的安全能力建立标准指南
2016-05-19
现行
DIN IEC/TR 80001-2-5
Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems (IEC/TR 80001-2-5:2014)
包含医疗设备的IT网络的风险管理应用第2-5部分:应用指南分布式报警系统指南(IEC/TR 80001-2-5-2014)
2016-03-01