However, standards that address usability for medical devices do exist. Companies must be familiar with these requirements if they want to prove to FDA or other regulatory bodies that they have a usability program in place. These standards also provide information that is specific to the medical ...
The usability engineering of medical devices for registration in China now have technical review guidelines. They were issued by the Center for Medical Device Evaluation (CMDE) on March 19, 2024. The guidelines set out the medical device usability engineering process, outline the nec...
Medical devices - Application of usability engineering to medical devices
IEC62366:2007EN-FRMedicaldevices-Applicationofusabilityengineeringtomedicaldevices是国际电工委员会(IEC)发布的一项标准,专门针对医疗设备的可用性工程应用。该标准提供了关于医疗设备可用性的全面指南,以确保患者安全,医护人员工作效率,以及设备对患者的吸引力。具体内容包括: 1.定义和术语:该标准定义了可用性工程的概念...
P.337: Standardizing usability testing for medical devices intended for intraoperative use during kidney transplantation. The development of equipment for the healthcare industry requires systematic management as, according to the standard of usability for medical equipment IE... J Freise,T Sorrentino,K...
内容简介· ··· To paraphrase a popular saying, usability testing should be done early and often. However, it doesn't have to be an onerous process. Informative, practical, and engaging, Usability Testing of Medical Devices provides a simple, easy to implement general understanding of usability...
内容提示: IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION INTERNATIONAL STANDARD NORME INTERNATIONALE Medical devices – Part 1: Application of usability engineering to medical devices Dispositifs médicaux – Partie 1: Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs ...
英文名称:Medical devices — Application of usability engineering to medical devices 标准状态:废止 发布日期:2007-11-13 文档简介 IEC62366:2007标准是关于医疗设备的可用性工程的应用。它主要关注医疗设备的易用性、安全性和病人友好的设计,包括评估医疗设备的人机交互和使用者的实际操作过程。它对设计医疗设备的各...
IECTR62366-2:2016ENMedicaldevices-Part2:Guidanceontheapplicationofusabilityengineeringtomedicaldevices是由国际电工委员会(IEC)发布的一份标准,其全称为“IECTR62366-2:2016电气设备与电子设备-第2部分:医疗设备的可用性工程应用指南”。该标准主要关注医疗设备的可用性设计,旨在确保医疗设备易于使用,符合用户的需求和...