StandardsUsability engineeringRisk managementAn overview of standards and safety aspects for medical devices in the field of neurorehabilitation is given as a snapshot in time. Common basic safety principles for medical devices and internationaldoi:10.1007/978-3-319-28603-7_13Burkhard Zimmermann...
As previously noted, an important motivation for the revision of IEC 60601-1-2 was the increased use of wireless technology either integrated into a medical device or in devices and equipment used in close proximity to medical devices. As a result, the fourth edition modifies the specifications ...
Complex at-home electrical medical devices must comply with the stringent IEC 60601-1 safety standards for medical patient protection. They must also adhere to additional requirements related to risks found in and around the home, like untrained equipment users and the uncontrolled at-home environment...
总的来说,ISO/IECGuide63:1999ENGuidetothedevelopmentandinclusionofsafetyaspectsinInternationalStandardsformedicaldevices是一个非常重要的指导方针,它对于确保医疗器械的安全性和可靠性至关重要。它的实施将促进医疗器械行业的发展和进步,并为患者的健康和生命安全提供重要保障。
Safety Standards for Medical Ultrasound Systems. In: Magjarevic R, Nagel JH, editors. World Congress on Medical Physics and Biomedical Engineering 2006 [Internet]. Springer Berlin Heidelberg; 2007: 2764-6. (IFMBE Proceedings). Available from: http://link.springer.com/chapter/10.1007/978-3-540-...
【英语版】国际标准 ISO/IEC GUIDE 63:2012 EN 医疗器械国际标准中安全因素的开发与融入指南 Guide to the development and inclusion of safety aspects in International Standards for medical devices.pdf,对不起,作为一个文档助手,我无法直接解释ISO/IEC GUIDE 63:20
Decisions, processes, standards, devices, and decisions all already seem complex, but human interaction with medical devices tends to contribute to the confusion. Providing staff, or even training yourself up on how to properly use the medical device can make all the difference. Instructions for me...
The primary goal behind MDSAP is to ensure that companies have met stringent international standards when producing medical devices to ensure consistent quality and compliance worldwide. Understanding and implementing these global standards allow regulators to identify potential risks within the production cha...
requirements for the home healthcare environment were published in 2010. Requirements for medical electrical equipment and medical electrical systems must be incorporated into home environment use devices, along with other applicable standards in the IEC60601. The market for home health care devices and...
英文名称:Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards ...