As EN 62304:2006 does not cover validation and final release of the medical device, is not sufficient to demonstrate compliance with the essential requirements of directives 90/385/EEC and 93/42/EEC. According to this directives, the software must be validated according the "state of the art"...
4Requirements 4.1ForaterminallysterilizedmedicaldevicetobedesignatedSTERILE”,theprobabilityoftherebeinga viablemicro-organismpresenton/inthedeviceshallbeequaltoorlessthan1×10-6. NOTE1Permissionforacceptanceofaprobabilitygreaterthanthatspecifiedin4.1maybesoughtthroughthe ...
Ensure medical device connectivity, visualization, analytics and much more. Learn more about how you can take charge of evolving design, quality, and regulatory requirements while empowering team autonomy. Learn more Connect to your essential tools ...
The Regulation (EU) 2017/745 for Medical Devices gives requirements on the content of the Information for Use, called the Essential Requirements. The IFU Medical Device Template contains all these mandatory elements that are placed in the right position, so you know exactly what to add and where...
Incorporating requirements from IEC 60601, the Medical Device Directive (2007/47/EC) is a mandatory step in the CE Marking process for medical products ranging from wheelchairs to bandages to diagnostic equipment. The MDD exists to ensure that all devices in the European Union are safe an...
英文名称:Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment 标准状态:现行 发布日期...
This chapter provides the necessary definition and classification of a medical device, essential requirements, conformity assessment procedures, obligation of manufacturers (authorized representatives), and other information related to these issues.Access through your organization Check access to the full text...
During hemofiltration, blood is drawn from the patient and passed through a hemofilter device. This device incorporates a semipermeable membrane that effectively separates small molecules like waste constituents and excess fluid while allowing larger blood cells and larger proteins to remain in circulation...
The adoption of protocols for medical devices based on well-known and trusted serialisation procedures is an essential step towards a secure system that ensures transparency and accountability in the medical device sector. In addition, advanced traceability metrics could allow further supply chain analytic...