What is EN 62366?
IEC 62366-1:2015 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. It strengthens links to ISO 14971:2007 and the related methods of risk management as applied to safety related aspects of medical device user interfaces.
Is IEC 62366 mandatory?
Usability is a requirement, which has been present in regulations since a long time. It stems from the assessment of user error as a hazardous situation.
Is EN 62366 harmonized?
IEC 62366:2007 is a harmonized standard, which means it is a European standard developed by one of the European standardization organizations at the request of the European Commission. Harmonized standards can be used by manufacturers to demonstrate that their products and processes comply with relevant EU legislation.
What is the latest version of IEC 62366?
IEC 62366-1:2015/Amd 1:2020.
What is usability in medical device?
“Usability” looks at how the user interacts with your device and forms a key component of overall risk management and safety. The ultimate goal of early planning for usability testing and validation of your medical device is to ensure you’re building a safe and effective product for the end user.
What is usability engineering medical devices?
Medical Device Usability Engineering Process It is a process which provides safety for the patient, user and others related to usability. This process mitigates the risks associated with the correct use and use errors due to usability problems.
What is a usability engineering file?
The Usability Engineering File is a table of contents that points to all the usability information and process evidence required for your project. The human factors group at a company should be responsible for the Usability Engineering File, including all contents.
What is medical device usability?
Medical device usability is the characteristics of the User Interface that facilitate Use, to make it easier for the users to perceive the information presented by the User Interface, to understand and make a decision based on that information.
Whats is IEC?
An Importer -Exporter Code (IEC) is a key business identification number which mandatory for export from India or Import to India. No export or import shall be made by any person without obtaining an IEC unless specifically exempted.
What is usability medical devices?