Standards play a crucial part in our lives. In healthcare, standards have an indispensable role for the proper functioning of medical devices, for correct transmission of information, for therapy, for monitoring and support in treatment, and much more. Thus, standards help manufacturers to produce safe medical devices with constant high quality and, as such, help competent authorities to ensure that medical devices in their country provide the performance they want for their citizens.
All stakeholders are invited to participate in the drafting of international standards so that the requirements in these standards get the widest possible support. The rules under which standards are developed in IEC reflect six principles: openness, transparency, impartiality and consensus, effectiveness and relevance, coherence, and development dimension. This is to make sure that the result reflects the state of the art, regardless whether the experts are from industry, medical practice, test institutes, or authorities. Decisions come through voting by the National Committees. Having multiple rounds of commenting, redrafting, and voting, the standards mature to a level that is relevant for all stakeholders.
March 19, 2021 from 12.00 to 13.30
IEC overview: the importance for the MPE community
- Remy Klausz, COCIR
- Regina Geierhofer, COCIR
- Loredana Marcu, EFOMP
- Alberto Torresin, EFOMP