Every specialist area has a greater or lesser need for agreements regarding requirements, interpretations and procedures for checking them. The standard provides a common basis so that apples and oranges are not compared in practice. Different specialist areas do this with various national and international standardisation committees.
In the field of medical technology in Germany, for example, there are standards committees for medicine (NAMed), emergency services and hospitals (NARK), Dental (NADENT), precision mechanics and optics (NAFuO), electrical engineering, electronics and information technology (DKE). Before a standard is published, there is usually a PROJECT. As part of the projects, draft standards are developed in working groups of the standards committees with representatives from industry, testing and science. The draft standards are then made available to other stakeholders for comment outside the working committee. After discussion of the collected comments and, if necessary, implementation of the changes, a standard is (eventually) released for publication. At this point, i.e. after publication, manufacturers and test laboratories have a NORM / a STANDARD on the basis of which verifications can be carried out, i.e. manufacturers can prove that their products, their methods, etc. comply with a current consensus.
Einige dieser Normen werden in einem weiteren Schritt harmonisiert. Ein harmonisierter Standard ist geeignet einige oder alle von der Gesetzgebung vorgesehenen zu erfüllenden Anforderungen zu belegen. In der Medizintechnik ist also die Anwendung der harmonisierten Normen geeignet, die Erfüllung der Grundlegenden Sicherheits- und Leistungsanforderungen nach Anhang I der MDR zu beweisen, mit anderen Worten die Konformität mit den Anforderungen zu belegen.
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