Health Care Portal
From A for antiseptics to B for blood bags, T for transfusion equipment –The subjects for standardization in the medical field are manifold and are covered by the scope of various standards committees.
How do I find projects that I am interested in?
This health care portal provides a comprehensive overview of how standardization in the domain of health care is organized at DIN.
Professionals are given information on competent national, European and international committees and are directed to published standards, specifications and projects in progress via the following link Topics. Since standardization in the field of health care is primarily European or international oriented, this health care portal also includes an overview of relevant European and international technical committees.
Standards are an effective tool to implement research results into marketable products and to promote a fast market entry for new innovations, which also applies for medicine. See research, innovation and standards.
Standardization and regualtion in the health care system
Standardization in health care has been closely linked to European regulations, especially since the introduction of the New Approach. In 2017, EU Regulations 2017/745 on medical devices and 2017/746 on in vitro diagnostic medical devices became effective to replace the three EU Directives 90/385/EEC on active implantable medical devices, 93/42/EEC on medical devices and 98/79/EC on in vitro diagnostic medical devices. These new EU regulations are to be applied after a three-year transitional period for medical devices and after a five-year transitional period for in vitro diagnostic devices.
Various harmonized standards have been developed to provide product specific requirements on the basis of the essential requriements as specified in the EU directives. These standards serve manufacturers, test centres and regulatoryauthorities as a tool for the demonstration of compliance with the legal requirements. You will find the corresponding DIN standards includinglegal requirments here: medical devices in Europe.
Harmonized standards are drafted following a request of the European Commission. For the new EU regulations, standardization requests are still pending.
This portal also includes information about the major national authorities and other institutions.
Sources of information
Our recommendations on where to find useful information on standards for your research, other publications, online services and events related to health care.
This health care portalwill lead you to contact personswho are available to answer any questions you may have aboutstandardization and whom you may contact at any time if you are interested in working with us.
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