VDI 5710 Blatt 1
Licensing and implementing of new nanotechnologies in the area of medical technology - Fundamentals
At a glance
- German title
-
Zulassung und Implementierung neuer Nanotechnologien in der Medizintechnik - Grundlagen
- Publication date
- 2019-07
- Publisher
- Engl. VDI-Gesellschaft Materials Engineering
- Related manuals
- Number of pages
- 40
- Available in
- German, English
- Abstract
-
This standard represents a guideline and gives recommendations on the necessary steps required for the CE marking (conformance assessment) and the implementation of new nanotechnologies in the area of medical technology to fulfil the regulatory demands of the different laws and regulations. It enables the user to recognise arising problems during the licencing process in an early stage in order to take suitable measures. In Germany and within the EU, special regulations apply to the use of nanoparticles in medical technology products, medicines, foods and cosmetics. The standard applies exclusively to medicine products which are subject to the medical device directive 93/42/EEC.