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Technical rule [CURRENT]

VDI 5710 Blatt 1:2019-07

Licensing and implementing of new nanotechnologies in the area of medical technology - Fundamentals

German title
Zulassung und Implementierung neuer Nanotechnologien in der Medizintechnik - Grundlagen
Publication date
2019-07
Original language
German, English
Pages
40

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Publication date
2019-07
Original language
German, English
Pages
40

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Short description
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.
Content
ICS
07.120, 11.040.01
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