VDI 5710 Part 1:2019 Edition

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

Published By	Publication Date	Number of Pages
DIN	2019-07	40

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Categories: 07.120 - Nanotechnologies, 11.040.01 - Medical equipment in general, DIN

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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.

Additional information

Published Code	DIN
Published By	Deutsches Institut für Normung
Publication Date	2019-07
Pages Count	40
Language	Germany
Descriptors	Approval, Chemical properties, Composite materials, Conformity assessment, Danger, Definitions, Evaluations, Marking, Materials, Medical devices, Medical technology, Nano particles, Nanotechnology, Particles, Physiological property, Properties, Release, Risk, Risk assessment, Safety, Specification (approval), Medical products, Distress
File Size	4.9 MB
ICS Codes	07.120 - Nanotechnologies 11.040.01 - Medical equipment in general

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VDI 5710 Part 1:2019 Edition

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