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

Please select

from 108.60 EUR VAT included

from 101.50 EUR VAT excluded

Purchasing options

PDF download

Language: German, English
108.60 EUR

Shipment (3-5 working days)

Language: German, English
120.70 EUR

Standards Ticker ¹

Language: German, English

Learn more about the standards ticker

Online service subscriptions

This document also features in an online service. Online services not only give you electronic access to collections of standards, they contain lots of extra information too (such as directives, legal texts, commentaries, etc.). There are automatic updates on a regular basis – and online services also give you large savings compared with the cost of purchasing standards individually.

Suitable online services

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

Product information on this site:

Quick delivery via download or delivery service

Buy securely with a credit card or pay upon receipt of invoice

All transactions are encrypted

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

Also available in

Loading recommended items...