Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Latest European device standards published:

This article was originally published in Clinica

Executive Summary

The latest series of European standards for medical devices and diagnostics have been published in the Official Journal of the European Communities (C 288/41). Manufacturers conform to these standards to imply that they meet the relevant essential requirements of the European Union medical device directives on in vitro diagnostics (IVDs), medical devices (MDs) and active implantable medical devices (AIMDs). The new standards or parts of standards cover: culture media for microbiology (IVD); tests for in vitro cytotoxicity (MD and AIMD); validation and routine control of sterilisation by irradiation (MD); and 15 parts to the standards on electricomedical equipment ranging from gamma beam therapy equipment to endoscopic equipment and infant radiant monitors (AIMD).

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT079974

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel