Wipes and CE marking

A number of our customers are facing confusion regarding the CE marking of the sterile wipes that they are using in aseptic preparation.

If a product is classified as a medical device as specified in the medical devices directive 93/42/EEC, then it must be CE marked.

SteriClean wipes are not classified as a medical device and therefore should not and cannot be CE marked.

With reference to the guide ‘Quality assurance of Aseptic Preparation Services’ fourth edition, P57 chapter 13, 13.2.1, sterile wipes are classified as a component and should be supplied with a documented from of approval, which in this case will be a sterility certificate.

I hope this clarifies the issue and for more information and samples of our SteriClean range of wipes please call 0800 0328 428

http://www.mhra.gov.uk/home/groups/es-era/documents/publication/con057319.pdf

Are infection control challenging your cleaning products?

Some hospitals are having problems with growth of coliform bacteria in their aseptic units and isolator cabinets.

Helapet take pride in supplying quality products that are both effective and validated. The results of the SteriClean Bio + I and Bio + II against european Standard EN 1276 including Escherichia coli (E. Coli) are proven to be excellent.

Units that have moved over to using the SteriClean range of cleaning and disinfection products have seen a significant fall in levels of contamination not only after cleaning, but in general background levels.

Why not try SteriClean in your unit for FREE and see the results for yourselves, call
0800 0328 428.

Study Day date

The last in the 3rd series of free study days 'Managing the risks in the preparation of aseptic products' takes place on 17th June 2010 at Crewe Hall Hotel in Cheshire.

For more information and to book your place please call 0800 0328 428
http://www.helapet.net/

The next series starts in September with the agenda and venues still to be finalised.