10/29/2007

Obelis European Authorized Representative Center (O.E.A.R.C.)

The Latest Globally Harmonized Medical Packaging Standards

Manufacturers should be aware of the two new global

harmonized medical packaging standards ISO EN 11607-1:2006

and ISO EN 11607-2:2006 officially ratified in April

2006, which replace the former European standard EN

868-1. These standards are not only recognized in Europe

but also in the US by the FDA (Scholla 7).

According to these latest standards, as of May 2007

manufacturers who place new terminally sterilized medical

devices on the European market must comply with the

ISO EN 11607 Parts 1 and 2 (Scholla 7).

Obelis s.a., as a member of the IBN (Belgium Standard

Institute) is able to assist non-EU manufacturers

identifying the latest globally harmonized standards, e.g. the ISO

EN 11607 Parts 1 and 2. The main goal of IBN is to produce

standards in order to create an economic and social

framework beneficial to the elimination of trade

barriers, to optimize products, services and

processes and to ensure personal and environmental

safety.

Obelis has been referred by the FDA as source to buy

these standards and offers official copies of the

European Harmonized standards for purchase at a reasonable

price.

The Globally Harmonized Medical Packaging Standards

are important matters that raise many questions

regarding the correct compliance for manufacturers

placing their products on the EU market.

Obelis has over 19 years of experience assisting

manufacturers with the EU regulations and global

harmonized standards. Please visit www.obelis.net, to

learn how we can provide you with the official copies of

these standards.


Source:

Scholla, M.H.. "Strategies for Complying with the Globally Harmonized Medical Packaging Standard." Med-Tech Packaging September 2007: 7.