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