Harmonization of Environmental Measurement

The Harmonization of Environmental Measurement (HEM) center was established in 1989 by UNEP with financial support from the German Ministry of the Environment (BMU) as part of the Global Environment Monitoring System (GEMS). The initiative to establish HEM was taken by the Economic Summit 

In contrast to chemicals, biomaterial and medical device testing constitutes an extremely diverse, heterogeneous category of evaluation. Because the use of these products normally entails direct or indirect contact with patients, there is an obligation for manufacturers to establish the product s safety before marketing. Medical device safety evaluation assesses the risk of adverse effects due to normal use and misuse. Since adverse effects could result from exposure to the materials from which a device is made, preclinical assessment is needed to minimize the potential hazard to the user, namely, the patient. 

---