Certificates and approvals
Certificates: ISO10993, FDA, REACH and ROHS. Below, we list some of the most common regulations, decrees and approvals pertaining to materials.
2002/95/EC (RoHS) directive
The Restriction of the use of certain Hazardous Substances
An EU regulation that restricts the use of certain harmful substances in electrical and electronic devices. These substances include lead, mercury, cadmium, hexavalent chromium and fire retardants polybrominated biphenyls (PBB) and polybrominated diphenyl ether (PBDE). The directive entered into force on 1 July 2006.
1907/2006/EC (REACH) regulation
Registration, Evaluation, Authorisation and Restriction of Chemicals. This refers to the EU regulation on the registration, evaluation, authorisation and permit processes related to chemicals and restrictions on their use.
Plastics Implementation Measure (PIM) (10/2011/EG)
A regulation that pertains to materials that come into direct contact with foodstuffs. Traceability of materials in production chains.
Food and Drug Administration
A list of materials suitable for applications in which they come into direct contact with foodstuffs issued by the Food and Drug Administration.
Standard, defines the materials that are biocompatible with humans and animals in continuous direct contact lasting no longer than 24 h.