meliflex compliance

meliflex is designed in accordance with customer requirements and to comply with the scope of the regulatory standards for pharmaceutical packaging and medical devices:

• REACH (1907/2006/EC)
• FDA requirements (eg. CFR 21 177.2600c, 177.1810b)
• Monomers and raw materials used in the manufacture conform to EC directive 2011/10/EC
• European Pharmacopoeia - list of additives according to monograph 3.1.3
• designed to meet the European Pharmacopoeia application requirements, monograph 3.2.2
• designed to meet the ISO 10993 requirements
• designed to meet the SFDA requirements (incl. low residual limits)

In addition, meliflex materials are tested with independent international test institutes to certify that meliflex materials comply with:

• USP <88> in vivo testing (Class VI test)
  (intracutaneous injection, systemic injection and implantation)
• USP <661> Physico-chemical tests for plastics
  (non-volatile residues, residue on ignition, heavy metals, buffering capacity)
• ISO10993-5 / USP <87> in vitro testing (Cytotoxicity)