Regulatory compliance

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

meliflex regulatory compliance

 

meliflex is designed to meet the following standards:

  • REACH (1907/2006/EC)
  • EC directive 10/2011 on plastic materials and articles intended to come into contact with foodstuffs
  • The list of additives according to European Pharmacopoeia, monograph 3.1.3
  • The European Pharmacopoeia application requirements, monograph 3.2.2
  • ISO 10993
  • The CFDA requirements (incl. low residual limits)

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

  • Cytotoxicity in Vitro (USP 87 / ISO 10993-5)
  • USP 88 (Class VI)
  • USP 661 (Physicochemical tests for plastics)