Compliance with national and international regulations are a critical topic for us and our customers. These include requirements for food, drug and potable water contact and medical device applications. Many of our TOPAS® COC products comply with these requirements.
For specific compliance information on any product or grade, please click Contact in the toolbar above and ask for Regulatory information in the text of your message. We will respond promptly.
FDA food contact approval:
FDA regulatory status for contact with medicines and in the medical devices sector:
- FDA Drug Master File (DMF 12132) and Device Master File (MAF 1043) established
- Biocompatibility meets requirements of USP Class VI and cytotoxicity protocols
EU food contact:
- Monomers and additives are listed in the EU Plastics Regulation 10/2011 (PIM - Plastic Implementation Measure)
EU pharmaceutical products and medical devices:
- Complies with the test procedures described in European Pharmacopoeia, section 3.1.3
- Complies with European Pharmacopoeia, section 220.127.116.11
- Biocompatibility meets requirements of ISO 10993