BIEGLO reports successful certification of PEEK powder and granules (CoPEEK) for medical application following ISO 10993.
ISO 10993 certification of CoPEEK enables BIEGLO to serve existing and new customers in the medical field with CoPEEK, strong service, quality and competitive prices.
The CEO of BIEGLO GmbH John Biesterfeld commented the certification:
“CoPEEK has always been convincing for our customers with its quality and price competitiveness. With our ISO 10993 certification, all PEEK material processors in the European medical market have gained a new first-class supplier.”
BIEGLO GmbH is one of the leading distributors of Polyetheretherketone (PEEK) raw materials and semi-finished products in Europe. Founded in 2011, BIEGLO is the exclusive agent for the CoPEEK of Panjin Zhongrun High Performance Polymer Co. Ltd. in Europe. Panjin Zhongrun is one of the largest producer of PEEK raw materials with more than 1.000 metric ton production capacity.
| TEST | STANDARD | YEAR |
| Test for skin sensitization (Maximization test) | ISO 10993-10: 2010 ISO 10993-12: 2012 | 2017 |
| Test for irritation (Animal Skin irritation test) | ISO 10993-10: 2010 ISO 10993-12: 2012 | 2016 |
| Test for irritation (Intracutaneous reactivity test) | ISO 10993-10: 2010 ISO 10993-12: 2012 | 2016 |
| Acute systemic toxicity test | ISO 10993-11: 2006 ISO 10993-12: 2012 | 2016 |
| Tests for in vitro cytotoxicity (MTT cytotoxicity test) | ISO 10993-5: 2009 ISO 10993-12: 2012 | 2016 |
PEEK for medical application