Document O3wpRjB77r8Bo43b1dNEyen8e

Dyneon GmbH 3M Advanced Materials Division Industrieparkstr. 1 84508 Burgkirchen Germany Phone: +49 (0) 8679 7-0 Internet: www.d neon.eu E-Mail: mmm.com VAT-ID: DE 813 030 203 Dyneon GmbH Industrieparkstr.1 84508 Burgkirchen Germany IDT Industrie- and Dichtungstechnik GmbH Mr. Christian Hofmann Gewerbering 6 09456 Annaberg-Buchholz GERMANY Dr. Hans-Peter Muhlbauer Product Stewardship, Fluoroplastics Phone Fax Email mmm.com Burgkirchen, 10.04.2013 3MTM DyneonTM TFMTM Modified PTFE Granules TFM 1600 3MTM DyneonTM PTFE Granules TF 1620 USP Class VI -121C / 70 C - Compliance Status Dear valued customer, 1. Representative samples manufactured with the following product have been certified in accordance with USP protocol (USP Class VI - 121C) by North American Science Associates (NAMSA) -- Ohio / USA: 3M-rm DyneonTM TFMTM Modified PTFE Granules TFM 1600 (28.05.2010) Three USP Biological Reactivity Test, In Vivo have been carried out to satisfy USP Plastic Class VI - 121 C requirements with the corresponding ISO standards indicated in brackets: USP Systemic Toxicity Study in the Mouse USP Intracutaneous Toxicity Study in the Rabbit USP Muscle Implantation Study in the Rabbit The test articles met the requirements of USP Plastic Class VI for use up to 121C. 2. Representative samples manufactured with the following product have been certified in accordance with USP protocol (USP Class VI - 70 C) by Toxikon Corporation: 3MTM DyneonTM PTFE Granules TF 1620 (27.10.2004) Sitz: D-84508 Burgkirchen Handelsregister: Amtsgericht Traunstein HRB 18573 GeschaftsfOhrer: Burkhard Anders (Sprecher), Michael Peters Vorsitzender des Aufsichtsrates: GOnter Gressler Bankverbindung: Deutsche Bank AG, Dusseldorf BLZ 300 700 10 Kto.-Nr. 656 706 900 IBAN: DE83 3007 0010 0656 7069 00 BIC: DEUTDEDD Dyneon GmbH 3M Advanced Materials Division Page 2 Three USP Biological Reactivity Test, In Vivo have been carried out to satisfy USP Plastic Class VI - 70 C requirements with the corresponding ISO standards indicated in brackets: USP Systemic Injection Test in the Mouse USP Intracutaneous Test in the Rabbit USP Implantation Test in the Rabbit The test articles met the requirements of USP Plastic Class VI for use up to 70C. Based on our experiences with other fluoropolymers we expect same results also at the extractions temperature of 121 C. All testing in accordance with USP protocol has to be carried out on finished products as ,,article tests" and is the responsibility of the manufacturer or seller. It is the responsibility of the customer to determine whether its specific formulation and intended use comply with applicable laws and is suitable for its intended applications. Please feel free to contact us for any further question. Kind regards Dr. Hans-Peter Mhlbauer Dyneon GmbH Product Stewardship - Compliance Management Fluoroplastics