Ultradur® B4521 PRO

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Ultradur® PRO offers a comprehensive service package, which supports customers in product development for the medical technology market.
Ultradur® PRO is in compliance with Pharmacopoeia and Biocompatibility-Tests in Europe, United States and Japan as
specified below. However, the biocompatibility tests were recorded on tests specimens of Ultradur PRO to show compatibility of the material in general. The biocompatibility-tests listed below are not part of any continuous production control.
European Pharmacopoeia, Japanese Pharmacopoeia:
The composition of the product complies with the requirements of the European Pharmacopoeia 7th Edition, Chap. 3.2.2.
"Plastic Containers and Closures for Pharmaceutical Use" and with the requirements of the Japanese Pharmacopoeia,
15th Edition, General Information, “17. Plastic Containers for Pharmaceutical Products”.
However, suitability for the end application concerned including observation of given limitations and toxicological thresholds have to be ensured on the final article by the producer.
US Pharmacopoeia: Biological Reactivity Tests, USP Plastic Class VI (USP VI)
ISO 10993-5: Biological Evaluation of Medical Devices Part 5: Test for Cytotoxicity
DMF: A Drug Master File (DMF) has been registered at FDA for Ultradur® PRO.
Food Contact: Ultradur® PRO is in compliance with multiple regional food contact regulations, especially for Europe and United States.
Additional compliances may also be available. Please contact your local representative or the Ultraplaste Infopoint (e-mail: ultraplaste.infopoint@basf.com, telephone: +49 621-60-78780, fax: +49 621-60-78730).
For notice:
However, BASF has not designed or tested its plastics with respect to all of the special requirements related to their use in medical devices (defined in risk classes I to III according to the European and US Medical Device legislation) and
pharmaceutical applications. Therefore BASF makes no warranties, express or implied, concerning the suitability of any BASF plastics for use in any medical device and pharmaceutical applications.
Abbreviated designation according to ISO 1043-1: PBT

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