RTF Template

Product: Ultrasint TPU01 for HP Jet Fusion printer
Revision: 10.11.2020
Version: 4.0

Contact:
BASF 3D Printing Solutions GmbH
Speyer Straße 4
69115 Heidelberg, Germany
sales@basf-3dps.com

3D printed test items of the above stated product have fulfilled the requirements of tests as
stated below:

Cytotoxicity Testing- Neutral red: Pass
(ISO 10993-5 (2009))

In vitro Skin Irritation Testing- Human Skin Model: Pass
(OECD Guideline No. 439)

In vivo Sensitisation Testing- Local Lymph Node Assay: Pass
(ISO 10993-10 (2013); OECD Guideline No. 429)

However, the biocompatibility tests were recorded on test specimen of the above referenced product to
show compatibility of the material in general. The biocompatibility tests listed are not part of any
continuous production protocol. The test assessments reflect only the test specimen and have to be
retested on the final product. It remains the responsibility of the device manufacturers and/or end-users
to determine the suitability of all printed parts for their respective application.

F o r n o t i c e:

We give no warranties, expressed or implied, concerning the suitability of above-mentioned product for
use in any medical device and pharmaceutical applications.

All information contained in this document is given in good faith and is based on sources believed to be
eliable and accurate at the date of publication of this document.

It is the responsibility of those to whom we supply our products to ensure that any proprietary rights and
existing laws and legislation are observed. The certificate is exclusively for our customers and
respective competent authorities. It is not intended for publication either in printed or electronic form
(e.g. via Internet) by others. Thus, neither partial nor full publication is allowed without written
permission.

This product information was generated electronically and is valid without signature.