Translation of the supplier's letter
DSM has developed a material Arnitel® ID2045 for use in a large number of applications and has tested it on test articles.
Prod:2016, March, Batch 237902 for ISO 10993-5 cytotoxicity, ISO 10993-10 irritation & sensitization and USP VI.
Advanced Medical Solutions sro can refer to these test certificates for device registration of optical sensors
that are connected to the skin surface of class IIa medical devices. The medical device measures the condition of the venous system.
DSM is now and will be cooperating in the preparation of the test reports with regard to the security mentioned above
Tests available on request to national authorities and/or certification bodies. Advanced medical solutions
sro will forward such a request to DSM and provide the contact information of the named authorities
the information can be sent. Under all circumstances these reports will be treated confidentially.
It affects the following reports:
Cytotoxicity according to ISO 10993-5
o Reference report:18-02043-G1
ISO 10993-10 Irritation and Sensitization
o Reference report:18-02018-G1
o Reference report:18-02018-G2
This letter is being made available to the customer by DSM as a courtesy and solely for reasons of transparency. Therefore, DSM
no representations or warranties of any conclusions as to the fitness for use in any particular
Application (purpose), nor does it assume any liability in relation to that purpose. This summary does not prevent the customer from doing so
nor does it replace the implementation of all relevant tests in accordance with legal and regulatory requirements.