KRAIBURG TPE’s materials comply with new VDI guideline
10.09.2019
KRAIBURG TPE has announced that its THERMOLAST M compounds meet the requirements of the guideline 2017 for medical grade plastics (MGPs) passed by the Association of German Engineers (VDI) in July 2019.
Intended as a guideline for manufacturers and users of plastics for medical products, the VDI guideline 2017 regulates the requirements qualified MGPs have to meet, from basic requirements to formulation consistency and change management through to withdrawal terms.
Twenty materials suppliers, users and appointed bodies had formed a guidelines committee (RA) to work on a common minimum standard for MGPs, as there had previously been no clear guidelines or standards in the EU and the USA relating to the polymers used in this vital field of application.
Oliver Kluge, a member of the guidelines committee and advisor for medical products at KRAIBURG TPE, said: “The VDI 2017 is an important first step toward harmonising the range of performance that a medical grade plastic must fulfil, and it creates obligatory guidance in the communication between manufacturers of MGPs and OEMs and/or the manufacturers of medical, pharmaceutical and in vitro products. The new guideline explicitly provides scope for the respective materials suppliers and their customers to make broader arrangements.”
One of the main consequences of VDI 2017 is a restriction of the range of raw materials and auxiliary agents permitted for MGPs, which means that some manufacturers are having to adjust their materials formulations.
The VDI 2017 Medical Grade Plastics guidelines committee is planning to revise the current version for the first time as early as in 2020. The set of rules was presented and discussed in great detail at the VDI conference on MGPs held in Berlin in early July 2019.