NAFT fulfils formal technical requirements

Feb 21, 2017

According to conformity tests at the Physikalisch-Technische Bundesanstalt, NAFT fulfils the technical requirements of the standard EN 61331-1.

Ten Medical Design AB (10MD) is a medical technology company committed to providing innovative products to healthcare professionals. 10MD has developed an attenuating material, NAFT, that enables design of ergonomic and hygienic personal protection equipment. The Physikalisch-Technische Bundesanstalt (PTB), the National Metrology Institute of Germany, is a scientific and technical higher federal authority. PTB was chosen by 10MD to perform conformity assessment services on NAFT as a basis for European and International market access. 

According to conformity tests performed by the Physikalisch-Technische Bundesanstalt, NAFT has relevant lead equivalent thickness and fulfils the technical requirements of the standard EN 61331-1. Tests according to the standard IEC 61331-1 applies to materials used for the manufacturing of protective devices against X-radiation of radiation qualities generated with X-ray. The IEC 61331-1 standard has been adopted as the European standard under the designation EN 61331-1. The attenuation properties are given in terms of attenuation ratio and an indication of homogenity. 

"The formal approval from PTB is very encouraging and we will now proceed with the CE marking process", says Petra Apell, one of the founders of 10MD. 

Ten Medical Design AB (10MD) is a medical technology company committed to providing innovative products to healthcare professionals. 10MD has developed an attenuating material, NAFT, that enables design of ergonomic and hygienic personal protection equipment. 

 

For more information, please contact fredrik.gellerstedt@10md.se.