Guidelines on phthalates in medical devices -

The European commission has approved additional Guidelines on phthalates that are carcinogenic, mutagenic, or toxic to reproduction (CMR), or have endocrine-disrupting (ED) properties. NIOMs Head of laboratory Dr. Hilde M. Kopperud is among the experts behind the new guidelines, which complement the legal documentation to the MDR.

Commentary Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties -

The guidelines provide a framework to perform a BRA to justify the presence of CMR or ED phthalates in medical devices.
They also describe the evaluation of possible alternatives for these phthalates used in medical devices.
Manufacturers are encouraged to generate data that are needed for the BRA on potential alternatives to be used in medical devices.

Bond strength between dentine and a novel fast-setting calcium silicate cement with fluoride -

The aim of this study was to evaluate the dentine bond strength of a novel fast‐setting calcium silicate cement (Protooth) versus a calcium hydroxide‐based cement (Dycal), a calcium silicate cement (ProRoot MTA), and a glass ionomer cement (Ketac‐Molar). Mid‐root dentine slices of 1 mm thickness were obtained from human maxillary incisors. After enlarging the lumen […]

Update your technical documentation before MDR -

3D-printers open up exciting new fields of research, treatment and testing. This makes one a natural acquisition for NIOM’s instrument park. Read more about which printer we chose, and why.