N
4 Posts in this encyclopedia categoryNicht wiederverwendbar
The "do not re-use" symbol under EN ISO 15223-1 marks medical devices intended for a single use on a single patient. It is shown as a crossed-out figure 2. Reprocessing by the user is not covered by the regulatory framework.
Nitrile
Nitrile (Nitrile Butadiene Rubber, NBR) is a synthetic rubber used as the primary material for latex-free protective and examination gloves. Nitrile gloves offer good resistance to oils, fats, solvents, and many chemicals. Nitrile is latex-free but typically contains vulcanisation accelerators.
NON STERILE
NON STERILE is a labelling designation for medical devices indicating that the product is not supplied in a sterile condition. It appears on primary packaging in accordance with ISO 15223-1. Non-sterile products must not be used in sterile fields without prior validated sterilisation.
Notified Body
A Notified Body is a conformity assessment organisation officially designated by an EU Member State to evaluate and certify products where third-party assessment is legally required – such as medical devices from Class IIa (MDR) or PPE from Category II. Notified Bodies are independent, state-supervised, and listed in the EU NANDO database.