In the Danish Medicines Act there are a number of provisions on the control of medicines and medical utensils under the National Board of Health.
Under the Danish Medicines Act s.1, subsection 1.a, a medicine is an item to be administered to persons or animals to prevent, realise, relieve, treat or cure a disease, symptoms of a disease and pain or to affect body functions.
Under the Danish Medicines Act s.2, medical utensils (medical equipment) are items which are not a medicine, but which are to be applied for prevention, realisation and treatment of diseases.
Medical equipment are items such as thermometers, hypodermic needles and surgical instruments; i.e. equipment which is not administered to the patient. However, medical equipment also comprises materials for surgical purposes like suture materials and others for implantation into tissue. In addition, this concept includes dental materials, hearing aids and anaesthesia equipment, for example.
How can the Danish Technological Institute help you?
The Chemical and Microbiological Laboratory is an impartial and independent laboratory accredited by DANAK pursuant to DS/EN ISO/IEC 17025 (former EN 45001). Accredited testing is carried out with high demands on quality control and is ensured authorisation all over Europe.
The Laboratory is authorised by the Danish Medicines Agency under s.39 to carry out analyses of medicines.
The Laboratory offers to provide documentation under current legislation and requirements from authorities. This applies to both products and their packaging.
Chemistry and Water Technology has many years of experience in analysis of materials and textiles and can assist in connection with;
- Global and specific migration in various simulants
- Screening analyses of unknown constituent substances
- Analyses of contents of residual solvents
- Analyses of contents of ethylenoxide
- Analyses of contents of heavy metals
- Control of manufactured products
- Validation of analysis methods