Standardization in healthcare includes international (ISO, IEC) and European (CEN, CENELEC) standards from different areas of the sciences of pharmacy, medicine, dentistry, veterinary medicine, including: medical devices, medical laboratories, in vitro diagnostic systems, optics and photonics, surgery, transfusion equipment, anesthesia equipment, aids for people with disabilities, sterilization of health products, clinical laboratory tests, etc.

Particularly important in the area of healthcare are Medical devices, which are regulated by the Regulations on medical devices (Medical Devices, 2017/745 - MDR and In Vitro Diagnostic medical devices 2017/746 - IVDR), available in the Official Journal of the European Union (The Official Journal of the European Union - OJEU). These Regulations contain harmonized standards, which are periodically updated, and reference data on harmonized standards are available on the European Commission website.

Manufacturers or conformity assessment bodies can apply harmonized standards to demonstrate that their products, services or processes comply with relevant European Union legislation.

Contact person:

M.Pharm. Tatjana Vidović

Specialist

tatjana.vidovic@isbih.gov.ba

057/310-592

Useful links: