Harmonized standards

Are applied the harmonized standards for EEC European Directive 98/79 “In-vitro diagnostic medical devices” and 93/42 “medical devices. For example:

EN 556-1 Sterilization of medical devices
EN 15223 Graphic symbols used for the labeling
EN ISO 14971 Risk management
EN 14254 In-vitro diagnostic medical devices – Disposable containers for the collection of human samples, different from blood
EN 14820 Single-use containers for venous blood samples
EN ISO 18113-1 In-vitro diagnostic medical devices – Informations by manufacturer (labeling)