At the latest since the entry into force of the European Medical Devices Directive (93/42/EEC) on June 14, 1993, medical devices must undergo a series of application-specific tests. Medical devices are first divided into active (operation is directly dependent on a power source such as electricity) and non-active medical devices. We test non-active medical devices including class III.
These include things such as the following, for example:
- Medical face masks (surgical masks)
- surgical drapes
- surgical gowns
- surgical gloves
- abdominal swabs and compresses
- packing materials
- contact lenses
- and much more
To ensure the safety of patients and staff special physical requirements are placed on non-active medical devices. Therefore, we test these products on tear resistance, resistance to penetration by liquids and microorganisms, particle emission, and water absorption capacity as well as harmful substances such as latex proteins or endotoxins may be released from gloves themselves.
Medical face masks (surgical masks) in accordance with the European standard EN 14683
Medical face masks serve to limit the transmission of infections germs from staff to patients during surgical operations and other medical situations with similar requirements. Medical face masks thereby meet the definition for medical devices in accordance with Article 1 (2a) of Directive 93/42/EEC on medical devices (MDD) with the purpose of preventing illness. EN 14683 described the requirements for medical face masks to ensure the safety of patients and staff.
Compliance with the essential safety and performance requirements of Regulation 2017/745/EU on medical devices (MDR) must be proven. This is described as a conformity assessment as well. The distributor must prove that its product complies with the provisions, essential requirements, and harmonized standards of the Regulation (EU).