At the latest since the entry into force of the European Medical Devices Directive (93/42/EEC) on the 14th in June 1993 medical devices must be subjected to a series of application related tests.
Medical devices are first divided into active (operating is directly dependent on a power source such e.g. as electricity) and in non-active medical devices.
We test non-active medical devices including class IIb.
With regard to the "basic requirements for medical devices" a mutual compatibility between the materials used, the tissue, the biological cells and the body fluids of the patient must be taken into account by the manufacturer (MDD 93/42/EEC).
Requirements and test methods for the biological safety of medical devices are specified more precisely in EN ISO standard 10993 "Biological Evaluation of Medical Devices".
The test on the biological characteristics starts with the definition of the extent of the test (EN ISO 10993-1). Depending on the type of body contact and the contact time different tests are required.
These are for example:
- Determination of bioburden
- Sterility Testing
- Residue analyzes of medical devices
- Determination of residual protein count
To ensure the safety of patients and staff special physical requirements are placed on non-active medical devices. These include for example:
- Surgical drapes, surgical gowns, surgical masks
- Personal protective equipment(protective clothing,gloves)
- Abdominal swabsand sponges
Therefore, we test these products on tear resistance, resistance to penetration by liquids and microorganisms, particle emission and water absorption capacity.
In addition to testing in accordance with EN 149:2001 + A1: 2009 of filtering half masks to protect against particles (FFP mask 1-3) we also determine in accordance with EN 14683 bacterial filtration efficacy, the pressure difference and fluid resistance of masks.
Besides the special requirements in terms of tear strength, no harmful substances such as latex proteins or endotoxins may be released from gloves themselves.
Test and evaluation of the information to be provided by the manufacturer for the processing of resterilizable medical devices (EN ISO 17664). The marketability of a reusable medical device implies that the manufacturer must provide the user with corresponding precise information on processing, including cleaning / disinfection, rinsing, drying, sterilization, transport and proper storage (processing instructions).
HygCen verifies with particularly matched procedures in the course of type tests including relevant risk analysis, whether the manufacturer's processing instructions reproducibly result in a hygienically correct re-usable medical device and therefore the requirements of EN ISO 17664 and the Medical Device Directive are met.