SMP stands for excellent services in the field of medical devices focusing on validation on reprocessing processes. To support our customers in the course of the development of medical devices we offer customized hygiene related testing. With the validation of reprocessing processes we provide prerequisites needed for successful marketing of medical products and to fulfil ISO 17664. For the investigation of cleaning processes different methods described in the relevant standards are used. Additionally by using radioactively labeled test soil we are able to provide spatial resolution and identify difficult to clean areas of device designs.
Research activities and participation in regulatory and standard committees are the base to provide services at the latest state of the art.
SMP is accredited according to ISO 17025. Most of the services including the variety of test kits for performance qualification of cleaning, disinfection and sterilization processes are part of the accreditation.
Validation of cleaning and disinfection processes for surgical instruments and flexible endoscopes as well as of washer/ disinfectors to demonstrate ISO 15883 (Part 1-5) compliance using
Testing and Validation of
Removal evaluation for Biofilms
Artificial aging of instruments and materials
Additional services on request
By using radioactively labelled and clinically relevant test soil SMP offers with the radionuclide method (RNM) a unique approach for verifying the cleanability of surgical instruments.
The gamma radiation of the radioactive labelling penetrates all materials commonly used for medical devices and is detected spatially-resolved with the aid of a gamma camera.
Even on hidden and internal surfaces the applied test soil can be determined at any time during the cleaning process.
SMP offers examinations in the area of disinfection according to EN and ISO standards as well as to ASTM E1837 – 96(2014) “Standard Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Devices”.
Furthermore test for Hygienic Hand Disinfection are carried out as well as tests for the clearance of disinfection agents for device and surface disinfection. Specific requirements of National standards like the VAH in Germany can be followed as well.
For validating sterilization processes of medical devices with moist heat according to DIN EN 17665-1, SMP operates steam sterilizers and has the technical equipment for quality assurance and monitoring of these processes. Furthermore SMP offers the examination of low temperature sterilization processes (ethylene oxide, hydrogen peroxide, formaldehyde). Newly developed sterilization methods are also examined and evaluated by SMP according to ISO 14937.
Phone: +49 177 6258499