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 eg as electricity) and in non-active medical devices.
Active medical devices or other medical equipment can be used for the production or processing of medical devices themselves or for use during diagnosis or therapy in humans.
The experts at HygCen assist you in ensuring the safe processing of medical devices:
- Validations and re-validations of processes in washer-disinfectors, sterilizers and other processes
- Quantification of cleaning and disinfection efficacy
- Type testing of devices
- Sealing devices
- Bedpan washer-disinfectors
- Washers (modern textile processing)
The safety of the overall processes can only be ensured by the safety of the sub-processes.
The essential process steps of cleaning and disinfecting therefore have to be qualitatively and quantitatively characterized and be analyzed in their mutual dependence with all the other steps of the entire processing procedure.
The results of validation of the partial steps (washer-disinfectors, sterilizers, sealing machines) must be understood as links in a chain.
The entire "safety" of the processing utilizes this elements and combines them with transportation, packaging, storage and documentation (medical reprocessing cycle).
In addition to the process steps themselves the quality of the media supply is of great importance for the overall outcome of processing (e.g. chemical and microbiological contamination in drinking and industrial water).
Besides the active medical devices, there is also other equipment both in health and from other sectors that may be of indirect hygienic relevance.
Large-scale systems are of importance in the production, but also in the environment of all living things. In the foreground this involves securing the function, as well as the safety and the prevention of unwanted side effects. This includes also the ecological safety, and the safety for operators and users. We test, among others, the emission in order to detect a potential influence on the ecological system. We also test the operation on spreading of germs respectively chemical discharge, whether in to atmosphere or in the outgoing water. Conformity with relevant standards tests, routine monitoring and actual analyzes as prophylaxis but also tests for specific and non-specific problems are conducted.
This involves, for example:
Air conditioning systems in hospitals, public buildings, production facilities
No area with high requirements to indoor climate can work without appropriate air-conditioning systems. The normal "user" only knows the openings where air blows out. Behind this often hides a complex conditioning system with ducts, fans, dampers, filters, Trockungseinrichtungen, humidification, cooling devices, heating equipment and heat recovery systems respectively heat exchangers. At some points of this complex system improper construction, maintenance or operation management can lead to hygienically questionable growth of microorganisms, which are then blown into the room and may even cause serious diseases. By cooling the air in the air conditioning, the moisture starts to condense - an ideal growth factor for many microorganisms. Our inspectors will help, to take timely and appropriate actions.
Cooling towers of power plants and industrial facilities
When planning power plants, which are equipped with cooling towers and used with pass through modes , the heat dissipated may at elevated water temperature of the surrounding waters, may not be discharged directly into surface waters. This heat must be dissipated via the cooling tower into the atmosphere. The cooling tower thus serves to discharge the water. Therefore, it must be ensured during operation that no hygiene risks can arise. We analyze the constructions and the planned operating modes.
Water treatment, these include elevated water tank, water dispenser, water treatment, etc.
Waste Disinfection Systems
Cooling systems on buildings
Textiles - Textiles processed in laundries-monitoring system for Biocontamination
In the hospital-health and the food processing sector special requirements in terms of purity and hygiene are put on textiles. In order to ensure that the laundry is hygienically clean after processing, disinfected and no more germs are present, we check the processing of textiles in laundries according to the modern European RABC concept and thus can provide quality-assured hygienic purity of the textiles. With this system laundries can monitor their processes and efficiently control them and therefore can always provide and proof optimal hygienic product quality.
HygCen Austria GmbH
Accredited Testing Laboratory and Inspection Body for Hygiene and Medical Devices