Services provided by HygCen
HygCen tests and ensures the quality of your medical devices, disinfectants and similar products. As an accredited test laboratory we test according to European (EN) and international (ISO) standards. The German Accreditation Body (DAkkS) certifies our competent, independent and non-partisan working method according to EN ISO / IEC 17025
Benefit from our qualified and independent test results. Our tests demonstrate compliance with current quality standards for your medical devices. In addition, you will receive a test report that serves as a basis for important product and market entry decisions. The ultimate goal of the test standards is the protection of patients, users and the environment.
Tests for medical devices
- Biocompatibility test – EN ISO 10993 series
With this series of standards, we check whether your medical device poses a biological risk. - Manufacturer information - EN ISO 17664
In the procedure, we test whether your information on the reprocessing of a medical device is valid. - Efficacy tests for disinfectants - EN ISO 14885
Disinfectants are subject to complex regulations. We examine whether your disinfectant or biocide complies with all specifications.
- Validation according to EN ISO 15883 series
We validate the cleaning-disinfection processes of your washer-disinfectors. - Validation of sterilization processes
We validate the sterilization processes of all sterilization processes (steam, FO, EO etc.). - Type testing of your reprocessing devices
We carry out type tests of your washer-disinfectors and sterilizers.
Working and living in Schwerin
The HygCen testing laboratory is where real laboratory experts work. By this we mean all our employees: the laboratory and pharmaceutical technical assistants as well as the office personnel (m / f / d). As a team, we make the world of medical devices safer every day. We work to the highest standards and guarantee without animal experiments. HygCen actively promotes work-life balance. Schwerin itself offers numerous highlights as a place of work and residence. You will find here for example a colorful art and theater landscape, lovely cafés and numerous lakes and forests.
Accreditations from HygCen
HygCen Germany GmbH is an accredited testing laboratory. This is certified by the German Accreditation Body (DAkkS). This means that we test according to EN ISO / IEC 17025.
We test medical devices for medical device manufacturers according to European (EN) and international (ISO) standards. The accredited quality assurance test includes:
Since 2013, Dr. Sebastian Werner has headed the accredited and recognized testing laboratory HygCen Germany GmbH Schwerin. At the same time he acts as head of scientific-technical affairs. Various activities outside of our laboratory complement his professional experience.
So is Dr. Werner Deputy Chairman of the "Hygienic Safety of Medical Products and Procedures" commission of the DGKH. At the same time he is currently trying to revive the professional association of German medical specialists in hygiene.
In the field of research, Dr. Werner focuses on quality assurance in the reprocessing of medical devices.
As a member of the Scientific Advisory Board of the journal "Hygiene & Medicine", Sebastian Werner wants to make a special contribution to providing practice-relevant topics in technical hygiene with sufficient space for technical discussion.
His professional qualification was gained by Dr. Werner during his studies in Innsbruck. He is specialized as a medical specialist in hygiene and environmental medicine through his specialist training at the Hygiene Institute of the Ruhr University Bochum.
Since 2012 Mr. PD Dr. rer. nat. Dr. med. habil. Friedrich v. Rheinbaben works at HygCen Germany GmbH. Before that, Mr. v. Rheinbaben worked more than 10 years on the board of DGKH. Currently he works in various professional committees, e.g. in the expert committee "virucidal activity" of the German Association for the Control of Viral Diseases (DVV). Dr. v. Rheinbaben is author and co-author of several books and numerous articles.
Dr. v. Rheinbaben completed his studies in microbiology and virology at the universities in Bonn and Giessen. He then habilitated at the University of Witten-Herdecke for the subjects of microbiology, virology and hygiene. In 1987 he moved to the industry. There he set up a virology department and supervised the department of hygiene and infection prevention for the areas of human hygiene - later also for veterinary, textile and institutional hygiene.
Since 2016, Dr. Hildebrandt is department director at HygCen. She is responsible for microbiological test methods with focus on methods for testing the efficacy of disinfectants in the medical, veterinary and food, industrial, household and public sector and PT 1-5 according to the biocide legislation.
In numerous publications and lectures, she shares her knowledge about the practical implementation of infection prevention. Likewise, she is an active member of the professional societies, such e.g. the TC216. Dr. Hildebrandt studied chemistry and business administration in Münster. Subsequently, she obtained a doctorate in extra-occupational to the Dr. rer. med. (Doctor of Natural Sciences in Medicine) at the University of Greifswald. The Institute for Hygiene and Environmental Medicine with a focus on bacterial biofilms - disinfectant methods honored Hildebrandt's doctoral thesis with "summa cum laude". Subsequently, Dr. Hildebrandt from 2010 to 2016 the medical-scientific department in the industry for the development, production and distribution of disinfectants in the field of healthcare, industry and pharmaceuticals. In addition, Dr. Hildebrandt is responsible for regulatory affairs and product registration processes (medical devices, pharmaceuticals, biocides, cosmetics) as well as product specific quality management processes according to EN ISO 9001 and EN ISO 13485.
In 2006, Dipl.-Ing Christian Lösche began working with HygCen Germany on various projects relating to innovative processes for the hygiene of medical devices. Since 2020, as department director, he has been responsible for testing medical devices with a focus on the reprocessing of medical devices and biocompatibility.
Previously, Mr. Lösche held various senior positions in development and validation as well as a consultant for quality management (EN ISO 13485) and regulatory affairs (Medical Devices Directive 93/42 EEC / Medical Devices Regulation (EU) 2017/745) for manufacturers and processors of medical devices.
After training in mechanical engineering, he studied biomedical engineering at the Technical University of Berlin. A particular interest was in innovative processes and methods relating to hygiene and medicine. He worked on the foundations for medical device identification systems (now known as UDI) as well as on various research projects on plasma decontamination and plasma medicine. Today he supports R&D projects at HygCen Germany on the topics of sustainability in the laboratory and the virucidal effectiveness of physical plasmas.
Dr. rer. nat. Oliver Riebe received his PhD in 2009 in the Department of Microbiology of the Institute of Biosciences at the University of Rostock with the distinction "summa cum laude".
The focus of the thesis was the investigation of defense mechanisms of anaerobic microorganisms against radical oxygen species.
This was followed by 3 years of research in collaboration with national and international scientists on the topic of genetic modification of surface proteins for use in nanosensors.
Since 2013, Dr. O. Riebe has been employed at the accredited testing laboratory Hygcen Germany GmbH, where he took over the division management for the area of reprocessing medical devices in 2014.
The focus of the testing area is the validation of manual and mechanical reprocessing procedures for medical devices in accordance with the requirements of EN ISO 17664 and American and international standards.
Dr. Riebe has many years of experience in the validation of reprocessing instructions according to EN ISO 17664 and FDA guidelines, for example, for dental instruments, endoscopes, dialysis units, heater-cooler units (hypothermia devices), probes, sensors, catheters, etc.
Dr. Riebe is also a medical device consultant in accordance with Section 31 of the Medical Devices Act and Medical Device Law Implementation Act §83 (TÜV SÜD Academy) and participates in various standardization committees in the field of medical devices.
He is a member of the Method Development Working Group (Method Group 2.0) for the Guideline for the Validation of Manual Cleaning and Manual Chemical Disinfection Processes for the Reprocessing of Thermolabile Endoscopes and a member of NA 063 DIN-Normenausschuss Medizin (NAMed) NA 063-04-10 AA Working Committee Sterilization and Reprocessing of Medical Devices. He is also a member of the AG-RMT of the DGKH and participated in this working group in the development of methods for comparative detergent testing.
On ISO level, Dr. Riebe is one of the German experts of ISO/TC 330 "Surfaces with biocidal and antimicrobial properties" and is also involved in CEN/TC 204 for the revision of EN 556-1 in the field of sterilization of medical devices.
Dr. Riebe's work has been published in various journals at national and international level.
Since July 2023, Dr. Riebe holds the position of Vice Department Director for Medical Devices.
How we check your medical devices and manufacturer information
Request a Quote: Register by Phone or Online Form. Please indicate which medical devices, disinfectants or manufacturer information you would like to have tested. According to which standards and specifications should we check? Then we discuss the procedure and costs of the test procedure. You will learn how long the test series lasts and when you will receive the test report.
Send product to HygCen: If you accept our offer, please send us your medical device or similar. to the testing laboratory.
Prepare exams: If your medical device or disinfectant meets us as agreed, we will initiate the exams directly. We test it in original condition. That is, as your product is used in practice.
Performing the standard tests: We test in accordance with all common EN ISO standard series and other specific specifications, e.g. certain list standards.
You will receive a test report incl. evaluation from us. Our scientific head assigns the results of the test report to you in this assessment.