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Logo HygCen
Proband testet Desinfektionsmittel in Petrischalen

Accredited Test Laboratory

Quality assurance testing for medical devices and biocides

Expert laboratory staff
Tests according to (inter-)national standards & guidelines
All tests animal-free

Services provided by HygCen

HygCen tests and ensures the quality of your medical devices, disinfectants and similar products. As an accredited and recognized 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.

Accreditations from HygCen

HygCen Germany GmbH is an accredited and recognized testing laboratory. This is certified by several independent bodies for the testing of medical devices. This means that we test according to the guidelines in accordance with 93/42 / EEC, 90/385 / EEC and EN ISO / IEC 17025. Our main references are the German Accreditation Body (DAkkS) and the Central Office of the Federal States for Health Protection of Medicinal Products and Medical Devices (ZLG).

We test medical devices for medical device manufacturers according to European (EN) and international (ISO) standards. The accredited quality assurance test include:

Accreditation certificates & accreditation lists according to DAkkS / ZLG

Competence according to guidelines 93/42 / EWG, 90/385 / EWG and EN ISO / IEC 17025

Accreditation by the DAkkS according to EN ISO / IEC 17025, D-PL-18818-02

Recognition according to § 15 (5) German medical devices act (MPG) by the ZLG, ZLG-AP-314.10.23


Insights into our testing laboratory


Our managing and department directors

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 for microbiological test methods. 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.

Als 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.

In 1996, Professor Heinz-Peter Werner founded the HygCen testing laboratory, the Center for Hygiene and Medical Device Safety, as the center for the implementation of European quality parameters with a focus on medical devices. With the foundation, Werner intended to extend his scientific background and experience in public health to all areas of the health care system.

Prof. Dr. Werner studied medicine at the University of Vienna. His specialist training completed Dr. med. Werner at the Hygiene Institute of the University of Vienna in microbiological and serological routine diagnostics and in the vaccination center. From 1970 to 1973 he headed the Laboratory for Hospital Hygiene in Vienna. In 1973 he moved to the Hygiene Institute of Johannes Gutenberg University Mainz as a department head with a focus on hospital hygiene and hospital planning in the state of Rhineland-Palatinate. In 1977 he acquired the venia legendi for hygiene. In January 1980 he was appointed professor for life at the Hygiene Institute of Johannes Gutenberg University Mainz. Prof. Dr. Werner took over overall responsibility for hospital hygiene in the university clinics and was appointed managing director of the Hygiene Institute (1989-1992). At the same time, Werner headed the MTLA school. In 1988 he obtained a diploma in tropical medicine followed by extensive preparatory work for the establishment of an outstation in Rwanda. In the period from 1992 to 1996 he worked as a director at the federal hygiene institute of the state of Mecklenburg-Vorpommern. His work focused on rebuilding work for the entire public health service after the reunification in 1989. He was responsible for the draft of the Land Health Regulation for the state of Mecklenburg-Vorpommern.

 

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.

 

Ms. Monika Feltgen heads the medical devices department for HygCen Germany GmbH. She is a nurse and hygiene specialist. After her advanced technical college entrance qualification for social education she graduated in 1985 training as a nurse. In 1989 she completed training as a hygiene specialist. During her training she worked in the Ferdinand-Sauerbruch hospital Wuppertal as well as in the general hospital of the city of Hagen.

In 1994 she moved to the federal state hygiene institute Mecklenburg-Vorpommern. 1996 to 1997 she was quality officer of the medical service of health insurance for the state of Mecklenburg-Western Pomerania, in addition she was from 1997 to 2000 Senior Instructor for qualification measures under § 80 SGB XI at the Social Academy Güstrow. From 1997 to 1999, she was an external employee of HygCen Germany GmbH - in 1998 and 1999 she also acquired additional knowledge through additional training as a medical device consultant and as an internal auditor. In 1999, she trained in risk management.

 


How we check your medical devices and manufacturer information

  1. 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.

  2. Send product to HygCen: If you accept our offer, please send us your medical device or similar. to the testing laboratory.

  3. 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.

  4. Performing the standard tests: We test in accordance with all common EN ISO standard series and other specific specifications, e.g. certain list standards.

  5. 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.

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, e.g. about child care grants. 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. And when can we welcome you to the HygCen team?

 

  • Family-friendly corporate culture

    Enjoy regular working hours without weekend or shift work. You still remain flexible - e.g. for important errands in the city.
  • Self-determined work

    Your opinion counts. Thanks to flat hierarchies, we make decisions transparent and work at eye level.
  • High living and quality of life

    Schwerin is a modern and lively city. Here you will find well-developed child care structures, cheap old town apartments and, for example, a (large) water sports offer.
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HygCen Germany GmbH
Bornhövedstrasse 78
19055 Schwerin

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