Department of Medical and Dental Devices (WM)

Personnel:

Head of the Department: Jan Maurin Ph.D
phone 022 841-48-69 ex. 440, 022 331-15-60;
Witold Bojar Ph. D - Deputy manager
phone 022 841-36-89 ex. 452;
Małgorzata Bukat - Senior technician
phone 022 841-36-89 ex. 433/250, 022 851-52-44;
Waldemar Jaskulski - Senior technician
phone 022 841-36-89 ex. 453;
Grażyna Lissowska - Senior technician
phone 022 841-36-89 ex. 453

Activities:

Quality control of medical devices:

  • tests on medical devices and pharmaceutical packages according to internal standards and specifications, international standards (EEC 93/42 Directive harmonized standards, ISO, ASTM norms etc.), Polish or European Pharmacopoeias, USP and others.
  •  evaluation of analytical documentation concerning medical and dental devices,
  • verification of Internal Standards.

Quality assurance;

  • Implementation of quality system according to PN-EN ISO/IEC 17025: 2001 standard;
  • tests are performed according to standard operating procedures or specifications,
  • equipment is subjected to legalization, calibration etc.
  • methods used are validated.

Research:

  • elaboration of testing methods for performance characteristics of hypodermic needle and forces required to operate plunger of hypodermic syringes for single use.
  • testing of hygienic tampons absorbency of model fluids.
  • elaboration of routine method for the determination of protein content leachable from medical gloves for single use.
  • study on direct posterior restorative materials. Comparison of compressive strength properties under static and dynamic loading.
  • estimation of stress contribution in tooth cavity restored with class II filling.
  • estimation of the corrosion behavior of chosen metallic implants.
  • study on elasticity modulus of restorative composite resins.
  • evaluation of chosen test methods of medical devices hemolytic activity.
  • evaluation of proteins leachable  form medical devices containing natural rubber latex.

Cooperation:

  • Dental School of Warsaw Medical University.
  • Polish Pharmacopoeia Commission.
  • Polish Committee for Standardization - Technical Committee nr 247 for Medical Materials and Biomaterials

Services:

  • evaluation and expertise of medical devices, chosen raw materials and hygienic products
  • evaluation and testing of pharmaceutical packages (issuing the Quality Certificate, if desired)
  • physico-mechanical tests of medical devices: dental materials, dressings, suture materials, condoms, medical gloves, needles, catheters according to national or international standards

Equipment:

  • universal strength testing machine for static tests, Instron 1185
  • spectrophotometer UV-VIS device- Shimadzu;
  • incubators, driers, muffle oven with data logger, jolt-moulding machine, heating baths, thermostats, pH-meters, centrifuges, peristaltic pump, electronic weights, light microscopes. 

Main publications since 2000:

  • Bojar W, Kobyłecki W, Tyski S, Zaręba T. Comparison of antibacterial properties of chosen restorative materials.
    Nowa Stomatologia, 2000, V, 12, 1-2, 13-6
  • Bojar W, Chladek W, Karczewicz A, Kobyłecki W.  Young's modulus and compressive strength of chosen posterior restoratives. Comparison and model analysis.
    Annales Academia Medicae Silesiensis. Supl.31, Katowice 2000, 34-9
  • Bojar W, Kobyłecki W, Jóźwiak S, Komorek Z. Posterior restoratives. Comparison of compressive strength under static and dynamic loading.
    Nowa Stomatologia, 2001, VI, 16, 2, 8-10
  • Bojar W, Kobyłecki W, Zaręba T. Bactericidal activity of endodontic sealers. An in vitro evaluation.
    Czas. Stomat., 2002, LV, 11, 695-9
  • Bojar W, Koronkiewicz M, Skierski J. Evaluation of cytotoxicity potential of root canal filling materials by flow cytometry. Czas. Stomat., 2005, 12, 1, 13-7
  • Bojar W, Koziożemska B, Szwojnicka D. Influence of ozone on compressive strength of direct r estorative materials. Czas. Stomat., 2005, 12, 2, 15-9