Tests for genotoxicity of medical devices

 

DEPARTMENT OF BIOCHEMISTRY AND BIOPHARMACEUTICALS ENSURES THE QUALITY, TIMELINESS AND RELIABILITY OF THE ASSESSMENT OF CYTO- AND GENOTOXICITY OF MEDICAL DEVICES.

accreditation

[Request for analysis]

TESTS FOR CYTOTOXICITY OF MEDICAL DEVICES

Laboratory performs the biological evaluation of medical devices according to EN ISO 10993 in vitro.

 

TESTS FOR CYTOTOXICITY IN VITRO (PCA ACCREDITATION ?AB774, EDQM/MJA-078):

  1. test on extracts PN-EN ISO 10993-5, PN-EN ISO 10993-12;
  2. by direct contact PN-EN ISO 10993-5, PN-EN ISO 10993-12;
  3. agar diffusion PN-EN ISO 10993-5, PN-EN ISO 10993-12;
  4. filter diffusion PN-EN ISO 10993-5, PN-EN ISO 10993-12.

 

TESTS FOR GENOTOXICITY OF MEDICAL DEVICES

TESTS FOR GENOTOXICITY IN VITRO:

  1. AMES test (PCA ACCREDITATION ?AB774, EDQM/MJA-078);

Guidelines: PN-EN ISO 10993-3;
PN-EN ISO 10993-12;
OECD 471.

  1. Micronucleus test (during the application for accreditation);

Guidelines: PN-EN ISO 10993-3;
PN-EN ISO 10993-12;
OECD TG 487.