Toxicology - Biological evaluation of medical devices; Cosmetics; Biocides; MPCA products (19 accredited tests)

  1. ISO 7405-Evaluation of biocompatibility of medical devices used in dentistry. ISO 7405: 2018 Standard.
  2. Stability testing of Pharmaceutical products based on ICH Guide
  3. Toxicology tests - Submission form to order tests of Medical devices or MPCA products.
  4. Toxicology tests - In vitro Cytotoxicity tests. UNE-EN ISO 10993-5: 2009. Biological Evaluation of Medical Devices, part 5: In vitro cytotoxicity tests. Accredited by ENAC.
  5. Toxicology tests - Acute skin irritation test (Draize Test for skin). UNE-EN ISO 10993-10: 2013. Biological Evaluation of Medical Devices, Part 10: Irritation and Skin Sensitization. Accredited by ENAC.
  6. Toxicology tests - Acute Dermal Irritation test (Draize Skin test). UNE-EN-ISO 10993-23: 2021. Biological Evaluation of Medical Devices. Part 23: Irritation tests).
  7. Toxicology tests - Acute skin Irritation / corrosion . OECD 404: 2015; EPA 870.2500 OPPTS: 1998; or Directive 92/69 / EEC of 31 July 1992, section B.4. Accredited by ENAC.
  8. Toxicology tests - Acute Intracutaneous Irritation test. UNE-EN-ISO 10993-10: 2013 . Biological Evaluation of Medical Devices. Part 10: Irritation and sensitization tests. Accredited by ENAC.
  9. Toxicology tests - Acute intracutaneous irritation test. ISO 10993-23: 2021 (Biological Evaluation of Medical Devices. Part 23: Irritation tests).
  10. Toxicology tests - In vitro Skin irritation: Reconstructed Human Epidermis Test Method –RhE- (OECD 439: 2010 standard guideline).
  11. Toxicology tests - Corrosive activity of products in human skin model in vitro. OECD 431: 2004. Test method skin corrosion in vitro Reconstructed Human Epidermis (RhE).
  12. Toxicology tests - Acute Ocular Irritation (Draize for mucosa). UNE-EN ISO 10993-10: 2013; EPA 870.2400 OPPTS: 1998; OECD 405: 2012; Directive 92/69 / EEC of 31 July 1992, section B.4. Accredited by ENAC.
  13. Toxicology tests - Ocular Irritation test. UNE-EN 10993-23: 2021. Biological evaluation of medical devices - Part 23: Tests for irritation. Annex D.2-Ocular Irritation test.
  14. Toxicology tests - Acute Eye Irritation/Corrosion (OECD 405: 2020).
  15. Toxicology tests - HET-CAM test (Hen´s Egg Test chorioallantoic membrane test) - Mucosal irritation test with chicken egg chorioallantoic membrane. Accredited by ENAC; GLPs approved.
  16. Toxicology tests - Vaginal Irritation Test. UNE-EN ISO 10993-23: 2021. Annex D.
  17. Toxicology tests -Oral mucosa irritation test. UNE-EN ISO 10993-10: 2013. Biological Evaluation of Medical Devices. Tests for irritation and sensitization, Annex B.
  18. Toxicology tests - Rectal mucosa irritation test. UNE-EN ISO 10993-10: 2013. Biological Evaluation of Medical Devices -Part 10: Test for irritation and skin sensitization, Annex B.
  19. Toxicology tests - Penile mucosa irritation Test (ISO 10993-23: 2021. Biological evaluation of medical devices - Part 23: Tests for irritation. Annex D.4. Penile Irritation Test).
  20. Toxicology tests - Acute Dermal Toxicity. OECD 402: 2017; EPA OPPTS 870.1200 OPPTS: 1998.
  21. Toxicology tests - Repeated Dose Dermal Toxicity 21/28 day study. OECD 410: 1981.s
  22. Toxicology tests - 90-Day Dermal Toxicity – EPA-OPPTS 870-3250: 1998.
  23. Toxicology tests - Acute oral toxicity. OECD 423: 2001; EPA OPPTS 870.1100: 2002; Directive 92/69/EEC July 31, 1992, Paragraph B.1.
  24. Toxicology tests - Repeated dose 28 days oral toxicity study in rodents - OECD 407: 2008
  25. Toxicology tests - Repeated Dose 90-Days Oral Toxicity Study in Rodents. OECD 408: 2018.
  26. Toxicology tests - Acute Oral Toxicity: Up and down procedure-UPD- (OECD 425: 2008).
  27. Toxicology tests - Acute systemic toxicity test. UNE-EN ISO 10993-11. Biological Evaluation of Medical Devices. Accredited by ENAC.
  28. Toxicology tests - Systemic toxicity tests of medical devices with repeated exposure (subacute, subchronic and chronic systemic toxicity). EN ISO 10993-11: 2018.
  29. Toxicology tests - Acute systemic toxicity test by dermal route (UNE-EN ISO 10993-11: 2018 Standard). Biological evaluation of medical devices. Systemic toxicity tests. Accredited by ENAC
  30. Toxicology tests - Abnormal toxicity. European Phamacopoeia (2.6.9 Abnormal toxicity). Biological Evaluation of Medical Devices.
  31. Toxicology tests - Acute pulmonary toxicity / pathogenicity evaluation of MPCA. Microbial Pest Control Agents. EPA-Microbial Pesticide Test Guideline OPPTS 885.3150: 1996. Accredited by ENAC.
  32. Toxicology tests - Acute oral toxicity/pathogenicity for the evaluation of MPCA (Microbial Pest Control Agents) products. EPA-Microbial Pesticide Test Guideline OPPTS 885. 3050: 1996.
  33. Toxicology tests - Acute Injection Toxicity/Pathogenicity for the assesment of MPCA products (Microbial Pest Control Agents). EPA-Microbial Pesticide Test Guideline OPPTS 885. 3200: 1996.
  34. Toxicology tests - Chronic toxicity tests. OECD 452: 2018.
  35. Toxicology tests - Tests for local effects after implantation. Subcutaneous implantation (UNE-EN ISO 10993-06: 2017).
  36. Toxicology tests - Quantitative detection of endotoxin (European Pharmacopoeia 2.6.14: Method E -Chromogenic end-point method): LAL (Limulus Amebocyte Lysate) chromogenic Test. Biological evaluation of medical devices. Accredited by ENAC.
  37. Toxicology tests - Pyrogenicity induced by materials. UNE-EN ISO 10993-11: 2009-Biological Evaluation of Medical Devices; European Pharmacopoeia, pyrogens 2.6.8. Accredited by ENAC.
  38. Toxicology tests - Hemocompatibility tests. UNE-EN ISO 10993-4: Biological Evaluation of Medical Devices-Part 4: Selection of tests for interactions with blood. Tests Accredited by ENAC.
  39. Toxicology tests - Hemolysis test. UNE-EN 10993-4: 2018. Biological Evaluation of Medical Devices: Selection of tests for interactions with blood. ASTM F 756-93 method. Accredited by ENAC.
  40. Toxicology tests - Hemocompatibility-Activation of the complement system. EN ISO 10993-4: 2018 and ASTM F1984-99. Testing the Whole Complement Activation in Serum by Solid Material. Accredited by ENAC.
  41. Toxicology tests - Hemocompatibility: Thrombogenicity - Platelets and leukocytes count test. ASTM F2888-13: 2013 Method. Biological Evaluation of Medical Devices. Accredited by ENAC.
  42. Toxicology tests - Hemocompatibility: Thrombogenicity - Partial thromboplastin time (PTT) test. ASTM F2382-04: 2010 - Method for Assesment of Intravascular Medical Device materials on Partial Thromboplastin time (PTT). Accredited by ENAC
  43. Toxicology tests-Phototoxicity test with 3T3 cells and reading of results with Neutral Red uptake (OECD 432: 2019. In vitro 3T3 NRU phototoxicity test). Accredited by ENAC.
  44. Toxicology Tests - Patch Test
  45. Toxicology tests - Skin sensitization test (GPMT:Guinea pig maximization test of Magnusson and Kligman). UNE-EN ISO 10993-10: 2013: Biological Evaluation of Medical Devices, Part 10: Tests for irritation and sensitization. Accredited by ENAC
  46. Toxicology tests - In vitro skin hypersensivity test. h-CLAT method (Human Cell-Line Activation Test). OECD 442E: 2017 standard guideline. Accredited by ENAC
  47. Toxicology tests - Genotoxicity: Bacterial Reverse Mutations Test. UNE-EN ISO 10993-3: 2015 - Biological evaluation of medical devices, Part 3. Test for Genotoxicity; OECD 471: 1997 - Bacterial Reverse Mutation Test. Accredited by ENAC.
  48. Toxicology tests - Genotoxicity - ISO 10993-3: 2014. Biological Evaluation of Medical Devices, Part 3: Test for Genotoxicity, Carcinogenicity and Reproductive Toxicity) and OECD 476: 2016 (In vitro mammalian cell gene mutation test using the Hpr