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

  1. Microbiological tests of sterility of medical devices. EN ISO 11737-1: 2018, Part 1: Determination of the population of microorganisms in products.
  2. Microbiological tests of sterility of medical devices. EN ISO 11737-2: 2020, Part 2: Sterility tests carried out for the definition, validation and maintenance of a sterilization process.
  3. In vitro Cytotoxicity tests. EN ISO 10993-5: 2009. Biological Evaluation of Medical Devices, part 5: In vitro cytotoxicity tests.
  4. Citotoxicity test in dentistry. ISO 7405: 2018 - Evaluation of biocompatibility of medical devices used in dentistry.
  5. Acute Dermal Irritation test (Draize Skin test). EN-ISO 10993-23: 2021 - Biological Evaluation of Medical Devices. Part 23: Irritation tests.
  6. Acute intracutaneous irritation test (Draize Skin test). ISO 10993-23: 2021 - Biological Evaluation of Medical Devices. Part 23: Irritation tests.
  7. Acute skin Irritation-corrosion test. OECD 404: 2015.
  8. In vitro Skin irritation test: Reconstructed Human Epidermis Test Method -RhE-. OECD 439: 2010.
  9. Corrosive activity test of products in human skin model in vitro. OECD 431: 2004 - Test method skin corrosion in vitro Reconstructed Human Epidermis -RhE-.
  10. HET-CAM test (Hen´s Egg Test chorioallantoic membrane test) - Mucosal irritation test with chicken egg chorioallantoic membrane.
  11. Ocular Irritation test. EN 10993-23: 2021 - Biological evaluation of medical devices - Part 23: Tests for irritation. Annex D.2-Ocular Irritation test.
  12. In vivo Eye Irritation / Serius Eye Damage Test (OECD 405: 2021 guideline).
  13. Oral mucosa irritation test. EN ISO 10993-23: 2021 - Biological Evaluation of Medical Devices. Irritation tests.
  14. Rectal mucosa irritation test. EN ISO 10993-23: 2021 - Biological Evaluation of Medical Devices - Irritation tests.
  15. Vaginal Irritation Test (UNE-EN ISO 10993-23: 2021. Biological evaluation of medical devices - Part 23: Tests for irritation; Anexo D6. Vaginal irritation test).
  16. Penile mucosa irritation Test. ISO 10993-23: 2021. Biological evaluation of medical devices. Part 23 - Tests for irritation. Annex D.4. Penile Irritation Test.
  17. Quantitative detection of endotoxin test. European Pharmacopoeia 2.6.14 - Method E - Chromogenic end-point method: LAL (Limulus Amebocyte Lysate) chromogenic Test.
  18. Hemocompatibility tests. EN ISO 10993-4 - Biological Evaluation of Medical Devices-Part 4: Selection of tests for interactions with blood.
  19. Hemocompatibility: Pyrogenicity induced by materials - Pyrogens test. EN ISO 10993-11: 2018 - Biological Evaluation of Medical Devices and European Pharmacopoeia, 2.6.8. Pyrogens.
  20. Hemocompatibility: Hemolysis test. EN 10993-4: 2018 - Biological Evaluation of Medical Devices: Selection of tests for interactions with blood; ASTM F 756-93 method.
  21. Hemocompatibility: Activation of the complement system test. EN ISO 10993-4: 2018 and ASTM F1984-99. Testing the Whole Complement Activation in Serum by Solid Material.
  22. Hemocompatibility: Thrombogenicity - Platelets and leukocytes count test. ASTM F2888-13: 2013 Method. Biological Evaluation of Medical Devices.
  23. Hemocompatibility: Thrombogenicity - Partial thromboplastin time (PTT) test. ASTM F2382-04: 2010 - Method for Assesment of Intravascular Medical Device materials on Partial Thromboplastin time (PTT).
  24. Patch Test
  25. Skin sensitization test (GPMT:Guinea pig maximization test of Magnusson and Kligman). EN ISO 10993-10: 2021 - Biological Evaluation of Medical Devices: Tests for skin sensitization.
  26. In vitro skin hypersensivity test. h-CLAT method (Human Cell-Line Activation Test). OECD 442E: 2017.
  27. Acute systemic toxicity test (EN ISO 10993-11: 2018. Biological Evaluation of Medical Devices).
  28. Acute dermal systemic toxicity test. EN ISO 10993-11: 2018 - Biological evaluation of medical devices. Systemic toxicity tests.
  29. Acute oral systemic toxicity test. EN ISO 10993-11: 2018 - Biological evaluation of medical devices. Oral toxicity assay.
  30. Acute subcutaneous systemic toxicity test. EN ISO 10993-11: 2018 - Biological evaluation of medical devices. Test for systemic toxicity by subcutaneous exposure.
  31. Acute vaginal systemic toxicity test. EN ISO 10993-11: 2018 - Biological evaluation of medical devices. Acute systemic toxicity by vaginal exposure.
  32. Acute dermal toxicity. OECD 402: 2017; EPA-OPPTS 870.1200: 1998.
  33. Repeated Dose Dermal Toxicity 21/28 day study. OECD 410: 1981.s
  34. 90-Days Dermal Toxicity. EPA-OPPTS 870-3250: 1998.
  35. Acute oral toxicity test. OECD 423: 2001; EPA OPPTS 870.1100: 2002; Directive 92/69/EEC July 31, 1992, Paragraph B.1.
  36. Repeated dose 28 days oral toxicity study in rodents. OECD 407: 2008.
  37. Repeated dose 90-days oral toxicity study in rodents. OECD 408: 2018.
  38. Acute oral toxicity test: Up and down procedure-UPD-. OECD 425: 2022.
  39. Chronic toxicity tests. OECD 452: 2018 - Chronic Toxicity Studies..
  40. Abnormal toxicity test.. European Phamacopoeia 6.0: 2008, 2.6.9 - Methods of Analysis. Abnormal toxicity.
  41. Systemic toxicity tests of medical devices with repeated exposure (subacute, subchronic and chronic systemic toxicity). EN ISO 10993-11: 2018.
  42. Local effects after subcutaneous implantation test. EN ISO 10993-6: 2017.
  43. Phototoxicity test with 3T3 cells and reading of results with Neutral Red uptake. OECD 432: 2019 - In vitro 3T3 NRU phototoxicity test.
  44. Genotoxicity: In vitro Bacterial Reverse Mutations Test. ISO 10993-3: 2014 - Biological evaluation of medical devices, Part 3. Test for Genotoxicity, and OECD 471: 1997 - Bacterial Reverse Mutation Test.
  45. Genotoxicity: In vitro mammalian cell gene mutation test using the Hprt and xprt gene. ISO 10993-3: 2014 - Part 3, Test for Genotoxicity, Carcinogenicity and Reproductive Toxicity and OECD 476: 2016.
  46. Acute pulmonary toxicity / pathogenicity test for the evaluation of MPCA (Microbial Pest Control Agents). EPA-OPPTS 885.3150: 1996 - Acute pulmonary toxicity, pathogenicity evaluation.
  47. Acute oral toxicity/pathogenicity for the evaluation of MPCA (Microbial Pest Control Agents) products. EPA-OPPTS 885. 3050: 1996 - Acute Oral Toxicity/Pathogenicity.
  48. Acute Injection Toxicity/Pathogenicity for the assesment of MPCA products (Microbial Pest Control Agents). EPA-OPPTS 885. 3200: 1996.
  49. Stability testing of Pharmaceutical products based on ICH Guide (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use)