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

  1. Sterilization of health care products. Microbiological methods. Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018/Amd 1:2021).
  2. Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2: 2019).
  3. Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing (ISO 11737-3: 2023).
  4. Microbiological examination of non-sterile products. Screening tests and microbiological counts (Eur Pharmacopoeia 11, chapters 2.6.12 and 2.6.13.).
  5. Tests for impermeability against microorganisms on plastics for intravenous injections (ISO 15747: 2018).
  6. Stability testing of Pharmaceutical products based on ICH Guide (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use)
  7. In vitro Cytotoxicity tests with medical devices, cosmetics and disinfectants (ISO 10993-5: 2009).
  8. Citotoxicity test in dentistry (ISO 7405: 2018) - Evaluation of biocompatibility of medical devices used in dentistry.
  9. Acute Dermal Irritation test (Draize Skin test) with medical devices (ISO 10993-23: 2021).
  10. Acute intracutaneous irritation test with medical devices (ISO 10993-23: 2021).
  11. Acute skin Irritation-corrosion test. OECD 404: 2015.
  12. HET-CAM test (Hen´s Egg Test chorioallantoic membrane test) - Mucosal irritation test with chicken egg chorioallantoic membrane.
  13. Ocular Irritation test with medical devices (EN 10993-23: 2021).
  14. In vivo Eye Irritation / Serius Eye Damage Test (OECD 405: 2023).
  15. Oral mucosa irritation test with medical devices (ISO 10993-23: 2021).
  16. Rectal mucosa irritation test with medical devices (ISO 10993-23: 2021).
  17. Vaginal Irritation test with medical devices (ISO 10993-23: 2021).
  18. Penile mucosa irritation Test with medical devices (ISO 10993-23: 2021).
  19. Quantitative detection of endotoxin test. European Pharmacopoeia 2.6.14 - Method E - Chromogenic end-point method: LAL (Limulus Amebocyte Lysate) chromogenic Test.
  20. Endotoxins in medical gloves for single use (EN 455-3: 2023). Quantitative Endotoxin test (European Pharmacopoeia 2.6.14: Method E – Chromogenic end-point method): LAL (Limulus Amebocyte Lysate). Chromogenic test.
  21. Hemocompatibility tests (ISO 10993-4: 2017 + Amd1: 2025) - Biological Evaluation of Medical Devices-Part 4: Selection of tests for interactions with blood.
  22. Hemocompatibility: Pyrogenicity induced by materials - Pyrogens test with medical devices (ISO 10993-11: 2017 and European Pharmacopoeia, 2.6.8. Pyrogens).
  23. Hemocompatibility: Hemolysis test with medical devices (ISO 10993-4: 2017 + Amd1: 2025 and ASTM F756-17 method).
  24. Hemocompatibility: Activation of the complement system test (ISO 10993-4: 2017 + Amd1 : 2025 and ASTM F1984-99 (2018). Testing for Whole Complement Activation in Serum by Solid Materials).
  25. Hemocompatibility: Thrombogenicity - Platelets and leukocytes count test (ISO 10993-4: 2017 + Amd1: 2025, and ASTM F2888-19. Platelet and Leucocyte count method).
  26. Hemocompatibility: Thrombogenicity with medical devices - Partial thromboplastin time test (PTT) (ASTM F2382-24. Standard Test Method for Assesment of Intravascular Medical Device materials on Partial Thromboplastin time).
  27. Patch Test
  28. Skin sensitization test with medical devices (GPMT: Guinea pig maximization test of Magnusson and Kligman) (ISO 10993-10: 2021. Biological Evaluation of Medical Devices: Tests for skin sensitization).
  29. In vitro Human Cutaneous Hypersensitivity test with medical devices, cosmetics and disinfectants (h-CLAT: Human Cell-Line Activation Test) (Internal method based on OECD 442E: 2024).
  30. Phototoxicity test with 3T3 cells and reading of results with Neutral Red uptake (Internal method based on OECD 432: 2019).
  31. Genotoxicity - In vitro Bacterial Reverse Mutations Test with medical devices, cosmetics and disinfectants (ISO 10993-3: 2014 and OECD 471: 2020).
  32. Genotoxicity - In vitro mammalian cell gene mutation test using the Hprt and xprt genes with medical devices, cosmetics and disinfectants (ISO 10993-3: 2014 and OECD 476: 2016).
  33. Acute systemic toxicity test with medical devices (ISO 10993-11: 2017).
  34. Acute dermal systemic toxicity test with medical devices (ISO 10993-11: 2017).
  35. Acute oral systemic toxicity test with medical devices (ISO 10993-11: 2017).
  36. Acute subcutaneous systemic toxicity test with medical devices (ISO 10993-11: 2017).
  37. Acute vaginal systemic toxicity test with medical devices (ISO 10993-11: 2017).
  38. Acute dermal toxicity. OECD 402: 2017; EPA-OPPTS 870.1200: 1998.
  39. Repeated Dose Dermal Toxicity 21/28 day study (OECD 410: 1981).
  40. 90-Days Dermal Toxicity. EPA-OPPTS 870-3250: 1998.
  41. Acute oral toxicity test (OECD 423: 2001); (EPA -Environmental Protection Agency); (OPPTS 870.1100: 2002 - Office of prevention, Pesticides and Toxic Substances, USA).
  42. Acute Oral Toxicity test – Fixed Dose Procedure (OECD 420: 2001).
  43. Repeated dose 28 days oral toxicity study in rodents (OECD 407: 2008).
  44. Repeated dose 90-days oral toxicity study in rodents (OECD 408: 2018).
  45. Acute oral toxicity test: Up and down procedure -UPD- (OECD 425: 2022).
  46. Subacute systemic toxicity test by oral route (ISO 10993-11: 2017).
  47. Subacute systemic toxicity test by topical/dermal route with medical devices (ISO 10993-11: 2017).
  48. Subacute systemic toxicity test by intravenous route with medical devices (ISO 10993-11: 2017).
  49. Subacute systemic toxicity test for vaginal applied products with medical devices (ISO 10993-11: 2017).
  50. Chronic toxicity tests (OECD 452: 2018).
  51. Systemic toxicity tests of medical devices with repeated exposure (subacute, subchronic and chronic systemic toxicity) (ISO 10993-11: 2017).
  52. Local effects after subcutaneous implantation test with medical devices (ISO 10993-6: 2016).
  53. Test for Chronic systemic toxicity (ISO 10993-11: 2017) and Tests for local effects after subcutaneous implantation (ISO 10993-06: 2016).
  54. Acute pulmonary toxicity / pathogenicity test for the evaluation of MPCA (Microbial Pest Control Agents) (Internal Procedure based on EPA-OPPTS 885.3150: 1996).
  55. Acute oral toxicity/pathogenicity for the evaluation of MPCA (Microbial Pest Control Agents) products (EPA-OPPTS 885. 3050: 1996).
  56. Acute Injection Toxicity/Pathogenicity for the assesment of MPCA products (Microbial Pest Control Agents) (EPA-OPPTS 885. 3200: 1996).