Toxicology - Biological evaluation of medical devices; Cosmetics; Biocides; MPCA products (19 accredited tests)
- Microbiological tests of sterility of medical devices. EN ISO 11737-1: 2018, Part 1: Determination of the population of microorganisms in products.
- 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.
- In vitro Cytotoxicity tests. EN ISO 10993-5: 2009. Biological Evaluation of Medical Devices, part 5: In vitro cytotoxicity tests.
- Citotoxicity test in dentistry. ISO 7405: 2018 - Evaluation of biocompatibility of medical devices used in dentistry.
- Acute Dermal Irritation test (Draize Skin test). EN-ISO 10993-23: 2021 - Biological Evaluation of Medical Devices. Part 23: Irritation tests.
- Acute intracutaneous irritation test (Draize Skin test). ISO 10993-23: 2021 - Biological Evaluation of Medical Devices. Part 23: Irritation tests.
- Acute skin Irritation-corrosion test. OECD 404: 2015.
- In vitro Skin irritation test: Reconstructed Human Epidermis Test Method -RhE-. OECD 439: 2010.
- Corrosive activity test of products in human skin model in vitro. OECD 431: 2004 - Test method skin corrosion in vitro Reconstructed Human Epidermis -RhE-.
- HET-CAM test (Hen´s Egg Test chorioallantoic membrane test) - Mucosal irritation test with chicken egg chorioallantoic membrane.
- Ocular Irritation test. EN 10993-23: 2021 - Biological evaluation of medical devices - Part 23: Tests for irritation. Annex D.2-Ocular Irritation test.
- In vivo Eye Irritation / Serius Eye Damage Test (OECD 405: 2021 guideline).
- Oral mucosa irritation test. EN ISO 10993-23: 2021 - Biological Evaluation of Medical Devices. Irritation tests.
- Rectal mucosa irritation test. EN ISO 10993-23: 2021 - Biological Evaluation of Medical Devices - Irritation tests.
- Vaginal Irritation Test (UNE-EN ISO 10993-23: 2021. Biological evaluation of medical devices - Part 23: Tests for irritation; Anexo D6. Vaginal irritation test).
- Penile mucosa irritation Test. ISO 10993-23: 2021. Biological evaluation of medical devices. Part 23 - Tests for irritation. Annex D.4. Penile Irritation Test.
- Quantitative detection of endotoxin test. European Pharmacopoeia 2.6.14 - Method E - Chromogenic end-point method: LAL (Limulus Amebocyte Lysate) chromogenic Test.
- Hemocompatibility tests. EN ISO 10993-4 - Biological Evaluation of Medical Devices-Part 4: Selection of tests for interactions with blood.
- Hemocompatibility: Pyrogenicity induced by materials - Pyrogens test. EN ISO 10993-11: 2018 - Biological Evaluation of Medical Devices and European Pharmacopoeia, 2.6.8. Pyrogens.
- Hemocompatibility: Hemolysis test. EN 10993-4: 2018 - Biological Evaluation of Medical Devices: Selection of tests for interactions with blood; ASTM F 756-93 method.
- 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.
- Hemocompatibility: Thrombogenicity - Platelets and leukocytes count test. ASTM F2888-13: 2013 Method. Biological Evaluation of Medical Devices.
- Hemocompatibility: Thrombogenicity - Partial thromboplastin time (PTT) test. ASTM F2382-04: 2010 - Method for Assesment of Intravascular Medical Device materials on Partial Thromboplastin time (PTT).
- Patch Test
- 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.
- In vitro skin hypersensivity test. h-CLAT method (Human Cell-Line Activation Test). OECD 442E: 2017.
- Acute systemic toxicity test (EN ISO 10993-11: 2018. Biological Evaluation of Medical Devices).
- Acute dermal systemic toxicity test. EN ISO 10993-11: 2018 - Biological evaluation of medical devices. Systemic toxicity tests.
- Acute oral systemic toxicity test. EN ISO 10993-11: 2018 - Biological evaluation of medical devices. Oral toxicity assay.
- Acute subcutaneous systemic toxicity test. EN ISO 10993-11: 2018 - Biological evaluation of medical devices. Test for systemic toxicity by subcutaneous exposure.
- Acute vaginal systemic toxicity test. EN ISO 10993-11: 2018 - Biological evaluation of medical devices. Acute systemic toxicity by vaginal exposure.
- Acute dermal toxicity. OECD 402: 2017; EPA-OPPTS 870.1200: 1998.
- Repeated Dose Dermal Toxicity 21/28 day study. OECD 410: 1981.s
- 90-Days Dermal Toxicity. EPA-OPPTS 870-3250: 1998.
- Acute oral toxicity test. OECD 423: 2001; EPA OPPTS 870.1100: 2002; Directive 92/69/EEC July 31, 1992, Paragraph B.1.
- Repeated dose 28 days oral toxicity study in rodents. OECD 407: 2008.
- Repeated dose 90-days oral toxicity study in rodents. OECD 408: 2018.
- Acute oral toxicity test: Up and down procedure-UPD-. OECD 425: 2022.
- Chronic toxicity tests. OECD 452: 2018 - Chronic Toxicity Studies..
- Abnormal toxicity test.. European Phamacopoeia 6.0: 2008, 2.6.9 - Methods of Analysis. Abnormal toxicity.
- Systemic toxicity tests of medical devices with repeated exposure (subacute, subchronic and chronic systemic toxicity). EN ISO 10993-11: 2018.
- Local effects after subcutaneous implantation test. EN ISO 10993-6: 2017.
- Phototoxicity test with 3T3 cells and reading of results with Neutral Red uptake. OECD 432: 2019 - In vitro 3T3 NRU phototoxicity test.
- 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.
- 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.
- Acute pulmonary toxicity / pathogenicity test for the evaluation of MPCA (Microbial Pest Control Agents). EPA-OPPTS 885.3150: 1996 - Acute pulmonary toxicity, pathogenicity evaluation.
- Acute oral toxicity/pathogenicity for the evaluation of MPCA (Microbial Pest Control Agents) products. EPA-OPPTS 885. 3050: 1996 - Acute Oral Toxicity/Pathogenicity.
- Acute Injection Toxicity/Pathogenicity for the assesment of MPCA products (Microbial Pest Control Agents). EPA-OPPTS 885. 3200: 1996.
- Stability testing of Pharmaceutical products based on ICH Guide (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use)