Toxicology - Biological evaluation of medical devices; Cosmetics; Biocides; MPCA products (19 accredited tests)
- Sterilization of health care products. Microbiological methods. Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018/Amd 1:2021).
- 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).
- Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing (ISO 11737-3: 2023).
- Microbiological examination of non-sterile products. Screening tests and microbiological counts (Eur Pharmacopoeia 11, chapters 2.6.12 and 2.6.13.).
- Tests for impermeability against microorganisms on plastics for intravenous injections (ISO 15747: 2018).
- Stability testing of Pharmaceutical products based on ICH Guide (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use)
- In vitro Cytotoxicity tests with medical devices, cosmetics and disinfectants (ISO 10993-5: 2009).
- Citotoxicity test in dentistry (ISO 7405: 2018) - Evaluation of biocompatibility of medical devices used in dentistry.
- Acute Dermal Irritation test (Draize Skin test) with medical devices (ISO 10993-23: 2021).
- Acute intracutaneous irritation test with medical devices (ISO 10993-23: 2021).
- Acute skin Irritation-corrosion test. OECD 404: 2015.
- HET-CAM test (Hen´s Egg Test chorioallantoic membrane test) - Mucosal irritation test with chicken egg chorioallantoic membrane.
- Ocular Irritation test with medical devices (EN 10993-23: 2021).
- In vivo Eye Irritation / Serius Eye Damage Test (OECD 405: 2023).
- Oral mucosa irritation test with medical devices (ISO 10993-23: 2021).
- Rectal mucosa irritation test with medical devices (ISO 10993-23: 2021).
- Vaginal Irritation test with medical devices (ISO 10993-23: 2021).
- Penile mucosa irritation Test with medical devices (ISO 10993-23: 2021).
- Quantitative detection of endotoxin test. European Pharmacopoeia 2.6.14 - Method E - Chromogenic end-point method: LAL (Limulus Amebocyte Lysate) chromogenic Test.
- 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.
- Hemocompatibility tests (ISO 10993-4: 2017) - Biological Evaluation of Medical Devices-Part 4: Selection of tests for interactions with blood.
- Hemocompatibility: Pyrogenicity induced by materials - Pyrogens test with medical devices (ISO 10993-11: 2017 and European Pharmacopoeia, 2.6.8. Pyrogens).
- Hemocompatibility: Hemolysis test with medical devices (ISO 10993-4: 2017 and ASTM F756-17 method).
- Hemocompatibility: Activation of the complement system test (ISO 10993-4: 2017 and ASTM F1984-99 (2018). Testing for Whole Complement Activation in Serum by Solid Materials).
- Hemocompatibility: Thrombogenicity - Platelets and leukocytes count test (ISO 10993-4: 2017, and ASTM F2888-19. Platelet and Leucocyte count method).
- 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).
- Patch Test
- 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).
- 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).
- Phototoxicity test with 3T3 cells and reading of results with Neutral Red uptake (Internal method based on OECD 432: 2019).
- Genotoxicity - In vitro Bacterial Reverse Mutations Test with medical devices, cosmetics and disinfectants (ISO 10993-3: 2014 and OECD 471: 2020).
- 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).
- Acute systemic toxicity test with medical devices (ISO 10993-11: 2017).
- Acute dermal systemic toxicity test with medical devices (ISO 10993-11: 2017).
- Acute oral systemic toxicity test with medical devices (ISO 10993-11: 2017).
- Acute subcutaneous systemic toxicity test with medical devices (ISO 10993-11: 2017).
- Acute vaginal systemic toxicity test with medical devices (ISO 10993-11: 2017).
- Acute dermal toxicity. OECD 402: 2017; EPA-OPPTS 870.1200: 1998.
- Repeated Dose Dermal Toxicity 21/28 day study (OECD 410: 1981).
- 90-Days Dermal Toxicity. EPA-OPPTS 870-3250: 1998.
- Acute oral toxicity test (OECD 423: 2001); (EPA -Environmental Protection Agency); (OPPTS 870.1100: 2002 - Office of prevention, Pesticides and Toxic Substances, USA).
- Acute Oral Toxicity test – Fixed Dose Procedure (OECD 420: 2001).
- 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).
- Subacute systemic toxicity test by oral route (ISO 10993-11: 2017).
- Subacute systemic toxicity test by topical/dermal route with medical devices (ISO 10993-11: 2017).
- Subacute systemic toxicity test by intravenous route with medical devices (ISO 10993-11: 2017).
- Subacute systemic toxicity test for vaginal applied products with medical devices (ISO 10993-11: 2017).
- Chronic toxicity tests (OECD 452: 2018).
- Systemic toxicity tests of medical devices with repeated exposure (subacute, subchronic and chronic systemic toxicity) (ISO 10993-11: 2017).
- Local effects after subcutaneous implantation test with medical devices (ISO 10993-6: 2016).
- Test for Chronic systemic toxicity (ISO 10993-11: 2017) and Tests for local effects after subcutaneous implantation (ISO 10993-06: 2016).
- Acute pulmonary toxicity / pathogenicity test for the evaluation of MPCA (Microbial Pest Control Agents) (Internal Procedure based on EPA-OPPTS 885.3150: 1996).
- Acute oral toxicity/pathogenicity for the evaluation of MPCA (Microbial Pest Control Agents) products (EPA-OPPTS 885. 3050: 1996).
- Acute Injection Toxicity/Pathogenicity for the assesment of MPCA products (Microbial Pest Control Agents) (EPA-OPPTS 885. 3200: 1996).