Our company provides internationally approved and accredited testing, inspection and inspection services to the following standards.
TS EN ISO 10993-17 Biological evaluation of medical devices - part 17: Determination of acceptable limits for permeable substances
TS EN ISO 10993-2 Biological evaluation of medical devices - Part 2: Animal health characteristics
ISO EN ISO 10993-7 / AC Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residues - Technical correction 1 (ISO 10993-7: 2008 / Correction 1: 2009)
TS EN ISO 10993-18 Biological evaluation of medical devices - Part 18: Chemical properties of materials
TS EN ISO 10993-17 Biological evaluation of medical devices - Part 17: Determination of permissible limits for permeable substances
TS EN ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residues (ISO 10993-7: 2008)
TS EN ISO 10993-4 Biological evaluation of medical devices - Part 4: Selection of blood interaction experiments
TS EN ISO 10993-5 Biological evaluation of medical devices - Part 5: In vitro cytotoxicity assays
TS EN ISO 10993-11 Biological evaluation of medical devices - Part 11: Systemic toxicity tests
TS EN ISO 10993-13 Biological evaluation of medical devices - Part 13: Identification and quantification of decomposition products of medical devices made of polymer
TS EN ISO 10993-10Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10: 2010)
ISO EN ISO 10993-1 / AC Biological evaluation of medical devices - Part 1: Assessment and testing in a risk management process - Technical Correction 1 (ISO 10993-1: 2009 / Correction 1: 2010)
TS EN ISO 7405 Biological test methods for materials used in dentistry-dentistry
TS EN ISO 10993-1 Biological assessment of medical devices - Part 1: Assessment and testing in a risk management process (ISO 10993-1: 2009)
TS EN ISO 14155 Clinical research of medical devices for humans - Good clinical practice (ISO 14155: 2011)
TS EN ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Assessment and testing in a risk management process (ISO 10993-1: 2009)
10993-1 / AC: Biological evaluation of medical devices - Part 2010: Evaluation and testing
TS EN ISO 10993-13 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymetric medical devices
TS EN ISO 10993-16 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for decomposition products and extractable products
TS EN ISO 10993-12 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
TS EN ISO 10993-12 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12: 2012)
TS EN ISO 10993-4 Biological evaluation of medical devices - Part 4: Selection of blood interaction experiments (including ISO 10993-4: 2002, A1: 2006)
TS EN ISO 10993-2 Biological evaluation of medical devices - Part 2: Requirements for animal welfare (ISO 10993-2: 2006)
TS EN ISO 7405 / A1 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry - Annex 1: Positive control material
TS EN ISO 10993-10 Biological evaluation of medical devices - Part 10: Irritation and delayed type hypersensitivity tests
TS EN ISO 10993-3 Biological assessment of medical devices - Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity
TS EN ISO 10993-9 Biological evaluation of medical devices - Part 9: Preliminary study to identify and quantify potential degradation products
TS EN ISO 10993-6 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
TS EN ISO 10993-5 Biological evaluation of medical devices - part 5: Extracorporeal cytotoxicity assays
TS EN ISO 10993-7 Biological assessment of medical devices - Part 7: Sterilization residues with ethylene oxide
TS EN ISO 10993-7 / AC Biological evaluation of medical devices - Part 7: Sterilization residues with ethylene oxide
TS EN ISO 10993-11 Biological evaluation of medical devices - part 11: Systemic toxicity tests
TS EN ISO 10993-14 Biological evaluation of medical devices - Part 14: Identification and quantification of decomposition products from ceramics
TS EN ISO 10993-15 Biological evaluation of medical devices - Part 15: Identification and quantification of decomposition products from metals and their alloys
TS EN ISO 10993-16 Biological evaluation of medical materials - Part 16: Design of toxicokinetic studies for decomposition products and extractable products
TS EN ISO 10993-18 Biological evaluation of medical devices - part 18: Determination of chemical properties of materials
tst EN ISO 14155 / AC Clinical research of medical devices for humans -
TS EN ISO 20776-2 Clinical laboratory testing and diagnostic test systems used outside the body - Sensitivity testing of infectious agents and evaluation of the performance of antimicrobial susceptibility testers - Part 2: Evaluation of performance of antimicrobial susceptibility testers