Our company provides internationally approved and accredited testing, inspection and inspection services to the following standards.
TS EN 13612 Medical diagnostic equipment for extracorporeal use - Performance evaluation
TS EN 13612 / AC Performance evaluation of extracorporeal medical diagnostic devices
TS EN ISO 18113-5 Extracorporeal medical diagnostic equipment - Information provided by the manufacturer (labeling) - Part 5: Intra-body diagnostic measuring instruments for self-testing (ISO 18113-5: 2009)
TS EN ISO 18113-4 Extracorporeal medical diagnostic devices - Information provided by the manufacturer (labeling) - Part 4: Extra-body diagnostic reagents for self-testing (ISO 18113-4: 2009)
TS EN ISO 18113-3 Extracorporeal medical diagnostic equipment - Information provided by the manufacturer (labeling) - Part 3: Extra-body diagnostic measuring instruments for professional use (ISO 18113-3: 2009)
TS EN ISO 18113-2Optomatic medical diagnostic devices - Information provided by the manufacturer (labeling) - Part 2: Extra-body diagnostic reagents for professional use (ISO 18113-2: 2009)
TS EN ISO 18113-1 Extracorporeal medical diagnostic equipment - Information provided by the manufacturer (labeling) - Part 1: Terms, descriptions and general requirements (ISO 18113-1: 2009)
TS EN ISO 18113-1 Extracorporeal medical diagnostic equipment - Information provided by the manufacturer (labeling) - Section 1: Terms, descriptions and general specifications
TS EN ISO 18113-2 Extracorporeal medical diagnostic devices - Information provided by the manufacturer (labeling) - Section 2: Extracorporeal diagnostic reagents for professional use
TS EN ISO 18113-3 Extracorporeal medical diagnostic equipment - Information provided by the manufacturer (labeling) - Section 3: Extracorporeal diagnostic equipment for professional use
TS EN ISO 18113-4 Extracorporeal medical diagnostic devices - Information provided by the manufacturer (labeling) - Section 4: Self-testing extracorporeal diagnostic reagents
TS EN ISO 18113-5 Extracorporeal medical diagnostic equipment - Information provided by the manufacturer (labeling) - Section 5: Self-testing extracorporeal diagnostic equipment
TS EN ISO 16256 Clinical, laboratory tests and in vitro diagnostic systems - Antimicrobial agents of fungi against fungi Reference method, including in vitro activity, infectious diseases
TS EN ISO 19001 Extracorporeal medical diagnostic devices - Information provided by the manufacturer with extracorporeal medical diagnostic reagents for staining in biology
TS EN ISO 15197 Extracorporeal medical diagnostic measuring systems - Characteristics of blood glucose monitoring systems used for personal measurement for the control of diabetes (diabetes mellitus)
TS EN ISO 23640 Extracorporeal medical diagnostic equipment - Evaluation of stability of extracorporeal diagnostic reagents
TS EN 13532 Out-of-body medical diagnostic equipment - For self-testing - General specifications
TS EN 13612 / AC Medical diagnostic equipment for external use - Performance evaluation
TS EN 13641 Reducing or eliminating the risk of infection related to extracorporeal diagnostic reagents
TS EN 14254 Medical diagnostic equipment for extracorporeal use - Disposable sample cups for collection of non-human blood samples
tst EN ISO 15193 Out-of-body medical diagnostic equipment - Measurement of biological origin samples - Presentation and specification of reference measurement procedures
TS EN ISO 15193 Out-of-body medical diagnostic equipment - Measurement of biological origin samples - Presentation of reference measurement procedures and features
tst EN ISO 15194 Medical diagnostic equipment for extracorporeal use - Quantification of samples of biological origin - Specifications and ancillary document for the identification of reference materials
TS EN ISO 15194 Medical diagnostic equipment for extracorporeal use - Quantification of samples of biological origin - Specifications and ancillary document for the identification of reference materials
TS EN ISO 20776-1 Clinical laboratory test and diagnostic test systems used outside the body - Sensitivity test of infectious agents and evaluation of the performance of antimicrobial susceptibility test devices - Part 1: The method of testing the antimicrobial agents against rapidly proliferating aerobic bacteria in infectious diseases
tst EN ISO 20776-1 Clinical laboratory test and in vitro diagnostic test systems -Infection of susceptibility test of infectious agents and evaluation of the performance of antimicrobial susceptible test apparatus-Section 1-Reference method for testing the invitro activity of antimicrobial agents against the rapid growth of aerobic bacteria containing infectious diseases.
TS EN ISO 29701 Nanotechnology - Endoxin test for nanomaterials for vitro systems-Limulus amebocyte lysate (lal) denyi