Medical Laboratories Standards

Our company provides internationally approved and accredited testing, inspection and inspection services to the following standards.

TS EN 13612 Performance evaluation of extracorporeal medical diagnostic devices

TS EN 13641 Reducing or eliminating the risk of infection related to extracorporeal diagnostic reagents

TS EN 13612 Medical diagnostic equipment for extracorporeal use - Performance evaluation

TS EN 13975 Sampling methods for statistical acceptance of vitro diognastic medical devices (statistical methods)

TS EN ISO 15195 Medical laboratories - Requirements for reference measurement laboratories

TS EN ISO 10993-17 Biological evaluation of medical devices - part 17: Determination of acceptable limits for permeable substances

TS EN 13612 / AC Performance evaluation of extracorporeal medical diagnostic devices

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 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 18113-2 Extracorporeal 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)

TSE CEN ISO / TS 22367 Medical laboratories - Reduction of errors through risk management and continuous improvement (including ISO / TS 22367: 2008, Correction 1: 2009)

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

TSE CEN ISO / TS 22367 Medical laboratories - Reducing errors through risk management and continuous improvement

TS EN ISO 10993-1 Biological evaluation of medical devices - Part 13: Identification and quantification of decomposition products of medical devices made of polymer

TS EN ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitivity (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 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 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 15189 Medical laboratories - Requirements for quality and competence

TS EN ISO 15189 Medical laboratories - Special requirements for quality and qualification

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 7405 / A1 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry - Annex 1: Positive control material

TS EN ISO 15195 Medical laboratories - Requirements for reference measurement laboratories (ISO 15195: 2003)

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 7405 / A1 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry - Amendment 1: Positive control material (ISO 7405: 2008 / Amendment 1: 2013)

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

Molecular in vitro diagnostic investigations - Features of preliminary examination procedures for venous whole blood - Part 16835: Isolated cellular RNA

TSE CEN / TS 16826-1 Molecular in vitro diagnostic investigations - Properties of preliminary examination procedures for snap frozen tissue - Part 1: Isolated RNA

TSE CEN / TS 16826-2 Molecular in vitro diagnostic investigations - Characteristics of preliminary examination procedures for snap frozen tissue - Part 2: Isolated proteins

TSE CEN / TS 16827-1 Molecular in vitro diagnostic investigations - Characteristics of preliminary examination procedures for FFPE tissue - Part 1: isolated RNA

TSE CEN / TS 16827-2 Molecular in vitro diagnostic investigations - Characteristics of pre-examination procedures for FFPE tissue - Part 2: Isolated proteins

Molecular in vitro diagnostic investigations - Characteristics of pre-examination procedures for FFPE tissue - Part 16827: Isolated DNA TSE CEN / TS 3-3

Molecular in vitro diagnostic investigations - Features of pre-examination procedures for venous whole blood - Part 16835: Isolated genomic DNA

Molecular in vitro diagnostic investigations - Features of preliminary examination procedures for venous whole blood - Part 16835: Extracellular DNA isolation from plasma in circulation

TS EN ISO 7405 Dentistry - Evaluation of the biocompatibility of medical devices used in dentistry (ISO 7405: 2008)

TS EN ISO 22442-1 Medical devices using animal tissues and derivatives - Part 1: Implementing risk management

TS EN ISO 22442-2 Medical devices using animal tissues and their derivatives - Part 2: Sourcing, collection and processing controls

TSE CEN / TS 16945 Molecular in vitro diagnostic investigations - Characteristics of preliminary examination procedures for metabolomics in urine, venous blood serum and plasma

TS EN ISO 10993-9 Biological evaluation of medical devices - Part 9: Preliminary study to identify and quantify potential degradation products

TS EN ISO 22870 Bedside testers (POCT) - Requirements for quality and competence

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

TS EN 12376 Medical devices for in vitro diagnosis - Manufacturer's information on the release agents used for in vitro diagnostics in biology

TS EN ISO 13132: 2011 Laboratory glassware-Petri dishes

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 14136 Use of external quality assessment schemes to assess the performance of diagnostic examinations used outside the body

TS EN 14254 Medical diagnostic equipment for extracorporeal use - Disposable sample cups for collection of non-human blood samples

TS ISO 15190 Medical laboratories - Safety regulations

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 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

TS EN ISO 22442-3 Animal tissues and derivatives used in the manufacture of medical devices - Part 3: Validity of inactivation and / or removal of viruses and infectious substances

TS EN ISO 29701 Nanotechnology - Endoxin test for nanomaterials for vitro systems-Limulus amebocyte lysate (lal) denyi