11.100 : Laboratory medicine

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  • 24/30472744 DC:2024

    BS ISO 7405 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
    3/18/2024 - PDF - English - BSI
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    €24.00

  • BS ISO 35001:2019+A1:2024

    Biorisk management for laboratories and other related organisations
    3/11/2024 - PDF - English - BSI
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    €293.00

  • BS EN ISO 20916:2024

    In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice
    3/7/2024 - PDF - English - BSI
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    €377.00

  • 24/30463717 DC:2023

    BS EN ISO 15193 In vitro diagnostic medical devices - Requirements for reference measurement procedures
    12/26/2023 - PDF - English - BSI
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    €24.00

  • 24/30463721 DC:2023

    BS EN ISO 15194 In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation
    12/26/2023 - PDF - English - BSI
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    €24.00

  • 24/30449670 DC:2023

    BS EN ISO 5649 Medical laboratories - Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests
    12/25/2023 - PDF - English - BSI
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    €24.00

  • BS EN ISO 10993-17:2023 + Redline

    Tracked Changes. Biological evaluation of medical devices Toxicological risk assessment device constituents
    12/20/2023 - PDF - English - BSI
    Learn More
    €490.00

  • BS EN ISO 15189:2022+A11:2023

    Medical laboratories. Requirements for quality and competence
    12/6/2023 - PDF - English - BSI
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    €377.00

  • PD CEN/TS 17981-1:2023

    In vitro diagnostic Next Generation Sequencing (NGS) workflows Human DNA examination
    12/4/2023 - PDF - English - BSI
    Learn More
    €348.00

  • PD CEN/TS 17981-2:2023

    In vitro diagnostic Next Generation Sequencing (NGS) workflows Human RNA examination
    12/4/2023 - PDF - English - BSI
    Learn More
    €348.00

  • BS EN ISO 10993-17:2023

    Biological evaluation of medical devices Toxicological risk assessment device constituents
    11/23/2023 - PDF - English - BSI
    Learn More
    €377.00

  • 23/30449561 DC:2023

    BS ISO 21474-3. In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids Part 3. Interpretation and reports
    10/30/2023 - PDF - English - BSI
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    €24.00

  • 23/30478370 DC:2023

    BS EN 18000-2 Animal health diagnostic analyses. Control of in-vitro reagents Part 2. Reagents for immunological techniques
    9/21/2023 - PDF - English - BSI
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    €24.00

  • PD ISO/TS 11796:2023

    Biological evaluation of medical devices. Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
    8/2/2023 - PDF - English - BSI
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    €293.00

  • BS EN ISO 10993-18:2020+A1:2023

    Biological evaluation of medical devices Chemical characterization device materials within a risk management process
    7/27/2023 - PDF - English - BSI
    Learn More
    €377.00

  • BS EN ISO 13132:2023 + Redline

    Tracked Changes. Laboratory glassware. Petri dishes
    6/1/2023 - PDF - English - BSI
    Learn More
    €197.00

  • BS EN ISO 10993-15:2023 + Redline

    Tracked Changes. Biological evaluation of medical devices Identification and quantification degradation products from metals alloys
    5/26/2023 - PDF - English - BSI
    Learn More
    €326.00

  • BS EN ISO 10993-15:2023

    Biological evaluation of medical devices Identification and quantification degradation products from metals alloys
    5/24/2023 - PDF - English - BSI
    Learn More
    €250.00

  • BS ISO 20658:2023

    Requirements for the collection and transport of samples for medical laboratory examinations
    5/22/2023 - PDF - English - BSI
    Learn More
    €348.00

  • BS EN ISO 13132:2023

    Laboratory glassware. Petri dishes
    5/11/2023 - PDF - English - BSI
    Learn More
    €151.00

  • PD ISO/TR 10993-55:2023

    Biological evaluation of medical devices Interlaboratory study on cytotoxicity
    2/20/2023 - PDF - English - BSI
    Learn More
    €250.00

  • BS EN ISO 10993-10:2023 + Redline

    Tracked changes. Biological evaluation of medical devices Tests for skin sensitization
    2/17/2023 - PDF - English - BSI
    Learn More
    €454.00

  • BS EN ISO 10993-10:2023

    Biological evaluation of medical devices Tests for skin sensitization
    2/8/2023 - PDF - English - BSI
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    €348.00

  • BS EN ISO 10993-2:2022

    Biological evaluation of medical devices Animal welfare requirements
    11/30/2022 - PDF - English - BSI
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    €250.00

  • 22/30447779 DC:2022

    BS ISO 20658. Medical laboratories. Requirements for collection and transport of samples
    8/3/2022 - PDF - English - BSI
    Learn More
    €24.00

  • PD CEN/TS 17811:2022

    Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for urine and other body fluids. Isolated cell free DNA
    7/19/2022 - PDF - English - BSI
    Learn More
    €250.00

  • BS EN ISO 10993-9:2021 + Redline

    Tracked Changes. Biological evaluation of medical devices Framework for identification and quantification potential degradation products
    6/7/2022 - PDF - English - BSI
    Learn More
    €326.00

  • PD CEN/TS 17747:2022

    Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood. DNA, RNA and proteins
    5/26/2022 - PDF - English - BSI
    Learn More
    €250.00

  • BS EN ISO 10993-9:2021

    Biological evaluation of medical devices Framework for identification and quantification potential degradation products
    5/19/2022 - PDF - English - BSI
    Learn More
    €250.00

  • BS EN ISO 10993-7:2008+A1:2022 + Redline

    Tracked Changes. Biological evaluation of medical devices Ethylene oxide sterilization residuals
    5/19/2022 - PDF - English - BSI
    Learn More
    €492.00

  • BS EN IEC 61010-2-011:2021+A11:2021

    Safety requirements for electrical equipment measurement, control, and laboratory use Particular refrigerating
    5/19/2022 - PDF - English - BSI
    Learn More
    €348.00

  • BS ISO 21474-2:2022

    In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids Validation and verification
    5/17/2022 - PDF - English - BSI
    Learn More
    €250.00

  • PD CEN/TS 17742:2022

    Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood. Isolated circulating cell free RNA from plasma
    5/11/2022 - PDF - English - BSI
    Learn More
    €250.00

  • PD ISO/TS 5798:2022

    In vitro diagnostic test systems. Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods
    4/26/2022 - PDF - English - BSI
    Learn More
    €348.00

  • BS ISO 17593:2022 + Redline

    Tracked Changes. Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
    3/28/2022 - PDF - English - BSI
    Learn More
    €454.00

  • BS ISO 17593:2022

    Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
    3/15/2022 - PDF - English - BSI
    Learn More
    €348.00

  • BS EN ISO 10993-11:2018

    Biological evaluation of medical devices Tests for systemic toxicity
    2/2/2022 - PDF - English - BSI
    Learn More
    €331.00

  • BS EN ISO 20776-2:2021 + Redline

    Tracked Changes. Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility of infectious agents evaluation performance antimicrobial susceptibility devices Evaluation against reference broth micro-dilution
    2/1/2022 - PDF - English - BSI
    Learn More
    €326.00

  • BS EN ISO 23118:2021 + Redline

    Tracked Changes. Molecular in vitro diagnostic examinations. Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma
    1/27/2022 - PDF - English - BSI
    Learn More
    €326.00

  • BS EN ISO 10993-7:2008+A1:2022

    Biological evaluation of medical devices Ethylene oxide sterilization residuals
    1/26/2022 - PDF - English - BSI
    Learn More
    €377.00

  • BS EN ISO 20776-2:2021

    Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility of infectious agents evaluation performance antimicrobial susceptibility devices Evaluation against reference broth micro-dilution
    1/21/2022 - PDF - English - BSI
    Learn More
    €250.00

  • PD CEN/TS 17688-2:2021

    Molecular in vitro diagnostic examinations. Specifications for pre-examination processes Fine Needle Aspirates (FNAs) Isolated proteins
    12/23/2021 - PDF - English - BSI
    Learn More
    €250.00

  • PD CEN/TS 17688-1:2021

    Molecular in vitro diagnostic examinations. Specifications for pre-examination processes Fine Needle Aspirates (FNAs) Isolated cellular RNA
    12/23/2021 - PDF - English - BSI
    Learn More
    €293.00

  • PD CEN/TS 17688-3:2021

    Molecular in vitro diagnostic examinations. Specifications for pre-examination processes Fine Needle Aspirates (FNAs) Isolated genomic DNA
    12/23/2021 - PDF - English - BSI
    Learn More
    €293.00

  • BS EN ISO 4307:2021 + Redline

    Tracked Changes. Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA
    12/17/2021 - PDF - English - BSI
    Learn More
    €235.00

  • BS EN ISO 17511:2021 + Redline

    Tracked Changes. In vitro diagnostic medical devices. Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
    12/10/2021 - PDF - English - BSI
    Learn More
    €454.00

  • BS EN ISO 20184-3:2021 + Redline

    Tracked Changes. Molecular in vitro diagnostic examinations. Specifications for pre-examination processes frozen tissue Isolated DNA
    11/30/2021 - PDF - English - BSI
    Learn More
    €326.00

  • BS EN ISO 6717:2021 + Redline

    Tracked Changes. In vitro diagnostic medical devices. Single-use containers for the collection of specimens from humans other than blood
    11/23/2021 - PDF - English - BSI
    Learn More
    €235.00

  • 21/30379304 DC:2021

    BS EN ISO 10993-17. Biological evaluation of medical devices Part 17. Toxicological risk assessment device constituents
    11/22/2021 - PDF - English - BSI
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    €24.00

  • BS EN ISO 16256:2021 + Redline

    Tracked Changes. Clinical laboratory testing and in vitro diagnostic test systems. Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
    11/17/2021 - PDF - English - BSI
    Learn More
    €326.00

  • BS EN ISO 10993-12:2021 + Redline

    Tracked Changes. Biological evaluation of medical devices Sample preparation and reference materials
    11/16/2021 - PDF - English - BSI
    Learn More
    €382.00

  • BS EN IEC 61326-2-6:2021 + Redline

    Tracked Changes. Electrical equipment for measurement, control and laboratory use. EMC requirements Particular requirements. In vitro diagnostic (IVD) medical
    11/10/2021 - PDF - English - BSI
    Learn More
    €235.00

  • BS EN ISO 4307:2021

    Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA
    11/4/2021 - PDF - English - BSI
    Learn More
    €180.00

  • BS EN ISO 16256:2021

    Clinical laboratory testing and in vitro diagnostic test systems. Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
    10/27/2021 - PDF - English - BSI
    Learn More
    €250.00

  • BS EN ISO 6717:2021

    In vitro diagnostic medical devices. Single-use containers for the collection of specimens from humans other than blood
    9/8/2021 - PDF - English - BSI
    Learn More
    €180.00

  • 21/30439273 DC:2021

    BS EN ISO 10993-18 AMD1. Biological evaluation of medical devices Part 18. Chemical characterization device materials within a risk management process
    8/17/2021 - PDF - English - BSI
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    €24.00

  • 21/30416029 DC:2021

    BS EN ISO 18113-1. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Part 1. Terms, definitions, and general requirements
    8/11/2021 - PDF - English - BSI
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    €24.00

  • 21/30416033 DC:2021

    BS EN ISO 18113-2. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Part 2. reagents for professional use
    8/11/2021 - PDF - English - BSI
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    €24.00

  • 21/30416037 DC:2021

    BS EN ISO 18113-3. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Part 3. instruments for professional use
    8/11/2021 - PDF - English - BSI
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    €24.00

  • 21/30416041 DC:2021

    BS EN ISO 18113-4. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Part 4. reagents for self-testing
    8/11/2021 - PDF - English - BSI
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    €24.00

  • 21/30416045 DC:2021

    BS EN ISO 18113-5. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Part 5. instruments for self-testing
    8/11/2021 - PDF - English - BSI
    Learn More
    €24.00

  • BS EN ISO 20166-4:2021

    Molecular in vitro diagnostic examinations. Specifications for preexamination processes formalin-fixed and paraffin-embedded (FFPE) tissue In situ detection techniques
    7/28/2021 - PDF - English - BSI
    Learn More
    €293.00

  • PD ISO/TR 21582:2021

    Pyrogenicity. Principles and methods for pyrogen testing of medical devices
    7/28/2021 - PDF - English - BSI
    Learn More
    €250.00

  • BS EN ISO 23162:2021

    Basic semen examination. Specification and test methods
    7/20/2021 - PDF - English - BSI
    Learn More
    €293.00

  • BS EN ISO 10993-12:2021

    Biological evaluation of medical devices Sample preparation and reference materials
    6/21/2021 - PDF - English - BSI
    Learn More
    €293.00

  • BS EN IEC 61326-2-6:2021

    Electrical equipment for measurement, control and laboratory use. EMC requirements Particular requirements. In vitro diagnostic (IVD) medical
    6/8/2021 - PDF - English - BSI
    Learn More
    €180.00

  • BS EN ISO 23118:2021

    Molecular in vitro diagnostic examinations. Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma
    6/7/2021 - PDF - English - BSI
    Learn More
    €250.00

  • BS EN ISO 17511:2021

    In vitro diagnostic medical devices. Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
    6/7/2021 - PDF - English - BSI
    Learn More
    €348.00

  • BS EN ISO 20184-3:2021

    Molecular in vitro diagnostic examinations. Specifications for pre-examination processes frozen tissue Isolated DNA
    6/1/2021 - PDF - English - BSI
    Learn More
    €250.00

  • PD CEN/TS 17626:2021

    Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for human specimen. Isolated microbiome DNA
    5/10/2021 - PDF - English - BSI
    Learn More
    €293.00

  • BS EN ISO 10993-23:2021

    Biological evaluation of medical devices Tests for irritation
    4/9/2021 - PDF - English - BSI
    Learn More
    €377.00

  • BS ISO 17822:2020

    In vitro diagnostic test systems. Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens. Laboratory quality practice guide
    1/29/2021 - PDF - English - BSI
    Learn More
    €331.00

  • BS EN ISO 10993-1:2020 + Redline

    Tracked Changes. Biological evaluation of medical devices Evaluation and testing within a risk management process
    12/21/2020 - PDF - English - BSI
    Learn More
    €432.00

  • BS EN ISO 10993-1:2020

    Biological evaluation of medical devices Evaluation and testing within a risk management process
    12/16/2020 - PDF - English - BSI
    Learn More
    €331.00

  • BS EN ISO 22442-1:2020

    Medical devices utilizing animal tissues and their derivatives Application of risk management
    12/14/2020 - PDF - English - BSI
    Learn More
    €293.00

  • BS EN ISO 22442-2:2020

    Medical devices utilizing animal tissues and their derivatives Controls on sourcing, collection handling
    12/14/2020 - PDF - English - BSI
    Learn More
    €250.00

  • BS EN ISO 14155:2020

    Clinical investigation of medical devices for human subjects. Good clinical practice
    11/26/2020 - PDF - English - BSI
    Learn More
    €377.00

  • BS ISO 15190:2020 + Redline

    Tracked Changes. Medical laboratories. Requirements for safety
    11/12/2020 - PDF - English - BSI
    Learn More
    €492.00

  • BS ISO 21474-1:2020

    In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids Terminology and general requirements acid quality evaluation
    8/24/2020 - PDF - English - BSI
    Learn More
    €250.00

  • BS EN ISO 20776-1:2020

    Susceptibility testing of infectious agents and evaluation performance antimicrobial susceptibility test devices Broth micro-dilution reference method for the in vitro activity against rapidly growing aerobic bacteria involved diseases
    7/7/2020 - PDF - English - BSI
    Learn More
    €250.00

  • BS ISO 21151:2020

    In vitro diagnostic medical devices. Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples
    5/27/2020 - PDF - English - BSI
    Learn More
    €250.00

  • BS EN ISO 22367:2020

    Medical laboratories. Application of risk management to medical laboratories
    5/6/2020 - PDF - English - BSI
    Learn More
    €377.00

  • BS EN ISO 10993-16:2017

    Biological evaluation of medical devices Toxicokinetic study design for degradation products and leachables
    3/30/2020 - PDF - English - BSI
    Learn More
    €250.00

  • PD ISO/TS 10993-19:2020

    Biological evaluation of medical devices Physico-chemical, morphological and topographical characterization materials
    3/16/2020 - PDF - English - BSI
    Learn More
    €250.00

  • BS ISO 15190:2020

    Medical laboratories. Requirements for safety
    3/3/2020 - PDF - English - BSI
    Learn More
    €377.00

  • BS EN ISO 15195:2019 + Redline

    Tracked Changes. Laboratory medicine. Requirements for the competence of calibration laboratories using reference measurement procedures
    2/28/2020 - PDF - English - BSI
    Learn More
    €235.00

  • PD ISO/TR 15499:2016 + Redline

    Tracked Changes. Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
    2/26/2020 - PDF - English - BSI
    Learn More
    €326.00

  • BS EN ISO 15197:2015 + Redline

    Tracked Changes. In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
    2/25/2020 - PDF - English - BSI
    Learn More
    €454.00

  • BS EN ISO 23640:2015 + Redline

    Tracked Changes. In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
    2/24/2020 - PDF - English - BSI
    Learn More
    €235.00

  • BS EN ISO 10993-6:2016 + Redline

    Tracked Changes. Biological evaluation of medical devices Tests for local effects after implantation
    2/24/2020 - PDF - English - BSI
    Learn More
    €432.00

  • PD CEN/TS 17390-1:2020

    Molecular in vitro diagnostic examinations. Specifications for pre-examination processes circulating tumor cells (CTCs) venous whole blood Isolated RNA
    1/24/2020 - PDF - English - BSI
    Learn More
    €250.00

  • PD CEN/TS 17390-2:2020

    Molecular in vitro diagnostic examinations. Specifications for pre-examination processes circulating tumor cells (CTCs) venous whole blood Isolated DNA
    1/24/2020 - PDF - English - BSI
    Learn More
    €250.00

  • PD CEN/TS 17390-3:2020

    Molecular in vitro diagnostic examinations. Specifications for pre-examination processes circulating tumor cells (CTCs) venous whole blood Preparations analytical CTC staining
    1/24/2020 - PDF - English - BSI
    Learn More
    €180.00

  • BS EN ISO 20186-3:2019

    Molecular in-vitro diagnostic examinations. Specifications for pre-examination processes venous whole blood Isolated circulating cell free DNA from plasma
    11/27/2019 - PDF - English - BSI
    Learn More
    €250.00

  • PD ISO/TS 22583:2019

    Guidance for supervisors and operators of point-of-care testing (POCT) devices
    11/20/2019 - PDF - English - BSI
    Learn More
    €293.00

  • 19/30381866 DC:2019

    BS ISO 17822-2. In vitro diagnostic test systems. Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens Part 2. Laboratory quality practice guide
    11/11/2019 - PDF - English - BSI
    Learn More
    €24.00

  • PD ISO/TS 20914:2019

    Medical laboratories. Practical guidance for the estimation of measurement uncertainty
    8/5/2019 - PDF - English - BSI
    Learn More
    €377.00

  • BS EN ISO 20186-2:2019

    Molecular in vitro diagnostic examinations. Specifications for pre-examination processes venous whole blood Isolated genomic DNA
    5/10/2019 - PDF - English - BSI
    Learn More
    €250.00

  • BS EN ISO 20186-1:2019

    Molecular in vitro diagnostic examinations. Specifications for pre-examination processes venous whole blood Isolated cellular RNA
    4/2/2019 - PDF - English - BSI
    Learn More
    €250.00

  • BS EN ISO 20184-2:2018

    Molecular in vitro diagnostic examinations. Specifications for pre-examination processes frozen tissue Isolated proteins
    2/22/2019 - PDF - English - BSI
    Learn More
    €250.00

  • BS EN ISO 20166-1:2018

    Molecular in vitro diagnostic examinations. Specifications for pre-examination processes formalin-fixed and paraffin-embedded (FFPE) tissue Isolated RNA
    2/22/2019 - PDF - English - BSI
    Learn More
    €250.00

  • BS EN ISO 15195:2019

    Laboratory medicine. Requirements for the competence of calibration laboratories using reference measurement procedures
    2/6/2019 - PDF - English - BSI
    Learn More
    €180.00

  • PD ISO/TS 21726:2019

    Biological evaluation of medical devices. Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
    2/5/2019 - PDF - English - BSI
    Learn More
    €180.00

  • BS EN ISO 20166-3:2019

    Molecular in vitro diagnostic examinations. Specifications for pre-examination processes formalin-fixed and paraffin-embedded (FFPE) tissue Isolated DNA
    1/28/2019 - PDF - English - BSI
    Learn More
    €250.00

  • BS EN ISO 20166-2:2018

    Molecular in vitro diagnostic examinations. Specifications for pre-examinations processes formalin-fixed and paraffin-embedded (FFPE) tissue Isolated proteins
    1/4/2019 - PDF - English - BSI
    Learn More
    €250.00

  • BS EN ISO 20184-1:2018

    Molecular in vitro diagnostic examinations. Specifications for pre-examination processes frozen tissue Isolated RNA
    12/19/2018 - PDF - English - BSI
    Learn More
    €250.00

  • BS EN ISO 7405:2018

    Dentistry. Evaluation of biocompatibility of medical devices used in dentistry
    11/28/2018 - PDF - English - BSI
    Learn More
    €348.00

  • PD ISO/TS 20658:2017

    Medical laboratories. Requirements for collection, transport, receipt, and handling of samples
    11/9/2017 - PDF - English - BSI
    Learn More
    €331.00

  • BS EN ISO 6710:2017

    Single-use containers for human venous blood specimen collection
    10/3/2017 - PDF - English - BSI
    Learn More
    €250.00

  • BS EN 61010-2-011:2017

    Safety requirements for electrical equipment measurement, control, and laboratory use Particular refrigerating
    9/18/2017 - PDF - English - BSI
    Learn More
    €348.00

  • PD ISO/TR 10993-22:2017

    Biological evaluation of medical devices Guidance on nanomaterials
    7/19/2017 - PDF - English - BSI
    Learn More
    €377.00

  • BS EN ISO 10993-4:2017

    Biological evaluation of medical devices Selection tests for interactions with blood
    5/25/2017 - PDF - English - BSI
    Learn More
    €377.00

  • PD ISO/TR 15499:2016

    Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
    1/31/2017 - PDF - English - BSI
    Learn More
    €250.00

  • BS EN ISO 10993-6:2016

    Biological evaluation of medical devices Tests for local effects after implantation
    12/31/2016 - PDF - English - BSI
    Learn More
    €331.00

  • PD ISO/TS 16782:2016

    Clinical laboratory testing. Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
    11/30/2016 - PDF - English - BSI
    Learn More
    €250.00

  • BS EN ISO 15193:2009

    In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for content and presentation of reference measurement procedures
    1/31/2016 - PDF - English - BSI
    Learn More
    €250.00

  • BS EN ISO 15194:2009

    In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for certified reference materials and the content of supporting documentation
    1/31/2016 - PDF - English - BSI
    Learn More
    €250.00

  • BS EN ISO 15197:2015

    In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
    6/30/2015 - PDF - English - BSI
    Learn More
    €348.00

  • BS EN ISO 23640:2015

    In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
    6/30/2015 - PDF - English - BSI
    Learn More
    €180.00

  • PD ISO/TS 17518:2015

    Medical laboratories. Reagents for staining biological material. Guidance for users
    5/31/2015 - PDF - English - BSI
    Learn More
    €250.00

  • PD ISO/TR 10993-33:2015

    Biological evaluation of medical devices Guidance on tests to evaluate genotoxicity. Supplement ISO 10993-3
    3/31/2015 - PDF - English - BSI
    Learn More
    €348.00

  • PD ISO/TS 17822-1:2014

    In vitro diagnostic test systems. Qualitative nucleic acid-based in examination procedures for detection and identification of microbial pathogens General requirements, terms definitions
    12/31/2014 - PDF - English - BSI
    Learn More
    €293.00

  • BS EN ISO 10993-3:2014

    Biological evaluation of medical devices Tests for genotoxicity, carcinogenicity and reproductive toxicity
    10/31/2014 - PDF - English - BSI
    Learn More
    €331.00

  • 14/30264453 DC:2014

    BS ISO 16782. Clinical laboratory testing. Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
    6/26/2014 - PDF - English - BSI
    Learn More
    €24.00

  • BS EN ISO 19001:2013

    In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
    8/31/2013 - PDF - English - BSI
    Learn More
    €250.00

  • BS EN ISO 18113-1:2011

    In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions and general requirements
    1/31/2012 - PDF - English - BSI
    Learn More
    €348.00

  • BS EN ISO 18113-2:2011

    In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) reagents for professional use
    1/31/2012 - PDF - English - BSI
    Learn More
    €250.00

  • BS EN ISO 18113-4:2011

    In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) reagents for self-testing
    1/31/2012 - PDF - English - BSI
    Learn More
    €250.00

  • BS EN ISO 18113-5:2011

    In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) instruments for self-testing
    1/31/2012 - PDF - English - BSI
    Learn More
    €180.00

  • BS EN ISO 18113-3:2011

    In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) instruments for professional use
    11/30/2011 - PDF - English - BSI
    Learn More
    €180.00

  • BS EN ISO 13130:2011

    Laboratory glassware. Desiccators
    8/31/2011 - PDF - English - BSI
    Learn More
    €180.00

  • BS EN ISO 13132:2011

    Laboratory glassware. Petri dishes
    8/31/2011 - PDF - English - BSI
    Learn More
    €151.00

  • BS EN ISO 13079:2011

    Laboratory glass and plastics ware. Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method
    8/31/2011 - PDF - English - BSI
    Learn More
    €250.00

  • PD ISO/TR 22442-4:2010

    Medical devices utilizing animal tissues and their derivatives Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents validation assays those processes
    2/28/2011 - PDF - English - BSI
    Learn More
    €250.00

  • BS EN ISO 29701:2010

    Nanotechnologies. Endotoxin test on nanomaterial samples for in vitro systems. Limulus amebocyte lysate (LAL) test
    10/31/2010 - PDF - English - BSI
    Learn More
    €250.00

  • BS EN ISO 10993-13:2010

    Biological evaluation of medical devices Identification and quantification degradation products from polymeric
    10/31/2010 - PDF - English - BSI
    Learn More
    €250.00

  • BS EN ISO 24998:2008

    Plastics laboratory ware. Single-use Petri dishes for microbiological procedures
    3/31/2010 - PDF - English - BSI
    Learn More
    €180.00

  • BS EN ISO 10993-5:2009

    Biological evaluation of medical devices Tests for in vitro cytotoxicity
    7/31/2009 - PDF - English - BSI
    Learn More
    €331.00

  • BS EN ISO 10993-14:2009

    Biological evaluation of medical devices Identification and quantification degradation products from ceramics
    6/30/2009 - PDF - English - BSI
    Learn More
    €180.00

  • BS EN ISO 22442-3:2007

    Medical devices utilizing animal tissues and their derivatives Validation of the elimination and/or inactivation viruses transmissible spongiform encephalopathy (TSE) agents
    2/29/2008 - PDF - English - BSI
    Learn More
    €293.00

  • DD ISO/TS 10993-20:2006

    Biological evaluation of medical devices Principles and methods for immunotoxicology testing
    9/29/2006 - PDF - English - BSI
    Learn More
    €250.00

  • BS ISO 15198:2004

    Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user quality control procedures by the manufacturer
    7/23/2004 - PDF - English - BSI
    Learn More
    €180.00

  • BS EN 14136:2004

    Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
    5/26/2004 - PDF - English - BSI
    Learn More
    €151.00

  • BS 3985:2003

    Haemiglobincyanide (cyanmethaemoglobin) preparation as a standard for spectrometric haemoglobinometry
    10/10/2003 - PDF - English - BSI
    Learn More
    €151.00

  • BS EN ISO 18153:2003

    In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials
    8/19/2003 - PDF - English - BSI
    Learn More
    €180.00

  • BS EN ISO 18812:2003

    Health informatics. Clinical analyser interfaces to laboratory information systems. Use profiles
    6/24/2003 - PDF - English - BSI
    Learn More
    €348.00

  • BS EN 13975:2003

    Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects
    3/28/2003 - PDF - English - BSI
    Learn More
    €180.00

  • BS EN 13612:2002

    Performance evaluation of in vitro diagnostic medical devices
    2/27/2003 - PDF - English - BSI
    Learn More
    €180.00

  • BS EN 13641:2002

    Elimination or reduction of risk of infection related to in vitro diagnostic reagents
    5/27/2002 - PDF - English - BSI
    Learn More
    €151.00

  • BS EN 13532:2002

    General requirements for in vitro diagnostic medical devices for self-testing
    5/8/2002 - PDF - English - BSI
    Learn More
    €151.00

  • BS ISO 12771:1997

    Plastics laboratory ware. Disposable serological pipettes
    9/15/1997 - PDF - English - BSI
    Learn More
    €151.00

  • BS ISO 12772:1997

    Laboratory glassware. Disposable microhaematocrit capillary tubes
    8/15/1997 - PDF - English - BSI
    Learn More
    €151.00

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