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11.100.20 : Biological evaluation of medical devices

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  • BS EN ISO 10993-17:2023 + Redline

    BS EN ISO 10993-17:2023 + Redline

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

  • BS EN ISO 10993-17:2023

    BS EN ISO 10993-17:2023

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

  • PD ISO/TS 11796:2023

    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 -
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    €293.00

  • BS EN ISO 10993-18:2020+A1:2023

    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 -
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    €377.00

  • BS EN ISO 10993-15:2023 + Redline

    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 -
    Learn More
    €326.00

  • BS EN ISO 10993-15:2023

    BS EN ISO 10993-15:2023

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

  • PD ISO/TR 10993-55:2023

    PD ISO/TR 10993-55:2023

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

  • BS EN ISO 10993-10:2023 + Redline

    BS EN ISO 10993-10:2023 + Redline

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

  • BS EN ISO 10993-10:2023

    BS EN ISO 10993-10:2023

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

  • BS EN ISO 10993-2:2022

    BS EN ISO 10993-2:2022

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

  • BS EN ISO 10993-9:2021 + Redline

    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 -
    Learn More
    €326.00

  • BS EN ISO 10993-9:2021

    BS EN ISO 10993-9:2021

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

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

    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 -
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    €492.00

  • BS ISO 17593:2022 + Redline

    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 -
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    €454.00

  • BS ISO 17593:2022

    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 -
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    €348.00

  • BS EN ISO 10993-11:2018

    BS EN ISO 10993-11:2018

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

  • BS EN ISO 20776-2:2021 + Redline

    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 -
    Learn More
    €326.00

  • BS EN ISO 10993-7:2008+A1:2022

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

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

  • BS EN ISO 20776-2:2021

    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 -
    Learn More
    €250.00

  • 21/30379304 DC:2021

    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 -
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    €24.00

  • BS EN ISO 10993-12:2021 + Redline

    BS EN ISO 10993-12:2021 + Redline

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

  • 21/30439273 DC:2021

    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 -
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    €24.00

  • PD ISO/TR 21582:2021

    PD ISO/TR 21582:2021

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

  • BS EN ISO 10993-12:2021

    BS EN ISO 10993-12:2021

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

  • BS EN ISO 10993-23:2021

    BS EN ISO 10993-23:2021

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

  • BS EN ISO 10993-1:2020 + Redline

    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 -
    Learn More
    €432.00

  • BS EN ISO 10993-1:2020

    BS EN ISO 10993-1:2020

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

  • BS EN ISO 22442-1:2020

    BS EN ISO 22442-1:2020

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

  • BS EN ISO 22442-2:2020

    BS EN ISO 22442-2:2020

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

  • BS EN ISO 14155:2020

    BS EN ISO 14155:2020

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

  • BS EN ISO 20776-1:2020

    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 -
    Learn More
    €250.00

  • BS EN ISO 10993-16:2017

    BS EN ISO 10993-16:2017

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

  • PD ISO/TS 10993-19:2020

    PD ISO/TS 10993-19:2020

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

  • PD ISO/TR 15499:2016 + Redline

    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 -
    Learn More
    €326.00

  • BS EN ISO 10993-6:2016 + Redline

    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 -
    Learn More
    €432.00

  • PD ISO/TS 21726:2019

    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 -
    Learn More
    €180.00

  • BS EN ISO 7405:2018

    BS EN ISO 7405:2018

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

  • PD ISO/TR 10993-22:2017

    PD ISO/TR 10993-22:2017

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

  • BS EN ISO 10993-4:2017

    BS EN ISO 10993-4:2017

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

  • PD ISO/TR 15499:2016

    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 -
    Learn More
    €250.00

  • BS EN ISO 10993-6:2016

    BS EN ISO 10993-6:2016

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

  • PD ISO/TS 16782:2016

    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 -
    Learn More
    €250.00

  • PD ISO/TR 10993-33:2015

    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 -
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    €348.00

  • BS EN ISO 10993-3:2014

    BS EN ISO 10993-3:2014

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

  • 14/30264453 DC:2014

    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 -
    Learn More
    €24.00

  • PD ISO/TR 22442-4:2010

    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 -
    Learn More
    €250.00

  • BS EN ISO 10993-13:2010

    BS EN ISO 10993-13:2010

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

  • BS EN ISO 10993-5:2009

    BS EN ISO 10993-5:2009

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

  • BS EN ISO 10993-14:2009

    BS EN ISO 10993-14:2009

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

  • BS EN ISO 22442-3:2007

    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 -
    Learn More
    €293.00

  • DD ISO/TS 10993-20:2006

    DD ISO/TS 10993-20:2006

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

  • BS EN ISO 18812:2003

    BS EN ISO 18812:2003

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

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