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11.100.20 : Biological evaluation of medical devices

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  • ISO/TS 21726:2019

    Biological evaluation of medical devices -- Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
    2/1/2019 - Paper - English -
    Learn More
    €61.00

  • ASTM E2805-18

    Standard Practice for Measurement of the Biological Activity of Ricin
    12/1/2018 - PDF - English -
    Learn More
    €49.00

  • ASTM E2805-18 + Redline

    Standard Practice for Measurement of the Biological Activity of Ricin
    12/1/2018 - PDF - English -
    Learn More
    €59.00

  • DIN EN ISO 22442-2:2018-12

    Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO/DIS 22442-2:2018); German and English version prEN ISO 22442-2:2018
    12/1/2018 - PDF - English, German -
    Learn More
    €96.00

  • PR NF S99-501-7/A1, PR NF EN ISO 10993-7/A1 (10/2018)

    Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1
    10/1/2018 - Paper - French -
    Learn More
    €63.03

  • DIN EN ISO 10993-11:2018-09

    Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017); German version EN ISO 10993-11:2018
    9/1/2018 - PDF - German -
    Learn More
    €125.30

  • DIN EN ISO 10993-11:2018-09

    Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017); German version EN ISO 10993-11:2018
    9/1/2018 - PDF - English -
    Learn More
    €156.50

  • DIN EN ISO 22442-1:2018-09

    Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO/DIS 22442-1:2018); German and English version prEN ISO 22442-1:2018
    9/1/2018 - PDF - English, German -
    Learn More
    €114.10

  • DIN EN ISO 10993-18:2018-09

    Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO/DIS 10993-18:2018); German and English version prEN ISO 10993-18:2018
    9/1/2018 - PDF - English, German -
    Learn More
    €175.40

  • PR NF S92-053-1, PR NF EN ISO 20776-1 (08/2018)

    Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases
    8/15/2018 - Paper - English, French -
    Learn More
    €105.05

  • PR NF S99-201, PR NF EN ISO 14155 (08/2018)

    Clinical investigation of medical devices for human subjects - Good clinical practice
    8/12/2018 - Paper - English, French -
    Learn More
    €183.81

  • DIN EN ISO 14155:2018-08

    Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2018); German and English version prEN ISO 14155:2018
    8/1/2018 - PDF - English, German -
    Learn More
    €191.40

  • ISO 10993-1:2018

    Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
    8/1/2018 - Paper - French -
    Learn More
    €165.00

  • DIN EN ISO 10993-7/A1:2018-08

    Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1 (ISO 10993-7:2008/DAM 1:2018); German and English version EN ISO 10993-7:2008/prA1:2018
    8/1/2018 - PDF - English, German -
    Learn More
    €68.30

  • DIN EN ISO 20776-1:2018-08

    Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO/DIS 20776-1:2018); German and English version prEN ISO 20776-1:2018
    8/1/2018 - PDF - English, German -
    Learn More
    €96.00

  • ISO 10993-1:2018

    Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
    8/1/2018 - Paper - English -
    Learn More
    €165.00

  • NF S99-501-4, NF EN ISO 10993-4 (07/2018)

    Biological evaluation of medical devices - Part 4 : selection of tests for interactions with blood
    7/13/2018 - Paper - English -
    Learn More
    €127.55

  • NF S99-501-4, NF EN ISO 10993-4 (07/2018)

    Biological evaluation of medical devices - Part 4 : selection of tests for interactions with blood
    7/13/2018 - Paper - French -
    Learn More
    €127.55

  • PR NF S99-501-15, PR NF ISO 10993-15 (07/2018)

    Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
    7/10/2018 - Paper - English, French -
    Learn More
    €95.10

  • PR NF S99-501-9, PR NF EN ISO 10993-9 (06/2018)

    Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
    6/22/2018 - Paper - English, French -
    Learn More
    €86.46

  • NBN EN ISO 10993-11:2018

    Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
    6/20/2018 - PDF - English -
    Learn More
    €56.00

  • BS EN ISO 10993-11:2018

    Biological evaluation of medical devices. Tests for systemic toxicity
    6/18/2018 - PDF - English -
    Learn More
    €236.90

  • NF S99-501-11, NF EN ISO 10993-11 (05/2018)

    Biological evaluation of medical devices - Part 11 : tests for systemic toxicity
    5/30/2018 - Paper - French -
    Learn More
    €87.56

  • DIN EN ISO 10993-15:2018-05

    Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO/DIS 10993-15:2018); German and English version prEN ISO 10993-15:2018
    5/1/2018 - PDF - English, German -
    Learn More
    €96.00

  • VDI 5701:2018-05

    Biomaterials in medicine - Classification, requirements, and applications
    5/1/2018 - PDF - English, German -
    Learn More
    €183.17

  • DIN EN ISO 10993-9:2018-05

    Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO/DIS 10993-9:2018); German and English version prEN ISO 10993-9:2018
    5/1/2018 - PDF - English, German -
    Learn More
    €89.00

  • VDI 2017:2018-04

    Medical-grade plastics
    4/1/2018 - PDF - German -
    Learn More
    €94.38

  • CWA 17253-2:2018

    Joint implants - Part 2: Tiered toolkit approach to evaluate the biological impact of wear particles from joint replacements and related devices
    3/30/2018 - PDF - English -
    Learn More
    €77.00

  • DIN EN ISO 10993-16:2018-02

    Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017); German version EN ISO 10993-16:2017
    2/1/2018 - PDF - German -
    Learn More
    €89.00

  • DIN EN ISO 10993-16:2018-02

    Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017); German version EN ISO 10993-16:2017
    2/1/2018 - PDF - English -
    Learn More
    €111.40

  • ASTM E3152-18

    Standard Guide for Standard Test Methods and Practices Available for Determining Antifungal Activity on Natural or Synthetic Substrates Treated with Antimicrobial Agents
    2/1/2018 - PDF - English -
    Learn More
    €49.00

  • NBN EN ISO 10993-16:2018

    Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
    1/30/2018 - PDF - French -
    Learn More
    €45.00

  • NBN EN ISO 10993-16:2018

    Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
    1/30/2018 - PDF - German -
    Learn More
    €45.00

  • NBN EN ISO 10993-16:2018

    Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
    1/30/2018 - PDF - English -
    Learn More
    €45.00

  • UNE-EN ISO 10993-4:2018

    Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
    1/24/2018 - PDF - Spanish -
    Learn More
    €107.00

  • BS EN ISO 10993-16:2017

    Biological evaluation of medical devices. Toxicokinetic study design for degradation products and leachables
    1/9/2018 - PDF - English -
    Learn More
    €202.40

  • NF S99-501-16, NF EN ISO 10993-16 (12/2017)

    Biological evaluation of medical devices - Part 16 : Toxicokinetic study design for degradation products and leachables
    12/6/2017 - Paper - English -
    Learn More
    €66.72

  • NF S99-501-16, NF EN ISO 10993-16 (12/2017)

    Biological evaluation of medical devices - Part 16 : Toxicokinetic study design for degradation products and leachables
    12/6/2017 - Paper - French -
    Learn More
    €66.72

  • DIN EN ISO 10993-4:2017-12

    Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017); German version EN ISO 10993-4:2017
    12/1/2017 - PDF - German -
    Learn More
    €191.40

  • DIN EN ISO 10993-4:2017-12

    Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017); German version EN ISO 10993-4:2017
    12/1/2017 - PDF - English -
    Learn More
    €239.20

  • NBN EN ISO 10993-4:2017

    Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
    11/22/2017 - PDF - English -
    Learn More
    €45.00

  • NBN EN ISO 10993-4:2017

    Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
    11/22/2017 - PDF - French -
    Learn More
    €45.00

  • NBN EN ISO 10993-4:2017

    Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
    11/22/2017 - PDF - German -
    Learn More
    €45.00

  • UNE-EN ISO 10993-6:2017

    Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
    10/25/2017 - PDF - Spanish -
    Learn More
    €66.00

  • DIN EN ISO 10993-6:2017-09

    Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016); German version EN ISO 10993-6:2016
    9/1/2017 - PDF - German -
    Learn More
    €119.60

  • ISO 10993-11:2017

    Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
    9/1/2017 - Paper - English -
    Learn More
    €144.00

  • DIN EN ISO 10993-6:2017-09

    Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016); German version EN ISO 10993-6:2016
    9/1/2017 - PDF - English -
    Learn More
    €149.40

  • ISO 10993-11:2017

    Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
    9/1/2017 - Paper - French -
    Learn More
    €144.00

  • FD S99-501-22, FD ISO/TR 10993-22 (08/2017)

    Biological evaluation of medical devices - Part 22 : guidance on nanomaterials
    8/23/2017 - Paper - French -
    Learn More
    €127.55

  • FD S99-501-22, FD ISO/TR 10993-22 (08/2017)

    Biological evaluation of medical devices - Part 22 : guidance on nanomaterials
    8/23/2017 - Paper - English -
    Learn More
    €127.55

  • PD ISO/TR 10993-22:2017

    Biological evaluation of medical devices. Guidance on nanomaterials
    7/19/2017 - PDF - English -
    Learn More
    €282.90

  • ISO/TR 10993-22:2017

    Biological evaluation of medical devices -- Part 22: Guidance on nanomaterials
    7/1/2017 - Paper - French -
    Learn More
    €186.00

  • ISO/TR 10993-22:2017

    Biological evaluation of medical devices -- Part 22: Guidance on nanomaterials
    7/1/2017 - Paper - English -
    Learn More
    €186.00

  • BS EN ISO 10993-4:2017

    Biological evaluation of medical devices. Selection of tests for interactions with blood
    5/25/2017 - PDF - English -
    Learn More
    €236.90

  • ISO 10993-16:2017

    Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables
    5/1/2017 - Paper - English -
    Learn More
    €92.00

  • ISO 10993-16:2017

    Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables
    5/1/2017 - Paper - French -
    Learn More
    €92.00

  • PR NF S99-501-1, PR NF EN ISO 10993-1 (04/2017)

    Biological evaluation of medical devices - Part 1 : Evaluation and testing within a risk management process
    4/21/2017 - Paper - English, French -
    Learn More
    €121.66

  • PR NF S91-224, PR NF EN ISO 7405 (04/2017)

    Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
    4/20/2017 - Paper - English, French -
    Learn More
    €121.66

  • NF S99-501-6, NF EN ISO 10993-6 (04/2017)

    Biological evaluation of medical devices - Part 6 : tests for local effects after implantation
    4/15/2017 - Paper - French -
    Learn More
    €87.56

  • NF S99-501-6, NF EN ISO 10993-6 (04/2017)

    Biological evaluation of medical devices - Part 6 : tests for local effects after implantation
    4/15/2017 - Paper - English -
    Learn More
    €87.56

  • ISO 10993-4:2017

    Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood
    4/1/2017 - Paper - English -
    Learn More
    €186.00

  • ISO 10993-4:2017

    Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood
    4/1/2017 - Paper - French -
    Learn More
    €186.00

  • DIN EN ISO 10993-1:2017-04

    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO/DIS 10993-1:2017); German and English version prEN ISO 10993-1:2017
    4/1/2017 - PDF - English, German -
    Learn More
    €136.80

  • 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
    €202.40

  • NBN EN ISO 10993-6:2017

    Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
    1/27/2017 - PDF - French -
    Learn More
    €56.00

  • NBN EN ISO 10993-6:2017

    Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
    1/27/2017 - PDF - German -
    Learn More
    €56.00

  • NBN EN ISO 10993-6:2017

    Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
    1/27/2017 - PDF - English -
    Learn More
    €56.00

  • AAMI/ISO 10993-6:2017

    Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
    1/1/2017 - PDF sécurisé - English -
    Learn More
    €128.76

  • BS EN ISO 10993-6:2016

    Biological evaluation of medical devices. Tests for local effects after implantation
    12/31/2016 - PDF - English -
    Learn More
    €257.60

  • PR NF S97-001-3/A1, PR NF EN 455-3/A1 (12/2016)

    Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
    12/8/2016 - Paper - English, French -
    Learn More
    €34.76

  • ISO/TR 15499:2016

    Biological evaluation of medical devices -- Guidance on the conduct of biological evaluation within a risk management process
    12/1/2016 - Paper - English -
    Learn More
    €92.00

  • ISO 10993-6:2016

    Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
    12/1/2016 - Paper - English -
    Learn More
    €144.00

  • ISO/TR 15499:2016

    Biological evaluation of medical devices -- Guidance on the conduct of biological evaluation within a risk management process
    12/1/2016 - Paper - French -
    Learn More
    €92.00

  • ISO 10993-6:2016

    Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
    12/1/2016 - Paper - French -
    Learn More
    €144.00

  • 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 -
    Learn More
    €202.40

  • ISO/TS 16782:2016

    Clinical laboratory testing -- Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
    10/1/2016 - Paper - English -
    Learn More
    €123.00

  • JIS T 6001/AMENDMENT 1:2016

    Evaluation of biocompatibility of medical devices used in dentistry (Amendment 1)
    10/1/2016 - PDF - Japanese -
    Learn More
    €25.00

  • NF S97-601-1, NF EN ISO 22442-1 (07/2016)

    Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
    7/15/2016 - Paper - French -
    Learn More
    €76.40

  • NF S97-601-2, NF EN ISO 22442-2 (07/2016)

    Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
    7/15/2016 - Paper - English -
    Learn More
    €66.72

  • NF S97-601-2, NF EN ISO 22442-2 (07/2016)

    Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
    7/15/2016 - Paper - French -
    Learn More
    €66.72

  • NF S97-601-1, NF EN ISO 22442-1 (07/2016)

    Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
    7/15/2016 - Paper - English -
    Learn More
    €76.40

  • ASTM E3060-16

    Standard Guide for Subvisible Particle Measurement in Biopharmaceutical Manufacturing Using Dynamic (Flow) Imaging Microscopy
    6/1/2016 - PDF - English -
    Learn More
    €49.00

  • UNE-EN ISO 22442-1:2016

    Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
    4/27/2016 - PDF - Spanish -
    Learn More
    €60.00

  • UNE-EN ISO 22442-2:2016

    Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015)
    2/10/2016 - PDF - Spanish -
    Learn More
    €55.00

  • BS EN ISO 22442-2:2015

    Medical devices utilizing animal tissues and their derivatives. Controls on sourcing, collection and handling
    12/31/2015 - PDF - English -
    Learn More
    €202.40

  • BS EN ISO 22442-1:2015

    Medical devices utilizing animal tissues and their derivatives. Application of risk management
    11/30/2015 - PDF - English -
    Learn More
    €236.90

  • ISO 22442-2:2015

    Medical devices utilizing animal tissues and their derivatives -- Part 2: Controls on sourcing, collection and handling
    11/1/2015 - Paper - French -
    Learn More
    €92.00

  • ISO 22442-2:2015

    Medical devices utilizing animal tissues and their derivatives -- Part 2: Controls on sourcing, collection and handling
    11/1/2015 - Paper - English -
    Learn More
    €92.00

  • ISO 22442-1:2015

    Medical devices utilizing animal tissues and their derivatives -- Part 1: Application of risk management
    11/1/2015 - Paper - French -
    Learn More
    €144.00

  • ISO 22442-1:2015

    Medical devices utilizing animal tissues and their derivatives -- Part 1: Application of risk management
    11/1/2015 - Paper - English -
    Learn More
    €144.00

  • NF S97-001-3, NF EN 455-3 (05/2015)

    Medical gloves for single use - Part 3 : requirements and testing for biological evaluation
    5/29/2015 - Paper - English -
    Learn More
    €87.56

  • NF S97-001-3, NF EN 455-3 (05/2015)

    Medical gloves for single use - Part 3 : requirements and testing for biological evaluation
    5/29/2015 - Paper - French -
    Learn More
    €87.56

  • UNE-EN ISO 10993-3:2015

    Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
    5/6/2015 - PDF - Spanish -
    Learn More
    €65.00

  • PD ISO/TR 10993-33:2015

    Biological evaluation of medical devices. Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3
    3/31/2015 - PDF - English -
    Learn More
    €282.90

  • ISO/TR 10993-33:2015

    Biological evaluation of medical devices -- Part 33: Guidance on tests to evaluate genotoxicity -- Supplement to ISO 10993-3
    3/1/2015 - Paper - English -
    Learn More
    €165.00

  • DIN EN ISO 10993-3:2015-02

    Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014); German version EN ISO 10993-3:2014
    2/1/2015 - PDF - German -
    Learn More
    €119.60

  • DIN EN ISO 10993-3:2015-02

    Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014); German version EN ISO 10993-3:2014
    2/1/2015 - PDF - English -
    Learn More
    €149.40

  • NF S99-501-3, NF EN ISO 10993-3 (12/2014)

    Biological evaluation of medical devices - Part 3 : tests for genotoxicity, carcinogenicity and reproductive toxicity
    12/5/2014 - Paper - English -
    Learn More
    €95.37

  • NF S99-501-3, NF EN ISO 10993-3 (12/2014)

    Biological evaluation of medical devices - Part 3 : tests for genotoxicity, carcinogenicity and reproductive toxicity
    12/5/2014 - Paper - French -
    Learn More
    €95.37

  • NBN EN ISO 10993-3:2014

    Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
    11/28/2014 - PDF - French -
    Learn More
    €105.00

  • NBN EN ISO 10993-3:2014

    Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
    11/28/2014 - PDF - German -
    Learn More
    €105.00

  • NBN EN ISO 10993-3:2014

    Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
    11/28/2014 - PDF - English -
    Learn More
    €105.00

  • 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
    €257.60

  • ISO 10993-3:2014

    Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
    10/1/2014 - Paper - English -
    Learn More
    €144.00

  • DIN EN ISO 10993-10:2014-10

    Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010); German version EN ISO 10993-10:2013
    10/1/2014 - PDF - German -
    Learn More
    €169.80

  • ISO 10993-3:2014

    Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
    10/1/2014 - Paper - French -
    Learn More
    €144.00

  • DIN EN ISO 10993-10:2014-10

    Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010); German version EN ISO 10993-10:2013
    10/1/2014 - PDF - English -
    Learn More
    €212.40

  • €488.00

  • DIN ISO 13022:2014-06

    Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012)
    6/1/2014 - PDF - German -
    Learn More
    €141.90

  • DIN ISO 13022:2014-06

    Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012)
    6/1/2014 - PDF - English -
    Learn More
    €177.20

  • BS EN ISO 10993-10:2013 (R2016)

    Biological evaluation of medical devices. Tests for irritation and skin sensitization
    2/28/2014 - PDF - English -
    Learn More
    €303.60

  • AAMI/ISO 10993-3:2014

    Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
    1/1/2014 - PDF sécurisé - English -
    Learn More
    €103.53

  • NF S99-501-10, NF EN ISO 10993-10 (12/2013)

    Biological evaluation of medical devices - Part 10 : tests for irritation and skin sensitization
    12/6/2013 - Paper - French -
    Learn More
    €127.55

  • NF S99-501-10, NF EN ISO 10993-10 (12/2013)

    Biological evaluation of medical devices - Part 10 : tests for irritation and skin sensitization
    12/6/2013 - Paper - English -
    Learn More
    €127.55

  • UNE-EN ISO 10993-10:2013

    Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
    11/20/2013 - PDF - Spanish -
    Learn More
    €90.00

  • NBN EN ISO 10993-10:2013

    Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
    10/25/2013 - PDF - French -
    Learn More
    €145.00

  • NBN EN ISO 10993-10:2013

    Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
    10/25/2013 - PDF - German -
    Learn More
    €145.00

  • NBN EN ISO 10993-10:2013

    Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
    10/25/2013 - PDF - English -
    Learn More
    €145.00

  • NF S91-224/A1, NF EN ISO 7405/A1 (09/2013)

    Dentistry - Evaluation of biocompatibility of medical devices used in dentistry - Amendment 1 : positive control material
    9/28/2013 - Paper - English -
    Learn More
    €22.83

  • UNE-EN ISO 10993-12:2013

    Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
    2/27/2013 - PDF - Spanish -
    Learn More
    €57.00

  • BS EN ISO 10993-12:2012

    Biological evaluation of medical devices. Sample preparation and reference materials
    10/31/2012 - PDF - English -
    Learn More
    €236.90

  • DIN EN ISO 10993-12:2012-10

    Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012); German version EN ISO 10993-12:2012
    10/1/2012 - PDF - English -
    Learn More
    €128.80

  • DIN EN ISO 10993-12:2012-10

    Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012); German version EN ISO 10993-12:2012
    10/1/2012 - PDF - German -
    Learn More
    €103.00

  • NF S99-501-12, NF EN ISO 10993-12 (09/2012)

    Biological evaluation of medical devices - Part 12 : sample preparation and reference materials
    9/1/2012 - Paper - French -
    Learn More
    €76.40

  • NF S99-501-12, NF EN ISO 10993-12 (09/2012)

    Biological evaluation of medical devices - Part 12 : sample preparation and reference materials
    9/1/2012 - Paper - English -
    Learn More
    €76.40

  • NBN EN ISO 10993-12:2012

    Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
    8/31/2012 - PDF - French -
    Learn More
    €105.00

  • NBN EN ISO 10993-12:2012

    Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
    8/31/2012 - PDF - German -
    Learn More
    €105.00

  • NBN EN ISO 10993-12:2012

    Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
    8/31/2012 - PDF - English -
    Learn More
    €105.00

  • ISO 10993-12:2012

    Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials
    7/1/2012 - Paper - French -
    Learn More
    €123.00

  • ISO 10993-12:2012

    Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials
    7/1/2012 - Paper - Russian -
    Learn More
    €123.00

  • ISO 10993-12:2012

    Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials
    7/1/2012 - Paper - English -
    Learn More
    €123.00

  • BIP 0113:2012

    Guide to European medical device trials and BS EN ISO 14155
    6/13/2012 - PDF - English -
    Learn More
    €66.70

  • NF S99-201, NF EN ISO 14155 (05/2012)

    Clinical investigation of medical devices for human subjects - Good clinical practice
    5/1/2012 - Paper - English -
    Learn More
    €127.55

  • NF S99-201, NF EN ISO 14155 (05/2012)

    Clinical investigation of medical devices for human subjects - Good clinical practice
    5/1/2012 - Paper - French -
    Learn More
    €127.55

  • ISO 13022:2012 (R2017)

    Medical products containing viable human cells -- Application of risk management and requirements for processing practices
    4/1/2012 - Paper - Russian -
    Learn More
    €165.00

  • ISO 13022:2012 (R2017)

    Medical products containing viable human cells -- Application of risk management and requirements for processing practices
    4/1/2012 - Paper - English -
    Learn More
    €165.00

  • JIS T 0993-1:2012 (R2016)

    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
    3/1/2012 - PDF - Japanese -
    Learn More
    €36.27

  • JIS T 6001:2012

    Evaluation of biocompatibility of medical devices used in dentistry
    3/1/2012 - PDF - Japanese -
    Learn More
    €41.86

  • JIS T 0993-7:2012 (R2016)

    Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
    3/1/2012 - PDF - Japanese -
    Learn More
    €58.50

  • UNE-EN ISO 14155:2012

    Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
    2/22/2012 - PDF - Spanish -
    Learn More
    €82.00

  • DIN EN ISO 14155:2012-01

    Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011 + Cor. 1:2011); German version EN ISO 14155:2011 + AC:2011
    1/1/2012 - PDF - English -
    Learn More
    €191.70

  • AAMI/ISO 13022:2012

    Medical products containing viable human cells -- Application of risk management and requirements for processing practices
    1/1/2012 - PDF sécurisé - English -
    Learn More
    €211.41

  • AAMI/ISO 10993-12:2012

    Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
    1/1/2012 - PDF sécurisé - English -
    Learn More
    €128.76

  • DIN EN ISO 14155:2012-01

    Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011 + Cor. 1:2011); German version EN ISO 14155:2011 + AC:2011
    1/1/2012 - PDF - German -
    Learn More
    €153.40

  • ISO 14155:2011/Cor 1:2011

    Clinical investigation of medical devices for human subjects -- Good clinical practice
    7/1/2011 - Paper - French -
    Learn More
    €0.00

  • ISO 14155:2011/Cor 1:2011

    Clinical investigation of medical devices for human subjects -- Good clinical practice
    7/1/2011 - Paper - English -
    Learn More
    €0.00

  • BS EN ISO 14155:2011

    Clinical investigation of medical devices for human subjects. Good clinical practice
    2/28/2011 - PDF - English -
    Learn More
    €282.90

  • PD ISO/TR 22442-4:2010 (R2016)

    Medical devices utilizing animal tissues and their derivatives. Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes
    2/28/2011 - PDF - English -
    Learn More
    €202.40

  • ISO 14155:2011

    Clinical investigation of medical devices for human subjects -- Good clinical practice
    2/1/2011 - Paper - Russian -
    Learn More
    €186.00

  • ISO 14155:2011

    Clinical investigation of medical devices for human subjects -- Good clinical practice
    2/1/2011 - Paper - French -
    Learn More
    €186.00

  • ISO 14155:2011

    Clinical investigation of medical devices for human subjects -- Good clinical practice
    2/1/2011 - Paper - English -
    Learn More
    €186.00

  • ISO/TR 22442-4:2010 (R2016)

    Medical devices utilizing animal tissues and their derivatives -- Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes
    12/1/2010 - Paper - English -
    Learn More
    €92.00

  • UNE-EN ISO 10993-13:2010

    Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
    11/17/2010 - PDF - Spanish -
    Learn More
    €54.00

  • DIN EN ISO 10993-13:2010-11

    Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010); German version EN ISO 10993-13:2010
    11/1/2010 - PDF - German -
    Learn More
    €89.00

  • DIN EN ISO 10993-13:2010-11

    Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010); German version EN ISO 10993-13:2010
    11/1/2010 - PDF - English -
    Learn More
    €111.40

  • BS EN ISO 10993-13:2010 (R2013)

    Biological evaluation of medical devices. Identification and quantification of degradation products from polymeric medical devices
    10/31/2010 - PDF - English -
    Learn More
    €202.40

  • NF S99-501-13, NF EN ISO 10993-13 (09/2010)

    Biological evaluation of medical devices - Part 13 : identification and quantification of degradation products from polymeric medical devices
    9/1/2010 - Paper - English -
    Learn More
    €66.72

  • NF S99-501-13, NF EN ISO 10993-13 (09/2010)

    Biological evaluation of medical devices - Part 13 : identification and quantification of degradation products from polymeric medical devices
    9/1/2010 - Paper - French -
    Learn More
    €66.72

  • ISO 10993-10:2010 (R2016)

    Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
    8/1/2010 - Paper - French -
    Learn More
    €186.00

  • ISO 10993-10:2010 (R2016)

    Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
    8/1/2010 - Paper - English -
    Learn More
    €186.00

  • NBN EN ISO 10993-13:2010

    Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
    7/30/2010 - PDF - German -
    Learn More
    €77.00

  • NBN EN ISO 10993-13:2010

    Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
    7/30/2010 - PDF - English -
    Learn More
    €77.00

  • NBN EN ISO 10993-13:2010

    Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
    7/30/2010 - PDF - French -
    Learn More
    €77.00

  • NF S99-501-1, NF EN ISO 10993-1 (07/2010)

    Biological evaluation of medical devices - Part 1 : evaluation and testing within a risk management system process
    7/1/2010 - Paper - English -
    Learn More
    €76.40

  • NF S99-501-1, NF EN ISO 10993-1 (07/2010)

    Biological evaluation of medical devices - Part 1 : evaluation and testing within a risk management system process
    7/1/2010 - Paper - French -
    Learn More
    €76.40

  • NF S99-501-5, NF EN ISO 10993-5 (07/2010)

    Biological evaluation of medical devices - Part 5 : tests for in vitro cytotoxicity
    7/1/2010 - Paper - French -
    Learn More
    €87.56

  • NF S99-501-5, NF EN ISO 10993-5 (07/2010)

    Biological evaluation of medical devices - Part 5 : tests for in vitro cytotoxicity
    7/1/2010 - Paper - English -
    Learn More
    €87.56

  • BS EN ISO 10993-9:December 2009

    Biological evaluation of medical devices. Framework for identification and quantification of potential degradation products
    6/30/2010 - PDF - English -
    Learn More
    €144.90

  • BS EN ISO 10993-1:October 2009

    Biological evaluation of medical devices. Evaluation and testing within a risk management process
    6/30/2010 - PDF - English -
    Learn More
    €236.90

  • UNE-EN ISO 10993-9:2010

    Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
    6/9/2010 - PDF - Spanish -
    Learn More
    €51.00

  • ISO 10993-13:2010 (R2019)

    Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices
    6/1/2010 - Paper - French -
    Learn More
    €92.00

  • ISO 10993-13:2010 (R2019)

    Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices
    6/1/2010 - Paper - English -
    Learn More
    €92.00

  • NF S99-501-9, NF EN ISO 10993-9 (05/2010)

    Biological evaluation of medical devices - Part 9 : framework for identification and quantification of potential degradation products
    5/1/2010 - Paper - French -
    Learn More
    €53.41

  • NF S99-501-9, NF EN ISO 10993-9 (05/2010)

    Biological evaluation of medical devices - Part 9 : framework for identification and quantification of potential degradation products
    5/1/2010 - Paper - English -
    Learn More
    €53.41

  • UNE-EN ISO 10993-1:2010

    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
    4/7/2010 - PDF - Spanish -
    Learn More
    €57.00

  • DIN EN ISO 10993-9:2010-04

    Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009); German version EN ISO 10993-9:2009
    4/1/2010 - PDF - German -
    Learn More
    €75.40

  • DIN EN ISO 10993-1:2010-04

    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009
    4/1/2010 - PDF - German -
    Learn More
    €103.00

  • DIN EN ISO 10993-9:2010-04

    Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009); German version EN ISO 10993-9:2009
    4/1/2010 - PDF - English -
    Learn More
    €94.40

  • DIN EN ISO 10993-1:2010-04

    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009
    4/1/2010 - PDF - English -
    Learn More
    €128.80

  • NBN EN ISO 10993-9:2010

    Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
    2/19/2010 - PDF - English -
    Learn More
    €56.00

  • NBN EN ISO 10993-9:2010

    Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
    2/19/2010 - PDF - French -
    Learn More
    €56.00

  • NBN EN ISO 10993-9:2010

    Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
    2/19/2010 - PDF - German -
    Learn More
    €56.00

  • AAMI/ISO 10993-13:2010 (R2014)

    Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
    1/1/2010 - PDF sécurisé - English -
    Learn More
    €90.48

  • AAMI/ISO 14155:2010

    Clinical investigation of medical devices for human subjects - Good clinical practice
    1/1/2010 - PDF sécurisé - English -
    Learn More
    €193.14

  • AAMI/ISO 10993-10:2010 (R2014)

    Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
    1/1/2010 - PDF sécurisé - English -
    Learn More
    €181.83

  • NBN EN ISO 10993-1 (12/2009):2009

    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
    12/16/2009 - PDF - English -
    Learn More
    €77.00

  • NBN EN ISO 10993-1 (12/2009):2009

    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
    12/16/2009 - PDF - French -
    Learn More
    €77.00

  • NBN EN ISO 10993-1 (12/2009):2009

    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
    12/16/2009 - PDF - German -
    Learn More
    €77.00

  • UNE-EN ISO 10993-5:2009

    Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
    12/9/2009 - PDF - Spanish -
    Learn More
    €62.00

  • NF S91-155, NF EN ISO 22794 (12/2009)

    Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file
    12/1/2009 - Paper - English -
    Learn More
    €53.41

  • NF S91-155, NF EN ISO 22794 (12/2009)

    Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file
    12/1/2009 - Paper - French -
    Learn More
    €53.41

  • NF S99-501-18, NF EN ISO 10993-18 (12/2009)

    Biological evaluation of medical devices - Part 18 : chemical characterization of materials
    12/1/2009 - Paper - French -
    Learn More
    €66.72

  • NF S99-501-18, NF EN ISO 10993-18 (12/2009)

    Biological evaluation of medical devices - Part 18 : chemical characterization of materials
    12/1/2009 - Paper - English -
    Learn More
    €66.72

  • ISO 10993-9:2009 (R2013)

    Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products
    12/1/2009 - Paper - French -
    Learn More
    €61.00

  • ISO 10993-9:2009 (R2013)

    Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products
    12/1/2009 - Paper - English -
    Learn More
    €61.00

  • UNE-EN ISO 10993-15:2009

    Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)
    11/4/2009 - PDF - Spanish -
    Learn More
    €52.00

  • ISO 10993-7:2008/Cor 1:2009

    Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals
    11/1/2009 - Paper - English -
    Learn More
    €0.00

  • ISO 10993-7:2008/Cor 1:2009

    Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals
    11/1/2009 - Paper - French -
    Learn More
    €0.00

  • DIN EN ISO 10993-5:2009-10

    Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); German version EN ISO 10993-5:2009
    10/1/2009 - PDF - German -
    Learn More
    €119.60

  • DIN EN ISO 10993-15:2009-10

    Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000); German version EN ISO 10993-15:2009
    10/1/2009 - PDF - German -
    Learn More
    €82.60

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