11.100.20 : Biological evaluation of medical devices

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  • BS EN ISO 10993-18:2020

    Biological evaluation of medical devices Chemical characterization device materials within a risk management process
    6/1/2020 - PDF - English - BSI
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    €324.69

  • PR NF EN ISO 10993-2, S99-501-2PR (04/2020)


    4/1/2020 - Paper - English, French - AFNOR
    Learn More
    €91.25

  • PR NF EN ISO 10993-10, S99-501-10PR (04/2020)


    4/1/2020 - Paper - English, French - AFNOR
    Learn More
    €145.65

  • 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
    €215.67

  • 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
    €215.67

  • 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
    €280.37

  • 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
    €369.72

  • BS EN ISO 22442-1:2015 + Redline

    Tracked Changes. Medical devices utilizing animal tissues and their derivatives Application of risk management
    2/24/2020 - PDF - English - BSI
    Learn More
    €329.67

  • BS EN ISO 22442-2:2015 + Redline

    Tracked Changes. Medical devices utilizing animal tissues and their derivatives Controls on sourcing, collection handling
    2/24/2020 - PDF - English - BSI
    Learn More
    €280.37

  • 20/30398724 DC:2020

    BS EN ISO 10993-2. Biological evaluation of medical devices Part 2. Animal welfare requirements
    2/17/2020 - PDF - English - BSI
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    €23.70

  • 20/30377819 DC:2020

    BS EN ISO 10993-10. Biological evaluation of medical devices Part 10. Tests for skin sensitization
    2/17/2020 - PDF - English - BSI
    Learn More
    €23.70

  • PR NF EN ISO 10993-12, S99-501-12PR (07/2019)

    Évaluation biologique des dispositifs médicaux - Partie 12 : Préparation des échantillons et matériaux de référence
    7/1/2019 - Paper - English, French - AFNOR
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    €108.02

  • PR NF EN ISO 10993-23, S99-501-23PR (07/2019)

    Évaluation biologique des dispositifs médicaux - Partie 23 : Essais d'irritation
    7/1/2019 - Paper - English, French - AFNOR
    Learn More
    €143.65

  • 19/30372368 DC:2019

    BS EN ISO 10993-23. Biological evaluation of medical devices Part 23. Tests for irritation
    5/13/2019 - PDF - English - BSI
    Learn More
    €23.70

  • 19/30376763 DC:2019

    BS EN ISO 10993-12. Biological evaluation of medical devices Part 12. Sample preparation and reference materials
    5/13/2019 - PDF - English - BSI
    Learn More
    €23.70

  • 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
    €154.05

  • 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 - ISO
    Learn More
    €61.00

  • PR NF EN ISO 22442-2, S97-601-2PR (02/2019)

    Dispositifs médicaux utilisant des tissus animaux et leurs dérivés - Partie 2 : contrôles de l'origine, de la collecte et du traitement
    2/1/2019 - Paper - English, French - AFNOR
    Learn More
    €96.05

  • UNE-EN ISO 10993-11:2018

    Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
    12/26/2018 - PDF - Spanish - AENOR
    Learn More
    €72.00

  • UNE-EN ISO 10993-11:2018

    Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
    12/26/2018 - PDF - English - AENOR
    Learn More
    €86.00

  • 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 - DIN
    Learn More
    €96.00

  • ASTM E2805-18

    Standard Practice for Measurement of the Biological Activity of Ricin
    12/1/2018 - PDF - English - ASTM
    Learn More
    €52.00

  • ASTM E2805-18 + Redline

    Standard Practice for Measurement of the Biological Activity of Ricin
    12/1/2018 - PDF - English - ASTM
    Learn More
    €62.00

  • PR NF EN ISO 22442-1, S97-601-1PR (12/2018)

    Dispositifs médicaux utilisant des tissus animaux et leurs dérivés - Partie 1 : Application de la gestion des risques
    12/1/2018 - Paper - English, French - AFNOR
    Learn More
    €113.71

  • BS EN ISO 7405:2018

    Dentistry. Evaluation of biocompatibility of medical devices used in dentistry
    11/28/2018 - PDF - English - BSI
    Learn More
    €300.99

  • 18/30380349 DC:2018

    BS ENISO 22442-2. Medical devices utilizing animal tissues and their derivatives Part 2. Controls on sourcing, collection handling
    11/28/2018 - PDF - English - BSI
    Learn More
    €23.70

  • NF EN ISO 7405, S91-224 (11/2018)

    Dentistry - Evaluation of biocompatibility of medical devices used in dentistry - Médecine bucco-dentaire - Évaluation de la biocompatibilité des dispositifs médicaux utilisés en médecine bucco-dentaire
    11/1/2018 - Paper - French - AFNOR
    Learn More
    €100.63

  • PR NF EN ISO 10993-7/A1, S99-501-7/A1PR (10/2018)

    Évaluation biologique des dispositifs médicaux - Partie 7: Résidus de stérilisation à l'oxyde d'éthylène - Amendement 1
    10/1/2018 - Paper - French - AFNOR
    Learn More
    €63.66

  • 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 - DIN
    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 - DIN
    Learn More
    €175.40

  • 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 - - - DIN
    Learn More
    From: €125.30

  • 18/30355036 DC:2018

    BS EN ISO 10993-7 AMD1. Biological evaluation of medical devices Part 7. Ethylene oxide sterilization residuals
    8/16/2018 - PDF - English - BSI
    Learn More
    €23.70

  • 18/30358832 DC:2018

    BS EN ISO 10993-18. Biological evaluation of medical devices Part 18. Chemical characterization device materials within a risk management process
    8/15/2018 - PDF - English - BSI
    Learn More
    €23.70

  • 18/30375452 DC:2018

    BS EN ISO 22442-1. Medical devices utilizing animal tissues and their derivatives Part 1. Application of risk management
    8/15/2018 - PDF - English - BSI
    Learn More
    €23.70

  • 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 - DIN
    Learn More
    €96.00

  • 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 - DIN
    Learn More
    €191.40

  • 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 - DIN
    Learn More
    €68.30

  • ISO 10993-1:2018

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

  • ISO 10993-1:2018

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

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

    Investigation clinique des dispositifs médicaux pour sujets humains - Bonnes pratiques cliniques
    8/1/2018 - Paper - English, French - AFNOR
    Learn More
    €185.65

  • 18/30370871 DC:2018

    BS EN ISO 20776-1. Susceptibility testing of infectious agents and evaluation performance antimicrobial susceptibility test devices Part 1. Broth micro-dilution reference method for the in vitro activity against rapidly growing aerobic bacteria involved diseases
    7/6/2018 - PDF - English - BSI
    Learn More
    €23.70

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

    Biological evaluation of medical devices - Part 4 : selection of tests for interactions with blood - Evaluation biologique des dispositifs médicaux - Partie 4 : Choix des essais pour les interactions avec le sang
    7/1/2018 - Paper - French - AFNOR
    Learn More
    €122.38

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

    Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys - Évaluation biologique des dispositifs médicaux - Partie 15 : Identification et quantification des produits de dégradation issus des métaux et alliages
    7/1/2018 - Paper - English, French - AFNOR
    Learn More
    €96.05

  • 18/30344902 DC:2018

    BS EN ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice
    6/26/2018 - PDF - English - BSI
    Learn More
    €23.70

  • 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 - NBN
    Learn More
    €56.00

  • BS EN ISO 10993-11:2018

    Biological evaluation of medical devices Tests for systemic toxicity
    6/18/2018 - PDF - English - BSI
    Learn More
    €253.59

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

    Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products - Évaluation biologique des dispositifs médicaux - Partie 9 : Cadre pour l'identification et la quantification des produits potentiels de dégradation
    6/1/2018 - Paper - English, French - AFNOR
    Learn More
    €87.32

  • UNE-EN ISO 10993-16:2018

    Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
    5/16/2018 - PDF - Spanish - AENOR
    Learn More
    €58.00

  • UNE-EN ISO 10993-16:2018

    Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
    5/16/2018 - PDF - English - AENOR
    Learn More
    €69.00

  • 18/30354689 DC:2018

    BS EN ISO 10993-9. Biological evaluation of medical devices Part 9. Framework for identification and quantification potential degradation products
    5/4/2018 - PDF - English - BSI
    Learn More
    €23.70

  • 18/30354781 DC:2018

    BS EN ISO 10993-15. Biological evaluation of medical devices Part 15. Identification and quantification degradation products from metals alloys
    5/2/2018 - PDF - English - BSI
    Learn More
    €23.70

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

    Biological evaluation of medical devices - Part 11 : tests for systemic toxicity - Évaluation biologique des dispositifs médicaux - Partie 11 : essais de toxicité systémique
    5/1/2018 - Paper - French - AFNOR
    Learn More
    €84.02

  • VDI 5701:2018-05

    Biomaterials in medicine - Classification, requirements, and applications
    5/1/2018 - PDF - English, German - VDI
    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 - DIN
    Learn More
    €89.00

  • 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 - DIN
    Learn More
    €96.00

  • VDI 2017:2018-04

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

  • 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 - ASTM
    Learn More
    €52.00

  • 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 - - - DIN
    Learn More
    From: €89.00

  • 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 - NBN
    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 - NBN
    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 - French - NBN
    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 - AENOR
    Learn More
    €113.00

  • 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 - English - AENOR
    Learn More
    €135.00

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

    Biological evaluation of medical devices - Part 16 : Toxicokinetic study design for degradation products and leachables - Évaluation biologique des dispositifs médicaux - Partie 16 : Conception des études toxicocinétiques des produits de dégradation et des substances relargables
    12/1/2017 - Paper - French - AFNOR
    Learn More
    €64.01

  • 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 - - - DIN
    Learn More
    From: €191.40

  • 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 - AENOR
    Learn More
    €70.00

  • 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 - English - AENOR
    Learn More
    €84.00

  • ISO 10993-11:2017

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

  • ISO 10993-11:2017

    Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
    9/1/2017 - Paper - French - ISO
    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 - - - DIN
    Learn More
    From: €119.60

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

    Biological evaluation of medical devices - Part 22 : guidance on nanomaterials - Évaluation biologique des dispositifs médicaux - Partie 22 : lignes directrices sur la nanomatériaux
    8/1/2017 - Paper - French - AFNOR
    Learn More
    €122.38

  • PD ISO/TR 10993-22:2017

    Biological evaluation of medical devices Guidance on nanomaterials
    7/19/2017 - PDF - English - BSI
    Learn More
    €324.69

  • ISO/TR 10993-22:2017

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

  • ISO/TR 10993-22:2017

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

  • 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
    €324.69

  • ISO 10993-16:2017

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

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

    Biological evaluation of medical devices - Part 6 : tests for local effects after implantation - Évaluation biologique des dispositifs médicaux - Partie 6 : essais concernant les effets locaux après implantation
    4/1/2017 - Paper - French - AFNOR
    Learn More
    €84.02

  • 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 - DIN
    Learn More
    €136.80

  • ISO 10993-4:2017

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

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

    Biological evaluation of medical devices - Part 1 : Evaluation and testing within a risk management process - Évaluation biologique des dispositifs médicaux - Partie 1 : Évaluation et essais au sein d'un processus de gestion du risque
    4/1/2017 - Paper - English, French - AFNOR
    Learn More
    €116.74

  • 17/30344601 DC:2017

    BS EN ISO 10993-1. Biological evaluation of medical devices. Part 1. Evaluation and testing within a risk management process
    2/20/2017 - PDF - English - BSI
    Learn More
    €23.70

  • 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
    €215.67

  • BS EN ISO 10993-1:October 2009

    Biological evaluation of medical devices Evaluation and testing within a risk management process
    1/31/2017 - PDF - English - BSI
    Learn More
    €253.59

  • 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 - NBN
    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 - NBN
    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 - French - NBN
    Learn More
    €56.00

  • 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
    €284.40

  • ISO 10993-6:2016

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

  • ISO 10993-6:2016

    Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
    12/1/2016 - Paper - French - ISO
    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 - BSI
    Learn More
    €215.67

  • 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 - ISO
    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 - JSA
    Learn More
    €25.00

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

    Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management - Dispositifs médicaux utilisant des tissus animaux et leurs dérivés - Partie 1 : Application de la gestion des risques
    7/1/2016 - Paper - French - AFNOR
    Learn More
    €73.30

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

    Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling - Dispositifs médicaux utilisant des tissus animaux et leurs dérivés - Partie 2 : Contrôles de l'origine, de la collecte et du traitement
    7/1/2016 - Paper - French - AFNOR
    Learn More
    €64.01

  • ASTM E3060-16

    Standard Guide for Subvisible Particle Measurement in Biopharmaceutical Manufacturing Using Dynamic (Flow) Imaging Microscopy
    6/1/2016 - PDF - English - ASTM
    Learn More
    €52.00

  • 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 - AENOR
    Learn More
    €63.00

  • 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 - English - AENOR
    Learn More
    €75.00

  • 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 - AENOR
    Learn More
    €58.00

  • 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 - English - AENOR
    Learn More
    €69.00

  • BS EN ISO 22442-2:2015

    Medical devices utilizing animal tissues and their derivatives Controls on sourcing, collection handling
    12/31/2015 - PDF - English - BSI
    Learn More
    €215.67

  • BS EN ISO 22442-1:2015

    Medical devices utilizing animal tissues and their derivatives Application of risk management
    11/30/2015 - PDF - English - BSI
    Learn More
    €253.59

  • ISO 22442-1:2015

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

  • 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 - ISO
    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 - French - ISO
    Learn More
    €92.00

  • 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 - AENOR
    Learn More
    €69.00

  • 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 - English - AENOR
    Learn More
    €82.00

  • 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
    €300.99

  • 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 - ISO
    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 - - - DIN
    Learn More
    From: €119.60

  • 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 - NBN
    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 - NBN
    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 - French - NBN
    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 - BSI
    Learn More
    €284.40

  • ISO 10993-3:2014

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

  • ISO 10993-3:2014

    Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
    10/1/2014 - Paper - French - ISO
    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 - - - DIN
    Learn More
    From: €169.80

  • 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
    €23.70

  • €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 - - - DIN
    Learn More
    From: €141.90

  • BS EN ISO 10993-10:2013

    Biological evaluation of medical devices Tests for irritation and skin sensitization
    2/28/2014 - PDF - English - BSI
    Learn More
    €324.69

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

    Biological evaluation of medical devices - Part 10 : tests for irritation and skin sensitization - Évaluation biologique des dispositifs médicaux
    12/1/2013 - Paper - French - AFNOR
    Learn More
    €122.38

  • 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 - AENOR
    Learn More
    €95.00

  • 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 - English - AENOR
    Learn More
    €114.00

  • 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 - NBN
    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 - NBN
    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 - French - NBN
    Learn More
    €145.00

  • 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 - AENOR
    Learn More
    €60.00

  • 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 - English - AENOR
    Learn More
    €72.00

  • BS EN ISO 10993-12:2012

    Biological evaluation of medical devices Sample preparation and reference materials
    10/31/2012 - PDF - English - BSI
    Learn More
    €253.59

  • 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 - - - DIN
    Learn More
    From: €103.00

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

    Biological evaluation of medical devices - Part 12 : sample preparation and reference materials
    9/1/2012 - Paper - French - AFNOR
    Learn More
    €73.30

  • 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 - NBN
    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 - NBN
    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 - French - NBN
    Learn More
    €105.00

  • ISO 10993-12:2012

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

  • ISO 10993-12:2012

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

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

    Clinical investigation of medical devices for human subjects - Good clinical practice - Investigation clinique des dispositifs médicaux pour sujets humains
    5/1/2012 - Paper - French - AFNOR
    Learn More
    €122.38

  • ISO 13022:2012

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

  • ISO 13022:2012

    Medical products containing viable human cells — Application of risk management and requirements for processing practices
    4/1/2012 - Paper - Russian - ISO
    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 - JSA
    Learn More
    €36.27

  • JIS T 6001:2012

    Evaluation of biocompatibility of medical devices used in dentistry
    3/1/2012 - PDF - Japanese - JSA
    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 - JSA
    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 - AENOR
    Learn More
    €87.00

  • UNE-EN ISO 14155:2012

    Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
    2/22/2012 - PDF - English - AENOR
    Learn More
    €104.00

  • 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 - - - DIN
    Learn More
    From: €153.40

  • 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 - AAMI
    Learn More
    €223.56

  • BS EN ISO 14155:2011

    Clinical investigation of medical devices for human subjects. Good clinical practice
    9/30/2011 - PDF - English - BSI
    Learn More
    €300.99

  • 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
    €215.67

  • ISO 14155:2011

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

  • ISO 14155:2011

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

  • ISO 14155:2011

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

  • ISO/TR 22442-4:2010

    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 - ISO
    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 - AENOR
    Learn More
    €57.00

  • 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 - English - AENOR
    Learn More
    €68.00

  • 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 - - - DIN
    Learn More
    From: €89.00

  • 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
    €215.67

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

    Biological evaluation of medical devices - Part 13 : identification and quantification of degradation products from polymeric medical devices
    9/1/2010 - Paper - French - AFNOR
    Learn More
    €64.01

  • ISO 10993-10:2010

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

  • ISO 10993-10:2010

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

  • BS EN ISO 10993-7:2008

    Biological evaluation of medical devices Ethylene oxide sterilization residuals
    7/31/2010 - PDF - English - BSI
    Learn More
    €324.69

  • BS EN ISO 10993-9:December 2009

    Biological evaluation of medical devices Framework for identification and quantification potential degradation products
    7/31/2010 - PDF - English - BSI
    Learn More
    €154.05

  • 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 - NBN
    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 - NBN
    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 - NBN
    Learn More
    €77.00

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

    Biological evaluation of medical devices - Part 5 : tests for in vitro cytotoxicity
    7/1/2010 - Paper - French - AFNOR
    Learn More
    €84.02

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

    Biological evaluation of medical devices - Part 1 : evaluation and testing within a risk management system process
    7/1/2010 - Paper - French - AFNOR
    Learn More
    €73.30

  • 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 - AENOR
    Learn More
    €54.00

  • 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 - English - AENOR
    Learn More
    €64.00

  • ISO 10993-13:2010

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

  • ISO 10993-13:2010

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

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

    Biological evaluation of medical devices - Part 9 : framework for identification and quantification of potential degradation products
    5/1/2010 - Paper - French - AFNOR
    Learn More
    €51.24

  • 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 - AENOR
    Learn More
    €60.00

  • 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 - English - AENOR
    Learn More
    €72.00

  • 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 - - - DIN
    Learn More
    From: €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 - - - DIN
    Learn More
    From: €75.40

  • 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 - NBN
    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 - English - NBN
    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 - NBN
    Learn More
    €56.00

  • AAMI/ISO 14155:2010

    Clinical investigation of medical devices for human subjects - Good clinical practice
    1/1/2010 - PDF sécurisé - English - AAMI
    Learn More
    €204.24

  • 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 - NBN
    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 - English - NBN
    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 - NBN
    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 - AENOR
    Learn More
    €66.00

  • 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 - English - AENOR
    Learn More
    €79.00

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

    Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file - Art dentaire
    12/1/2009 - Paper - French - AFNOR
    Learn More
    €51.24

  • 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 - AENOR
    Learn More
    €55.00

  • 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 - English - AENOR
    Learn More
    €66.00

  • 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 - - - DIN
    Learn More
    From: €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 - - - DIN
    Learn More
    From: €82.60

  • NBN EN ISO 10993-5:2009

    Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
    9/11/2009 - PDF - German - NBN
    Learn More
    €77.00

  • NBN EN ISO 10993-5:2009

    Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
    9/11/2009 - PDF - English - NBN
    Learn More
    €77.00

  • NBN EN ISO 10993-5:2009

    Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
    9/11/2009 - PDF - French - NBN
    Learn More
    €77.00

  • NBN 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)
    9/11/2009 - PDF - German - NBN
    Learn More
    €56.00

  • NBN 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)
    9/11/2009 - PDF - English - NBN
    Learn More
    €56.00

  • NBN 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)
    9/11/2009 - PDF - French - NBN
    Learn More
    €56.00

  • UNE-EN ISO 10993-14:2009

    Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
    9/9/2009 - PDF - Spanish - AENOR
    Learn More
    €54.00

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