11 : Health care technology

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  • IEC 80601-2-26:2019/AMD1:2024

    IEC 80601-2-26:2019/AMD1:2024 Amendment 1 - Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
    2/14/2024 - PDF - English, French - IEC
    Learn More
    €23.00

  • NF EN ISO 11139/A1, S98-131/A1 (01/2024)

    Stérilisation des produits de santé - Vocabulaire des termes utilisés dans les normes de procédés de stérilisation et les équipements connexes - Amendement 1 : termes et définitions modifiés et supplémentaires
    1/1/2024 - Paper - French - AFNOR
    Learn More
    €75.67

  • NF EN IEC 60601-2-35/A1, C74-330/A1 (01/2024)

    Appareils électromédicaux - Partie 2-35 : exigences particulières pour la sécurité de base et les performances essentielles des dispositifs de réchauffage utilisant des couvertures, des coussins ou des matelas et destinés au réchauffage des patients en usage médical
    1/1/2024 - Paper - French - AFNOR
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    €54.67

  • NBN ISO 18242:2016/A1:2023

    Cardiovascular implants and extracorporeal systems — Centrifugal blood pumps — Amendment 1: Worst-case conditions for testing ISO 18242:2016/Amd 1:2023
    12/22/2023 - PDF - English - NBN
    Learn More
    €20.00

  • IEC 60601-2-35:2020/AMD1:2023

    IEC 60601-2-35:2020/AMD1:2023 Amendment 1 - Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use
    12/21/2023 - PDF - English, French - IEC
    Learn More
    €23.00

  • ISO 80601-2-55:2018/AMD1:2023

    ISO 80601-2-55:2018/AMD1:2023 Amendment 1 - Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
    12/6/2023 - PDF - English - ISOIEC
    Learn More
    €19.00

  • ISO 80601-2-55:2018/AMD1:2023

    ISO 80601-2-55:2018/AMD1:2023 Amendment 1 - Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
    12/6/2023 - PDF - French - ISOIEC
    Learn More
    €19.00

  • NF EN ISO 80601-2-55/A1, S95-186-2-55/A1 (12/2023)

    Appareils électromédicaux - Partie 2-55 : exigences particulières relatives à la sécurité de base et aux performances essentielles des moniteurs de gaz respiratoires - Amendement 1
    12/1/2023 - Paper - French - AFNOR
    Learn More
    €54.50

  • NF EN IEC 60601-2-19/A1, C74-320/A1 (12/2023)

    Appareils électromédicaux - Partie 2-19 : exigences particulières pour la sécurité de base et les performances essentielles des incubateurs pour nouveau-nés
    12/1/2023 - Paper - French - AFNOR
    Learn More
    €88.33

  • NF EN IEC 60601-2-21/A1, C74-324/A1 (12/2023)

    Appareils électromédicaux - Partie 2-21 : exigences particulières pour la sécurité de base et les performances essentielles des incubateurs radiants pour nouveau-nés
    12/1/2023 - Paper - French - AFNOR
    Learn More
    €65.00

  • NF EN IEC 60601-2-20/A1, C74-321/A1 (12/2023)

    Appareils électromédicaux - Partie 2-20 : exigences particulières pour la sécurité de base et les performances essentielles des incubateurs de transport pour nouveau-nés
    12/1/2023 - Paper - French - AFNOR
    Learn More
    €79.50

  • NF EN IEC 60601-2-50/A1, C74-350/A1 (12/2023)

    Appareils électromédicaux - Partie 2-50 : exigences particulières pour la sécurité de base et les performances essentielles des appareils de photothérapie pour nouveau-nés
    12/1/2023 - Paper - French - AFNOR
    Learn More
    €49.50

  • NF EN IEC 80601-2-77/A1, C74-397/A1 (12/2023)

    Appareils électromédicaux - Partie 2-77 : exigences particulières pour la sécurité de base et les performances essentielles des appareils chirurgicaux robotiquement assistés
    12/1/2023 - Paper - French - AFNOR
    Learn More
    €65.00

  • IEC 80601-2-77:2019/AMD1:2023

    IEC 80601-2-77:2019/AMD1:2023 Amendment 1 - Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
    11/15/2023 - PDF - English, French - IEC
    Learn More
    €23.00

  • IEC 60601-2-19:2020/AMD1:2023

    IEC 60601-2-19:2020/AMD1:2023 Amendment 1 - Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
    11/9/2023 - PDF - English, French - IEC
    Learn More
    €46.00

  • IEC 60601-2-20:2020/AMD1:2023

    IEC 60601-2-20:2020/AMD1:2023 Amendment 1 - Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
    11/9/2023 - PDF - English, French - IEC
    Learn More
    €46.00

  • UNE-EN IEC 60601-2-76:2019/A1:2023

    Medical electrical equipment - Part 2-76: Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment (Endorsed by Asociación Española de Normalización in November of 2023.)
    11/3/2023 - PDF - English - AENOR
    Learn More
    €35.00

  • IEC 60601-2-21:2020/AMD1:2023

    IEC 60601-2-21:2020/AMD1:2023 Amendment 1 - Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
    11/3/2023 - PDF - English, French - IEC
    Learn More
    €46.00

  • NF EN ISO 15189/A11, S92-060/A11 (11/2023)

    Laboratoires médicaux - Exigences concernant la qualité et la compétence
    11/1/2023 - Paper - French - AFNOR
    Learn More
    €25.67

  • NF EN ISO 10524-1/A1, S95-159-1/A1 (11/2023)

    Détendeurs pour l'utilisation avec les gaz médicaux - Partie 1 : détendeurs et détendeurs-débitmètres - Amendement 1
    11/1/2023 - Paper - French - AFNOR
    Learn More
    €25.67

  • IEC 60601-2-50:2020/AMD1:2023

    IEC 60601-2-50:2020/AMD1:2023 Amendment 1 - Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
    10/26/2023 - PDF - English, French - IEC
    Learn More
    €23.00

  • UNE-EN ISO 3826-1:2020/A1:2023

    Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers - Amendment 1 (ISO 3826-1:2019/Amd1:2023)
    10/25/2023 - PDF - Spanish - AENOR
    Learn More
    €34.00

  • UNE-EN ISO 3826-1:2020/A1:2023

    Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers - Amendment 1 (ISO 3826-1:2019/Amd1:2023)
    10/25/2023 - PDF - English - AENOR
    Learn More
    €40.80

  • IEC 60050-871:2018/AMD1:2023

    IEC 60050-871:2018/AMD1:2023 Amendment 1 - International Electrotechnical Vocabulary - Part 871: Active assisted living (AAL)
    10/3/2023 - PDF - English, French - IEC
    Learn More
    €173.00

  • NF EN IEC 60601-2-76/A1, C74-276/A1 (10/2023)

    Appareils électromédicaux - Partie 2-76 : exigences particulières pour la sécurité de base et les performances essentielles des appareils d'hémostase à gaz ionisé à faible pouvoir calorifique
    10/1/2023 - Paper - French - AFNOR
    Learn More
    €31.33

  • NF EN ISO 11607-2/A1, S98-052-2/A1 (10/2023)

    Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2 : exigences de validation pour les procédés de formage, scellage et assemblage - Amendement 1 : application de la gestion des risques
    10/1/2023 - Paper - French - AFNOR
    Learn More
    €43.50

  • NF EN ISO 11607-1/A1, S98-052-1/A1 (10/2023)

    Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 1 : exigences relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage - Amendement 1 : application de la gestion des risques
    10/1/2023 - Paper - French - AFNOR
    Learn More
    €68.50

  • DIN 6876 Beiblatt 1:2023-10

    Operation of medical magnetic resonance systems, Supplement 1: General explanations and rationales
    10/1/2023 - PDF - German - DIN
    Learn More
    €141.96

  • UNE-EN IEC 61010-2-101:2023/A11:2023

    Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment
    9/27/2023 - PDF - Spanish - AENOR
    Learn More
    €68.00

  • UNE-EN IEC 61010-2-101:2023/A11:2023

    Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment
    9/27/2023 - PDF - English - AENOR
    Learn More
    €81.60

  • IEC 60601-2-76:2018/AMD1:2023

    IEC 60601-2-76:2018/AMD1:2023 Amendment 1 - Medical electrical equipment - Part 2-76: Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment
    8/31/2023 - PDF - English, French - IEC
    Learn More
    €12.00

  • UNE-CEN ISO/TS 11137-4:2023

    Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020) (Endorsed by Asociación Española de Normalización in August of 2023.)
    8/2/2023 - PDF - English - AENOR
    Learn More
    €95.00

  • UNE-EN ISO 80369-3:2017/A1:2023

    Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1 (ISO 80369-3:2016/Amd 1:2019)
    7/19/2023 - PDF - Spanish - AENOR
    Learn More
    €52.00

  • UNE-EN ISO 80369-3:2017/A1:2023

    Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1 (ISO 80369-3:2016/Amd 1:2019)
    7/19/2023 - PDF - English - AENOR
    Learn More
    €62.40

  • UNE-EN ISO 11137-2:2015/A1:2023

    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)
    7/12/2023 - PDF - Spanish - AENOR
    Learn More
    €57.00

  • UNE-EN ISO 11137-2:2015/A1:2023

    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)
    7/12/2023 - PDF - English - AENOR
    Learn More
    €68.40

  • NF EN ISO 10993-18/A1, S99-501-18/A1 (07/2023)

    Évaluation biologique des dispositifs médicaux - Partie 18 : caractérisation chimique des matériaux des dispositifs médicaux au sein d'un processus de gestion du risque - Amendement 1 : détermination du coefficient d'incertitude
    7/1/2023 - Paper - French - AFNOR
    Learn More
    €31.00

  • UNE-EN ISO 8536-15:2022/A1:2023

    Infusion equipment for medical use - Part 15: Light-protective infusion sets for single use - Amendment 1 (ISO 8536-15:2022/Amd 1:2023)
    6/21/2023 - PDF - Spanish - AENOR
    Learn More
    €34.00

  • UNE-EN ISO 8536-15:2022/A1:2023

    Infusion equipment for medical use - Part 15: Light-protective infusion sets for single use - Amendment 1 (ISO 8536-15:2022/Amd 1:2023)
    6/21/2023 - PDF - English - AENOR
    Learn More
    €40.80

  • UNE-EN ISO 8362-2:2015/A1:2023

    Injection containers and accessories - Part 2: Closures for injection vials - Amendment 1 (ISO 8362-2:2015/Amd 1:2022)
    4/26/2023 - PDF - Spanish - AENOR
    Learn More
    €39.00

  • UNE-EN ISO 8362-2:2015/A1:2023

    Injection containers and accessories - Part 2: Closures for injection vials - Amendment 1 (ISO 8362-2:2015/Amd 1:2022)
    4/26/2023 - PDF - English - AENOR
    Learn More
    €46.80

  • UNE-EN ISO 8536-3:2009/A1:2023

    Infusion equipment for medical use - Part 3: Aluminium caps for infusion bottles - Amendment 1 (ISO 8536-3:2009/Amd 1:2022)
    4/26/2023 - PDF - Spanish - AENOR
    Learn More
    €34.00

  • UNE-EN ISO 8536-3:2009/A1:2023

    Infusion equipment for medical use - Part 3: Aluminium caps for infusion bottles - Amendment 1 (ISO 8536-3:2009/Amd 1:2022)
    4/26/2023 - PDF - English - AENOR
    Learn More
    €40.80

  • UNE-EN IEC 80601-2-59:2019/A1:2023

    Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening (Endorsed by Asociación Española de Normalización in April of 2023.)
    4/21/2023 - PDF - English - AENOR
    Learn More
    €42.00

  • NF EN ISO 11137-2/A1, S98-103-2/A1 (04/2023)

    Sterilization of health care products - Radiation - Part 2 : Establishing the sterilization dose - Amendment 1
    4/1/2023 - Paper - French - AFNOR
    Learn More
    €31.00

  • NF EN ISO 3826-1/A1, S93-230-1/A1 (04/2023)

    Poches en plastique souple pour le sang et les composants du sang - Partie 1 : poches conventionnelles - Amendement 1
    4/1/2023 - Paper - French - AFNOR
    Learn More
    €25.67

  • NF EN ISO 8536-15/A1, S93-123-15/A1 (03/2023)

    Matériel de perfusion à usage médical - Partie 15 : perfuseurs photoprotecteurs à usage unique - Amendement 1
    3/1/2023 - Paper - French - AFNOR
    Learn More
    €25.67

  • IEC 60601-2-2:2017/AMD1:2023

    IEC 60601-2-2:2017/AMD1:2023 Amendment 1 - Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
    2/21/2023 - PDF - English, French - IEC
    Learn More
    €46.00

  • NBN ISO 7206-13:2016/A1:2023

    Implants for surgery — Partial and total hip joint prostheses — Part 13: Determination of resistance to torque of head fixation of stemmed femoral components — Amendment 1 ISO 7206-13:2016/Amd 1:2022
    2/1/2023 - PDF - English - NBN
    Learn More
    €20.00

  • NF EN IEC 80601-2-59/A1, C74-394/A1 (02/2023)

    Appareils électromédicaux - Partie 2-59 : exigences particulières pour la sécurité de base et les performances essentielles des imageurs thermiques pour le dépistage des humains fébriles
    2/1/2023 - Paper - French - AFNOR
    Learn More
    €54.67

  • IEC 60601-2-75:2017/AMD1:2023

    IEC 60601-2-75:2017/AMD1:2023 Amendment 1 - Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment
    1/30/2023 - PDF - English, French - IEC
    Learn More
    €46.00

  • IEC 80601-2-59:2017/AMD1:2023

    IEC 80601-2-59:2017/AMD1:2023 Amendment 1 - Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
    1/18/2023 - PDF - English, French - IEC
    Learn More
    €23.00

  • IEC 60601-2-10:2012/AMD2:2023

    IEC 60601-2-10:2012/AMD2:2023 Amendment 2 - Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
    1/18/2023 - PDF - English, French - IEC
    Learn More
    €23.00

  • UNE-EN ISO 25424:2020/A1:2022

    Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/Amd 1:2022)
    12/21/2022 - PDF - Spanish - AENOR
    Learn More
    €58.00

  • UNE-EN ISO 25424:2020/A1:2022

    Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/Amd 1:2022)
    12/21/2022 - PDF - English - AENOR
    Learn More
    €69.60

  • UNE-EN ISO 11607-1:2020/A11:2022

    Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
    12/21/2022 - PDF - Spanish - AENOR
    Learn More
    €57.00

  • UNE-EN ISO 11607-1:2020/A11:2022

    Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
    12/21/2022 - PDF - English - AENOR
    Learn More
    €68.40

  • UNE-EN ISO 11607-2:2020/A11:2022

    Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
    12/21/2022 - PDF - Spanish - AENOR
    Learn More
    €57.00

  • UNE-EN ISO 11607-2:2020/A11:2022

    Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
    12/21/2022 - PDF - English - AENOR
    Learn More
    €68.40

  • IEC 60601-2-83:2019/AMD1:2022

    IEC 60601-2-83:2019/AMD1:2022 Amendment 1 - Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
    12/15/2022 - PDF - English, French - IEC
    Learn More
    €23.00

  • IEC TS 63134:2020/AMD1:2022

    IEC TS 63134:2020/AMD1:2022 Amendment 1 - Active Assisted Living (AAL) use cases
    12/1/2022 - PDF - English - IEC
    Learn More
    €46.00

  • NF EN IEC 61010-2-101/A11, C42-020-2-101/A11 (11/2022)

    Exigences de sécurité pour appareils électriques de mesurage, de régulation et de laboratoire - Partie 2-101 : Exigences particulières pour le matériel médical de diagnostic in vitro (DIV)
    11/1/2022 - Paper - French - AFNOR
    Learn More
    €88.33

  • NF EN ISO 80369-3/A1, S97-190-3/A1 (11/2022)

    Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie 3 : Raccords destinés à des applications entérales - Amendement 1
    11/1/2022 - Paper - French - AFNOR
    Learn More
    €48.00

  • UNE-EN 60601-1:2006/A2:2021

    Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Endorsed by Asociación Española de Normalización in December of 2022.)
    10/12/2022 - PDF - English - AENOR
    Learn More
    €98.00

  • UNE-CEN ISO/TS 5798:2022

    In vitro diagnostic test systems - Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods (ISO/TS 5798:2022) (Endorsed by Asociación Española de Normalización in January of 2023.)
    10/12/2022 - PDF - English - AENOR
    Learn More
    €84.00

  • UNE-CEN/TR 17825:2022

    Chemical disinfectants and antiseptics - Interpretation of water controls in EN 16615:2015 (Endorsed by Asociación Española de Normalización in October of 2022.)
    10/12/2022 - PDF - English - AENOR
    Learn More
    €28.00

  • UNE-EN 60731:2012/A1:2022

    Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy (Endorsed by Asociación Española de Normalización in September of 2022.)
    10/12/2022 - PDF - English - AENOR
    Learn More
    €24.00

  • UNE-EN ISO 13485:2018/A11:2022

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
    9/21/2022 - PDF - Spanish - AENOR
    Learn More
    €74.00

  • UNE-EN ISO 13485:2018/A11:2022

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
    9/21/2022 - PDF - English - AENOR
    Learn More
    €88.80

  • IEC 60601-2-6:2012/AMD2:2022

    IEC 60601-2-6:2012/AMD2:2022 Amendment 2 - Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment
    9/13/2022 - PDF - English, French - IEC
    Learn More
    €12.00

  • IEC 60601-2-3:2012/AMD2:2022

    IEC 60601-2-3:2012/AMD2:2022 Amendment 2 - Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment
    9/12/2022 - PDF - English, French - IEC
    Learn More
    €23.00

  • NF EN ISO 8536-3/A1, S93-123-3/A1 (09/2022)

    Matériel de perfusion à usage médical - Partie 3 : Capsules en aluminium pour flacons de perfusion - Amendement 1
    9/1/2022 - Paper - French - AFNOR
    Learn More
    €25.67

  • NF EN ISO 8362-2/A1, S93-110-2/A1 (09/2022)

    Récipients et accessoires pour produits injectables - Partie 2 : bouchons pour flacons - Amendement 1
    9/1/2022 - Paper - French - AFNOR
    Learn More
    €34.67

  • IEC 60601-2-45:2011/AMD2:2022

    IEC 60601-2-45:2011/AMD2:2022 Amendment 2 - Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
    8/2/2022 - PDF - English, French - IEC
    Learn More
    €46.00

  • NF EN 60731/A1, C74-205/A1 (08/2022)

    Appareils électromédicaux - Dosimètres à chambres d'ionisation utilisés en radiothérapie
    8/1/2022 - Paper - French - AFNOR
    Learn More
    €54.67

  • UNE-EN ISO 10993-7:2009/A1:2022

    Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)
    7/27/2022 - PDF - Spanish - AENOR
    Learn More
    €52.00

  • UNE-EN ISO 10993-7:2009/A1:2022

    Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)
    7/27/2022 - PDF - English - AENOR
    Learn More
    €62.40

  • UNE-EN ISO 14971:2020/A11:2022

    Medical devices - Application of risk management to medical devices (ISO 14971:2019)
    6/22/2022 - PDF - Spanish - AENOR
    Learn More
    €52.00

  • UNE-EN ISO 14971:2020/A11:2022

    Medical devices - Application of risk management to medical devices (ISO 14971:2019)
    6/22/2022 - PDF - English - AENOR
    Learn More
    €62.40

  • UNE-CEN ISO/TR 20342-7:2022

    Assistive products for tissue integrity when lying down - Part 7: Foam properties, characteristics and performance (ISO/TR 20342-7:2021) (Endorsed by Asociación Española de Normalización in June of 2022.)
    6/1/2022 - PDF - English - AENOR
    Learn More
    €62.00

  • UNE-CEN/TS 17747:2022

    Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - DNA, RNA and proteins (Endorsed by Asociación Española de Normalización in June of 2022.)
    6/1/2022 - PDF - English - AENOR
    Learn More
    €72.00

  • NF EN ISO 11607-1/A11, S98-052-1/A11 (06/2022)

    Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 1 : exigences relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage - Amendement A11
    6/1/2022 - Paper - French - AFNOR
    Learn More
    €48.00

  • NF EN ISO 11607-2/A11, S98-052-2/A11 (06/2022)

    Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2 : exigences de validation pour les procédés de formage, scellage et assemblage - Amendement A11
    6/1/2022 - Paper - French - AFNOR
    Learn More
    €48.00

  • NF EN ISO 25424/A1, S98-008/A1 (05/2022)

    Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1
    5/1/2022 - Paper - French - AFNOR
    Learn More
    €34.67

  • UNE-CEN ISO/TS 20342-10:2022

    Assistive products for tissue integrity when lying down - Part 10: Guidance to cleaning, disinfecting and care of polyurethane APTI covers (ISO/TS 20342-10:2022) (Endorsed by Asociación Española de Normalización in May of 2022.)
    5/1/2022 - PDF - English - AENOR
    Learn More
    €62.00

  • UNE-CEN/TS 17742:2022

    Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma (Endorsed by Asociación Española de Normalización in May of 2022.)
    5/1/2022 - PDF - English - AENOR
    Learn More
    €69.00

  • UNE-CEN/TS 15209:2022

    Tactile paving surface indicators produced from concrete, clay and stone
    4/20/2022 - PDF - Spanish - AENOR
    Learn More
    €73.00

  • UNE-CEN/TS 15209:2022

    Tactile paving surface indicators produced from concrete, clay and stone
    4/20/2022 - PDF - English - AENOR
    Learn More
    €87.60

  • UNE-EN ISO 11737-1:2018/A1:2022

    Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)
    2/16/2022 - PDF - Spanish - AENOR
    Learn More
    €58.00

  • UNE-EN ISO 11737-1:2018/A1:2022

    Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)
    2/16/2022 - PDF - English - AENOR
    Learn More
    €69.60

  • UNE-EN ISO 17254:2017/A1:2022

    Dentistry - Coiled springs for use in orthodontics - Amendment 1 (ISO 17254:2016/Amd 1:2020)
    2/9/2022 - PDF - Spanish - AENOR
    Learn More
    €34.00

  • UNE-EN ISO 17254:2017/A1:2022

    Dentistry - Coiled springs for use in orthodontics - Amendment 1 (ISO 17254:2016/Amd 1:2020)
    2/9/2022 - PDF - English - AENOR
    Learn More
    €40.80

  • UNE-CEN/TS 17688-1:2021

    Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 1: Isolated cellular RNA (Endorsed by Asociación Española de Normalización in February of 2022.)
    2/1/2022 - PDF - English - AENOR
    Learn More
    €76.00

  • UNE-CEN/TS 17688-2:2021

    Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 2: Isolated proteins (Endorsed by Asociación Española de Normalización in February of 2022.)
    2/1/2022 - PDF - English - AENOR
    Learn More
    €70.00

  • UNE-CEN/TS 17688-3:2021

    Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 3: Isolated genomic DNA (Endorsed by Asociación Española de Normalización in February of 2022.)
    2/1/2022 - PDF - English - AENOR
    Learn More
    €75.00

  • NF EN ISO 10993-7/A1, S99-501-7/A1 (01/2022)

    Biological evaluation of medical devices - Part 7 : Ethylene oxide sterilization residuals - Amendment 1
    1/1/2022 - Paper - French - AFNOR
    Learn More
    €43.50

  • UNE-CEN/TS 17500:2021

    Quality of care and support for older persons (Endorsed by Asociación Española de Normalización in January of 2022.)
    1/1/2022 - PDF - English - AENOR
    Learn More
    €99.00

  • UNE-CEN ISO/TS 16775:2021

    Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2021) (Endorsed by Asociación Española de Normalización in January of 2022.)
    1/1/2022 - PDF - English - AENOR
    Learn More
    €171.00

  • UNE-CEN/TS 14237:2021

    Textiles for healthcare and social services facilities (Endorsed by Asociación Española de Normalización in January of 2022.)
    1/1/2022 - PDF - English - AENOR
    Learn More
    €68.00

  • NF EN ISO 14971/A11, S99-211/A11 (12/2021)

    Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux
    12/1/2021 - Paper - French - AFNOR
    Learn More
    €48.00

  • NF ISO 7206-10/A1, S94-166-10/A1 (12/2021)

    Implants for surgery - Partial and total hip-joint prostheses - Part 10 : Determination of resistance to static load of modular femoral heads - Amendment 1
    12/1/2021 - Paper - French - AFNOR
    Learn More
    €25.67

  • NF EN 60601-1/A2, C74-011-1/A2 (10/2021)

    Medical electrical equipment - Part 1 : General requirements for basic safety and essential performance
    10/1/2021 - Paper - French - AFNOR
    Learn More
    €170.00

  • UNE-EN 62563-1:2010/A2:2021

    Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods (Endorsed by Asociación Española de Normalización in October of 2021.)
    10/1/2021 - PDF - English - AENOR
    Learn More
    €63.00

  • UNE-EN ISO 15841:2015/A1:2021

    Dentistry - Wires for use in orthodontics - Amendment 1 (ISO 15841:2014/Amd 1:2020)
    9/22/2021 - PDF - Spanish - AENOR
    Learn More
    €34.00

  • UNE-EN ISO 15841:2015/A1:2021

    Dentistry - Wires for use in orthodontics - Amendment 1 (ISO 15841:2014/Amd 1:2020)
    9/22/2021 - PDF - English - AENOR
    Learn More
    €40.80

  • NF EN ISO 13485/A11, S99-101/A11 (09/2021)

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
    9/1/2021 - Paper - French - AFNOR
    Learn More
    €108.00

  • UNE-EN 60601-1-6:2010/A2:2021

    Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (Endorsed by Asociación Española de Normalización in September of 2021.)
    9/1/2021 - PDF - English - AENOR
    Learn More
    €60.00

  • UNE-EN 60601-1-8:2007/A2:2021

    Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (Endorsed by Asociación Española de Normalización in September of 2021.)
    9/1/2021 - PDF - English - AENOR
    Learn More
    €100.00

  • UNE-EN 60601-1-10:2008/A2:2021

    Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers (Endorsed by Asociación Española de Normalización in September of 2021.)
    9/1/2021 - PDF - English - AENOR
    Learn More
    €63.00

  • UNE-EN 60601-1-11:2015/A1:2021

    Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (Endorsed by Asociación Española de Normalización in September of 2021.)
    9/1/2021 - PDF - English - AENOR
    Learn More
    €63.00

  • NF EN 62563-1/A2, C74-236-1/A2 (08/2021)

    Medical electrical equipment - Medical image display systems - Part 1 : Evaluation methods
    8/1/2021 - Paper - French - AFNOR
    Learn More
    €88.00

  • UNE-EN 60601-2-63:2015/A2:2021

    Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment (Endorsed by Asociación Española de Normalización in August of 2021.)
    8/1/2021 - PDF - English - AENOR
    Learn More
    €62.00

  • IEC 62563-1:2009/AMD2:2021

    IEC 62563-1:2009/AMD2:2021 Amendment 2 - Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods
    7/19/2021 - PDF - English, French - IEC
    Learn More
    €92.00

  • NF EN 60601-1-11/A1, C74-021/A1 (07/2021)

    Appareils électromédicaux - Partie 1-11 : exigences générales pour la sécurité de base et les performances essentielles - Norme Collatérale : exigences pour les appareils électromédicaux et les systèmes électromédicaux utilisés dans l'environnement des soins à domicile
    7/1/2021 - Paper - French - AFNOR
    Learn More
    €54.67

  • NF EN 60601-1-8/A2, C74-018/A2 (07/2021)

    Amendment 2 - Medical electrical equipment - Part 1-8 : General requirements for basic safety and essential performance - Collateral Standard : General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
    7/1/2021 - Paper - French - AFNOR
    Learn More
    €170.00

  • NF EN 60601-1-10/A2, C74-020/A2 (07/2021)

    Appareils électromédicaux - Partie 1-10 : exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale : exigences pour le développement des régulateurs physiologiques en boucle fermée
    7/1/2021 - Paper - French - AFNOR
    Learn More
    €88.33

  • NF EN 60601-1-6/A2, C74-016/A2 (07/2021)

    Amendment 2 - Medical electrical equipment - Part 1-6 : General requirements for basic safety and essential performance - Collateral standard : Usability - Amendement 2 - Appareils électromédicaux - Partie 1-6 : exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale : aptitude à l'utilisation
    7/1/2021 - Paper - French - AFNOR
    Learn More
    €72.00

  • UNE-EN 60601-2-65:2013/A2:2021

    Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment (Endorsed by Asociación Española de Normalización in July of 2021.)
    7/1/2021 - PDF - English - AENOR
    Learn More
    €46.00

  • NBN ISO 25841:2017/A1:2021

    Female condoms — Requirements and test methods — Amendment 1 ISO 25841:2017/Amd 1:2020
    6/2/2021 - PDF - English - NBN
    Learn More
    €20.00

  • NF EN ISO 11737-1/A1, S98-118-1/A1 (06/2021)

    Sterilization of health care products - Microbiological methods - Part 1 : determination of a population of microorganisms on products - Amendment 1
    6/1/2021 - Paper - French - AFNOR
    Learn More
    €25.67

  • NBN ISO 11418-3:2016/A1:2021

    Containers and accessories for pharmaceutical preparations — Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms — Amendment 1 ISO 11418-3:2016/AMD 1:2017
    6/1/2021 - PDF - English - NBN
    Learn More
    €20.00

  • NF EN 60601-2-63/A2, C74-263-2-63/A2 (06/2021)

    Medical electrical equipment - Part 2-63 : Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
    6/1/2021 - Paper - French - AFNOR
    Learn More
    €72.00

  • NF EN 60601-2-65/A2, C74-265/A2 (06/2021)

    Medical electrical equipment - Part 2-65 : Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
    6/1/2021 - Paper - French - AFNOR
    Learn More
    €54.67

  • NBN ISO 7206-10:2018/A1:2021

    Implants for surgery ? Partial and total hip-joint prostheses ? Part 10: Determination of resistance to static load of modular femoral heads ? Amendment 1
    6/1/2021 - PDF - French - NBN
    Learn More
    €20.00

  • NBN ISO 15675:2016/A1:2021

    Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters — Amendment 1: Connectors ISO 15675:2016/AMD 1:2020
    6/1/2021 - PDF - English - NBN
    Learn More
    €20.00

  • NBN ISO 18241:2016/A1:2021

    Cardiovascular implants and extracorporeal systems — Cardiopulmonary bypass systems — Venous bubble traps — Amendment 1: Connectors ISO 18241:2016/AMD 1:2019
    6/1/2021 - PDF - English - NBN
    Learn More
    €20.00

  • NBN ISO 7206-10:2018/A1:2021

    Implants for surgery — Partial and total hip-joint prostheses — Part 10: Determination of resistance to static load of modular femoral heads — Amendment 1 ISO 7206-10:2018/AMD 1:2021
    6/1/2021 - PDF - English - NBN
    Learn More
    €20.00

  • UNE-EN IEC 61010-2-091:2021/A11:2021

    Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-091: Particular requirements for cabinet X-ray systems (Endorsed by Asociación Española de Normalización in June of 2021.)
    6/1/2021 - PDF - English - AENOR
    Learn More
    €28.00

  • NBN ISO 11418-2:2016/A1:2021

    Containers and accessories for pharmaceutical preparations — Part 2: Screw-neck glass bottles for syrups — Amendment 1 ISO 11418-2:2016/AMD 1:2017
    5/31/2021 - PDF - English - NBN
    Learn More
    €20.00

  • NBN ISO 13779-3:2018/A1:2021

    Implants for surgery — Hydroxyapatite — Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity — Amendment 1 ISO 13779-3:2018/AMD 1:2021
    5/30/2021 - PDF - English - NBN
    Learn More
    €20.00

  • NBN ISO 15674:2016/A1:2021

    Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags — Amendment 1: Connectors ISO 15674:2016/AMD 1:2020
    5/30/2021 - PDF - English - NBN
    Learn More
    €20.00

  • IEC 60601-2-63:2012/AMD2:2021

    IEC 60601-2-63:2012/AMD2:2021 Amendment 2 - Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
    5/12/2021 - PDF - English - IEC
    Learn More
    €23.00

  • IEC 60601-2-63:2012/AMD2:2021

    IEC 60601-2-63:2012/AMD2:2021 Amendment 2 - Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
    5/12/2021 - PDF - English, French - IEC
    Learn More
    €23.00

  • IEC 60601-2-65:2012/AMD2:2021

    IEC 60601-2-65:2012/AMD2:2021 Amendment 2 - Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
    5/3/2021 - PDF - English - IEC
    Learn More
    €12.00

  • IEC 60601-2-65:2012/AMD2:2021

    IEC 60601-2-65:2012/AMD2:2021 Amendment 2 - Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
    5/3/2021 - PDF - English, French - IEC
    Learn More
    €12.00

  • UNE-EN 60601-1-2:2015/A1:2021

    Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (Endorsed by Asociación Española de Normalización in May of 2021.)
    5/1/2021 - PDF - English - AENOR
    Learn More
    €76.00

  • UNE-EN IEC 60601-2-83:2020/A11:2021

    Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment (Endorsed by Asociación Española de Normalización in May of 2021.)
    5/1/2021 - PDF - English - AENOR
    Learn More
    €46.00

  • UNE-EN ISO 81060-2:2020/A1:2021

    Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 1 (ISO 81060-2:2018/Amd 1:2020)
    4/28/2021 - PDF - Spanish - AENOR
    Learn More
    €46.00

  • UNE-EN ISO 81060-2:2020/A1:2021

    Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 1 (ISO 81060-2:2018/Amd 1:2020)
    4/28/2021 - PDF - English - AENOR
    Learn More
    €55.20

  • UNE-EN ISO 11978:2018/A1:2021

    Ophthalmic optics - Contact lenses and contact lens care products - Labelling - Amendment 1 (ISO 11978:2017/Amd 1:2020)
    4/28/2021 - PDF - Spanish - AENOR
    Learn More
    €52.00

  • UNE-EN ISO 11978:2018/A1:2021

    Ophthalmic optics - Contact lenses and contact lens care products - Labelling - Amendment 1 (ISO 11978:2017/Amd 1:2020)
    4/28/2021 - PDF - English - AENOR
    Learn More
    €62.40

  • NF EN ISO 17254/A1, S91-274/A1 (04/2021)

    Dentistry - Coiled springs for use in orthodontics - Amendment 1
    4/1/2021 - Paper - French - AFNOR
    Learn More
    €25.67

  • UNE-EN 60601-1-3:2008/A2:2021

    Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment (Endorsed by Asociación Española de Normalización in April of 2021.)
    4/1/2021 - PDF - English - AENOR
    Learn More
    €42.00

  • NF EN IEC 60601-2-83/A11, C74-283-2-83/A11 (04/2021)

    Appareils électromédicaux - Partie 2-83 : exigences particulières pour la sécurité de base et les performances essentielles des appareils de luminothérapie à domicile
    4/1/2021 - Paper - French - AFNOR
    Learn More
    €72.00

  • NF EN 60601-1-2/A1, C74-012/A1 (03/2021)

    Amendment 1 - Medical electrical equipment - Part 1-2 : General requirements for basic safety and essential performance - Collateral Standard : Electromagnetic disturbances - Requirements and tests.
    3/1/2021 - Paper - French - AFNOR
    Learn More
    €127.67

  • UNE-CEN ISO/TR 22411:2021

    Ergonomics data for use in the application of ISO/IEC Guide 71:2014 (ISO/TR 22411:2021) (Endorsed by Asociación Española de Normalización in March of 2021.)
    3/1/2021 - PDF - English - AENOR
    Learn More
    €208.00

  • NF EN 60601-1-3/A2, C74-014/A2 (03/2021)

    Medical electrical equipment - Part 1-3 : general requirements for basic safety and essential performance - Collateral Standard : radiation protection in diagnostic X-ray equipment - Amendement 2 - Appareils électromédicaux - Partie 1-3 : Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale : Radioprotection dans les appareils à rayonnement X de diagnostic
    3/1/2021 - Paper - French - AFNOR
    Learn More
    €31.33

  • IEC 60601-1-3:2008/AMD2:2021

    IEC 60601-1-3:2008/AMD2:2021 Amendment 2 - Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
    1/26/2021 - PDF - English, French - IEC
    Learn More
    €12.00

  • NF EN ISO 15841/A1, S91-270/A1 (12/2020)

    Dentistry - Wires for use in orthodontics - Amendment 1
    12/1/2020 - Paper - French - AFNOR
    Learn More
    €25.67

  • NF ISO 7207-2/A2, S94-175-2/A2 (11/2020)

    Implants for surgery - Components for partial and total knee joint prostheses - Part 2 : Articulating surfaces made of metal, ceramic and plastics materials - Amendment 2
    11/1/2020 - Paper - French - AFNOR
    Learn More
    €25.67

  • UNE-EN ISO 24157:2009/A1:2020

    Ophthalmic optics and instruments - Reporting aberrations of the human eye - Amendment 1 (ISO 24157:2008/Amd 1:2020)
    10/28/2020 - PDF - Spanish - AENOR
    Learn More
    €34.00

  • UNE-EN ISO 24157:2009/A1:2020

    Ophthalmic optics and instruments - Reporting aberrations of the human eye - Amendment 1 (ISO 24157:2008/Amd 1:2020)
    10/28/2020 - PDF - English - AENOR
    Learn More
    €40.80

  • UNE-CEN ISO/TR 20416:2020

    Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020) (Endorsed by Asociación Española de Normalización in October of 2020.)
    10/1/2020 - PDF - English - AENOR
    Learn More
    €90.00

  • UNE-EN 60601-1-12:2015/A1:2020

    Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment (Endorsed by Asociación Española de Normalización in October of 2020.)
    10/1/2020 - PDF - English - AENOR
    Learn More
    €57.00

  • UNE-EN 60601-1-9:2008/A2:2020

    Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design (Endorsed by Asociación Española de Normalización in October of 2020.)
    10/1/2020 - PDF - English - AENOR
    Learn More
    €42.00

  • NF EN ISO 11978/A1, S11-805/A1 (10/2020)

    Ophthalmic optics - Contact lenses and contact lens care products - Labelling - Amendment 1 - Optique ophtalmique - Lentilles de contact et produits d'entretien des lentilles de contact - Étiquetage - AMENDEMENT 1
    10/1/2020 - Paper - French - AFNOR
    Learn More
    €48.00

  • UNE-EN ISO 8596:2018/A1:2020

    Ophthalmic optics - Visual acuity testing - Standard and clinical optotypes and their presentation - Amendment 1 (ISO 8596:2017/Amd1:2019)
    9/30/2020 - PDF - Spanish - AENOR
    Learn More
    €34.00

  • UNE-EN ISO 8596:2018/A1:2020

    Ophthalmic optics - Visual acuity testing - Standard and clinical optotypes and their presentation - Amendment 1 (ISO 8596:2017/Amd1:2019)
    9/30/2020 - PDF - English - AENOR
    Learn More
    €40.80

  • UNE-EN ISO 80601-2-56:2018/A1:2020

    Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement - Amendment 1 (ISO 80601-2-56:2017/Amd 1:2018)
    9/9/2020 - PDF - Spanish - AENOR
    Learn More
    €39.00

  • UNE-EN ISO 80601-2-56:2018/A1:2020

    Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement - Amendment 1 (ISO 80601-2-56:2017/Amd 1:2018)
    9/9/2020 - PDF - English - AENOR
    Learn More
    €46.80

  • NF EN 60601-1-12/A1, C74-022/A1 (09/2020)

    Medical electrical equipment - Part 1-12 : general requirements for basic safety and essential performance - Collateral Standard : requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment - Appareils électromédicaux - Partie 1-12 : Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale : Exigences pour les appareils électromédicaux et les systèmes électromédicaux destinés à être utilisés dans l'environnement des services médicaux
    9/1/2020 - Paper - French - AFNOR
    Learn More
    €54.67

  • NF EN 60601-1-9/A2, C74-019/A2 (09/2020)

    Medical electrical equipment - Part 1-9 : General requirements for basic safety and essential performance - Collateral Standard : requirements for environmentally conscious design
    9/1/2020 - Paper - French - AFNOR
    Learn More
    €54.67

  • UNE-CEN ISO/TR 24971:2020

    Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020) (Endorsed by Asociación Española de Normalización in September of 2020.)
    9/1/2020 - PDF - English - AENOR
    Learn More
    €131.00

  • UNE-EN 62366-1:2015/A1:2020

    Medical devices - Part 1: Application of usability engineering to medical devices (Endorsed by Asociación Española de Normalización in September of 2020.)
    9/1/2020 - PDF - English - AENOR
    Learn More
    €69.00

  • IEC 60601-1-2:2014/AMD1:2020

    IEC 60601-1-2:2014/AMD1:2020 Amendment 1 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    9/1/2020 - PDF - English - IEC
    Learn More
    €270.00

  • IEC 60601-1-2:2014/AMD1:2020

    IEC 60601-1-2:2014/AMD1:2020 Amendment 1 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    9/1/2020 - PDF - English, French - IEC
    Learn More
    €270.00

  • NF EN ISO 81060-2/A1, S97-101-2/A1 (09/2020)

    Non-invasive sphygmomanometers - Part 2 : clinical investigation of intermittent automated measurement type - Amendment 1
    9/1/2020 - Paper - French - AFNOR
    Learn More
    €34.67

  • NF S61-527/A1 (09/2020)

    Firefighting and rescue service vehicles - Rescue tenders - Road rescue appliances
    9/1/2020 - Paper - French - AFNOR
    Learn More
    €25.50

  • IEC 60601-1:2005/AMD2:2020

    IEC 60601-1:2005/AMD2:2020 Amendment 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    8/20/2020 - PDF - English - IEC
    Learn More
    €345.00

  • IEC 60601-1:2005/AMD2:2020

    IEC 60601-1:2005/AMD2:2020 Amendment 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    8/20/2020 - PDF - English, French - IEC
    Learn More
    €345.00

  • NF EN 62366-1/A1, C74-054-1/A1 (08/2020)

    Medical devices - Part 1 : application of usability engineering to medical devices
    8/1/2020 - Paper - French - AFNOR
    Learn More
    €103.33

  • NF ISO 14243-1/A1, S94-176-1/A1 (08/2020)

    Implants for surgery - Wear of total knee-joint prostheses - Part 1 : Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test - Amendment 1
    8/1/2020 - Paper - French - AFNOR
    Learn More
    €25.50

  • UNE-EN ISO 80601-2-13:2013/A1:2020

    Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation - Amendment 1 (ISO 80601-2-13:2011/Amd 1:2015)
    7/29/2020 - PDF - Spanish - AENOR
    Learn More
    €68.00

  • UNE-EN ISO 80601-2-13:2013/A1:2020

    Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation - Amendment 1 (ISO 80601-2-13:2011/Amd 1:2015)
    7/29/2020 - PDF - English - AENOR
    Learn More
    €81.60

  • UNE-EN ISO 80601-2-13:2013/A2:2020

    Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation - Amendment 2 (ISO 80601-2-13:2011/Amd 2:2018)
    7/29/2020 - PDF - Spanish - AENOR
    Learn More
    €34.00

  • UNE-EN ISO 80601-2-13:2013/A2:2020

    Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation - Amendment 2 (ISO 80601-2-13:2011/Amd 2:2018)
    7/29/2020 - PDF - English - AENOR
    Learn More
    €40.80

  • UNE-EN ISO 3964:2017/A1:2020

    Dentistry - Coupling dimensions for handpiece connectors - Amendment 1: Interface dimensions (ISO 3964:2016/Amd 1:2018)
    7/29/2020 - PDF - Spanish - AENOR
    Learn More
    €53.00

  • UNE-EN ISO 3964:2017/A1:2020

    Dentistry - Coupling dimensions for handpiece connectors - Amendment 1: Interface dimensions (ISO 3964:2016/Amd 1:2018)
    7/29/2020 - PDF - English - AENOR
    Learn More
    €63.60

  • IEC 60601-1-8:2006/AMD2:2020

    IEC 60601-1-8:2006/AMD2:2020 Amendment 2 - Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
    7/23/2020 - PDF - English - IEC
    Learn More
    €345.00

  • IEC 60601-1-8:2006/AMD2:2020

    IEC 60601-1-8:2006/AMD2:2020 Amendment 2 - Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
    7/23/2020 - PDF - English, French - IEC
    Learn More
    €345.00

  • UNE-EN ISO 11135:2015/A1:2020

    Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)
    7/22/2020 - PDF - Spanish - AENOR
    Learn More
    €68.00

  • UNE-EN ISO 11135:2015/A1:2020

    Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)
    7/22/2020 - PDF - English - AENOR
    Learn More
    €81.60

  • UNE-EN ISO 11137-1:2015/A2:2020

    Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)
    7/22/2020 - PDF - Spanish - AENOR
    Learn More
    €68.00

  • UNE-EN ISO 11137-1:2015/A2:2020

    Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)
    7/22/2020 - PDF - English - AENOR
    Learn More
    €81.60

  • IEC 60601-1-10:2007/AMD2:2020

    IEC 60601-1-10:2007/AMD2:2020 Amendment 2 - Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
    7/22/2020 - PDF - English, French - IEC
    Learn More
    €46.00

  • IEC 60601-1-11:2015/AMD1:2020

    IEC 60601-1-11:2015/AMD1:2020 Amendment 1 - Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
    7/22/2020 - PDF - English, French - IEC
    Learn More
    €23.00

  • IEC 60601-1-12:2014/AMD1:2020

    IEC 60601-1-12:2014/AMD1:2020 Amendment 1 - Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
    7/22/2020 - PDF - English, French - IEC
    Learn More
    €23.00

  • IEC 60601-1-6:2010/AMD2:2020

    IEC 60601-1-6:2010/AMD2:2020 Amendment 2 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
    7/22/2020 - PDF - English, French - IEC
    Learn More
    €46.00

  • IEC 60601-1-9:2007/AMD2:2020

    IEC 60601-1-9:2007/AMD2:2020 Amendment 2 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
    7/22/2020 - PDF - English, French - IEC
    Learn More
    €12.00

  • UNE-EN ISO 10555-6:2018/A1:2020

    Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports - Amendment 1 (ISO 10555-6:2015/Amd 1:2019)
    7/15/2020 - PDF - Spanish - AENOR
    Learn More
    €34.00

  • UNE-EN ISO 10555-6:2018/A1:2020

    Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports - Amendment 1 (ISO 10555-6:2015/Amd 1:2019)
    7/15/2020 - PDF - English - AENOR
    Learn More
    €40.80

  • UNE-EN ISO 5356-2:2013/A1:2020

    Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors - Amendment 1 (ISO 5356-2:2012/Amd 1:2019)
    6/24/2020 - PDF - Spanish - AENOR
    Learn More
    €34.00

  • UNE-EN ISO 5356-2:2013/A1:2020

    Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors - Amendment 1 (ISO 5356-2:2012/Amd 1:2019)
    6/24/2020 - PDF - English - AENOR
    Learn More
    €40.80

  • UNE-EN ISO 15002:2008/A1:2020

    Flow-metering devices for connection to terminal units of medical gas pipeline systems - Amendment 1 (ISO 15002:2008/Amd 1:2018)
    6/24/2020 - PDF - Spanish - AENOR
    Learn More
    €34.00

  • UNE-EN ISO 15002:2008/A1:2020

    Flow-metering devices for connection to terminal units of medical gas pipeline systems - Amendment 1 (ISO 15002:2008/Amd 1:2018)
    6/24/2020 - PDF - English - AENOR
    Learn More
    €40.80

  • IEC 62366-1:2015/AMD1:2020

    IEC 62366-1:2015/AMD1:2020 Amendment 1 - Medical devices - Part 1: Application of usability engineering to medical devices
    6/17/2020 - PDF - English, French - IEC
    Learn More
    €132.00

  • NF ISO 11040-4/A1, S93-006-4/A1 (06/2020)

    Prefilled syringes - Part 4 : glass barrels for injectables and sterilized subassembled syringes ready for filling - Amendment 1 - Seringues préremplies - Partie 4 : cylindres en verre pour produits injectables et seringues pré-assemblées stérilisées préremplissables - Amendement 1
    6/1/2020 - Paper - French - AFNOR
    Learn More
    €34.67

  • NF ISO 14243-3/A1, S94-176-3/A1 (06/2020)

    Implants for surgery - Wear of total knee-joint prostheses - Part 3 : loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test - Amendment 1
    6/1/2020 - Paper - French - AFNOR
    Learn More
    €25.50

  • UNE-EN ISO 7199:2017/A1:2020

    Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) - Amendment 1: Connectors (ISO 7199:2016/Amd 1:2020) (Endorsed by Asociación Española de Normalización in May of 2020.)
    5/1/2020 - PDF - English - AENOR
    Learn More
    €63.00

  • UNE-EN 60601-2-43:2010/A2:2020

    Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures (Endorsed by Asociación Española de Normalización in May of 2020.)
    5/1/2020 - PDF - English - AENOR
    Learn More
    €68.00

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