11.040.01 : Medical equipment in general

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  • ASTM F3438-24

    Standard Guide for Detection and Quantification of Cleaning Markers (Analytes) for the Validation of Cleaning Methods for Reusable Medical Devices
    3/15/2024 - PDF - English - ASTM
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    €60.00

  • ASTM F3438-24 + Redline

    Standard Guide for Detection and Quantification of Cleaning Markers (Analytes) for the Validation of Cleaning Methods for Reusable Medical Devices
    3/15/2024 - PDF - English - ASTM
    Learn More
    €71.00

  • NF EN 302195, Z84-195 (03/2024)

    Dispositifs à courte portée (SRD) - Implants médicaux actifs de puissance ultra basse (ULP-AMI) et accessoires (ULP-AMI-P) fonctionnant dans la plage de fréquences de 9 kHz à 315 kHz - Norme harmonisée couvrant les exigences essentielles de l'article 3, paragraphe 2, de la Directive 2014/53/UE (V2.1.1)
    3/1/2024 - Paper - French - AFNOR
    Learn More
    €90.00

  • 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

  • IEC 80601-2-26:2019+AMD1:2024 Edition 1.1

    IEC 80601-2-26:2019+AMD1:2024 (Consolidated version) 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
    €506.00

  • 24/30450887 DC:2024

    BS 8684. Technology enabled care. Assessment of user needs and risks, system design, installation and maintenance. Code of practice
    2/5/2024 - PDF - English - BSI
    Learn More
    €24.00

  • BS EN IEC 60601-2-35:2021+A1:2024

    Medical electrical equipment Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses intended in medical use
    1/30/2024 - PDF - English - BSI
    Learn More
    €377.00

  • IEC 60601-1:2024 SER

    IEC 60601-1:2024 SER Medical electrical equipment - ALL PARTS
    1/9/2024 - PDF - English, French - IEC
    Learn More
    €5,328.00

  • BS EN IEC 80601-2-77:2021+A1:2023

    Medical electrical equipment Particular requirements for the basic safety and essential performance of robotically assisted surgical
    1/2/2024 - PDF - English - BSI
    Learn More
    €348.00

  • 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

  • IEC 60601-2-35:2020+AMD1:2023 Edition 2.1

    IEC 60601-2-35:2020+AMD1:2023 (Consolidated version) 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
    €558.00

  • NF EN ISO 17664-2, S98-116-2 (12/2023)

    Traitement de produits de soins de santé - Informations relatives au traitement des dispositifs médicaux à fournir par le fabricant du dispositif - Partie 2 : dispositifs médicaux non critiques
    12/1/2023 - Paper - French - AFNOR
    Learn More
    €86.67

  • XP S99-223 (12/2023)

    Dispositifs médicaux - Gestion du rapport bénéfice/risque
    12/1/2023 - Paper - French - AFNOR
    Learn More
    €118.00

  • 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 80601-2-77:2019+AMD1:2023 Edition 1.1

    IEC 80601-2-77:2019+AMD1:2023 (Consolidated version) 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
    €506.00

  • NF EN ISO 10993-17, S99-501-17 (11/2023)

    Évaluation biologique des dispositifs médicaux - Partie 17 : évaluation des risques toxicologiques des constituants des dispositifs médicaux
    11/1/2023 - Paper - French - AFNOR
    Learn More
    €144.50

  • BS EN IEC 60601-2-76:2019+A1:2023

    Medical electrical equipment Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis
    10/11/2023 - PDF - English - BSI
    Learn More
    €250.00

  • PR NF S97-414, S97-414PR (09/2023)

    Activité de remise en bon état d'usage de dispositifs médicaux à usage individuel - Exigences générales et de sécurité
    9/1/2023 - Paper - French - AFNOR
    Learn More
    €56.00

  • 23/30476395 DC:2023

    BS EN IEC 60601-2-93. Medical electrical equipment Part 2-93. Particular requirements for the basic safety and essential performance of neutron capture therapy
    7/5/2023 - PDF - English - BSI
    Learn More
    €24.00

  • 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

  • 23/30461083 DC:2023

    BS EN IEC 60601-2-64 AMD 1. Medical electrical equipment Part 2-64. Particular requirements for the basic safety and essential performance of light ion beam medical
    6/27/2023 - PDF - English - BSI
    Learn More
    €24.00

  • 23/30463777 DC:2023

    BS EN ISO 12487. Respiratory equipment. Clinical investigation of clinical thermometers
    6/27/2023 - PDF - English - BSI
    Learn More
    €24.00

  • 23/30475449 DC:2023

    BS EN IEC 63322. Security of Medical Electrical Equipment Containing High-Activity Sealed Radioactive Sources
    6/12/2023 - PDF - English - BSI
    Learn More
    €24.00

  • BS/AAMI 34971:2023

    Application of ISO 14971 to machine learning in artificial intelligence. Guide
    5/30/2023 - PDF - English - BSI
    Learn More
    €250.00

  • IEEE 2802:2022

    IEEE Standard for Performance and Safety Evaluation of Artificial Intelligence Based Medical Devices: Terminology
    5/5/2023 - PDF - English - IEEE
    Learn More
    €56.00

  • IEEE 2802:2022

    IEEE Standard for Performance and Safety Evaluation of Artificial Intelligence Based Medical Devices: Terminology
    5/5/2023 - Paper - English - IEEE
    Learn More
    €69.00

  • NF EN ISO 10993-15, S99-501-15 (05/2023)

    Évaluation biologique des dispositifs médicaux - Partie 15 : identification et quantification des produits de dégradation issus des métaux et alliages
    5/1/2023 - Paper - French - AFNOR
    Learn More
    €108.33

  • 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

  • 23/30472825 DC:2023

    BS IEC 80601-2-31. Medical electrical equipment Part 2-31. Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
    4/12/2023 - PDF - English - BSI
    Learn More
    €24.00

  • ASTM F2503-23e1

    Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
    4/1/2023 - PDF - English - ASTM
    Learn More
    €66.00

  • ASTM F2503-23e1 + Redline

    Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
    4/1/2023 - PDF - English - ASTM
    Learn More
    €79.00

  • BS EN ISO 15223-1:2021 (CD-ROM+PDF)

    Medical devices. Symbols to be used with medical device labels, labelling and information supplied General requirements
    3/26/2023 - PDF - English - BSI
    Learn More
    €391.00

  • DIN EN ISO 16571:2023-03

    Systems for evacuation of plume generated by medical devices (ISO/DIS 16571:2023), German and English version prEN ISO 16571:2023
    3/1/2023 - PDF - English, German - DIN
    Learn More
    €131.96

  • 23/30444557 DC:2023

    BS EN ISO 16571. Systems for evacuation of plume generated by medical devices
    2/2/2023 - PDF - English - BSI
    Learn More
    €24.00

  • NF EN ISO 10993-10, S99-501-10 (02/2023)

    Biological evaluation of medical devices - Part 10 : Tests for skin sensitization
    2/1/2023 - Paper - French - AFNOR
    Learn More
    €119.00

  • IEC 60601-2-75:2017+AMD1:2023 Edition 1.1

    IEC 60601-2-75:2017+AMD1:2023 (Consolidated version) 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
    €345.00

  • 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

  • BS EN IEC 60601-2-31:2020

    Medical electrical equipment Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
    1/27/2023 - PDF - English - BSI
    Learn More
    €348.00

  • NF EN ISO 10993-2, S99-502 (11/2022)

    Biological evaluation of medical devices - Part 2 : Animal welfare requirements
    11/1/2022 - Paper - French - AFNOR
    Learn More
    €75.67

  • 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-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

  • NF ISO 19461-2, M60-573 (08/2022)

    Radioprotection - Mesurage pour la libération des déchets contaminés par des radioisotopes lors des applications médicales - Partie 2 : Gestion des déchets radioactifs solides dans les installations de médecine nucléaire
    8/1/2022 - Paper - French - AFNOR
    Learn More
    €86.67

  • 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

  • NF S99-700 (06/2022)

    Solutions isothermes autonomes pour produits de santé - Méthode de qualification des performances thermiques
    6/1/2022 - Paper - French - AFNOR
    Learn More
    €99.33

  • XP ISO/TS 10993-19, S99-501-19 (06/2022)

    Évaluation biologique des dispositifs médicaux - Partie 19 : caractérisations physicochimique, morphologique et topographique des matériaux
    6/1/2022 - Paper - French - AFNOR
    Learn More
    €75.67

  • BS EN ISO 20417:2021

    Medical devices. Information to be supplied by the manufacturer
    5/27/2022 - PDF - English - BSI
    Learn More
    €377.00

  • DIN EN ISO 14971:2022-04

    Medical devices - Application of risk management to medical devices (ISO 14971:2019), German version EN ISO 14971:2019 + A11:2021
    4/1/2022 - PDF - German - DIN
    Learn More
    €131.96

  • DIN/TS 5343:2022-04

    Cleanliness of medical devices - Risk orientated validation of cleanliness, development of acceptance criteria and selection of test methods, Text in German and English
    4/1/2022 - PDF - English, German - DIN
    Learn More
    €84.02

  • UNE-EN ISO 15223-1:2022

    Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
    3/16/2022 - PDF - Spanish - AENOR
    Learn More
    €111.00

  • UNE-EN ISO 15223-1:2022

    Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
    3/16/2022 - PDF - English - AENOR
    Learn More
    €133.20

  • DIN EN ISO 20417:2022-03

    Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12), German version EN ISO 20417:2021
    3/1/2022 - PDF - German - DIN
    Learn More
    €184.58

  • UNE-EN IEC 81001-5-1:2022

    Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle (Endorsed by Asociación Española de Normalización in March of 2022.)
    3/1/2022 - PDF - English - AENOR
    Learn More
    €95.00

  • BS EN IEC 81001-5-1:2022

    Health software and health IT systems safety, effectiveness security Security. Activities in the product life cycle
    2/16/2022 - PDF - English - BSI
    Learn More
    €348.00

  • VDI 5700 Blatt 1:2022-01

    Reprocessing hazards - Risk management in reprocessing of medical devices - Measures for risk control
    2/2/2022 - PDF - English, German - VDI
    Learn More
    €173.95

  • DIN EN ISO 15223-1:2022-02

    Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021), German version EN ISO 15223-1:2021, with CD-ROM.
    2/1/2022 - PDF - German - DIN
    Learn More
    €169.25

  • BS EN 60335-2-26:2003+A11:2020

    Household and similar electrical appliances. Safety Particular requirements for clocks
    1/10/2022 - PDF - English - BSI
    Learn More
    €180.00

  • BS EN ISO 15223-1:2021 + Redline

    Tracked Changes. Medical devices. Symbols to be used with information supplied by the manufacturer General requirements
    1/4/2022 - PDF - English - BSI
    Learn More
    €454.00

  • 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

  • ASTM F3275-22

    Standard Guide for Using a Force Tester to Evaluate Performance of a Brush Part Designed to Clean the Internal Channel of a Medical Device
    1/1/2022 - PDF - English - ASTM
    Learn More
    €57.00

  • ASTM F3275-22 + Redline

    Standard Guide for Using a Force Tester to Evaluate Performance of a Brush Part Designed to Clean the Internal Channel of a Medical Device
    1/1/2022 - PDF - English - ASTM
    Learn More
    €68.00

  • ASTM F3276-22

    Standard Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to Clean the External Surface of a Medical Device
    1/1/2022 - PDF - English - ASTM
    Learn More
    €57.00

  • ASTM F3276-22 + Redline

    Standard Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to Clean the External Surface of a Medical Device
    1/1/2022 - PDF - English - ASTM
    Learn More
    €68.00

  • IEC 81001-5-1:2021

    IEC 81001-5-1:2021 Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
    12/16/2021 - PDF - English, French - IEC
    Learn More
    €345.00

  • BS EN ISO 14971:2019+A11:2021

    Medical devices. Application of risk management to medical devices
    12/15/2021 - PDF - English - BSI
    Learn More
    €348.00

  • NBN EN ISO 14971:2019/A11:2021

    Medical devices - Application of risk management to medical devices (ISO 14971:2019)
    12/11/2021 - PDF - French - NBN
    Learn More
    €58.00

  • NBN EN ISO 14971:2019/A11:2021

    Medical devices - Application of risk management to medical devices (ISO 14971:2019)
    12/11/2021 - PDF - German - NBN
    Learn More
    €58.00

  • NBN EN ISO 14971:2019/A11:2021

    Medical devices - Application of risk management to medical devices (ISO 14971:2019)
    12/11/2021 - PDF - English - NBN
    Learn More
    €58.00

  • UNE-EN ISO 20417:2021

    Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)
    12/7/2021 - PDF - Spanish - AENOR
    Learn More
    €127.00

  • UNE-EN ISO 20417:2021

    Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)
    12/7/2021 - PDF - English - AENOR
    Learn More
    €152.40

  • 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

  • DIN EN ISO 13485:2021-12

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016), German version EN ISO 13485:2016 + AC:2018 + A11:2021
    12/1/2021 - PDF - German - DIN
    Learn More
    €158.04

  • UNE-EN IEC 80001-1:2021

    Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software (Endorsed by Asociación Española de Normalización in December of 2021.)
    12/1/2021 - PDF - English - AENOR
    Learn More
    €78.00

  • UNE-EN IEC 80601-2-26:2020/AC:2021-10

    Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs (Endorsed by Asociación Española de Normalización in December of 2021.)
    12/1/2021 - PDF - English - AENOR
    Learn More
    €0.00

  • BS EN IEC 80001-1:2021 + Redline

    Tracked Changes. Application of risk management for IT-networks incorporating medical devices Safety, effectiveness and security in the implementation use connected or health software
    11/24/2021 - PDF - English - BSI
    Learn More
    €382.00

  • BS EN IEC 80601-2-26:2020

    Medical electrical equipment Particular requirements for the basic safety and essential performance of electroencephalographs
    11/5/2021 - PDF - English - BSI
    Learn More
    €293.00

  • BS EN 60601-1:2006+A2:2021

    Medical electrical equipment General requirements for basic safety and essential performance
    11/2/2021 - PDF - English - BSI
    Learn More
    €449.00

  • BS EN IEC 80001-1:2021

    Application of risk management for IT-networks incorporating medical devices Safety, effectiveness and security in the implementation use connected or health software
    11/1/2021 - PDF - English - BSI
    Learn More
    €293.00

  • 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

  • NBN EN ISO 15223-1:2021

    Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
    10/1/2021 - PDF - French - NBN
    Learn More
    €163.00

  • NBN EN ISO 15223-1:2021

    Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
    10/1/2021 - PDF - German - NBN
    Learn More
    €163.00

  • NBN EN ISO 15223-1:2021

    Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
    10/1/2021 - PDF - English - NBN
    Learn More
    €163.00

  • BS EN ISO 15223-1:2021 (CD-ROM)

    Medical devices. Symbols to be used with information supplied by the manufacturer General requirements
    9/29/2021 - PDF - English - BSI
    Learn More
    €348.00

  • BS EN ISO 15223-1:2021

    Medical devices. Symbols to be used with information supplied by the manufacturer General requirements
    9/29/2021 - PDF - English - BSI
    Learn More
    €348.00

  • UNE-EN ISO 14155:2021

    Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
    9/22/2021 - PDF - Spanish - AENOR
    Learn More
    €138.00

  • UNE-EN ISO 14155:2021

    Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
    9/22/2021 - PDF - English - AENOR
    Learn More
    €165.60

  • IEC 80001-1:2021

    IEC 80001-1:2021 Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software
    9/21/2021 - PDF - English, French - IEC
    Learn More
    €270.00

  • NBN EN ISO 13485:2016/A11:2021

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
    9/10/2021 - PDF - French - NBN
    Learn More
    €20.00

  • NBN EN ISO 13485:2016/A11:2021

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
    9/10/2021 - PDF - German - NBN
    Learn More
    €20.00

  • NBN EN ISO 13485:2016/A11:2021

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
    9/10/2021 - PDF - English - NBN
    Learn More
    €20.00

  • BS EN ISO 13485:2016+A11:2021

    Medical devices. Quality management systems. Requirements for regulatory purposes
    9/8/2021 - PDF - English - BSI
    Learn More
    €377.00

  • NF EN ISO 10993-9, S99-501-9 (09/2021)

    Biological evaluation of medical devices - Part 9 : Framework for identification and quantification of potential degradation products
    9/1/2021 - Paper - French - AFNOR
    Learn More
    €60.67

  • NF EN ISO 15223-1, S99-014-1 (09/2021)

    Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1 : General requirements
    9/1/2021 - Paper - French - AFNOR
    Learn More
    €108.33

  • NF EN ISO 17664-1, S98-116-1 (09/2021)

    Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1 : Critical and semi-critical medical devices
    9/1/2021 - Paper - French - AFNOR
    Learn More
    €86.67

  • 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

  • UNE-EN IEC 60601-2-35:2021

    Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use (Endorsed by Asociación Española de Normalización in September of 2021.)
    9/1/2021 - PDF - English - AENOR
    Learn More
    €112.00

  • BS EN 60601-1-11:2015+A1:2021

    Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Requirements medical systems used in the home healthcare environment
    8/20/2021 - PDF - English - BSI
    Learn More
    €377.00

  • BS EN 60601-1-8:2007+A2:2021

    Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: requirements, tests guidance alarm systems in medical
    8/20/2021 - PDF - English - BSI
    Learn More
    €449.00

  • BS EN 60601-1-10:2008+A2:2021

    Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Requirements the development of physiologic closed-loop controllers
    8/16/2021 - PDF - English - BSI
    Learn More
    €348.00

  • BS EN 60601-1-6:2010+A2:2021

    Medical electrical equipment General requirements for basic safety and essential performance. Collateral standard: Usability
    8/13/2021 - PDF - English - BSI
    Learn More
    €250.00

  • 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

  • 21/30433057 DC:2021

    BS EN 60601-2-35 AMD1. Medical electrical equipment Part 2-35. Particular requirements for the basic safety and essential performance of heating devices using blankets, pads mattresses intended in medical use
    6/25/2021 - PDF - English - BSI
    Learn More
    €24.00

  • 21/30433045 DC:2021

    BS EN IEC 60601-2-75 AMD1. Medical electrical equipment Part 2-75. Particular requirements for the basic safety and essential performance of photodynamic therapy diagnosis
    6/18/2021 - PDF - English - BSI
    Learn More
    €24.00

  • NF EN ISO 10993-12, S99-501-12 (06/2021)

    Biological evaluation of medical devices - Part 12 : Sample preparation and reference materials - Évaluation biologique des dispositifs médicaux - Partie 12 : Préparation des échantillons et matériaux de référence
    6/1/2021 - Paper - French - AFNOR
    Learn More
    €86.67

  • UNE-EN ISO 80601-2-87:2021

    Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators (ISO 80601-2-87:2021) (Endorsed by Asociación Española de Normalización in June of 2021.)
    6/1/2021 - PDF - English - AENOR
    Learn More
    €167.00

  • NBN ISO 20069:2021

    Guidance for assessment and evaluation of changes to drug delivery systems ISO 20069:2019
    6/1/2021 - PDF - English - NBN
    Learn More
    €163.00

  • NBN ISO 16142-1:2021

    Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards ISO 16142-1:2016
    5/29/2021 - PDF - English - NBN
    Learn More
    €58.00

  • NBN ISO 16142-2:2021

    Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards ISO 16142-2:2017
    5/29/2021 - PDF - English - NBN
    Learn More
    €58.00

  • NBN EN ISO 20417:2021

    Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)
    5/8/2021 - PDF - French - NBN
    Learn More
    €184.00

  • NBN EN ISO 20417:2021

    Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)
    5/8/2021 - PDF - German - NBN
    Learn More
    €184.00

  • NBN EN ISO 20417:2021

    Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)
    5/8/2021 - PDF - English - NBN
    Learn More
    €184.00

  • NF EN ISO 20417, S99-001 (05/2021)

    Medical devices - Information to be provided by the manufacturer
    5/1/2021 - Paper - French - AFNOR
    Learn More
    €144.67

  • 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

  • BS EN 60601-1-2:2015+A1:2021

    Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Electromagnetic disturbances. Requirements tests
    3/24/2021 - PDF - English - BSI
    Learn More
    €398.00

  • NF EN ISO 10993-23, S99-501-23 (03/2021)

    Biological evaluation of medical devices - Part 23 : tests for irritation - Évaluation biologique des dispositifs médicaux - Partie 23 : Essais d'irritation
    3/1/2021 - Paper - French - AFNOR
    Learn More
    €144.67

  • 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

  • PD IEC TR 60601-4-5:2021

    Medical electrical equipment Guidance and interpretation. Safety-related technical security specifications
    1/28/2021 - PDF - English - BSI
    Learn More
    €348.00

  • IEC TR 60601-4-5:2021

    IEC TR 60601-4-5:2021 Medical electrical equipment - Part 4-5: Guidance and interpretation - Safety-related technical security specifications
    1/18/2021 - PDF - English - IEC
    Learn More
    €345.00

  • 21/30421479 DC:2021

    BS IEC 63322. Security of Medical Electrical Equipment Containing High-Activity Sealed Radioactive Sources
    1/11/2021 - PDF - English - BSI
    Learn More
    €24.00

  • NF EN 301489-29, Z84-489-29 (01/2021)

    ElectroMagnetic Compatibility (EMC) standard for radio equipment and services - Part 29 : specific conditions for Medical Data Service Devices (MEDS) operating in the 401 MHz to 402 MHz and 405 MHz to 406 MHz bands - Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU (V2.2.1) - Norme de compatibilité électromagnétique (CEM) pour les équipements et les services radioélectriques - Partie 29 : Conditions spécifiques pour les dispositifs de services de données médicales (MEDS) fonctionnant dans les bandes de fréquences 401 MHz à 402 MHz et 405 MHz à 406 MHz - Norme
    1/1/2021 - Paper - French - AFNOR
    Learn More
    €86.67

  • NF EN 301489-35, Z84-489-35 (01/2021)

    ElectroMagnetic Compatibility (EMC) standard for radio equipment and services, Part 35 : Specific ElectroMagnetic Compatibility (EMC) standard for radio equipment and services - Part 35 : specific requirements for Low Power Active Medical Implants (LP-AMI) operating in the 2 483,5 MHz to 2 500 MHz bands - Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU (V2.2.1) - Norme de compatibilité électromagnétique (CEM) pour les équipements et les services radioélectriques - Partie 35 : Exigences spécifiques applicables aux implants médicaux actifs de faible puissance (LP-AMI) fonctionnant dans les bandes de fréquences 2 483,5 MHz à 2 500 MHz - Norme harmonisée
    1/1/2021 - Paper - French - AFNOR
    Learn More
    €86.67

  • UNE-EN IEC 60601-2-22:2020

    Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment (Endorsed by Asociación Española de Normalización in January of 2021.)
    1/1/2021 - PDF - English - AENOR
    Learn More
    €75.00

  • NF EN ISO 10993-1, S99-501-1 (12/2020)

    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
    12/1/2020 - Paper - French - AFNOR
    Learn More
    €108.33

  • NF EN ISO 22442-1, S97-601-1 (12/2020)

    Medical devices utilizing animal tissues and their derivatives - Part 1 : application of risk management
    12/1/2020 - Paper - French - AFNOR
    Learn More
    €86.67

  • NF EN ISO 22442-2, S97-601-2 (12/2020)

    Medical devices utilizing animal tissues and their derivatives - Part 2 : controls on sourcing, collection and handling
    12/1/2020 - Paper - French - AFNOR
    Learn More
    €75.67

  • BS EN IEC 80601-2-60:2020 + Redline

    Tracked Changes. Medical electrical equipment Particular requirements for the basic safety and essential performance of dental
    11/12/2020 - PDF - English - BSI
    Learn More
    €432.00

  • UNE-EN 13718-1:2015+A1:2020

    Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
    11/11/2020 - PDF - Spanish - AENOR
    Learn More
    €68.00

  • UNE-EN 13718-1:2015+A1:2020

    Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
    11/11/2020 - PDF - English - AENOR
    Learn More
    €81.60

  • UNE-EN 13718-2:2015+A1:2020

    Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
    11/11/2020 - PDF - Spanish - AENOR
    Learn More
    €83.00

  • UNE-EN 13718-2:2015+A1:2020

    Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
    11/11/2020 - PDF - English - AENOR
    Learn More
    €99.60

  • ASTM F3487-20

    Standard Guide for Assessing the Service Life of a Brush Part Intended to Clean a Medical Device
    10/15/2020 - PDF - English - ASTM
    Learn More
    €46.00

  • ASTM F3487-20 + Redline

    Standard Guide for Assessing the Service Life of a Brush Part Intended to Clean a Medical Device
    10/15/2020 - PDF - English - ASTM
    Learn More
    €53.00

  • NF EN 60601-2-22, C74-341 (10/2020)

    Medical electrical equipment - Part 2-22 : particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
    10/1/2020 - Paper - French - AFNOR
    Learn More
    €116.33

  • DIN EN 13718-1:2020-10

    Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances, German version EN 13718-1:2014+A1:2020
    10/1/2020 - PDF - German - DIN
    Learn More
    €72.80

  • DIN EN 13718-2:2020-10

    Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances, German version EN 13718-2:2015+A1:2020
    10/1/2020 - PDF - German - DIN
    Learn More
    €110.00

  • 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

  • UNE-EN ISO 14971:2020

    Medical devices - Application of risk management to medical devices (ISO 14971:2019)
    9/23/2020 - PDF - Spanish - AENOR
    Learn More
    €92.00

  • UNE-EN ISO 14971:2020

    Medical devices - Application of risk management to medical devices (ISO 14971:2019)
    9/23/2020 - PDF - English - AENOR
    Learn More
    €110.40

  • IEC 60601-2-35:2020

    IEC 60601-2-35:2020 Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
    9/21/2020 - PDF - English - IEC
    Learn More
    €397.00

  • IEC 60601-2-35:2020

    IEC 60601-2-35:2020 Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
    9/21/2020 - PDF - English, French - IEC
    Learn More
    €397.00

  • BS EN 60601-1-9:2008+A2:2020

    Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Requirements environmentally conscious design
    9/14/2020 - PDF - English - BSI
    Learn More
    €293.00

  • BS EN 60601-1-12:2015+A1:2020

    Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Requirements medical systems intended use in the emergency services environment
    9/4/2020 - PDF - English - BSI
    Learn More
    €348.00

  • IEC 60601-1-2:2014+AMD1:2020 Edition 4.1

    IEC 60601-1-2:2014+AMD1:2020 (Consolidated version) 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
    €920.00

  • IEC 60601-1-2:2014+AMD1:2020 Edition 4.1

    IEC 60601-1-2:2014+AMD1:2020 (Consolidated version) 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
    €920.00

  • 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

  • FD CEN ISO/TR 24971, S99-124 (09/2020)

    Medical devices - Guidance on the application of ISO 14971
    9/1/2020 - Paper - French - AFNOR
    Learn More
    €167.33

  • FD CEN ISO/TR 20416, S99-125 (09/2020)

    Medical devices - Post-market surveillance for manufacturers
    9/1/2020 - Paper - French - AFNOR
    Learn More
    €119.00

  • 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

  • CEN ISO/TR 20416:2020

    Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)
    8/25/2020 - PDF - French - NBN
    Learn More
    €163.00

  • CEN ISO/TR 20416:2020

    Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)
    8/25/2020 - PDF - English - NBN
    Learn More
    €163.00

  • IEC 60601-1:2005+AMD1:2012+AMD2:2020 Edition 3.2

    IEC 60601-1:2005+AMD1:2012+AMD2:2020 (Consolidated version) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    8/20/2020 - PDF - English - IEC
    Learn More
    €1,495.00

  • IEC 60601-1:2005+AMD1:2012+AMD2:2020 Edition 3.2

    IEC 60601-1:2005+AMD1:2012+AMD2:2020 (Consolidated version) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    8/20/2020 - PDF - English, French - IEC
    Learn More
    €1,495.00

  • 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 - 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

  • PD CEN ISO/TR 20416:2020

    Medical devices. Post-market surveillance for manufacturers
    8/19/2020 - PDF - English - BSI
    Learn More
    €348.00

  • BS EN 62366-1:2015+A1:2020

    Medical devices Application of usability engineering to medical
    8/19/2020 - PDF - English - BSI
    Learn More
    €348.00

  • PD CEN ISO/TR 24971:2020 + Redline

    Tracked Changes. Medical devices. Guidance on the application of ISO 14971
    8/14/2020 - PDF - English - BSI
    Learn More
    €492.00

  • 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

  • CEN ISO/TR 24971:2020

    Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
    7/25/2020 - PDF - French - NBN
    Learn More
    €205.00

  • CEN ISO/TR 24971:2020

    Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
    7/25/2020 - PDF - English - NBN
    Learn More
    €205.00

  • PD CEN ISO/TR 24971:2020 ExComm

    Expert Commentary for PD CEN ISO/TR 24971:2020. Medical devices. Guidance on the application of ISO 14971
    7/24/2020 - PDF - English - BSI
    Learn More
    €96.00

  • IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 Edition 2.2

    IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 (Consolidated version) 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
    €1,208.00

  • IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 Edition 2.2

    IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 (Consolidated version) 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
    €1,208.00

  • 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 - 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

  • PD CEN ISO/TR 24971:2020

    Medical devices. Guidance on the application of ISO 14971
    7/22/2020 - PDF - English - BSI
    Learn More
    €377.00

  • IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 Edition 3.2

    IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 (Consolidated version) 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
    €385.00

  • IEC 60601-1-9:2007+AMD1:2013+AMD2:2020 Edition 1.2

    IEC 60601-1-9:2007+AMD1:2013+AMD2:2020 (Consolidated version) 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
    €311.00

  • IEC 60601-1-10:2007+AMD1:2013+AMD2:2020 Edition 1.2

    IEC 60601-1-10:2007+AMD1:2013+AMD2:2020 (Consolidated version) 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
    €443.00

  • IEC 60601-1-11:2015+AMD1:2020 Edition 2.1

    IEC 60601-1-11:2015+AMD1:2020 (Consolidated version) 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
    €558.00

  • IEC 60601-1-12:2014+AMD1:2020 Edition 1.1

    IEC 60601-1-12:2014+AMD1:2020 (Consolidated version) 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
    €506.00

  • 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

  • ASTM F3208-20

    Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
    7/15/2020 - PDF - English - ASTM
    Learn More
    €51.00

  • ASTM F3208-20 + Redline

    Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
    7/15/2020 - PDF - English - ASTM
    Learn More
    €61.00

  • PD CEN ISO/TR 24971:2020 ExComm - SET

    Medical devices. Guidance on the application of ISO 14971
    6/19/2020 - PDF - English - BSI
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    €96.00

  • IEC 62366-1:2015+AMD1:2020 Edition 1.1

    IEC 62366-1:2015+AMD1:2020 (Consolidated version) Medical devices - Part 1: Application of usability engineering to medical devices
    6/17/2020 - PDF - English, French - IEC
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    €610.00

  • 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
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    €132.00

  • ISO/TR 24971:2020

    Medical devices
    Guidance on the application of ISO 14971
    6/16/2020 - Paper - English - ISO
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    €248.00

  • ISO TR 24971:2020

    ISO TR 24971:2020 Medical devices - Guidance on the application of ISO 14971
    6/16/2020 - PDF - English - ISOIEC
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    €225.00

  • DIN SPEC 91422:2020-06

    Requirements for planning and safety in the multifunctional high-tech working environment surgical theatre
    6/1/2020 - PDF - German - DIN
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    €0.00

  • 20/30419927 DC:2020

    BS EN IEC 80601-2-89. Medical electrical equipment Part 2-89. Particular requirements for the basic safety and essential performance of medical beds children
    5/6/2020 - PDF - English - BSI
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    €24.00

  • VDI/VDE/DGQ/DKD 2622 Blatt 9.2:2020-05

    Calibration of measuring equipment for electrical quantities - Test equipment for checking the safety of electrical devices - Electrical devices in medical technology according to DIN EN 65353 (VDE 0751-1)
    5/1/2020 - PDF - German - VDI
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    €72.31

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