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11.040.01 : Medical equipment in general

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  • IEC 80601-2-78 (2019-07)

    IEC 80601-2-78:2019 Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
    7/9/2019 - PDF - English, French - CEI
    Learn More
    €305.00

  • IEC 80601-2-77 (2019-07)

    IEC 80601-2-77:2019 Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
    7/9/2019 - PDF - English, French - CEI
    Learn More
    €274.00

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


    7/1/2019 - Paper - French - AFNOR
    Learn More
    €112.59

  • IEC 80601-2-60 (2019-06)

    IEC 80601-2-60:2019 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
    6/27/2019 - PDF - English, French - CEI
    Learn More
    €244.00

  • 19/30356480 DC


    6/5/2019 - PDF - English - BSI
    Learn More
    €23.00

  • 19/30357102 DC


    6/5/2019 - PDF - English - BSI
    Learn More
    €23.00

  • BS EN IEC 60601-2-76:2019


    6/4/2019 - PDF - English - BSI
    Learn More
    €202.40

  • 19/30357110 DC


    6/3/2019 - PDF - English - BSI
    Learn More
    €23.00

  • 19/30363066 DC


    5/24/2019 - PDF - English - BSI
    Learn More
    €23.00

  • IEC 80601-2-26 (2019-05)

    IEC 80601-2-26:2019 Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalograph
    5/20/2019 - PDF - English, French - CEI
    Learn More
    €203.00

  • IEC/TR 61289 Redline version (2019-05)

    IEC TR 61289:2019 RLV High frequency surgical equipment and high frequency surgical accessories - Operation and maintenance
    5/10/2019 - PDF - English - CEI
    Learn More
    €224.00

  • IEC/TR 61289 (2019-05)

    IEC TR 61289:2019 High frequency surgical equipment and high frequency surgical accessories - Operation and maintenance
    5/10/2019 - PDF - English - CEI
    Learn More
    €173.00

  • PR NF EN ISO 20417, S99-001PR (05/2019)


    5/1/2019 - Paper - French - AFNOR
    Learn More
    €156.42

  • ASTM F2901-19

    Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
    3/1/2019 - PDF - English - ASTM
    Learn More
    €43.00

  • ASTM F2901-19 + Redline

    Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
    3/1/2019 - PDF - English - ASTM
    Learn More
    €52.00

  • XP E67-305, E67-305 (03/2019)


    3/1/2019 - Paper - French - AFNOR
    Learn More
    €30.64

  • ASTM F3276-19

    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
    2/15/2019 - PDF - English - ASTM
    Learn More
    €49.00

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


    2/1/2019 - Paper - French - AFNOR
    Learn More
    €95.10

  • ASTM F3275-19

    Standard Guide for Using a Force Tester to Evaluate Performance of a Brush Part Designed to Clean the Internal Channel of a Medical Device
    1/15/2019 - PDF - English - ASTM
    Learn More
    €49.00

  • PD IEC/TR 60601-4-3:2018


    1/4/2019 - PDF - English - BSI
    Learn More
    €363.40

  • UNE-EN ISO 10993-11:2018

    Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
    12/26/2018 - PDF - English - AENOR
    Learn More
    €86.40

  • UNE-EN ISO 10993-11:2018

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

  • IEC/TR 60601-4-3 (2018-12)

    IEC TR 60601-4-3:2018 Medical electrical equipment - Part 4-3: Guidance and interpretation - Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements
    12/13/2018 - PDF - English - CEI
    Learn More
    €335.00

  • IEC/TR 60601-4-3 Redline version (2018-12)

    IEC TR 60601-4-3:2018 RLV Medical electrical equipment - Part 4-3: Guidance and interpretation - Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements
    12/13/2018 - PDF - English - CEI
    Learn More
    €435.00

  • NF EN 868-9, S98-051-9 (12/2018)

    Packaging for terminally sterilized medical devices - Part 9 : uncoated nonwoven materials of polyolefines - Requirements and test methods - Matériaux et systèmes d'emballage pour les dispositifs médicaux stérilisés au stade terminal - Partie 9 : Matériaux non tissés à base de polyoléfines, non enduits - Exigences et méthodes d'essai
    12/1/2018 - Paper - French - AFNOR
    Learn More
    €42.41

  • NF EN 868-10, S98-051-10 (12/2018)

    Packaging for terminally sterilized medical devices - Part 10 : adhesive coated nonwoven materials of polyolefines - Requirements and test methods - Matériaux et systèmes d'emballage pour les dispositifs médicaux stérilisés au stade terminal - Partie 10 : Matériaux non tissés à base de polyoléfines enduits d'adhésif - Exigences et méthodes d'essai
    12/1/2018 - Paper - French - AFNOR
    Learn More
    €53.41

  • NF EN 868-8, S98-051-8 (12/2018)

    Packaging for terminally sterilized medical devices - Part 8 : re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods - Matériaux et systèmes d'emballage pour les dispositifs médicaux stérilisés au stade terminal - Partie 8 : Conteneurs réutilisables de stérilisation pour stérilisateurs à la vapeur d'eau conformes à l'EN 285 - Exigences et méthodes d?essai
    12/1/2018 - Paper - French - AFNOR
    Learn More
    €66.72

  • PR NF EN 62366-1/A1, C74-054-1/A1PR (12/2018)


    12/1/2018 - Paper - French - AFNOR
    Learn More
    €63.76

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


    12/1/2018 - Paper - French - AFNOR
    Learn More
    €112.59

  • 18/30352729 DC


    11/29/2018 - PDF - English - BSI
    Learn More
    €23.00

  • 18/30357106 DC


    11/8/2018 - PDF - English - BSI
    Learn More
    €23.00

  • 18/30359002 DC


    11/6/2018 - PDF - English - BSI
    Learn More
    €23.00

  • FD CEN/TR 17223, S99-212 (11/2018)


    11/1/2018 - Paper - French - AFNOR
    Learn More
    €136.35

  • UNE-EN ISO 15378:2018

    Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
    10/24/2018 - PDF - English - AENOR
    Learn More
    €136.80

  • UNE-EN ISO 15378:2018

    Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
    10/24/2018 - PDF - Spanish - AENOR
    Learn More
    €114.00

  • BS EN IEC 60332-3-25:2018

    Tests on electric and optical fibre cables under fire conditions. Test for vertical flame spread of vertically-mounted bunched wires or cables. Category D
    10/19/2018 - PDF - English - BSI
    Learn More
    €144.90

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

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

  • ASTM F3208-18

    Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
    10/1/2018 - PDF - English - ASTM
    Learn More
    €43.00

  • ASTM F3208-18 + Redline

    Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
    10/1/2018 - PDF - English - ASTM
    Learn More
    €52.00

  • DIN EN 60601-1/A2 VDE 0750-1/A2:2018-09

    Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 62A/1237/CD:2018); Text in German and English
    9/1/2018 - Paper - German - VDE
    Learn More
    €38.31

  • DIN EN 80001-1 VDE 0756-1:2018-09

    Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software - Part 1: Application of risk management (IEC 62A/1244/CD:2018); Text in German and English
    9/1/2018 - Paper - German - VDE
    Learn More
    €42.45

  • PR NF EN ISO 14971, S99-211PR (09/2018)

    Medical devices - Application of risk management to medical devices
    9/1/2018 - Paper - French - AFNOR
    Learn More
    €139.59

  • DIN EN ISO 14971:2018-08

    Medical devices - Application of risk management to medical devices (ISO/DIS 14971:2018); German and English version prEN ISO 14971:2018
    8/1/2018 - PDF - English, German - DIN
    Learn More
    €147.20

  • UNE-EN ISO 13485:2018

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016). (Consolidated version)
    7/25/2018 - PDF - English - AENOR
    Learn More
    €110.40

  • UNE-EN ISO 13485:2018

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016). (Consolidated version)
    7/25/2018 - PDF - Spanish - AENOR
    Learn More
    €92.00

  • 18/30350509 DC


    7/6/2018 - PDF - English - BSI
    Learn More
    €23.00

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

    Biological evaluation of medical devices - Part 4 : selection of tests for interactions with blood - Evaluation biologique des dispositifs médicaux - Partie 4 : Choix des essais pour les interactions avec le sang
    7/1/2018 - Paper - French - AFNOR
    Learn More
    €127.55

  • DIN EN 60601-1-10/A2 VDE 0750-1-10/A2:2018-07

    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 (IEC 62A/1208/CD:2017); Text in German and English
    7/1/2018 - Paper - German - VDE
    Learn More
    €18.19

  • DIN EN 60601-1-6/A2 VDE 0750-1-6/A2:2018-07

    Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 62A/1204/CD:2017); Text in German and English
    7/1/2018 - Paper - German - VDE
    Learn More
    €18.19

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

    Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys - Évaluation biologique des dispositifs médicaux - Partie 15 : Identification et quantification des produits de dégradation issus des métaux et alliages
    7/1/2018 - Paper - French - AFNOR
    Learn More
    €95.10

  • ASTM E3173-18

    Standard Guide for Decommissioning and Disposal of Medical Equipment
    7/1/2018 - PDF - English - ASTM
    Learn More
    €38.00

  • DIN EN 62304 VDE 0750-101:2018-06

    Health software - Software life cycle processes (IEC 62A/1235/CDV:2018); German and English version prEN 62304:2018
    6/1/2018 - Paper - German - VDE
    Learn More
    €95.02

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

    Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products - Évaluation biologique des dispositifs médicaux - Partie 9 : Cadre pour l'identification et la quantification des produits potentiels de dégradation
    6/1/2018 - Paper - French - AFNOR
    Learn More
    €86.46

  • UNE-EN ISO 10993-16:2018

    Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
    5/16/2018 - PDF - English - AENOR
    Learn More
    €69.60

  • UNE-EN ISO 10993-16:2018

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

  • 18/30347831 DC


    5/4/2018 - PDF - English - BSI
    Learn More
    €23.00

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

    Biological evaluation of medical devices - Part 11 : tests for systemic toxicity - Évaluation biologique des dispositifs médicaux - Partie 11 : essais de toxicité systémique
    5/1/2018 - Paper - French - AFNOR
    Learn More
    €87.56

  • VDI 5701:2018-05

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

  • PR NF EN 13718-2/A1, S95-202-2/A1PR (05/2018)

    Medical vehicles and their equipment - Air ambulances - Part 2 : Operational and technical requirements for air ambulances - Véhicules sanitaires et leur équipement - Ambulances aériennes - Partie 2 : Exigences opérationnelles et techniques pour les ambulances aériennes
    5/1/2018 - Paper - French - AFNOR
    Learn More
    €63.03

  • PR NF EN 13718-1/A1, S95-202-1/A1PR (05/2018)

    Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances - Véhicules sanitaires et leur équipement - Ambulances aériennes - Partie 1 : Exigences pour les dispositifs médicaux utilisés dans les ambulances aériennes
    5/1/2018 - Paper - French - AFNOR
    Learn More
    €63.03

  • ASTM F3293-18

    Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
    5/1/2018 - PDF - English - ASTM
    Learn More
    €38.00

  • NBN EN ISO 13485:2016/AC:2018

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
    4/27/2018 - PDF - English - NBN
    Learn More
    €45.00

  • NF C74-018/A11, NF EN 60601-1-8/A11 (04/2018)

    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
    4/21/2018 - PDF - English - UTE
    Learn More
    €48.40

  • NF C74-017/A1, NF EN 62304/A1 (04/2018)

    Medical device software - Software life-cycle processes
    4/14/2018 - PDF - English - UTE
    Learn More
    €124.52

  • DIN EN 13718-1/A1:2018-04

    Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances; German and English version EN 13718-1:2014/prA1:2018
    4/1/2018 - PDF - English, German - DIN
    Learn More
    €54.80

  • DIN EN 13718-2/A1:2018-04

    Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances; German and English version EN 13718-2:2015/prA1:2018
    4/1/2018 - PDF - English, German - DIN
    Learn More
    €61.70

  • DIN EN ISO 15378:2018-04

    Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017); German version EN ISO 15378:2017
    4/1/2018 - PDF - German - DIN
    Learn More
    €191.40

  • NF EN 60601-1-8/A11, C74-018/A11 (04/2018)

    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 - Appareils électromédicaux - Partie 1-8 : exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale : exigences générales, essais et guide pour les systèmes d'alarme des appareils et des systèmes électromédicaux
    4/1/2018 - Paper - French - AFNOR
    Learn More
    €48.40

  • DIN EN ISO 15378:2018-04

    Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017); German version EN ISO 15378:2017
    4/1/2018 - PDF - English - DIN
    Learn More
    €239.20

  • NF EN 62304/A1, C74-017/A1 (04/2018)

    Medical device software - Software life-cycle processes - Logiciels de dispositifs médicaux - Processus du cycle de vie du logiciel
    4/1/2018 - Paper - French - AFNOR
    Learn More
    €124.52

  • CEN/TR 17223:2018

    Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
    3/23/2018 - PDF - English - NBN
    Learn More
    €135.00

  • CEN/TR 17223:2018

    Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
    3/23/2018 - PDF - French - NBN
    Learn More
    €135.00

  • IEC 80601-2-30 (2018-03)

    IEC 80601-2-30:2018 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
    3/22/2018 - PDF - English, French - CEI
    Learn More
    €274.00

  • IEC 80601-2-30 Redline version (2018-03)

    IEC 80601-2-30:2018 RLV Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
    3/22/2018 - PDF - English - CEI
    Learn More
    €356.00

  • 18/30344861 DC


    3/14/2018 - PDF - English - BSI
    Learn More
    €41.40

  • BS EN ISO 389-1:2018

    Acoustics. Reference zero for the calibration of audiometric equipment. Reference equivalent threshold sound pressure levels for pure tones and supra-aural earphones
    3/2/2018 - PDF - English - BSI
    Learn More
    €144.90

  • IEC 60601-1-SER (2018-02)

    IEC 60601-1:2018 SER Medical electrical equipment - ALL PARTS
    2/20/2018 - PDF - English, French - CEI
    Learn More
    €3,154.00

  • JIS T 1115:2018

    Non-invasive electro-mechanical sphygmomanometers
    2/1/2018 - PDF - Japanese - JSA
    Learn More
    €52.91

  • PR NF EN 60601-2-22, C74-341PR (01/2018)

    Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment - Appareils électromédicaux - Partie 2-22 : Exigences particulières pour la sécurité de base et les performances essentielles des appareils chirurgicaux, esthétiques, thérapeutiques et de diagnostic à laser
    1/1/2018 - Paper - French - AFNOR
    Learn More
    €71.80

  • NF EN ISO 15378, S93-200 (01/2018)

    Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) - Articles d'emballage primaire pour médicaments - Exigences particulières pour l'application de l'ISO 9001:2008 prenant en considération les Bonnes Pratiques de Fabrication (BPF)
    1/1/2018 - Paper - French - AFNOR
    Learn More
    €136.35

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

    Biological evaluation of medical devices - Part 16 : Toxicokinetic study design for degradation products and leachables - Évaluation biologique des dispositifs médicaux - Partie 16 : Conception des études toxicocinétiques des produits de dégradation et des substances relargables
    12/1/2017 - Paper - French - AFNOR
    Learn More
    €66.72

  • NF EN 301559, Z84-559 (12/2017)

    Short Range Devices (SRD) - Low Power Active Medical Implants (LP-AMI) and associated Peripherals (LP-AMI-P) operating in the frequency range 2 483,5 MHz to 2 500 MHz - Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU (V2.1.1) - Dispositifs à courte portée (SRD) ; implants médicaux actifs de faible puissance (LP-AMI) et périphériques associés (LP-AMI-P) fonctionnant dans la plage de fréquences de 2 483,5 MHz à 2 500 MHz; Norme harmonisée couvrant les exigences essentielles de l'article 3.2 de la Directive 2014/53/UE
    12/1/2017 - Paper - French - AFNOR
    Learn More
    €104.89

  • NF EN 302537, Z84-537 (12/2017)

    Ultra Low Power Medical Data Service (MEDS) Systems operating in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz - Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU (V2.1.1) - Systèmes de services de données médicales de très faible puissance (MEDS) fonctionnant dans la plage de fréquences 401 MHz à 402 MHz et 405 MHz à 406 MHz ; Norme harmonisée couvrant les exigences essentielles de l'article 3.2 de la Directive 2014/53/UE (V2.0.1)
    12/1/2017 - Paper - French - AFNOR
    Learn More
    €104.89

  • NBN EN ISO 15378:2017

    Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
    11/22/2017 - PDF - German - NBN
    Learn More
    €135.00

  • NBN EN ISO 15378:2017

    Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
    11/22/2017 - PDF - English - NBN
    Learn More
    €135.00

  • NBN EN ISO 15378:2017

    Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
    11/22/2017 - PDF - French - NBN
    Learn More
    €135.00

  • BS EN ISO 15378:2017

    Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
    11/15/2017 - PDF - English - BSI
    Learn More
    €303.60

  • DIN EN 60601-1-2/A1 VDE 0750-1-2/A1:2017-11

    Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (IEC 62A/1202/CD:2017)
    11/1/2017 - Paper - German - VDE
    Learn More
    €45.89

  • VDI/VDE 2426 Blatt 1:2017-11

    Catalogues in maintenance and management of medical devices - Basics
    11/1/2017 - PDF - German - VDI
    Learn More
    €127.14

  • PD ISO/TR 80002-2:2017

    Medical device software. Validation of software for medical device quality systems
    10/31/2017 - PDF - English - BSI
    Learn More
    €303.60

  • NBN - Handbook ISO 13485:2016

    ISO 13485:2016 - Medical devices - A practical guide
    10/5/2017 - PDF - English - NBN
    Learn More
    €77.00

  • BS ISO 16142-2:2017

    Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
    9/20/2017 - PDF - English - BSI
    Learn More
    €282.90

  • PD IEC/TR 60601-4-4:2017

    Medical electrical equipment. Guidance and interpretation. Guidance for writers of particular standards when creating alarm system-related requirements
    9/19/2017 - PDF - English - BSI
    Learn More
    €202.40

  • PR NF EN 302510, Z82-510PR (09/2017)

    Short Range Devices (SRD); Ultra Low Power Active Medical Membrane Implants (ULP-AMI-M) and Peripherals (ULP-AMI-M-P) operating in the frequency range 30 MHz to 37,5 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU (V2.1.6) - Dispositifs à courte portée (SRD);Implants médicaux actifs de puissance ultra basse de type membrane (ULP-AMI-M) et périphériques (ULP-AMI-M-P) fonctionnant dans la plage de fréquences de 30 MHz à 37,5 MHz;Norme harmonisée couvrant les exigences essentielles de l'article 3, paragraphe 2, de la
    9/1/2017 - Paper - French - AFNOR
    Learn More
    €112.59

  • ISO 15378:2017

    Primary packaging materials for medicinal products -- Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
    9/1/2017 - Paper - English - ISO
    Learn More
    €186.00

  • ISO 15378:2017

    Primary packaging materials for medicinal products -- Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
    9/1/2017 - Paper - French - ISO
    Learn More
    €186.00

  • IEC/TR 60601-4-4 (2017-08)

    IEC TR 60601-4-4:2017 Medical electrical equipment - Part 4-4: Guidance and interpretation - Guidance for writers of particular standards when creating alarm system-related requirements
    8/17/2017 - PDF - English - CEI
    Learn More
    €142.00

  • ISO 16142-2:2017

    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
    8/1/2017 - Paper - English - ISO
    Learn More
    €165.00

  • BS EN 60601-1-8:2007+A11:2017

    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
    7/31/2017 - PDF - English - BSI
    Learn More
    €303.60

  • 17/30347827 DC


    7/12/2017 - PDF - English - BSI
    Learn More
    €23.00

  • NF EN 13718-1, S95-202-1 (07/2017)

    Medical vehicles and their equipment - Air ambulances - Part 1 : requirements for medical devices used in air ambulances - Véhicules sanitaires et leur équipement - Ambulances aériennes - Partie 1 : Exigences pour les dispositifs médicaux utilisés dans les ambulances aériennes
    7/1/2017 - Paper - French - AFNOR
    Learn More
    €66.72

  • DIN EN 62366-1 VDE 0750-241-1:2017-07

    Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015 + COR1:2016); German version EN 62366-1:2015 + AC:2015
    7/1/2017 - Paper - German - VDE
    Learn More
    €126.54

  • DIN EN 61340-6-1 VDE 0300-6-1:2017-07

    Electrostatics - Part 6-1: Electrostatic control for healthcare - General requirements for facilities (IEC 101/528/CD:2017)
    7/1/2017 - Paper - German - VDE
    Learn More
    €22.72

  • BS EN ISO 15223-1:2016 (CD-ROM)


    6/30/2017 - PDF - English - BSI
    Learn More
    €262.20

  • PD IEC/TR 60601-4-1:2017

    Medical electrical equipment. Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy
    6/23/2017 - PDF - English - BSI
    Learn More
    €303.60

  • ISO/TR 80002-2 (2017-06)

    ISO TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems
    6/13/2017 - PDF - English - ISO
    Learn More
    €206.00

  • NF EN 302510, Z82-510 (06/2017)

    Short range devices (SRD) - Ultra low power active medical membrane implants (ULP-AMI-M) and peripherals (ULP-AMI-M-P) operating in the frequency range 30 MHz to 37,5 MHz - Harmonised standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU (V2.1.1) - Dispositifs à courte portée (SRD);Implants médicaux actifs de puissance ultra-basse de type membrane (ULP-AMI-M) et périphériques (ULP-AMI-M-P) fonctionnant dans la plage de fréquences de 30 MHz à 37,5 MHz;Norme européenne (EN) harmonisée couvrant les exigences essentielles de l'article 3,
    6/1/2017 - Paper - French - AFNOR
    Learn More
    €87.56

  • VDI 5700 Blatt 2:2017-06

    Reprocessing hazards - Risk management in reprocessing of medical devices - Trainings
    6/1/2017 - PDF - English, German - VDI
    Learn More
    €83.07

  • PR NF EN 301489-27, Z84-489-27PR (06/2017)

    ElectroMagnetic Compatibility (EMC) standard for radio equipment and services - Part 27: Specific conditions for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices (ULP-AMI-P) operating in the 402 MHz to 405 MHz bands - Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU (V2.2.0) - Norme de compatibilité électromagnétique (CEM) pour les équipements et services radioélectriques - Partie 27 : Conditions spécifiques pour les implants médicaux actifs de puissance ultra basse (ULP-AMI) et dispositifs périphériques associés (ULP-AMI-P) fonctionnant dans les bandes de 402 MHz
    6/1/2017 - Paper - French - AFNOR
    Learn More
    €86.46

  • PR NF EN 301489-29, Z84-489-29PR (06/2017)

    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 (V2.1.2) - 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
    6/1/2017 - Paper - French - AFNOR
    Learn More
    €86.46

  • PR NF EN 301489-35, Z84-489-35PR (06/2017)

    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 (V2.2.0) - 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
    6/1/2017 - Paper - French - AFNOR
    Learn More
    €86.46

  • ISO/TR 80002-2:2017

    Medical device software -- Part 2: Validation of software for medical device quality systems
    6/1/2017 - Paper - English - ISO
    Learn More
    €207.00

  • IEC 60601-2-75 (2017-05)

    IEC 60601-2-75:2017 Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment
    5/30/2017 - PDF - English, French - CEI
    Learn More
    €173.00

  • IEC/TR 60601-4-1 (2017-05)

    IEC TR 60601-4-1:2017 Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy
    5/22/2017 - PDF - English - CEI
    Learn More
    €305.00

  • NF EN 301489-35, Z84-489-35 (05/2017)

    ElectroMagnetic compatibility (EMC) standard for radio equipment and services - Harmonised standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU - Part 35 : specific requirements for Low Power Active Medical Implants (LP-AMI) operating in the 2 483,5 MHz to 2 500 MHz bands (V2.1.0) - Norme de compatibilité électromagnétique (CEM) pour les équipements et les services radioélectriques;Norme harmonisée couvrant les exigences essentielles de l'article 3.1(b) de la Directive 2014/53/UE - Partie 35 : Exigences spécifiques applicables aux implants médicaux actifs de faible puissance
    5/1/2017 - Paper - French - AFNOR
    Learn More
    €66.72

  • NF EN 301489-29, Z84-489-29 (05/2017)

    ElectroMagnetic Compatibility (EMC) standard for radio equipment and services - Harmonized Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU - 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 (V.2.1.0) - Norme de compatibilité électromagnétique (CEM) pour les équipements et les services radioélectriques - Norme harmonisée couvrant les exigences essentielles de l'article 3.1(b) de la Directive 2014/53/UE - Partie 29 : Conditions spécifiques pour les dispositifs de services de données
    5/1/2017 - Paper - French - AFNOR
    Learn More
    €76.40

  • NF EN 301489-27, Z84-489-27 (05/2017)

    ElectroMagnetic Compatibility (EMC) standard for radio equipment and services - Part 27 : specific conditions for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices (ULP-AMI-P) - Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU (V2.1.1) - Norme de compatibilité électromagnétique (CEM) pour les équipements et services radioélectriques;norme harmonisée couvrant les exigences essentielles de l'article 3, paragraphe 1(b), de la Directive 2014/53/UE;Partie 27 : Conditions spécifiques pour implants médicaux actifs de puissance ultra
    5/1/2017 - Paper - French - AFNOR
    Learn More
    €66.72

  • VDI 5710 Blatt 1:2017-05

    Licensing and implementing of new nanotechnologies in the area of medical technology - Fundamentals
    5/1/2017 - PDF - German - VDI
    Learn More
    €103.22

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

    Biological evaluation of medical devices - Part 6 : tests for local effects after implantation - Évaluation biologique des dispositifs médicaux - Partie 6 : essais concernant les effets locaux après implantation
    4/1/2017 - Paper - French - AFNOR
    Learn More
    €87.56

  • DIN EN ISO 15223-1:2017-04

    Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03); German version EN ISO 15223-1:2016, with CD-ROM
    4/1/2017 - PDF - German - DIN
    Learn More
    €136.80

  • VDI 5702 Blatt 1:2017-04

    Medical device software - Medical SPICE Process assessment model
    4/1/2017 - PDF - English, German - VDI
    Learn More
    €380.90

  • DIN EN ISO 15223-1:2017-04

    Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03); German version EN ISO 15223-1:2016, with CD-ROM
    4/1/2017 - PDF - English - DIN
    Learn More
    €171.10

  • UNE-EN 60601-1-8:2007/A11:2017

    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 April of 2017.)
    4/1/2017 - PDF - English - AENOR
    Learn More
    €16.00

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

    Biological evaluation of medical devices - Part 1 : Evaluation and testing within a risk management process - Évaluation biologique des dispositifs médicaux - Partie 1 : Évaluation et essais au sein d'un processus de gestion du risque
    4/1/2017 - Paper - French - AFNOR
    Learn More
    €121.66

  • BS EN ISO 15223-1:2016


    3/31/2017 - PDF - English - BSI
    Learn More
    €236.90

  • UNE-EN ISO 15223-1:2017

    Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)
    3/29/2017 - PDF - English - AENOR
    Learn More
    €79.20

  • UNE-EN ISO 15223-1:2017

    Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)
    3/29/2017 - PDF - Spanish - AENOR
    Learn More
    €66.00

  • 17/30359001 DC


    3/23/2017 - PDF - English - BSI
    Learn More
    €23.00

  • JIS T 0601-1:2017

    Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    3/1/2017 - PDF - Japanese - JSA
    Learn More
    €132.34

  • JIS T 2304:2017

    Medical device software - Software life cycle processes
    3/1/2017 - PDF - Japanese - JSA
    Learn More
    €58.50

  • NF S99-172, S99-172 (02/2017)

    Use and maintenance of medical devices - Risk management système for risks associated with the use of medical devices - Exploitation et maintenance des dispositifs médicaux - Système de management du risque lié à l'exploitation des dispositifs médicaux
    2/1/2017 - Paper - French - AFNOR
    Learn More
    €115.12

  • BS EN 80601-2-35:2009+A1:2016


    1/31/2017 - PDF - English - BSI
    Learn More
    €303.60

  • BS EN ISO 13485:2016


    1/31/2017 - PDF - English - BSI
    Learn More
    €282.90

  • PD IEC/TR 80001-2-9:2017

    Application of risk management for it-networks incorporating medical devices. Application guidance. Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities
    1/30/2017 - PDF - English - BSI
    Learn More
    €236.90

  • IEC/TR 80001-2-9 (2017-01)

    IEC TR 80001-2-9:2017 Application of risk management for IT-networks incorporating medical devices - Part 2-9: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities
    1/30/2017 - PDF - English - CEI
    Learn More
    €203.00

  • NF EN ISO 15223-1, S99-014-1 (01/2017)

    Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1 : general requirements - Dispositifs médicaux - Symboles à utiliser avec les étiquettes, l'étiquetage et les informations à fournir relatifs aux dispositifs médicaux - Partie 1 : exigences générales
    1/1/2017 - Paper - French - AFNOR
    Learn More
    €76.40

  • AAMI/ISO 16142-2:2017

    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
    1/1/2017 - PDF sécurisé - English - AAMI
    Learn More
    €193.14

  • AS IEC 60601.1.11:2017

    Medical electrical equipment 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
    1/1/2017 - PDF sécurisé - English - SA
    Learn More
    €134.70

  • AS IEC 60601.1.10:2017

    Medical electrical equipment General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
    1/1/2017 - PDF sécurisé - English - SA
    Learn More
    €98.77

  • AS IEC 60601.1.6:2017

    Medical electrical equipment General requirements for basic safety and essential performance - Collateral standard: Usability
    1/1/2017 - PDF sécurisé - English - SA
    Learn More
    €82.87

  • AS IEC 60601.1.9:2017

    Medical electrical equipment General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
    1/1/2017 - PDF sécurisé - English - SA
    Learn More
    €98.77

  • AS IEC 60601.1.2:2017

    Medical electrical equipment General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    1/1/2017 - PDF sécurisé - English - SA
    Learn More
    €153.30

  • UNE-EN 80601-2-35:2009/A1:2016

    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 January of 2017.)
    1/1/2017 - PDF - English - AENOR
    Learn More
    €35.00

  • NBN EN ISO 15223-1:2016

    Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)
    12/21/2016 - PDF - German - NBN
    Learn More
    €56.00

  • NBN EN ISO 15223-1:2016

    Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)
    12/21/2016 - PDF - English - NBN
    Learn More
    €56.00

  • NBN EN ISO 15223-1:2016

    Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)
    12/21/2016 - PDF - French - NBN
    Learn More
    €56.00

  • NF C74-012, NF EN 60601-1-2 (12/2016)

    Medical electrical equipment - Part 1-2 : general requirements for basic safety and essential performance - Collateral standard : electromagnetic disturbances - Requirements and tests
    12/9/2016 - PDF - English - UTE
    Learn More
    €193.11

  • NF EN 60601-1-2, C74-012 (12/2016)

    Medical electrical equipment - Part 1-2 : general requirements for basic safety and essential performance - Collateral standard : electromagnetic disturbances - Requirements and tests - Appareils électromédicaux
    12/1/2016 - Paper - French - AFNOR
    Learn More
    €193.11

  • 16/30347647 DC


    10/5/2016 - PDF - English - BSI
    Learn More
    €23.00

  • DIN EN 62304 VDE 0750-101:2016-10

    Medical device software - Software life-cycle processes (IEC 62304:2006 + A1:2015); German version EN 62304:2006 + Cor.:2008 + A1:2015
    10/1/2016 - Paper - German - VDE
    Learn More
    €178.39

  • NF EN 301839, Z84-839 (10/2016)

    Ultra Low Power Active Medical Implants (ULP-AMI) and associated Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz - Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU (V2.1.1) - Implants médicaux actifs de puissance ultra basse (ULP-AMI) et périphériques associés (ULP-AMI-P) fonctionnant dans la plage de fréquences de 402 MHz à 405 MHz - Norme harmonisée couvrant les exigences essentielles de l’article 3, paragraphe 2, de la Directive 2014/53/UE (V2.1.1)
    10/1/2016 - Paper - French - AFNOR
    Learn More
    €104.89

  • NF EN 60601-1/A12, C74-011/A12 (08/2016)

    Medical electrical equipment - Part 1 : general requirements for basic safety and essential performance - Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles
    8/1/2016 - Paper - French - AFNOR
    Learn More
    €77.83

  • DIN EN ISO 13485:2016-08

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016
    8/1/2016 - PDF - German - DIN
    Learn More
    €169.80

  • DIN EN ISO 11197 VDE 0750-211:2016-08

    Medical supply units (ISO 11197:2016); German version EN ISO 11197:2016
    8/1/2016 - Paper - German - VDE
    Learn More
    €98.49

  • DIN EN ISO 13485:2016-08

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016
    8/1/2016 - PDF - English - DIN
    Learn More
    €212.40

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

    Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management - Dispositifs médicaux utilisant des tissus animaux et leurs dérivés - Partie 1 : Application de la gestion des risques
    7/1/2016 - Paper - French - AFNOR
    Learn More
    €76.40

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

    Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling - Dispositifs médicaux utilisant des tissus animaux et leurs dérivés - Partie 2 : Contrôles de l'origine, de la collecte et du traitement
    7/1/2016 - Paper - French - AFNOR
    Learn More
    €66.72

  • PD IEC/TR 60601-4-2:2016

    Medical electrical equipment. Guidance and interpretation. Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
    5/31/2016 - PDF - English - BSI
    Learn More
    €282.90

  • PD IEC/TR 80001-2-8:2016

    Application of risk management for IT-networks incorporating medical devices. Application guidance. Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2
    5/19/2016 - PDF - English - BSI
    Learn More
    €282.90

  • IEC/TR 80001-2-8 (2016-05)

    IEC TR 80001-2-8:2016 Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2
    5/19/2016 - PDF - English - CEI
    Learn More
    €274.00

  • IEC/TR 60601-4-2 (2016-05)

    IEC TR 60601-4-2:2016 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
    5/13/2016 - PDF - English - CEI
    Learn More
    €274.00

  • DIN EN 60601-1-2 VDE 0750-1-2:2016-05

    Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests (IEC 60601-1-2:2014); German version EN 60601-1-2:2015
    5/1/2016 - Paper - German - VDE
    Learn More
    €192.57

  • BS EN ISO 15225:2016

    Medical devices. Quality management. Medical device nomenclature data structure
    4/30/2016 - PDF - English - BSI
    Learn More
    €202.40

  • IEC 80601-2-35 AMD 1 (2016-04)

    IEC 80601-2-35:2009/AMD1:2016 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
    4/29/2016 - PDF - English, French - CEI
    Learn More
    €20.00

  • IEC 80601-2-35 Edition 2.1 (2016-04)

    IEC 80601-2-35:2009+AMD1:2016 consolidated version Medical electrical equipment - Part 2-35: Particular requirementsfor the basic safety and essential performance of heating devicesusing blankets, pads and mattresses and intended for heating inmedical use
    4/29/2016 - PDF - English, French - CEI
    Learn More
    €406.00

  • IEC/TR 62366-2 (2016-04)

    IEC TR 62366-2:2016 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
    4/27/2016 - PDF - English - CEI
    Learn More
    €325.00

  • PD IEC/TR 62366-2:2016

    Medical devices. Guidance on the application of usability engineering to medical devices
    4/27/2016 - PDF - English - BSI
    Learn More
    €324.30

  • UNE-EN 62304:2007/A1:2016

    Medical device software - Software life-cycle processes
    4/13/2016 - PDF - English - AENOR
    Learn More
    €86.40

  • UNE-EN 62304:2007/A1:2016

    Medical device software - Software life-cycle processes
    4/13/2016 - PDF - Spanish - AENOR
    Learn More
    €72.00

  • NF EN ISO 13485, S99-101 (04/2016)

    Medical devices - Quality management systems - Requirements for regulatory purposes - Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires
    4/1/2016 - Paper - French - AFNOR
    Learn More
    €95.37

  • DIN EN 60601-1-10 VDE 0750-1-10:2016-04

    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 (IEC 60601-1-10:2007 + A1:2013); German version EN 60601-1-10:2008 + A1:2015
    4/1/2016 - Paper - German - VDE
    Learn More
    €104.79

  • BS ISO 16142-1:2016

    Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    3/31/2016 - PDF - English - BSI
    Learn More
    €282.90

  • 16/30340380 DC


    3/30/2016 - PDF - English - BSI
    Learn More
    €23.00

  • DIN IEC/TR 80001-2-5 VDE 0756-2-5:2016-03

    Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems (IEC/TR 80001-2-5:2014)
    3/1/2016 - Paper - German - VDE
    Learn More
    €98.49

  • ISO 16142-1:2016

    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
    3/1/2016 - Paper - English - ISO
    Learn More
    €165.00

  • BS EN ISO 389-3:2016

    Acoustics. Reference zero for the calibration of audiometric equipment. Reference equivalent threshold vibratory force levels for pure tones and bone vibrators
    2/29/2016 - PDF - English - BSI
    Learn More
    €202.40

  • NBN EN ISO 13485:2016

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
    2/26/2016 - PDF - German - NBN
    Learn More
    €155.00

  • NBN EN ISO 13485:2016

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
    2/26/2016 - PDF - French - NBN
    Learn More
    €155.00

  • NBN EN ISO 13485:2016

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
    2/26/2016 - PDF - Dutch - NBN
    Learn More
    €155.00

  • DIN EN 60601-1-6 VDE 0750-1-6:2016-02

    Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010 + A1:2013); German version EN 60601-1-6:2010 + A1:2015
    2/1/2016 - Paper - German - VDE
    Learn More
    €95.02

  • BS EN 62366-1:2015


    1/31/2016 - PDF - English - BSI
    Learn More
    €282.90

  • FMD-2016 Individual

    Failure Mode / Mechanism Distributions – FMD-2016
    1/1/2016 - Download - English - QUANTERION
    Learn More
    €220.00

  • AAMI/IEC 62304 AMD 1:2016

    Medical device software - Software life cycle processes, Amendment 1
    1/1/2016 - PDF sécurisé - English - AAMI
    Learn More
    €180.96

  • AAMI/ISO 15223-2:2016

    Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 2: Symbol development, selection and validation
    1/1/2016 - PDF sécurisé - English - AAMI
    Learn More
    €103.53

  • AAMI/ISO 13485:2016

    Medical devices - Quality management systems - Requirements for regulatory purposes
    1/1/2016 - PDF sécurisé - English - AAMI
    Learn More
    €193.14

  • AAMI/ISO 16142-1:2016

    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
    1/1/2016 - PDF sécurisé - English - AAMI
    Learn More
    €193.14

  • AAMI/ISO 15223-1:2016 (R2017)

    Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
    1/1/2016 - PDF sécurisé - English - AAMI
    Learn More
    €159.21

  • NF C74-054-1, NF EN 62366-1 (12/2015)

    Medical devices - Part 1 : application of usability engineering to medical devices
    12/18/2015 - PDF - English - UTE
    Learn More
    €149.88

  • NF EN 62366-1, C74-054-1 (12/2015)

    Medical devices - Part 1 : application of usability engineering to medical devices - Dispositifs médicaux - Partie 1 : application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs médicaux
    12/1/2015 - Paper - French - AFNOR
    Learn More
    €149.88

  • BS EN ISO 15378:2015

    Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
    11/30/2015 - PDF - English - BSI
    Learn More
    €303.60

  • BS EN 62304:2006+A1:2015


    11/30/2015 - PDF - English - BSI
    Learn More
    €303.60

  • UNE-EN 60601-1-2:2015

    Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (Endorsed by AENOR in November of 2015.)
    11/1/2015 - PDF - English - AENOR
    Learn More
    €126.00

  • BS EN 60601-1-2:2015

    Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests
    10/31/2015 - PDF - English - BSI
    Learn More
    €324.30

  • DIN EN 62353 VDE 0751-1:2015-10

    Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment (IEC 62353:2014); German version EN 62353:2014
    10/1/2015 - Paper - German - VDE
    Learn More
    €136.08

  • BS EN 13718-2:2015


    9/30/2015 - PDF - English - BSI
    Learn More
    €236.90

  • NPRD-2016 Individual

    Nonelectronic Parts Reliability Data
    9/15/2015 - Download - English - QUANTERION
    Learn More
    €330.00

  • VDI 5703:2015-09

    Systematical development for a model-based testing of medical devices
    9/1/2015 - PDF - English, German - VDI
    Learn More
    €127.14

  • NF C74-016/A1, NF EN 60601-1-6/A1 (08/2015)

    Medical electrical equipment - Part 1-6 : general requirements for basic safety and essential performance - Collateral standard : usability
    8/22/2015 - PDF - English - UTE
    Learn More
    €63.42

  • NF EN 60601-1-11, C74-021 (08/2015)

    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 - 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
    8/1/2015 - Paper - French - AFNOR
    Learn More
    €149.88

  • NF EN 60601-1-12, C74-022 (08/2015)

    Medical electrical equipment - Part 1-12 : general requirements for basic safety and essential performance - Collateral standard : requirements for medical equipment and medical electrical systems intended for use the emergency medical services environment
    8/1/2015 - Paper - French - AFNOR
    Learn More
    €135.47

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