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11.040.01 : Medical equipment in general

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  • 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 - Paper - English -
    Learn More
    €137.86

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

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

  • ASTM F3208-18 + Redline

    Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
    10/1/2018 - PDF - English -
    Learn More
    €51.00

  • ASTM F3208-18

    Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
    10/1/2018 - PDF - English -
    Learn More
    €42.00

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

    Medical devices - Application of risk management to medical devices
    9/28/2018 - Paper - English, French -
    Learn More
    €139.59

  • 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 -
    Learn More
    €42.45

  • 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 -
    Learn More
    €38.31

  • 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 -
    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 - Spanish -
    Learn More
    €87.00

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

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

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

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

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

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

  • ASTM E3173-18

    Standard Guide for Decommissioning and Disposal of Medical Equipment
    7/1/2018 - PDF - English -
    Learn More
    €37.00

  • 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 -
    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 -
    Learn More
    €18.19

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

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

  • ISO/DIS 20069:2018

    Guidance for assessment and evaluation of changes to drug delivery systems
    6/1/2018 - Paper - English -
    Learn More
    €61.00

  • 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 -
    Learn More
    €95.02

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

    Medical vehicles and their equipment - Air ambulances - Part 2 : Operational and technical requirements for air ambulances
    5/31/2018 - Paper - English, French -
    Learn More
    €63.03

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

    Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
    5/31/2018 - Paper - English, French -
    Learn More
    €63.03

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

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

  • 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 -
    Learn More
    €37.00

  • VDI 5701:2018-05

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

  • 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 -
    Learn More
    €48.40

  • 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 - French -
    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 -
    Learn More
    €124.52

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

    Medical device software - Software life-cycle processes
    4/14/2018 - PDF - French -
    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 -
    Learn More
    €54.80

  • 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 -
    Learn More
    €239.20

  • 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 -
    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 -
    Learn More
    €191.40

  • 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 -
    Learn More
    €297.00

  • 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 -
    Learn More
    €386.00

  • PD 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
    3/21/2018 - Paper - English -
    Learn More
    €287.02

  • 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 - Paper - English -
    Learn More
    €137.86

  • IEC 60601-1-SER (2018-02)

    IEC 60601-1:2018 SER Medical electrical equipment - ALL PARTS
    2/20/2018 - PDF - English, French -
    Learn More
    €3,418.00

  • JIS T 1115:2018

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

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

    Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
    1/19/2018 - Paper - French -
    Learn More
    €71.80

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

    Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
    1/6/2018 - Paper - English -
    Learn More
    €136.35

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

    Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
    1/6/2018 - Paper - French -
    Learn More
    €136.35

  • NBN EN ISO 13485:2016/AC

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
    1/4/2018 - PDF - English -
    Learn More
    €45.00

  • NBN EN ISO 13485:2016/AC

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
    1/4/2018 - PDF - French -
    Learn More
    €45.00

  • NBN EN ISO 13485:2016/AC

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
    1/4/2018 - PDF - German -
    Learn More
    €45.00

  • NF Z84-559, NF EN 301559 (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)
    12/15/2017 - Paper - French -
    Learn More
    €104.89

  • NF Z84-537, NF EN 302537 (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)
    12/15/2017 - Paper - French -
    Learn More
    €104.89

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

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

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

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

  • 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 - Paper - English -
    Learn More
    €287.02

  • 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 -
    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 -
    Learn More
    €127.14

  • PD ISO/TR 80002-2:2017

    Medical device software. Validation of software for medical device quality systems
    10/31/2017 - Paper - English -
    Learn More
    €287.02

  • PR NF S98-051-10, PR NF EN 868-10 (10/2017)

    Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
    10/10/2017 - Paper - English, French -
    Learn More
    €63.03

  • PR NF S98-051-8, PR NF EN 868-8 (10/2017)

    Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
    10/10/2017 - Paper - English, French -
    Learn More
    €78.60

  • PR NF S98-051-9, PR NF EN 868-9 (10/2017)

    Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
    10/10/2017 - Paper - English, French -
    Learn More
    €54.95

  • PR NF Z82-510, PR NF EN 302510 (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)
    9/29/2017 - Paper - English, French -
    Learn More
    €112.59

  • 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 - Paper - English -
    Learn More
    €253.12

  • 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 - Paper - English -
    Learn More
    €192.10

  • 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 -
    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 -
    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 -
    Learn More
    €154.00

  • 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 -
    Learn More
    €165.00

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

    Medical vehicles and their equipment - Air ambulances - Part 1 : requirements for medical devices used in air ambulances
    7/21/2017 - Paper - English -
    Learn More
    €66.72

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

    Medical vehicles and their equipment - Air ambulances - Part 1 : requirements for medical devices used in air ambulances
    7/21/2017 - Paper - French -
    Learn More
    €66.72

  • NF S95-202-2, NF EN 13718-2 (07/2017)

    Medical vehicles and their equipment - Air ambulances - Part 2 : operational and technical requirements for air ambulances
    7/21/2017 - Paper - English -
    Learn More
    €87.56

  • NF S95-202-2, NF EN 13718-2 (07/2017)

    Medical vehicles and their equipment - Air ambulances - Part 2 : operational and technical requirements for air ambulances
    7/21/2017 - Paper - French -
    Learn More
    €87.56

  • 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 -
    Learn More
    €22.72

  • 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 -
    Learn More
    €126.54

  • 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 - Paper - English -
    Learn More
    €287.02

  • NF Z82-510, NF EN 302510 (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)
    6/17/2017 - Paper - French -
    Learn More
    €87.56

  • 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 -
    Learn More
    €206.00

  • PR NF Z84-489-35, PR NF EN 301489-35 (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)
    6/5/2017 - Paper - English, French -
    Learn More
    €86.46

  • PR NF Z84-489-27, PR NF EN 301489-27 (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)
    6/5/2017 - Paper - English, French -
    Learn More
    €86.46

  • PR NF Z84-489-29, PR NF EN 301489-29 (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)
    6/5/2017 - Paper - English, French -
    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 -
    Learn More
    €207.00

  • VDI 5700 Blatt 2:2017-06

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

  • 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 -
    Learn More
    €187.00

  • NF S99-012, NF EN ISO 15225 (05/2017)

    Medical devices - Quality management - Medical device nomenclature data structure
    5/26/2017 - Paper - English -
    Learn More
    €66.72

  • 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 -
    Learn More
    €330.00

  • NF Z84-489-29, NF EN 301489-29 (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)
    5/12/2017 - Paper - French -
    Learn More
    €76.40

  • NF Z84-489-27, NF EN 301489-27 (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)
    5/12/2017 - Paper - French -
    Learn More
    €66.72

  • NF Z84-489-35, NF EN 301489-35 (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)
    5/12/2017 - Paper - French -
    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 -
    Learn More
    €103.22

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

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

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

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

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

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

  • 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 -
    Learn More
    €171.10

  • VDI 5702 Blatt 1:2017-04

    Medical device software - Medical SPICE Process assessment model
    4/1/2017 - PDF - English, German -
    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 - German -
    Learn More
    €136.80

  • 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 -
    Learn More
    €17.00

  • 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 -
    Learn More
    €62.00

  • JIS T 0601-1:2017

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

  • JIS T 2304:2017

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

  • 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
    2/28/2017 - Paper - English -
    Learn More
    €223.74

  • NF S99-172 (02/2017)

    Use and maintenance of medical devices - Risk management système for risks associated with the use of medical devices
    2/4/2017 - Paper - French -
    Learn More
    €115.12

  • UNE-EN 301489-29 V2.1.1

    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 (Endorsed by Asociación Española de Normalización in February of 2017.)
    2/1/2017 - PDF - English -
    Learn More
    €75.00

  • UNE-EN 301489-27 V2.1.1

    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 (Endorsed by Asociación Española de Normalización in February of 2017.)
    2/1/2017 - PDF - English -
    Learn More
    €75.00

  • 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 -
    Learn More
    €220.00

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

    Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1 : general requirements
    1/7/2017 - Paper - French -
    Learn More
    €76.40

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

    Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1 : general requirements
    1/7/2017 - Paper - English -
    Learn More
    €76.40

  • 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 -
    Learn More
    €134.70

  • 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 -
    Learn More
    €153.30

  • UNE-EN 301489-31 V2.1.1

    ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 31: Specific conditions for equipment in the 9 kHz to 315 kHz band 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 the Directive 2014/53/EU (Endorsed by Asociación Española de Normalización in January of 2017.)
    1/1/2017 - PDF - English -
    Learn More
    €74.00

  • ANSI/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 -
    Learn More
    €193.14

  • 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 -
    Learn More
    €98.77

  • NBN EN ISO 13485:2016/AC

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
    1/1/2017 - PDF - Dutch -
    Learn More
    €0.00

  • 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 -
    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 -
    Learn More
    €82.87

  • 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 -
    Learn More
    €37.00

  • BS EN ISO 15223-1:2016

    Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
    12/31/2016 - Paper - English -
    Learn More
    €223.74

  • 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 - French -
    Learn More
    €193.11

  • 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 -
    Learn More
    €193.11

  • UNE-EN 302195 V2.1.1

    Short Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI) and accessories (ULP-AMI-P) operating in the frequency range 9 kHz to 315 kHz Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU (Endorsed by AENOR in December of 2016.)
    12/1/2016 - PDF - English -
    Learn More
    €83.00

  • ISO 15223-1:2016

    Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
    11/1/2016 - Paper - French -
    Learn More
    €123.00

  • ISO 15223-1:2016

    Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
    11/1/2016 - Paper - English -
    Learn More
    €123.00

  • NF Z84-839, NF EN 301839 (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)
    10/7/2016 - Paper - French -
    Learn More
    €104.89

  • 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 -
    Learn More
    €178.39

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

    Medical electrical equipment - Part 1 : general requirements for basic safety and essential performance
    8/20/2016 - PDF - French -
    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 -
    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 -
    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 -
    Learn More
    €212.40

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

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

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

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

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

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

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

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

  • PD IEC/TR 62366-2:2016

    Medical devices. Guidance on the application of usability engineering to medical devices
    5/31/2016 - Paper - English -
    Learn More
    €307.36

  • 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
    5/31/2016 - Paper - English -
    Learn More
    €268.94

  • 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 - Paper - English -
    Learn More
    €268.94

  • 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 -
    Learn More
    €297.00

  • 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 -
    Learn More
    €297.00

  • 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 -
    Learn More
    €192.57

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

    Medical devices - Quality management systems - Requirements for regulatory purposes
    4/30/2016 - Paper - French -
    Learn More
    €95.37

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

    Medical devices - Quality management systems - Requirements for regulatory purposes
    4/30/2016 - Paper - English -
    Learn More
    €95.37

  • BS EN ISO 15225:2016

    Medical devices. Quality management. Medical device nomenclature data structure
    4/30/2016 - Paper - English -
    Learn More
    €192.10

  • 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 -
    Learn More
    €22.00

  • 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 -
    Learn More
    €440.00

  • 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 -
    Learn More
    €352.00

  • UNE-EN 62304:2007/A1:2016

    Medical device software - Software life-cycle processes
    4/13/2016 - PDF - Spanish -
    Learn More
    €68.00

  • 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 -
    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 - Paper - English -
    Learn More
    €268.94

  • 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 -
    Learn More
    €98.49

  • ISO 13485:2016

    Medical devices - Quality management systems - Requirements for regulatory purposes
    3/1/2016 - Paper - English -
    Learn More
    €165.00

  • ISO 13485:2016

    Medical devices - Quality management systems - Requirements for regulatory purposes
    3/1/2016 - Paper - French -
    Learn More
    €165.00

  • 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 -
    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 - Paper - English -
    Learn More
    €192.10

  • BS EN ISO 13485:2016

    Medical devices. Quality management systems. Requirements for regulatory purposes
    2/29/2016 - Paper - English -
    Learn More
    €268.94

  • ISO 11197:2016

    Medical supply units
    2/1/2016 - Paper - English -
    Learn More
    €123.00

  • 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 -
    Learn More
    €95.02

  • ISO 11197:2016

    Medical supply units
    2/1/2016 - Paper - French -
    Learn More
    €123.00

  • 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)
    1/12/2016 - PDF - German -
    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)
    1/12/2016 - PDF - English -
    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)
    1/12/2016 - PDF - French -
    Learn More
    €56.00

  • NBN EN ISO 15225

    Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
    1/5/2016 - PDF - French -
    Learn More
    €45.00

  • NBN EN ISO 15225

    Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
    1/5/2016 - PDF - German -
    Learn More
    €45.00

  • NBN EN ISO 15225

    Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
    1/5/2016 - PDF - English -
    Learn More
    €45.00

  • NBN EN ISO 13485:2016

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) (Corrected version, 2016-12-21)
    1/2/2016 - PDF - Dutch -
    Learn More
    €155.00

  • ANSI/AAMI/ISO 13485:2016

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

  • ANSI/AAMI/IEC 62304 AMD 1:2016

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

  • ANSI/AAMI/ISO 15223-1:2016

    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 -
    Learn More
    €159.21

  • FMD-2016 Individual

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

  • ANSI/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 -
    Learn More
    €193.14

  • ANSI/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 -
    Learn More
    €103.53

  • 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 -
    Learn More
    €149.88

  • 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 - French -
    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 - Paper - English -
    Learn More
    €287.02

  • 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 -
    Learn More
    €140.00

  • 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 - Paper - English -
    Learn More
    €307.36

  • 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 -
    Learn More
    €136.08

  • NPRD-2016 Individual

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

  • VDI 5703:2015-09

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

  • BS EN 13718-2:2015

    Medical vehicles and their equipment. Air ambulances. Operational and technical requirements for air ambulances
    8/31/2015 - Paper - English -
    Learn More
    €223.74

  • 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 - French -
    Learn More
    €63.42

  • 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 -
    Learn More
    €63.42

  • NF C74-021, NF EN 60601-1-11 (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
    8/8/2015 - PDF - French -
    Learn More
    €149.88

  • NF C74-020/A1, NF EN 60601-1-10/A1 (08/2015)

    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
    8/8/2015 - PDF - French -
    Learn More
    €48.40

  • NF C74-022, NF EN 60601-1-12 (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
    8/8/2015 - PDF - French -
    Learn More
    €135.47

  • UNE-EN 60601-1-6:2010/A1:2015

    Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
    7/29/2015 - PDF - Spanish -
    Learn More
    €45.00

  • UNE-EN 13718-2:2015

    Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
    7/15/2015 - PDF - Spanish -
    Learn More
    €59.00

  • UNE-EN 60601-1-10:2008/A1:2015

    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
    7/15/2015 - PDF - Spanish -
    Learn More
    €33.00

  • UNE-EN 80601-2-60:2015

    Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment (Endorsed by AENOR in July of 2015.)
    7/1/2015 - PDF - English -
    Learn More
    €81.00

  • UNE-EN 60601-1-12:2015

    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 AENOR in July of 2015.)
    7/1/2015 - PDF - English -
    Learn More
    €95.00

  • UNE-EN 80601-2-30:2010/A1:2015

    Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers (Endorsed by AENOR in July of 2015.)
    7/1/2015 - PDF - English -
    Learn More
    €50.00

  • UNE-EN 45502-1:2015

    Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer (Endorsed by AENOR in July of 2015.)
    7/1/2015 - PDF - English -
    Learn More
    €108.00

  • UNE-EN 60601-2-62:2015

    Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment (Endorsed by AENOR in July of 2015.)
    7/1/2015 - PDF - English -
    Learn More
    €111.00

  • UNE-EN 60601-1-11:2015

    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 (Endorsed by AENOR in July of 2015.)
    7/1/2015 - PDF - English -
    Learn More
    €108.00

  • BS EN 62366-1:2015

    Medical devices. Application of usability engineering to medical devices
    6/30/2015 - Paper - English -
    Learn More
    €268.94

  • BS EN 80601-2-60:2015

    Medical electrical equipment. Particular requirements for the basic safety and essential performance of dental equipment
    6/30/2015 - Paper - English -
    Learn More
    €223.74

  • BS EN 60601-1-11:2015

    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
    6/30/2015 - Paper - English -
    Learn More
    €268.94

  • BS EN 60601-2-62:2015

    Medical electrical equipment. Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
    6/30/2015 - Paper - English -
    Learn More
    €287.02

  • IEC 62304 AMD 1 (2015-06)

    IEC 62304:2006/AMD1:2015 Amendment 1 - Medical device software - Software life cycle processes
    6/26/2015 - PDF - English -
    Learn More
    €264.00

  • IEC 62304 Edition 1.1 (2015-06)

    IEC 62304:2006+AMD1:2015 consolidated version Medical device software - Software life cycle processes
    6/26/2015 - PDF - English, French -
    Learn More
    €770.00

  • IEC 62304 Edition 1.1 (2015-06)

    IEC 62304:2006+AMD1:2015 consolidated version Medical device software - Software life cycle processes
    6/26/2015 - PDF - English -
    Learn More
    €770.00

  • IEC 62304 AMD 1 (2015-06)

    IEC 62304:2006/AMD1:2015 Amendment 1 - Medical device software - Software life cycle processes
    6/26/2015 - PDF - English, French -
    Learn More
    €264.00

  • UNE-EN 60601-1:2008/A12:2015

    Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    6/24/2015 - PDF - Spanish -
    Learn More
    €46.00

  • UNE-EN 62366-1:2015

    Medical devices - Part 1: Application of usability engineering to medical devices (Endorsed by AENOR in June of 2015.)
    6/1/2015 - PDF - English -
    Learn More
    €100.00

  • IEC 62304 AMD 1 (2015-06)

    Medical device software - Software life cycle processes
    6/1/2015 - PDF - English, French -
    Learn More
    €264.00

  • €210.00

  • DIN EN 13718-2:2015-05

    Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances; German version EN 13718-2:2015
    5/1/2015 - PDF - English -
    Learn More
    €136.20

  • DIN EN 13718-2:2015-05

    Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances; German version EN 13718-2:2015
    5/1/2015 - PDF - German -
    Learn More
    €108.80

  • PD IEC/TR 60601-4-3:2015

    Medical electrical equipment. Guidance and interpretation. Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements
    4/30/2015 - Paper - English -
    Learn More
    €287.02

  • UNE-EN 13718-1:2015

    Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
    4/22/2015 - PDF - Spanish -
    Learn More
    €49.00

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