11.040.01 : Medical equipment in general

CEN ISO/TR 20416:2020

CEN ISO/TR 20416:2020

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Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)

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NBN EN ISO 15378:2017

NBN EN ISO 15378:2017

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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)

€187.00

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ISO/TR 24971:2020

ISO/TR 24971:2020

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Medical devices — Guidance on the application of ISO 14971

€261.00

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ISO 15223-1:2021

ISO 15223-1:2021

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Medical devices — Symbols to be used with information to be supplied by the manufacturer Part 1: General requirements

€225.00

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BS EN ISO 15378:2015

BS EN ISO 15378:2015

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Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)

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BS ISO 16142-1:2016

BS ISO 16142-1:2016

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Medical devices. Recognized essential principles of safety and performance medical devices General additional specific for all non-IVD guidance on the selection standards

€374.00

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BS EN 1041:2008+A1:2013

BS EN 1041:2008+A1:2013

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Information supplied by the manufacturer of medical devices

€269.00

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BS EN ISO 389-3:2016

BS EN ISO 389-3:2016

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Acoustics. Reference zero for the calibration of audiometric equipment equivalent threshold vibratory force levels pure tones and bone vibrators

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BS EN 80601-2-35:2009+A1:2016

BS EN 80601-2-35:2009+A1:2016

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Medical electrical equipment Particular requirements for the basic safety and essential performance of heating devices using blankets, pads mattresses intended in medical use

€404.00

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BS ISO 16142-2:2017

BS ISO 16142-2:2017

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Medical devices. Recognized essential principles of safety and performance medical devices General additional specific for all IVD guidance on the selection standards

€374.00

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BS EN ISO 389-1:2018

BS EN ISO 389-1:2018

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Acoustics. Reference zero for the calibration of audiometric equipment equivalent threshold sound pressure levels pure tones and supra-aural earphones

€193.00

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BS EN ISO 15223-1:2016 (CD-ROM)

BS EN ISO 15223-1:2016 (CD-ROM)

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Medical devices. Symbols to be used with medical device labels, labelling and information supplied General requirements

€299.00

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PD IEC/TR 60601-4-3:2018

PD IEC/TR 60601-4-3:2018

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Medical electrical equipment Guidance and interpretation. Considerations of unaddressed safety aspects in the third edition IEC 60601-1 proposals for new requirements

€404.00

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BS EN ISO 14971:2012

BS EN ISO 14971:2012

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Medical devices. Application of risk management to medical devices

€404.00

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BS EN ISO 15223-1:2016

BS EN ISO 15223-1:2016

Superseded Historical

Medical devices. Symbols to be used with medical device labels, labelling and information supplied General requirements

€316.00

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