11.040.01 : Medical equipment in general

PD CEN/TR 15133:2005

PD CEN/TR 15133:2005

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Nomenclature. Collective terms and codes for groups of medical devices

€201.00

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BS ISO 15223-2:2010

BS ISO 15223-2:2010

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Medical devices. Symbols to be used with medical device labels, labelling, and information supplied Symbol development, selection validation

€281.00

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BS EN 80001-1:2011

BS EN 80001-1:2011

Superseded Historical

Application of risk management for IT-networks incorporating medical devices Roles, responsibilities and activities

€370.00

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PD 6573:1994

PD 6573:1994

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Fundamental aspects of safety standards for medical electrical equipment

€390.00

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BS EN ISO 389-2:1997

BS EN ISO 389-2:1997

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

€172.00

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PD 6630:1998

PD 6630:1998

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Nomenclature system for medical devices for the purpose of regulatory data exchange. Rationale

€201.00

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BS EN ISO 389-4:1999

BS EN ISO 389-4:1999

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Acoustics. Reference zero for the calibration of audiometric equipment levels narrow-band masking noise

€201.00

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UNE-EN 62353:2015

UNE-EN 62353:2015

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Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment

€115.00

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UNE-EN 60601-1:2008/A12:2015

UNE-EN 60601-1:2008/A12:2015

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Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

€58.00

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UNE-EN 60601-1-10:2008/A1:2015

UNE-EN 60601-1-10:2008/A1:2015

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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

€47.00

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UNE-EN 60601-1-6:2010/A1:2015

UNE-EN 60601-1-6:2010/A1:2015

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Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

€54.00

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UNE-EN ISO 14971:2020

UNE-EN ISO 14971:2020

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Medical devices - Application of risk management to medical devices (ISO 14971:2019)

€98.00

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UNE-EN ISO 20417:2021

UNE-EN ISO 20417:2021

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Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)

€130.00

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UNE-EN ISO 14971:2020/A11:2022

UNE-EN ISO 14971:2020/A11:2022

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Medical devices - Application of risk management to medical devices (ISO 14971:2019)

€53.00

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UNE-EN 60601-1:2008

UNE-EN 60601-1:2008

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Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance

€206.00

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