11.040.01 : Medical equipment in general

UNE-EN ISO 10993-2:2007

UNE-EN ISO 10993-2:2007

Superseded Historical

Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)

€69.00

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UNE-EN 13718-1:2015+A1:2020

UNE-EN 13718-1:2015+A1:2020

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Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances

€69.00

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UNE-EN 13718-2:2015+A1:2020

UNE-EN 13718-2:2015+A1:2020

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Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances

€89.00

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UNE-EN ISO 14155:2021

UNE-EN ISO 14155:2021

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Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

€139.00

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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 15223-1:2022

UNE-EN ISO 15223-1:2022

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Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)

€118.00

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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 ISO 10993-7:2009/A1:2022

UNE-EN ISO 10993-7:2009/A1:2022

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Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)

€53.00

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UNE-EN 62304:2007/A1:2016

UNE-EN 62304:2007/A1:2016

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Medical device software - Software life-cycle processes

€96.00

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UNE-EN 60601-1-8:2008/A1:2013

UNE-EN 60601-1-8:2008/A1:2013

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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

€79.00

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UNE-EN 60601-1-9:2008/A1:2013

UNE-EN 60601-1-9:2008/A1:2013

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Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

€40.00

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UNE-EN 15986:2011

UNE-EN 15986:2011

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Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates

€58.00

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UNE-EN ISO 14155:2012

UNE-EN ISO 14155:2012

Superseded Historical

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

€116.00

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UNE-EN ISO 10993-7:2009

UNE-EN ISO 10993-7:2009

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Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

€132.00

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UNE-EN ISO 10993-7:2009/AC:2010

UNE-EN ISO 10993-7:2009/AC:2010

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Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009)

€0.00

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