11.040.01 : Medical equipment in general

NF EN ISO 10993-4/A1, S99-501-4/A1 (02/2025)

NF EN ISO 10993-4/A1, S99-501-4/A1 (02/2025)

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Évaluation biologique des dispositifs médicaux - Partie 4 : Choix des essais pour les interactions avec le sang - Amendement 1Automatic translation from French : Biological evaluation of medical devices - Part 4: Choice of tests for interactions with blood - Amendment 1

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PR NF S97-414, S97-414PR (09/2023)

PR NF S97-414, S97-414PR (09/2023)

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Activité de remise en bon état d'usage de dispositifs médicaux à usage individuel - Exigences générales et de sécuritéAutomatic translation from French : Activity of restoring medical devices for individual use to good condition - General and safety requirements

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NF EN ISO 15378/A1, S93-200/A1 (09/2024)

NF EN ISO 15378/A1, S93-200/A1 (09/2024)

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Articles d'emballage primaire pour médicaments - Exigences particulières pour l'application de l'ISO 9001:2015 prenant en considération les Bonnes Pratiques de Fabrication (BPF) - Amendement 1 : Actions relatives aux changements climatiquesAutomatic translation from French : Primary packaging items for medicinal products - Particular requirements for the application of ISO 9001:2015 taking into account Good Manufacturing Practices (GMP) - Amendment 1: Actions relating to climate change

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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

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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

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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

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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

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FD S98-113 (12/1996) (R2011)

FD S98-113 (12/1996) (R2011)

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Medical devices. Guidance for their preparation in cleanrooms. - Dispositifs médicaux

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NF EN 60601-1-4, C74-015 (10/1999)

NF EN 60601-1-4, C74-015 (10/1999)

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Medical electrical equipment - Part 1 : general requirements for safety - 4 - Collateral standard : programmable electrical medical systems

€126.00

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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

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UNE-EN 60601-1-8:2008/A1:2013/AC:2014

UNE-EN 60601-1-8:2008/A1:2013/AC:2014

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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

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FD X50-797 (10/2008)

FD X50-797 (10/2008)

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Availability of medical devices at home - Implementation of the service commitments for standard NF X50-796 - Mise à disposition de dispositifs médicaux à domicile

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

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

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Medical devices - Quality management systems - Requirements for regulatory purposes

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NF EN ISO 14971, S99-211 (11/2009)

NF EN ISO 14971, S99-211 (11/2009)

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Medical devices - Application of risk management to medical devices - Dispositifs médicaux

€159.33

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

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

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Medical devices - Quality management - Medical device nomenclature data structure

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