11.040.01 : Medical equipment in general

NF S97-414, S97-414PR (02/2026)

NF S97-414, S97-414PR (02/2026)

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Activité de remise en bon état d’usage de dispositifs médicaux à usage individuel – Exigences générales et de sécurité

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PR NF EN ISO 18969 (02/2026)

PR NF EN ISO 18969 (02/2026)

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Evaluation clinique des dispositifs médicaux

€105.50

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PR NF EN ISO 10993-16 (02/2026)

PR NF EN ISO 10993-16 (02/2026)

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Évaluation biologique des dispositifs médicaux — Partie 16 : Évaluation toxicocinétique des produits de dégradation et des substances relargables

€80.50

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BS EN IEC 60601-2-22:2020+A11:2026

BS EN IEC 60601-2-22:2020+A11:2026

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Medical electrical equipment Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic diagnostic laser

€316.00

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DIN EN ISO 18969:2026-01

DIN EN ISO 18969:2026-01

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Clinical evaluation of medical devices (ISO/DIS 18969:2025); German and English version prEN ISO 18969:2025

€134.02

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VDI 5702 Blatt 1:2026-01

VDI 5702 Blatt 1:2026-01

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Medical device software - Medical SPICE - Process assessment model

€384.00

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NF EN IEC 60601-2-22/A11 (01/2026)

NF EN IEC 60601-2-22/A11 (01/2026)

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Appareils electromedicaux - Partie 2-22 : Exigences particulières pour la sécurité de base et les performances essentielles des appareils chirurgicaux, esthétiques, thérapeutiques et de diagnostic à laser

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25/30551597 DC:2025

25/30551597 DC:2025

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Draft BS IEC 60601-1/FRAG4 ED4 Medical electrical equipment

€23.00

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26/30551596 DC:2025

26/30551596 DC:2025

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Draft BS IEC 60601-1/FRAG3 ED4 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - User interface hazards (Fragment 3)

€42.00

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25/30466216 DC:2025

25/30466216 DC:2025

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BS EN ISO 18969 Clinical evaluation of medical devices

€23.00

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IEC 81001-5-1:2021/ISH1:2025

IEC 81001-5-1:2021/ISH1:2025

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Interpretation Sheet 1 - Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle

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NF EN ISO 10993-17/A1 (12/2025)

NF EN ISO 10993-17/A1 (12/2025)

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Évaluation biologique des dispositifs médicaux - Partie 17: Appréciation du risque toxicologique des constituants des dispositifs médicaux - Amendement 1

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NF EN ISO 10993-1 (12/2025)

NF EN ISO 10993-1 (12/2025)

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Évaluation biologique des dispositifs médicaux - Partie 1: Exigences et principes généraux pour l’évaluation de la sécurité biologique au sein d’un processus de gestion des risques

€128.00

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25/30510772 DC:2025

25/30510772 DC:2025

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Draft BS EN IEC 80601-2-77 ED2 Medical electrical equipment Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical

€23.00

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25/30510776 DC:2025

25/30510776 DC:2025

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Draft BS EN IEC 80601-2-78 ED2 Medical electrical equipment Part 2-78: Particular requirements for basic safety and essential performance of medical robots rehabilitation, assessment, compensation or alleviation

€23.00

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