11.040.01 : Medical equipment in general

ASTM F3208-18

ASTM F3208-18

Superseded Historical

Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices

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NF EN 60601-1-8, C74-018 (09/2007)

NF EN 60601-1-8, C74-018 (09/2007)

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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

€141.50

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NF EN 868-9, S98-051-9 (12/2018)

NF EN 868-9, S98-051-9 (12/2018)

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Packaging for terminally sterilized medical devices - Part 9 : uncoated nonwoven materials of polyolefines - Requirements and test methods

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NF EN 868-10, S98-051-10 (12/2018)

NF EN 868-10, S98-051-10 (12/2018)

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Packaging for terminally sterilized medical devices - Part 10 : adhesive coated nonwoven materials of polyolefines - Requirements and test methods

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NF EN 868-8, S98-051-8 (12/2018)

NF EN 868-8, S98-051-8 (12/2018)

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Packaging for terminally sterilized medical devices - Part 8 : re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods - Matériaux et systèmes d'emballage pour les dispositifs médicaux stérilisés au stade terminal - Partie 8 : Conteneurs réutilisables de stérilisation pour stérilisateurs à la vapeur d'eau conformes à l'EN 285 - Exigences et méthodes d?essai

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NF EN ISO 10993-15, S99-501-15 (06/2023)

NF EN ISO 10993-15, S99-501-15 (06/2023)

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Évaluation biologique des dispositifs médicaux - Partie 15 : identification et quantification des produits de dégradation issus des métaux et alliages

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NF EN ISO 22442-1, S97-601-1 (01/2021)

NF EN ISO 22442-1, S97-601-1 (01/2021)

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Medical devices utilizing animal tissues and their derivatives - Part 1 : application of risk management

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NF ISO 19461-2, M60-573 (08/2022)

NF ISO 19461-2, M60-573 (08/2022)

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Radioprotection - Mesurage pour la libération des déchets contaminés par des radioisotopes lors des applications médicales - Partie 2 : gestion des déchets radioactifs solides dans les installations de médecine nucléaire

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ASTM F2809-10

ASTM F2809-10

Withdrawn Most Recent

Standard Terminology Relating to Medical and Surgical Materials and Devices (Withdrawn 2019)

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UNE-EN 61847:2000

UNE-EN 61847:2000

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ULTRASONICS- SURGICAL SYSTEMS - MEASUREMENT AND DECLARATION OF THE BASIC OUTPUT CHARACTERISTICS

€81.00

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UNE-ENV 13004:2000

UNE-ENV 13004:2000

Withdrawn Most Recent

Nomenclature system for medical devices for the purposes of regulatory data exchange - Recommendations for an interim system and rules for a future system

€40.00

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UNE 209001:2002 IN

UNE 209001:2002 IN

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Guide for the management and the maintenance of active non implantable medical devices.

€74.00

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UNE-EN 61847:2003 ERRATUM

UNE-EN 61847:2003 ERRATUM

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Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics.

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UNE-EN 62304:2007

UNE-EN 62304:2007

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Medical device software - Software life-cycle processes (IEC 62304:2006)

€129.00

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UNE-EN 60601-1-8:2008

UNE-EN 60601-1-8:2008

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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.

€128.00

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