AIMDD


EN ISO 10993-17

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances

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EN ISO 10993-18

Biological evaluation of medical devices - Part 18: Chemical characterization of materials

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EN ISO 14155

Clinical investigation of medical devices for human subjects - Good clinical practice

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EN 45502-1

Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer

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EN 45502-2-1

Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)

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EN 45502-2-2

Active implantable medical devices -- Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)

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EN 45502-2-3

Active implantable medical devices -- Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems

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EN 62304

Medical device software - Software life-cycle processes

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EN 60601-1

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

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EN 60601-1-6

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

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