STANDARD
ISO 14155:1996
Issue date: 1996 02 29
Clinical investigation of medical devices
Pertains to the clinical investigation in human subjects of those medical devices whose clinical performance needs assessment. Specifies the requirements for conducting the clinical investigation and documentation. Provides the framework for systematic written procedures for the organization, design, implementation and data collection.
General information on ISO 14155:1996
Timeline
An overview of the development of ISO 14155:1996 from 1996 til today.
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ISO 14155:20202020 07 28 Standard ISO 14155:2020, Edition: 2020 07 28Clinical investigation of medical devices for human subjects — Good clinical practice
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ISO 14155:20112011 01 21 Standard ISO 14155:2011, Edition: 2011 01 21Clinical investigation of medical devices for human subjects — Good clinical practice
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ISO 14155-2:2003Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
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ISO 14155-1:2003Clinical investigation of medical devices for human subjects — Part 1: General requirements
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ISO 14155:19961996 02 29 Standard ISO 14155:1996, Edition: 1996 02 29Clinical investigation of medical devices
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