Transcription of GHTF SG1 Principles of Medical Devices Classification ...
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GHTF SG1 Principles of Medical Devices Classification ...
Principles of Medical Devices Classification Study Group 1 Final Document GHTF/SG1/N77:2012 November 2nd , 2012 Page 2 of 30 Table of Contents Introduction .. Rationale, Purpose and Scope .. Rationale .. Purpose .. Scope .. References .. Definitions .. General Principles .. Classification System for Medical Devices .. Structure of the Classification Rules .. Diagrammatic Representation of the Classification System .. Manufacturer s Determination of Device Class .. Classification Rules .. Non-Invasive Devices .. Invasive Devices .. Active Devices .. Additional Rules .. Rationale for the inclusion of the Additional Rules within this document .. Reclassification of Medical Devices .
Standalone software is considered to be an active medical device. Active therapeutic device: Any active medical device, whether used alone or in combination with other medical devices, to support, modify, replace or restore biological functions or
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