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Statement regarding Use of IEC 60601-1 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance"

Statement regarding Use of ISO 10993-1:2009 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"

Statement regarding Use of ISO 11137-1:2006 "Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices"

IMDRF Table of Contents (ToC) Pilot Plan

Statement regarding Use of ISO 14155:2011 "Clinical investigation of medical devices for human subjects – Good clinical practice"

Standards WG: Final Report: 'List of international standards recognized by IMDRF management committee members' Current as of: March 2014

MDSAP: Overview of Auditing Organization Assessment and Recognition Decision Related Processes

Points to consider in the use of the IMDRF Table of Content for Medical Device Submissions pre-RPS