Essential Principles of Safety and Performance of Medical Devices

• Date: October 03, 2010
• Source: www.ghtf.org

This document describes six general requirements of safety and performance that apply to all medical devices.
It provides a comprehensive list of design and manufacturing requirements of safety and performance, some of which are relevant to each medical device. These are grouped as:

• Chemical, physical and biological properties.
• Infection and microbial contamination.
• Manufacturing and environmental properties.
• Devices with a diagnostic or measuring function.
• Protection against radiation.
• Requirements for medical devices connected to or equipped with an energy source.
• Protection against mechanical risks.
• Protection against the risks posed to the patient by supplied energy or substances.
• Protection against the risks posed to the patient for devices for self-testing or selfadministration.
• Information supplied by the manufacturer.
• Performance evaluation including, where appropriate, clinical evaluation

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