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Implants for surgery. Essential principles of safety and performance

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Implants for surgery. Essential principles of safety and performance1 Scope This document provides fundamental principles for the design and manufacture of active or non active implants in order that each implant can achieve its intended purpose. It is often the case that instruments and other equipment are used in association with implants. These devices might be useful or even essential for the safe implantation and or use of the implants. This document applies to implants, however, it also applies to associated

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