Non-active surgical implants. Implants for osteosynthesis. Particular requirements

Non-active surgical implants. Implants for osteosynthesis. Particular requirements

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1   Scope

This International Standard specifies particular requirements for non-active surgical implants for osteosynthesis, hereafter referred to as implants.
In addition to ISO 14630, this International Standard gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.