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Standards Development
This document specifies requirements for the cleanliness of orthopaedic implants, hereafter referred to as implants, and test methods for the cleaning process validation and controls, which are based on a risk management process.
This document does not specify requirements for packaging or sterilization which are covered by other International Standards.
This document applies to implants that require in-process cleaning and final cleaning.
This document does not apply to liquid, gaseous or biologically based implants.
This document does not apply to cleaning processes performed by the user or under the responsibility of the user.
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