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Implants for surgery. Cleanliness of orthopedic implants. General requirements
Description
Implants for surgery. Cleanliness of orthopedic implants. General requirements1 Scope 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 in process cleaning and final cleaning. This document does not
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consumer and/or a third party
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resistance to atmospheric corrosion and resistance to water
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1 or the resistance to peeling test described in BS 5131-1
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