ISO 19227:2018

Current Revision
Implants for surgery - Cleanliness of orthopedic implants - General requirements

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Implants for surgery - Cleanliness of orthopedic implants - General requirements

PUBLISH DATE 2018

ISO 19227:2018 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.

ISO 19227:2018 does not specify requirements for packaging or sterilization, which are covered by other International Standards.

ISO 19227:2018 applies to in-process cleaning and final cleaning.

ISO 19227:2018 does not apply to liquid or gaseous implants.

ISO 19227:2018 does not apply to cleaning processes performed by the user or under the responsibility of the user.

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