DANSK DS/ISO 19227 PDF

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.