Abstract
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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General information
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Status: PublishedPublication date: 2018-03Stage: International Standard to be revised [90.92]
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Edition: 1Number of pages: 17
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Technical Committee :ISO/TC 150ICS :11.040.40
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Life cycle
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Now
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Will be replaced by
Under developmentISO/AWI 19227
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