Abstract
Ïã¸ÛÁùºÏ²Ê¿ª½± 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.
Ïã¸ÛÁùºÏ²Ê¿ª½± 19227:2018 does not specify requirements for packaging or sterilization which are covered by other International Standards.
Ïã¸ÛÁùºÏ²Ê¿ª½± 19227:2018 applies to in-process cleaning and final cleaning.
Ïã¸ÛÁùºÏ²Ê¿ª½± 19227:2018 does not apply to liquid or gaseous implants.
Ïã¸ÛÁùºÏ²Ê¿ª½± 19227:2018 does not apply to cleaning processes performed by the user or under the responsibility of the user.
General information
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Status: Under developmentStage: New project registered in TC/SC work programme [20.00]
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Edition: 2
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Technical Committee :Ïã¸ÛÁùºÏ²Ê¿ª½±/TC 150
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PublishedÏã¸ÛÁùºÏ²Ê¿ª½± 19227:2018
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