<p>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.</p>
<p>ISO 19227:2018 does not specify requirements for packaging or sterilization which are covered by other International Standards.</p>
<p>ISO 19227:2018 applies to in-process cleaning and final cleaning.</p>
<p>ISO 19227:2018 does not apply to liquid or gaseous implants.</p>
<p>ISO 19227:2018 does not apply to cleaning processes performed by the user or under the responsibility of the user.</p>
Registration number (WIID)
89264
Scope
<p>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.</p>
<p>ISO 19227:2018 does not specify requirements for packaging or sterilization which are covered by other International Standards.</p>
<p>ISO 19227:2018 applies to in-process cleaning and final cleaning.</p>
<p>ISO 19227:2018 does not apply to liquid or gaseous implants.</p>
<p>ISO 19227:2018 does not apply to cleaning processes performed by the user or under the responsibility of the user.</p>
