ISO 19227:2018
Current
The latest, up-to-date edition.
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
French, English
03-21-2018
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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