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.
Document identifier
ISO 19227:2018
Title
Implants for surgery - Cleanliness of orthopedic implants - General requirements
ISO Category
Materials, TC 150: Implants for surgery
Publication date
2018-03-01
International Relationship
BS ISO 19227:2018
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103 vnd |
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