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ISO 19227:2018

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ISO 19227:2018

Implants for surgery — Cleanliness of orthopedic implants — General requirements

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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.

Author ISO/TC 150 Implants for surgery
Editor ISO
Document type Standard
Format Paper
Edition 1
ICS 11.040.40 : Implants for surgery, prosthetics and orthotics
Number of pages 17
Weight(kg.) 0.1289
Year 2018
Country Switzerland