BS ISO 19227:2018,Implants for surgery – Cleanliness of orthopedic implants – General requirements.BS ISO 19227:2018 pdf free download.The size of this pdf file is 4.15M,which is shared by Judy from England.
Cleaning of orthopaedic implants is an essential step for achieving their biocompatibility as well as controlling the microbiological load required for their sterilization process.
Cleanliness is a key factor to ensure the biocompatibility of an implant. When applicable, cleaning is an essential step to remove contaminations coming from the previous manufacturing steps. However, cleaning methods should not interact with materials and impair their biocompatibility or impair the performance of the implant.
As an alternative to final cleaning, the cleanliness of implants can be controlled by manufacturing in a clean environment and with clean processes. In this case, the cleaning of the implant before packaging might not be required but the cleanliness requirements defined in this document might apply.
BS ISO 19227:2018 specifies requirements for the cleanliness of orthopaedic implants, hereafter referre to as implants, and test methods for the cleaning process validation and controls, which are based on a risk
management process.
BS ISO 19227:2018 does not specify requirements for packaging or sterilization which are covered by other International Standards.