BS ISO 19227:2016 pdf free

BS ISO 19227:2016 pdf free.Implants for surgery一Cleaning of orthopedic implants一General requirements
The manufacturer, in cooperation with the cleaning subcontractor if applicable, shall define the critical in-process cleanings and the final cleaning, based on a risk analysis of the manufacturing process and the influence of the in-process cleaning step on the final cleanliness of the implant.. The risk assessment shall be used to determine sequence of events that have the highest probability of occurrence and/or severity.
Subsequent activities in the design, verification and validation of the product and processes (including inspection steps) should then concentrate on the development of control measures to mitigate these risks.
The design requirements for the critical in-process cleanings and the final cleaning shall be defined, based on implant characteristics, the intended performance of the implant as well as manufacturing steps before cleaning and an analysis of the hazards being introduced by the cleaning process itself (see Annex A). The cleaning processes shall be designed in order to reach the cleanliness requirements addressed in Clause 5.
The manufacturer may choose to define cleaning families in order to simplify validation or continued process verification activities of the cleaning process. In this case, criteria for defining the cleaning families shall be justified and documented. For inclusion of a new implant into a cleaning family, it shall be ensured that it is represented by the worst-case specimen. When determining if an implant is represented by the worst-case specimen for a cleaning family, the manufacturer shall take into account the cleanliness specifications, cleaning process and the ability of the implant to be cleaned.
Acceptance criteria for visual testing after cleaning shall be established by the manufacturer of the implant.After cleaning, the implant shall be inspected as specified in EN 13018. If contaminants appear on the implant, they shall comply with the acceptance criteria.
If the purpose of the cleaning process is to ensure that the microbiological contamination is kept under a predetermined maximum level, the populations of microorganisms on the implant shall be determined as specified in ISO 11737-1 after the cleaning of the implant.BS ISO 19227 pdf free.