The standard "ISO 19227 Implants for surgery - Cleaning of orthopaedic implants - General requirements," developed by the International Organization for Standardization (ISO), describes the requirements for the cleaning of orthopaedic implants and test methods for cleaning process verification and control based on a risk management process. This standard does not include packaging or sterilization requirements covered by other international standards. This standard applies to in-process cleaning and final cleaning. This standard does not apply to liquid or gaseous implants. It also does not apply to cleaning processes performed by or under the responsibility of the user.
The activities described in this standard must be carried out within a formal quality management system. A possible and widely used quality management system for medical devices is described in ISO 13485.
Risk management is an iterative process that should be implemented during the design and validation of the cleaning process and through its ongoing use. A potential and widely used risk management system for medical devices is described in the ISO 14971 standard. As part of risk management, the cleaning process should be evaluated in terms of the measures required to achieve the intended cleanliness level (e.g., controlled environment manufacturing or different cleaning methods) and their integration into the manufacturing sequence.
A cleaning process is included in the manufacturing process of an implant if hazards related to potential contaminants from previous manufacturing steps have been identified. Consequently, the design and validation of a cleaning process must be conducted within a risk management system. Cleaning-related hazards should be considered during the design of the cleaning process and when determining design requirements for critical in-process cleanings and final cleaning.
The annex to this standard describes some aspects of the cleaning process that may be considered sources of harm (Annex A). Risk assessment of cleaning-related hazards should be conducted after the cleaning process is designed and should consider implant characteristics, manufacturing steps prior to cleaning, cleaning process characteristics, and the environment after final cleaning. Cleaning requirements should be defined by considering the contaminants intended to be removed by any in-process or final cleaning, as well as any additional contaminants introduced by the cleaning process itself.
At a minimum, the following questions should be addressed during a risk assessment:
It is recognized that no single set of questions covers every implant. This list is not exhaustive, and additional questions may need to be addressed during the risk assessment. Based on the results of the risk assessment, at least the following additional questions should be answered:
Before evaluating the performance of a critical in-process cleaning process or final cleaning process, potential contaminants must be identified, appropriate test methods established, and acceptance criteria established as part of the risk management process. Cleaning validation can be performed based on the cleaning acceptance criteria. The figure illustrates the relationship between cleaning design, validation, and risk management.
Design requirements for critical in-process cleanings and final cleaning should be defined based on the implant characteristics, the intended performance of the implant and manufacturing steps prior to cleaning, and an analysis of the hazards introduced by the cleaning process itself. Cleaning processes should be designed to achieve the implant's cleanliness acceptance criteria after final cleaning, as described in this standard.
The manufacturer, in collaboration with any cleaning subcontractor, should define which cleaning steps are critical in-process cleaning steps and which are final cleaning steps based on a risk analysis of the manufacturing process and the impact of the in-process cleaning step on the final cleanliness of the implant. The risk assessment should be used to determine the sequence of events with the highest probability or severity of occurrence. Subsequent activities in the design, verification, and validation of products and processes (including inspection steps) should then focus on developing control measures to mitigate these risks.
If a drying process is performed at the end of the cleaning process, the drying process is considered part of the cleaning process. The cleaning process should be designed to not compromise the biocompatibility and intended performance of the implant. The cleaning process should be designed to limit contamination of the implant from cleaning agents, rinses, or contaminants from the cleaning process itself. The cleaning process should be capable of reducing contamination from previous manufacturing steps to a sufficient predetermined level. For final cleaning of implants, an adequate controlled environment or containment should be implemented between final cleaning and packaging to prevent contamination of the implants after cleaning.
A controlled environment does not necessarily mean the use of a clean room. While clean rooms are typically used for implants delivered sterile, this may not be the case for implants delivered non-sterile. ISO 14644 (all parts) contains information that may be useful if clean rooms and associated controlled environments are used.
Our organization, which has been supporting businesses across all sectors for years through a wide range of testing, measurement, analysis, and evaluation activities, has a strong team of employees who closely follow global developments in science and technology and are constantly improving themselves. In this context, we also provide testing services in accordance with the "ISO 19227 Implants for Surgery - Cleaning of Orthopedic Implants - General Requirements" standard.
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