ISO TS 19930 Sterility of a Finally Sterilized, Disposable Health Care Product - Guidance on Aspects of a Risk-Based Approach

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO TS 19930 testing. ISO/TS 19930 provides guidance for identifying considerations as part of a risk-based approach to selecting a sterility assurance level (SAL) for an ultimately sterilized, disposable healthcare product.

ISO/TS 19930 describes the elements of a quality management system implemented to ensure the selection of an appropriate SAL for a terminally sterilized, disposable healthcare product that cannot withstand processing to achieve a maximum SAL of 10−6.

It is not a requirement of international standards for development, validation and routine control of a sterilization process is done to have a complete quality management system.

Attention is drawn to the standard of quality management systems that control all stages of the life cycle of the health care product. ISO/TS 19930, can be applied to sterilization processes where microorganisms are inactivated by physical or chemical means.

ISO/TS 19930, does not describe detailed procedures for assessing microbial inactivation. ISO/TS 19930 does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.

EUROLAB assists manufacturers with ISO TS 19930 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.