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The National Standards Authority of Ireland (NSAI) will host a key plenary meeting later this year for the International Organization for Standardization Technical Committee 198 (ISO TC 198). The plenary event will take place from June 24th  to June 28th  at the Atlantic Technological University (ATU) Galway City Campus.

ISO/TC  198 is responsible for specifying requirements for cleaning, disinfecting, sterilizing and aseptic processing of health care products together with associated equipment and ancillary products used in ensuring effective application of these processes. ISO TC 198 is also responsible for harmonizing terminology related to its scope of work. This event will gather global experts in the field in the pursuit of the further development of standards in this area.

Standards play a key role in the quality assurance and sterility assurance processes in the area of Medical Technology (MedTech). Ireland is home to a wide variety of companies in the area of MedTech, including multinationals and SMEs. Ireland’s MedTech sector includes more than 300 companies, employing over 40,000 people.
 

Processes addressed by ISO/TC 198 comprise those used both in industrial facilities and by health care facilities. Industrial sterilization processes were initially addressed in the work of ISO/TC 198 because of the need for international standards to facilitate global trade of sterile medical devices.

Standardization in these areas achieves two important goals:

  • Promoting good cleaning, disinfection and sterilization practices in order to prevent infections and support patient health.
  • Providing global standards that can be used by manufacturers and regulatory agencies in order to minimize technical barriers to trade due to differences in regulation of sterile health care products, health care products intended to be reprocessed, associated equipment and ancillary products

Collaboration between industry, research and innovation centres, standards experts and a variety of other stakeholders is as the core of standards development. Ireland’s MedTech sector also boasts a strong collaborative environment spanning cutting-edge industry, academic and clinical research groups and government agencies.

In association with this plenary event, plenary attendees will be invited to attend the launch of the Master of Science in End-to-End Sterility Assurance during that week.  This Master of Science programme aims to address the demand for senior sterility assurance scientists and quality assurance roles, offering comprehensive training in sterility methodologies, innovation, industrial microbiology, and regulatory compliance.