1. European Union. Regulation (EU) 2017/745 of the European Parliament and of the council of 5 April 2017 on medical devices amending Directive 2001/83/EC Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745.
2. Food and Drug Administration. Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labelled as Sterile . www.fda.gov/media/74445/download. Accessed July 31 2023.
3. McDonnell G, Hansen J (Eds.). Block’s Disinfection, Sterilization and Preservation. 6th ed. London, UK: Wolters Kluwer Health; 2021.
4. ISO 17665-1:2006. Sterilization of health care products—Moist heat—Part 1: Requirements for the development validation and routine control of a sterilization process for medical devices. Geneva Switzerland: International Organization for Standardization.
5. EN 285:2015+A1:2021. Sterilization—Steam sterilizers—Large sterilizers . Brussels Belgium: European Committee for Standardization.