In order to sterilize medical devices, a low-temperature steam and formaldehyde (LTSF) sterilization process that operates below ambient pressure and uses a mixture of low-temperature steam and formaldehyde as the sterilizing agent is needed. This document outlines the requirements for its development, validation, and routine control. This guide is meant to be used by process designers, producers of sterilization tools, producers of medical devices that need to be sterilized, and organizations in charge of sterilizing medical devices.
Applications, CE marking, Definitions, Developments, Formaldehyde, Health care, Hygiene, Low temperatures, Medical devices, Medical equipment, Medical products, Medical sciences, Packages, Quality management, Specification (approval), Steam sterilization, Sterilization (hygiene), Use, Validation, Vapours, Implementation
