Small steam sterilizers

This document specifies requirements for the design, construction, testing, and marking of small steam sterilizers intended for use in healthcare and related applications. It covers aspects such as safety, performance, and user instructions to ensure proper operation and maintenance. The standard addresses the functional and structural characteristics of the equipment, including materials used, pressure resistance, and temperature control. It also outlines procedures for verification and validation of sterilization processes, as well as requirements for documentation and information provided to users. The scope includes both new and existing devices, ensuring that they meet essential safety and performance criteria throughout their intended lifespan. Additional requirements may apply depending on the specific application and environment in which the sterilizer is used.