Sterilizers for medical purposes - Small steam sterilizers - Requirements and testing

This document specifies the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials that are likely to come into contact with blood or body fluids. This document applies to automatically controlled small steam sterilizers that generate steam using electrical heaters or use steam that is generated by a system external to the sterilizer. This document applies to small steam sterilizers used primarily for the sterilization of medical devices with a chamber volume of less than 60 l and unable to accommodate a sterilization module (300 mm × 300 mm × 600 mm). The requirements concerning the quality management and risk management are addressed by other standards (e.g. EN ISO 13485, EN ISO 14971). This document does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products. This document does not specify safety requirements related to risks associated with the zone in which the sterilizer is used (e.g. flammable gases). This document does not specify requirements for the validation and routine control of sterilization by moist heat. This document does not specify requirements for other sterilization processes that also employ moist heat as part of the process (i.e. formaldehyde, ethylene oxide).