Sterilisering

This document specifies requirements and tests for low temperature hydrogen peroxide sterilizers, which use a vaporized aqueous solution of hydrogen peroxide as the sterilizing agent.

These sterilizers are used for the sterilization of medical devices, particularly thermolabile medical devices. This document specifies minimum requirements

for the performance and design of sterilizers intended to deliver a process capable of sterilizing medical devices;

for the equipment and controls of these sterilizers needed for operation, control and monitoring, and which can be used for validation of the sterilization processes;

for the test equipment and test procedures used to verify the sterilizer performance specified by this document.

This document does not specify requirements for equipment intended to process liquids, biological waste, or human tissues. This document does not describe a quality management system for the control of all stages of the manufacture of the sterilizer. This document does not specify requirements and tests for decontamination systems for use in rooms, enclosures, or environmental spaces.

NOTE: Attention is drawn to the standards for quality management, e.g. EN ISO 13485.

This document does not specify requirements and tests for decontamination systems for use in rooms, enclosures, or environmental spaces. 

This document specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water or - in the case of ready-to-use products - with water. Products can only be tested at a concentration of 80 % or less, as some dilution is always produced by adding the test organisms and interfering substance.

The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used. This document applies to products that are used for equipment disinfection by immersion, surface disinfection by wiping, spraying, flooding or other means and teat disinfection in the veterinary area – e.g. in the breeding, husbandry, production, veterinary care facilities, transport and disposal of all animals except when in the food chain following death and entry into processing industry. This document also applies to products used for teat disinfection in these veterinary areas.

This method is not applicable to evaluate the activity of hand hygiene products. For these products reference is made to EN 14885, which specifies in detail the relationship of the various tests to one another and to “use recommendations”.

NOTE This method corresponds to a phase 2 step 1 test.