TS 13402

TS 13402 sets out the rules for authorized services that work on sterilization equipment. The focus is not the sterilizer itself, but the service organization behind maintenance, repair, inspection and related technical support. In that sense, the standard defines the minimum framework for how such services should be structured and operated.

What an authorized sterilization service is expected to cover

According to the scope, the standard addresses business organization, physical characteristics, technical equipment and personnel qualifications. In practical terms, it is concerned with whether a service is arranged and equipped to carry out work on sterilization devices in a controlled and competent way. For equipment used in sterilization applications, this matters because service quality can affect reliability, continuity of operation and the consistency of the maintenance process.

Technical context for sterilization equipment

Sterilization equipment is used to reduce or eliminate microbial contamination in medical, laboratory and similar environments. Standards for authorized services help define the conditions under which maintenance and support activities are organized. The references to the Medical Devices Regulation and information gathered from inspections and technical interviews indicate that this document is grounded in both regulatory context and field practice. Its subject is the service infrastructure, not the design requirements of the sterilizers themselves.

• Applies to authorized services for sterilization equipment.
• Covers rules for business organization and operating structure.
• Addresses physical facilities and technical equipment.
• Includes personnel-related requirements for the service.
• Focuses on the service arrangement rather than the equipment design.