TS 13402

TS 13402 is a service standard concerned with how authorized services for sterilization equipment should be organized. Rather than defining the equipment itself, it sets rules for the service organization’s business structure, physical conditions, technical equipment, and personnel qualifications.

What an authorized service is expected to cover

Sterilization equipment is used in medical, laboratory, and other controlled environments to reduce or eliminate microbial contamination. For this type of equipment, reliable technical service matters not only for keeping the unit operational but also for supporting consistent processing performance and dependable use. In that general technical context, TS 13402 addresses the rules that an authorized service must meet in terms of organizational readiness, technical capability, and staff qualifications.

• Business organization and service structure
• Physical premises and working environment
• Technical equipment needed for service activities
• Professional and technical qualifications of personnel
• Rules linked to authorized service status

In practical terms, service work on sterilization equipment may include installation, periodic checks, fault repair, calibration-related activities, and replacement of parts. The focus of this standard, however, is not the detailed method for each task; it is the minimum institutional and technical conditions expected from the authorized service that performs them. The standard is positioned within a framework connected to consumer service rules and medical device regulation.

TS 13402 is a withdrawn TSE standard, so it is best understood as a historical reference for how authorized services were structured and assessed. The referenced TS standards and related legislation help place service competence within the wider technical and regulatory environment.