ISO/TS 5137:2026

Anotácia textu normy ISO/TS 5137:2026 :

Description / Abstract: This document specifies requirements for the maintenance management programme of reusable medical devices that require maintenance under the supervision of healthcare delivery organizations (HDOs). This document neither provides guidance nor is applicable to modification of medical device. This document does not apply to manufacturers that install, test, maintain, and service their own medical device. This document focuses on HDOs and biomedical engineering services (BES) responsibilities.