Medical device maintenance management programme for healthcare delivery organizations (HDO)

Informationen über die Norm:

Bezeichnung normen: ISO/TS 5137:2026
Ausgabedatum normen: 5.2.2026
Zahl der Seiten: 18
Gewicht ca.: 54 g (0.12 Pfund)
Land: Internationale technische Norm
Kategorie: Technische Normen ISO

Die Annotation des Normtextes 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.