ISO/TS 5137:2026
International Standard
Current Edition
·
Approved on
05 February 2026
Medical device maintenance management programme for healthcare delivery organizations (HDO)
ISO/TS 5137:2026 Files
English
18 Pages
Current Edition
BHD
47.79
ISO/TS 5137:2026 Scope
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.
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