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ISO/TS 5137:2026

Medical device maintenance management programme for healthcare delivery organizations (HDO) ISO/TS 5137:2026

Publication date:   Feb 5, 2026

General information

60.60   Standard published   Feb 5, 2026

ISO

ISO/TC 210 Quality management and corresponding general aspects for medical devices

Technical Specification

11.020.01   Quality and environmental management in health care

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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.

Life cycle

NOW

PUBLISHED
ISO/TS 5137:2026
60.60 Standard published
Feb 5, 2026




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