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ISO/TS 5137:2026

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

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This publication was last reviewed and confirmed in 2026.

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

SKU: df7f656f0259 Category:

Description

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.

Edition

1

Published Date

2026-06-19

Status

PUBLISHED

Pages

18

Language Detail Icon

English

Format Secure Icon

Secure PDF

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.

Previous Editions

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