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ISO/TS 5137:2026

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

Standard Details

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.

General Information

Status : Published
Standard Type: Main
Document No: ISO/TS 5137:2026
Document Year: 2026
Pages: 18
Edition: 1
  • Section Volume:
  • ISO/TC 210. Quality management and corresponding general aspects for medical devices
  • ICS:
  • 11.020.01 Quality and environmental management in health care *Including quality and environmental management in health care technology *Health care management systems, see 03.100.70 *IT applications in health care technology, see 35.240.80

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ISO/TS 5137:2026
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