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