ISO/CD TS 5137

Medical device maintenance management for healthcare delivery organizations

General information

30.60 Close of voting/ comment period   Jun 9, 2024

ISO

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

Technical Specification

Scope

This document provides guidance on the maintenance management of medical devices that are under the supervision of healthcare delivery organizations.
This document is not applicable to:
a) modification, refurbishment or remanufacturing of medical devices;
b) manufacturers that are responsible for installation, testing, maintenance, and servicing on medical devices that they have placed on the market; or
c) implantable or single-use medical devices.

Life cycle

NOW

IN_DEVELOPMENT
ISO/CD TS 5137
30.60 Close of voting/ comment period
Jun 9, 2024