ISO/AWI TS 5137
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ISO/AWI TS 5137
86275

Abstract

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.


General information 

  •  :  Under development
  •  : 1
  •  : ISO/TC 210 Quality management and corresponding general aspects for products with a health purpose including medical devices
  •  :

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