T/SXS 128-2023
Medical device safety management requirements specification (English Version)

Standard No.

T/SXS 128-2023

Language

Chinese, Available in English version

Release Date

2023

Published By

Group Standards of the People's Republic of China

Latest

T/SXS 128-2023

Scope

This document stipulates the management requirements, personnel requirements, environmental and facility control, process control, safety and performance testing, and supplier management of medical device safety management requirements. This document applies to medical device safety management requirements and specifications.

T/SXS 128-2023 history

• 2023 T/SXS 128-2023 Medical device safety management requirements specification