GB/Z 42217-2022
Medical device —Validation of software for medical device quality system (English Version)

Standard No.

GB/Z 42217-2022

Language

Chinese, English version preview

Release Date

2022

Published By

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China

Latest

GB/Z 42217-2022

Scope

This document applies to any software used in medical device design, testing, component receipt, manufacturing, marking, packaging, distribution, and complaint handling, or any other aspect of the medical device quality system described in GB/T 42061. Automated software. This document applies to: --- software for quality management systems; --- software for production and service provision; --- software for monitoring and measurement requirements. Not applicable to: --- software used as a component, part or accessory of a medical device, or publishers --- independent software for a medical device. Allow out

GB/Z 42217-2022 Referenced Document

• GB/T 19000 Quality management systems—Fundamentals and vocabulary
• GB/T 42061-2022 Medical devices—Quality management systems—Requirements for regulatory purposes

GB/Z 42217-2022 history

• 2022 GB/Z 42217-2022 Medical device —Validation of software for medical device quality system