GB/T 42218-2022
Clinical laboratory medicine—In vitro diagnostic medical devices—Validation of user quality control procedures by the manufacturer (English Version)

Standard No.

GB/T 42218-2022

Language

Chinese, Available in English version

Release Date

2022

Published By

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

Latest

GB/T 42218-2022

Scope

This document describes the process by which manufacturers of in vitro diagnostic medical devices validate quality control procedures recommended to users. The purpose of the quality control program is to provide the user with assurance that the performance of the device is consistent with its intended use and the manufacturer's claims. This document applies to all in vitro diagnostic medical devices.

GB/T 42218-2022 Referenced Document

• GB/T 29791.1 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 1:Terms, definitions and general requirements
• ISO 13485 
• ISO 14971 Medical devices - Application of risk management to medical devices
• ISO/IEC GUIDE 99 
• JJF 1001 General Terms in Metrology and Their Definitions

GB/T 42218-2022 history

• 2022 GB/T 42218-2022 Clinical laboratory medicine—In vitro diagnostic medical devices—Validation of user quality control procedures by the manufacturer