GB/T 22576.4-2021
Medical laboratories—Requirements for quality and competence—Part 4: Requirements in the field of clinical chemistry examination (English Version)

Standard No.

GB/T 22576.4-2021

Language

Chinese, Available in English version

Release Date

2021

Published By

国家市场监督管理总局、中国国家标准化管理委员会

Latest

GB/T 22576.4-2021

Scope

This document specifies the requirements for quality and competence of medical laboratories in the field of clinical chemistry testing. This document is applicable to medical laboratories that carry out clinical chemistry testing and also to medical laboratories that carry out quantitative clinical immunology testing.

GB/T 22576.4-2021 Referenced Document

• GB/T 21415 In vitro diagnostic medical devices.Measurement of quantities in biological samples.Metrological traceability of values assigned to calibrators and control materials
• GB/T 22576.1-2018 Medical laboratories—Requirements for quality and competence—Part 1: General requirements
• WS/T 403 Analytical quality specifications for routine analytes in clinical biochemistry
• WS/T 407 Guideline for comparability verification of quantitative results within one health care system

GB/T 22576.4-2021 history

• 2021 GB/T 22576.4-2021 Medical laboratories—Requirements for quality and competence—Part 4: Requirements in the field of clinical chemistry examination

GB/T 22576.4-2021 -All Parts