DB31/T 1408-2023 Active Shanghai CityLocal standards

DB31/T 1408-2023 Medical laboratory management regulations

DB31/T 1408-2023 Medical laboratory management regulations

Publish Date: 2023-06-11 Implement Date: 2023-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: DB31/T 1408-2023
Standard Type: Local standards
Standard Status: Active
is_force_gb: no
CCS Name: Health
ICS Name: Integrated medical science and healthcare devices
Publish Date: 2023-06-11
Implement Date: 2023-10-01
Pages: 16 pages

Scope

This document stipulates the institutional requirements, personnel management, quality management, self-built method management, biosafety management, and wastewater management of medical testing laboratories.
This document is applicable to independently established medical testing laboratories that conduct medical tests on human blood, body fluids, tissues, and other specimens.

Development Information

Word Count: 21 Thousand words Pages: 16 pages

Referenced Standards

GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB 15603-1995 Rule for storage of chemical dangers GB 15603-2022 General rules for the hazardous chemicals warehouse storage GB 15982-1995 Hygienic standard for disinfection in hospitals GB 15982-2012 Hygienic standard for disinfection in hospitals GB/T 17995-1999 Guidelines for administrative, medical, and nursing staff concerned with the safe use of medical electrical equipment GB 18466-2005 GB 19489-2004 Laboratories—General requirements for biosafety GB 19489-2008 Laboratories—General requirements for biosafety GB/T 20468-2006 Guideline for internal quality control for quantitative measurements in clinical laboratory GB/T 20470-2006 Requirements of external quality assessment for clinical laboratories GB/T 22239-2008 Information security technology—Baseline for classified protection of information system security GB/T 22239-2019 Information security technology—Baseline for classified protection of cybersecurity GB/T 22576.1-2018 Medical laboratories—Requirements for quality and competence—Part 1:General requirements GB/T 30690-2014 Monitoring requirements and evaluation of sterilization effect of small steam sterilizer WS 233-2002 General biosafety standard for microbiological and biomedical laboratories WS 233-2017 General biosafety guidelines for pathogenic microorganism laboratories WS 308-2019 Fire safety management of medical institutions WS 308-2009 Management of fire safety for medical institutions WS/T 313-2019 Hand hygiene guidelines for healthcare workers WS/T 313-2009 Standard for hand hygiene for healthcare workers in healthcare settings WS/T 367-2012 Regulation of disinfection technique in healthcare settings WS/T 589-2018 WS/T 589-2018 Biosafety labeling for pathogenic microorganisms in laboratory DB31/T 689.1 DB31/T 1249 GB 50346-2011 GB/T 22576.1-2026 Medical laboratories—Requirements for quality and competence—Part 1:General requirements

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