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clinical laboratory

clinical laboratory, Total:84 items.

In the international standard classification, clinical laboratory involves: Medical sciences and health care facilities in general, ENVIRONMENT. HEALTH PROTECTION. SAFETY, Laboratory medicine, Medical equipment, Applications of information technology, Construction materials, Thermodynamics and temperature measurements.


RU-GOST R, clinical laboratory

  • GOST R 53022.3-2008 Clinical laboratory technologies. Requirements of quality of clinical laboratory tests. Part 3. Assessment of laboratory tests clinical significance
  • GOST R 53022.4-2008 Medical laboratory technologies. Requirement of quality of clinical laboratory tests. Part 4. Rules for development of requirements to timeliness of laboratory information submitting
  • GOST R 53022.2-2008 Clinical laboratory technologies. Requirements for quility of clinical laboratory tests. Part 2. Assessment of methods analytical reliability (accuracy, censitivity, specificity)
  • GOST R 53079.2-2008 Medical laboratory technologies. Quality assurance of clinical laboratory tests. Part 2. Guidelines for improvements of quality in clinical-diagnostic laboratory. Typical model
  • GOST R 53133.1-2008 Clinical laboratory technologies. Quality control of clinical laboratory tests. Part 1. Limits of allowable errors of the results of the analyte measurements in clinical-diagnostics laboratories
  • GOST R 53133.3-2008 Medical laboratory technologies. Quality control of clinical laboratory tests. Description of materials for quality control of clinical laboratory investigations
  • GOST ISO 17593-2011 Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

Professional Standard - Hygiene , clinical laboratory

  • WS/T 251-2005 Guidelines for Clinical Laboratory Safety
  • WS/T 442-2014 Guideline for clinical laboratory biosafety
  • WS/T 249-2005 Clinical Laboratory Waste Management
  • WS/T 418-2013 Guidelines for the selection of referral clinical laboratories
  • WS/T 250-2005 Requirements of Quality Assurance for Clinical Laboratories
  • WS/T 402-2012 Define and determine the reference intervals in clinical laboratory
  • WS/T 420-2013 Verification of analytical performance of quantitative kits by clinical laboratory

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

  • GB/T 20469-2006 General guideline of the clinical laboratory design
  • GB/T 20470-2006 Requirements of external quality assessment for clinical laboratories
  • GB/T 20468-2006 Guideline for internal quality control for quantitative measurements in clinical laboratory

中华人民共和国国家卫生和计划生育委员会, clinical laboratory

  • WS/T 496-2017 Quality indicators in clinical laboratories
  • WS/T 498-2017 Performance guideline for clinical laboratory diagnosis of bacterial diarrhea
  • WS/T 497-2017 Performance guideline for clinical laboratory diagnosis of invasive fungal diseases

AENOR, clinical laboratory

卫生健康委员会, clinical laboratory

  • WS/T 574-2018 Purified water for clinical laboratory reagents
  • WS/T 616-2018 Automated review of quantitative test results in clinical laboratories

Zhejiang Provincial Standard of the People's Republic of China, clinical laboratory

  • DB33/T 903-2013 Classification and coding of clinical laboratory test items
  • DB33/T 893.3-2013 Clinical Laboratory Information System Part 3: Workflow Specification
  • DB33/T 893.1-2013 Clinical Laboratory Information System Part 1: Basic Functional Specifications
  • DB33/T 893.2-2013 Clinical Laboratory Information System Part 2: Data Transmission and Exchange

US-CLSI, clinical laboratory

  • CLSI GP17-A3-2012 Clinical Laboratory Safety; Approved Guideline - Third Edition
  • CLSI C28-A3c-2008 Defining, Establishing, and Verifying Reference Intervals in the Clinical laboratory
  • CLSI MM19-A-2011 Establishing Molecular Testing in Clinical Laboratory Environments; Approved Guideline
  • CLSI C56-A-2012 Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis; Approved Guideline

US-HHS, clinical laboratory

Group Standards of the People's Republic of China, clinical laboratory

  • T/SAME 003-2021 Norm for establishment of clinical laboratory of measurement integrity
  • T/SAME 001-2022 Management requirements for level II biosafety cabinets in clinical laboratories

US-FCR, clinical laboratory

Korean Agency for Technology and Standards (KATS), clinical laboratory

  • KS P 8428-2015(2020) General requirements for clinical laboratory automation system performance
  • KS P 8429-2015(2020) General requirements for clinical laboratory automation system information
  • KS P 8430-2015(2020) Management and safety requirements for clinical laboratory pre-analytical automation system
  • KS P ISO 15198:2006 Clinical laboratory medicine-In vitro diagnostic medical devices-Validation of user quality control procedures by the manufacturer
  • KS P ISO 15198:2017 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
  • KS P ISO TS 16782:2018 Clinical laboratory testing ─ Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
  • KS P ISO 17593-2009(2019) Clinical laboratory testing and in vitro medical devices-Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
  • KS P ISO 17593:2009 Clinical laboratory testing and in vitro medical devices-Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
  • KS P ISO 16256:2017 Clinical laboratory testing and in vitro diagnostic test systems ─ Reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
  • KS P ISO TR 18112-2009(2014) Clinical laboratory testing and in vitro diagnostic test systems-In vitro diagnostic medical devices for professional use-Summary of regulatory requirements for information supplied by the manufacture

American Society for Testing and Materials (ASTM), clinical laboratory

  • ASTM E1466-92(1999) Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory
  • ASTM E792-95e1 Standard Guide for Selection of a Clinical Laboratory Information Management System
  • ASTM E792-02 Standard Guide for Selection of a Clinical Laboratory Information Management System
  • ASTM E1029-84(1997) Standard Guide for Documentation of Clinical Laboratory Computer Systems
  • ASTM E1639-97 Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems
  • ASTM E1029-01 Standard Guide for Documentation of Clinical Laboratory Computer Systems
  • ASTM E102-93(1997) Standard Test Method for Saybolt Furol Viscosity of Bituminous Materials at High Temperatures
  • ASTM E1639-01 Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems
  • ASTM E1246-01 Standard Practice for Reporting Reliability of Clinical Laboratory Computer Systems
  • ASTM E879-01(2007) Standard Specification for Thermistor Sensors for Clinical Laboratory Temperature Measurements
  • ASTM E1246-88(1995) Standard Practice for Reporting Reliability of Clinical Laboratory Computer Systems
  • ASTM E879-01 Standard Specification for Thermistor Sensors for Clinical Laboratory Temperature Measurements
  • ASTM E879-93 Standard Specification for Thermistor Sensors for Clinical Laboratory Temperature Measurements
  • ASTM E1381-95 Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems
  • ASTM E1381-02 Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems

Association Francaise de Normalisation, clinical laboratory

  • NF EN ISO 18812:2003 Informatique de santé - Interfaces d'analyseur clinique pour systèmes d'information de laboratoire - Profils d'utilisation
  • NF S92-012*NF EN ISO 16256:2013 Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast of fungi involved in infectious diseases

Guangdong Provincial Standard of the People's Republic of China, clinical laboratory

  • DB44/T 2428-2023 Automatic review rules for quantitative biochemical test results in clinical laboratories of traditional Chinese medicine hospitals

British Standards Institution (BSI), clinical laboratory

  • BS PD ISO/TS 16782:2016 Clinical laboratory testing. Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
  • BS ISO 15198:2004 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
  • BS ISO 17593:2022 Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
  • BS ISO 17593:2007 Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
  • 21/30402425 DC BS ISO 17593. Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for selftesting of oral anticoagulant therapy
  • PD ISO/TS 16782:2016 Clinical laboratory testing. Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing

国家市场监督管理总局、中国国家标准化管理委员会, clinical laboratory

  • GB/T 40672-2021 Clinical laboratory testing—Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing

KR-KS, clinical laboratory

  • KS P ISO 15198-2017 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
  • KS P ISO TS 16782-2018 Clinical laboratory testing ─ Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
  • KS P ISO 15198-2017(2022) Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
  • KS P ISO 16256-2017 Clinical laboratory testing and in vitro diagnostic test systems ─ Reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases

International Organization for Standardization (ISO), clinical laboratory

  • ISO 15198:2004 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
  • ISO 17593:2022 Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
  • ISO 17593:2007 Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
  • ISO/TS 16782:2016 Clinical laboratory testing — Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
  • ISO 16256:2012 Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
  • ISO 16256:2021 Clinical laboratory testing and in vitro diagnostic test systems - Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases

Professional Standard - Medicine, clinical laboratory

  • YY/T 0690-2008 Clinical laboratory testing and in vitro medical devices -- Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

Indonesia Standards, clinical laboratory

  • SNI ISO 15198:2009 Clinical laboratory medicine - In vitro diagnostic medical devices - validation of user quality control procedures by the manufacturer

ASHRAE - American Society of Heating@ Refrigerating and Air-Conditioning Engineers@ Inc., clinical laboratory





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