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clinical laboratory of the future

clinical laboratory of the future, Total:102 items.

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


RU-GOST R, clinical laboratory of the future

  • 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 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 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 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 53079.3-2008 Medical laboratory technologies. Quality assurance of clinical laboratory tests. Part 3. Rules for interaction between personnel of clinical departments and personnel of clinical-diagnostic laboratory in medical institutions during fulfillment of clinical
  • 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 R 53133.4-2008 Medical laboratory technologies. Quality control of clinical laboratory tests. Part 4. Rules for conducting of clinical audit of efficiency of laboratory provision of medical institution activity
  • 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 of the future

  • 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 255-2005 Clinical laboratory medicine Reguirements for reference measurement laboratories
  • WS/T 489-2016 Clinical microbiological laboratory diagnosis of urinary tract infection;
  • WS/T 489-2015 Clinical Microbiological Laboratory Diagnosis of Urinary Tract Infection
  • 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 of the future

  • 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 of the future

  • 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

US-HHS, clinical laboratory of the future

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

AENOR, clinical laboratory of the future

  • UNE 129001:1997 CLINICAL LABORATORY REPORTS. PREPARING REQUIREMENTS.
  • UNE 129002:2000 IN Glossary of recommended terms in clinical laboratory sciences.
  • UNE-EN ISO 18812:2003 Health informatics - Clinical analyser interfaces to laboratry information systems - Use profiles (ISO 18812:2003)

卫生健康委员会, clinical laboratory of the future

  • 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 of the future

  • 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 of the future

  • 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

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

  • 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 of the future

国家卫生计生委, clinical laboratory of the future

  • WS/T 503-2017 Blood culture operating procedures in clinical microbiology laboratories

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

  • 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 X ISO 18812-2016(2021) Health informatics — Clinical analyser interfaces to laboratory information systems — Use profiles
  • KS P ISO TR 18112:2009 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 manufacturer
  • 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 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 of the future

  • 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 E1246-88(1995) Standard Practice for Reporting Reliability of Clinical Laboratory Computer Systems
  • 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 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

British Standards Institution (BSI), clinical laboratory of the future

  • DD ENV 13728-2001 Health informatics. Clinical analyser interfaces to laboratory information systems
  • 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

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

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

Association Francaise de Normalisation, clinical laboratory of the future

  • 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

German Institute for Standardization, clinical laboratory of the future

  • DIN 58937-7:1994 General laboratory medicine (clinical pathology); part 7: listing of features of in vitro diagnostic systems
  • DIN EN ISO 18812:2003 Health informatics - Clinical analyser interfaces to laboratory information systems - Use of profiles (ISO 18812:2003); German version EN ISO 18812:2003, text in English
  • DIN EN ISO 18812:2003-07 Health informatics - Clinical analyser interfaces to laboratory information systems - Use of profiles (ISO 18812:2003); German version EN ISO 18812:2003, text in English
  • DIN EN 15301-2:2007-07 Surfaces for sports areas - Part 2: Determination of shear strength by dynamic top layer testing of unbound mineral surfaces in the laboratory; German version EN 15301-2:2007

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

  • GB/T 40672-2021 Clinical laboratory testing—Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
  • GB/T 22576.4-2021 Medical laboratories—Requirements for quality and competence—Part 4: Requirements in the field of clinical chemistry examination
  • GB/T 22576.2-2021 Medical laboratories—Requirements for quality and competence—Part 2: Requirements in the field of clinical hematological examination
  • GB/T 22576.5-2021 Medical laboratories—Requirements for quality and competence—Part 5: Requirements in the field of clinical immunology examination
  • GB/T 22576.6-2021 Medical laboratories—Requirements for quality and competence—Part 6: Requirements in the field of clinical microbiological examination

International Organization for Standardization (ISO), clinical laboratory of the future

  • ISO/TR 18112:2006 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 manufacturer
  • 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

KR-KS, clinical laboratory of the future

  • 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 X ISO 18812-2016 Health informatics — Clinical analyser interfaces to laboratory information systems — Use profiles
  • KS P ISO 15198-2017(2022) Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer

American National Standards Institute (ANSI), clinical laboratory of the future

  • ANSI/HL7 V3 PORT, R 1-2004 HL7 Version 3 Standard: Regulated Studies - Periodic Reporting of Clinical Trials Laboratory Results, , Release 1

European Committee for Standardization (CEN), clinical laboratory of the future

  • DD ENV 13728-2000 Health Informatics - Clinical Analyser Interfaces to Laboratory Information Systems Ratified European Text

Danish Standards Foundation, clinical laboratory of the future

  • DS/EN ISO 18812:2003 Health informatics - Clinical analyser interfaces to laboratry information systems - Use profiles (ISO 18812:2003)

Lithuanian Standards Office , clinical laboratory of the future

  • LST EN ISO 18812:2003 Health informatics - Clinical analyser interfaces to laboratry information systems - Use profiles (ISO 18812:2003)

Indonesia Standards, clinical laboratory of the future

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

Professional Standard - Medicine, clinical laboratory of the future

  • 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




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