Clinical multi-center laboratory examination

Clinical multi-center laboratory examination, Total:115 items.

The international standard classification for "Clinical multi-center laboratory examination" includes: Medical Sciences and health care facilities in general , Laboratory medicine , Quality management and quality assurance .

The Chinese standard classification for "Clinical multi-center laboratory examination" includes: Sanitation in general , Medical laboratory equipment , Medical apparatus and devices in general , Legal medical expert .

Group Standards of the People's Republic of China

T/CACM 1231-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Xinzhang Disease (Hypertensive Left Ventricular Hypertrophy)
T/CGSS 008-2019 Clinical application guidelines for laboratory indicators of blood stasis syndrome in senile coronary heart disease
T/CAS 819-2024 General technical requirements for clinical laboratory automation system
T/CAME 68-2024 Guidelines for the establishment and application of autoverification procedures for clinical laboratory test results
T/CAGR 010-2023 Guidelines for laboratory examination of multiple myeloma
T/SHDSGY 066-2023 Inspection service specification of clinical trial research center
T/SAME 003-2021 Norm for establishment of clinical laboratory of measurement integrity
T/NAHIEM 146-2025 General Specifications for Clinical Mass Spectrometry Laboratories
T/SDHCST 003-2019 CTCs Test Preparation Center Laboratory Regulations
T/CGCPU 002-2023 Evaluation standard of centralized management of clinical investigational product
T/SAME 001-2022 Management requirements for level II biosafety cabinets in clinical laboratories
T/CGCPU 029-2023 Evaluation requirements of follow-up centers for primary clinical trials

Professional Standard - Hygiene

WS/T 442-2024 Clinical Laboratory Biosafety Guidelines
WS/T 489-2015 Clinical Microbiological Laboratory Diagnosis of Urinary Tract Infection
WS/T 489-2016 Laboratory diagnosis of urinary tract infections
WS/T 616-2018 Autoverification of Clinical Laboratory Quantitative Test Results
WS/T 503-2017 Blood culture operating procedures in clinical microbiology laboratories
WS/T 255-2005 Clinical laboratory medicine-Requirements for reference measurement laboratories
WS/T 442-2014 Guideline for clinical laboratory biosafety
WS/T 415-2024 Clinical laboratory quality assessment without external quality assessment
WS/T 249-2005 Clinical Laboratory Waste Management
WS/T 420-2013 Verification of analytical performance of quantitative kits by clinical laboratory
WS/T 418-2013 Guidelines for the ion of referral clinical laboratories
WS/T 250-2005 Requirements of Quality Assurance for Clinical Laboratories
WS/T 644-2018 Clinical laboratory quality evaluation
WS/T 574-2018 Purified reagent water in the clinical laboratory
WS/T 489-2024 Guidelines for clinical microbiology laboratory testing of urine specimens
WS/T 402-2012 Define and determine the reference intervals in clinical laboratory
WS/T 497-2017 Performance guideline for clinical laboratory diagnosis of invasive fungal diseases
WS/T 641-2018 Internal quality control for quantitative measurement in 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 230-2024 Real-time fluorescence polymerase chain reaction clinical laboratory application guide
WS/T 402-2024 Establishment of reference intervals for quantitative test items in clinical laboratories
WS/T 251-2005 Guidelines for Clinical Laboratory Safety

未注明发布机构

CLSI EP30-A-2010 Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine; Approved Guideline
NCCLS LIS6-A-2003 Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems
CLSI EP33-2016 Use of Delta Checks in the Medical Laboratory
CLSI GP05-A3-2011 Clinical Laboratory Waste Management; Approved Guideline—Third Edition
NCCLS LIS4-A-2003 Standard Guide for Documentation of Clinical Laboratory Computer Systems
CLSI MM07-A2-2013 Fluorescence In Situ Hybridization Methods for Clinical Laboratories; Approved Guideline—Second Edition
CLSI MM09-A2-2014 Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline—Second Edition
CLSI EP17-A2-2012 Guidelines for evaluating the performance of clinical laboratory measurement procedures (Second Edition)
NCCLS LIS3-A-2003 Clinical Laboratory Information System Selection Guide
CLSI C60-A-1997 Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline
NCCLS LIS7-A-2003 Regulations for the use of barcodes to label specimen tubes in clinical laboratories
CLSI GP40-A4-AMD-2012 Preparation and testing of reagent water for clinical laboratories
NCCLS LIS8-A-2003 Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems
CLSI M48-2018 Clinical and Laboratory Standards Institute guideline M48—Laboratory Detection and Identification of Mycobacteria
NCCLS LIS9-A-2003 Coordinate clinical laboratory services within an electronic health record environment and network architecture
NCCLS X4-R-2003 Report on the Challenges of Clinical Laboratory Operations in Disasters
NCCLS I6-A-1984 Clinical Laboratory Instrument Service Guide
CLSI GP46-R-2003 Report on the Challenges of Planning Clinical Laboratory Operations During Disasters
NCCLS X3-R-2002 Implementing a Needlestick and Sharps Injury Prevention Program in the Clinical Laboratory
CLSI C50-A-2007 Mass spectrometry in the clinical laboratory: basic principles and guidance
CLSI EP17-A2-2012 cor 2020 Evaluating the performance of clinical laboratory measurement procedures

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

GB/T 20469-2006 General guideline of the clinical laboratory design
GB/T 22576.2-2021 Medical laboratories-Requirements for quality and competence- Part 2:Requirements in the field of clinical hematological examination
GB/T 22576.4-2021 Medical laboratories-Requirements for quality and competence- Part 4:Requirements in the field of clinical chemistry examination
GB/T 40672-2021 Clinical laboratory testing—Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
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

Guangdong Provincial Standard of the People's Republic of China

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

Zhejiang Provincial Standard of the People's Republic of China

DB33/T 903-2013 Classification and coding of clinical laboratory test items

Professional Standard - Judicatory

SF/T 0112-2021 Implemental specification of clinical forensic imaging examination
SF/Z JD0103006-2014 Implementation Specification for Forensic Clinical Imaging Examination

Professional Standard - Machinery

JB/T 9922.2-1999 Center hole grinding machine precision inspection

Jiangsu Provincial Standard of the People's Republic of China

DB32/T 4652-2024 Guidelines for the development of multi-center drug clinical trial management systems based on blockchain technology

Professional Standard - Commodity Inspection

SN/T 3900-2014 Review specifications for laboratories of entry-exit inspection and quarantine

Gosstandart of Russia

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 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 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 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 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 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 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 57093-2016 Requirements for testing laboratories (centers) of railway products
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)

US-CLSI

CLSI MM19-A-2011 Establishing Molecular Testing in Clinical Laboratory Environments; Approved Guideline
CLSI C28-A3c-2008 Defining, Establishing, and Verifying Reference Intervals in the Clinical laboratory
CLSI GP17-A3-2012 Clinical Laboratory Safety; Approved Guideline - Third Edition

US-HHS

HHS 21 CFR PART 58-2011 GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES

Ente Nazionale Italiano di Unificazione

UNI EN ISO 15195:2004 Laboratory medicine - Requirements for reference measurement laboratories
UNI 9861:1991 Nomenclature, dimensions and units in the clinical laboratory.

American Society for Testing and Materials (ASTM)

ASTM STP 1217-1994 Clinical and Laboratory Performance of Bone Plates
ASTM STP 1008-1989 Internal fixation rods: clinical manifestations and relevant laboratory tests
ASTM E1466-92(1999) Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory
ASTM E1712-97 Standards for indicating clinical laboratory procedures and analyte names
ASTM STP 1008-89 Femoral Intramedullary Rods: Clinical Performance and Related Laboratory Testing
ASTM STP 100-1950 Femoral Intramedullary Rods: Clinical Performance and Related Laboratory Testing
ASTM E792-02 Standard Guide for Selection of a Clinical Laboratory Information Management System
ASTM E792-95e1 Standard Guide for Selection of a Clinical Laboratory Information Management System

American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE)

ASHRAE NO-94-29-1994 Validation of Pharmaceutical Clinical Supply Laboratories

GCC Standardization Organization

GSO ISO 14155:2015 Clinical investigation of medical devices for human subjects -- Good clinical practice

Spanish Association for Standardization (UNE)

UNE 129001:1997 CLINICAL LABORATORY REPORTS. PREPARING REQUIREMENTS.
UNE 129002:2000 IN Glossary of recommended terms in clinical laboratory sciences.
AENOR UNE-ISO/TR 22869 IN:2007 Clinical laboratories. Guide for the implementation in laboratories of the ISO 15189:2003 Standard. (ISO/TR 22869:2005)

US-FCR

FCR FED H-08-3 316-1-1988 RESEARCH AND CLINICAL LABORATORY GAS AND VACUUM SYSTEMS
FCR COE ETL 1110-2-309-1988 WATER AND WASTEWATER LABORATORY INSPECTIONS
FCR COE ETL 1110-2-268-1981 WATER AND WASTEWATER LABORATORY INSPECTIONS

Korean Agency for Technology and Standards (KATS)

KS P 8428-2020 General requirements for clinical laboratory automation system performance
KS P 8428-2015(2020) General requirements for clinical laboratory automation system performance
KS P 8429-2020 General requirements for clinical laboratory automation system information
KS P 8429-2015(2020) General requirements for clinical laboratory automation system information
KS P ISO TS 16782-2018 Clinical laboratory testing ─ Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing

Magyar Szabványügyi Testület

MSZ 18567/9.lap-1969 Laboratory testing and screening of black coal
MSZ 12000/3.lap-1968 Laboratory testing. General inspection standards for hard coal

Association Francaise de Normalisation

NF ISO 3875:2020 Machine tools - Test conditions for centerless external surface grinding machines - Checking accuracy

Standard Association of Australia （SAA）

AS ISO 20776.1:2017 Clinical laboratory testing and in vitro diagnostic test systems—Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices—Part 1: Reference method for testing the in vitro activity of antimicro

Canadian Standards Association (CSA)

CSA Z316.8-2018 Requirements for the design, development, and validation of laboratory-developed tests used for the screening, diagnosis, and management of clinical conditions
CAN/CSA Z316.8-18:2018 Requirements for the design, development and validation of laboratory-designed assays for the screening, diagnosis and management of clinical conditions
CSA Z316.8-2018(R2023) Requirements for the design, development, and validation of laboratory-developed tests used for the screening, diagnosis, and management of clinical conditions

BSI Group

BS PD ISO/TS 7122:2024 Health informatics. Guidelines for exchanging data generated by portable polymerase chain reaction (PCR) devices for point-of-care testing (POCT) between screening centre and clinical laboratory

International Electrotechnical Commission (IEC)

IECEE OD-2007-F3-2020 Relocation Checklist: to be filled in by the CBTL/SPTL
IECEE OD-2017-2018 Checklist for Testing and Calibration Laboratories

Others: Clinical multi-center laboratory examination