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Phase I Clinical Trial

Phase I Clinical Trial, Total:119 items.

In the international standard classification, Phase I Clinical Trial involves: Medical sciences and health care facilities in general, ENVIRONMENT. HEALTH PROTECTION. SAFETY, Medical equipment, Laboratory medicine, Hospital equipment, Applications of information technology, Veterinary medicine, Pharmaceutics, Test conditions and procedures in general, Construction materials, Thermodynamics and temperature measurements, Quality.

RU-GOST R, Phase I Clinical Trial

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 56701-2015 Medicines for medical applications. Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals
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 , Phase I Clinical Trial

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, Phase I Clinical Trial

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, Phase I Clinical Trial

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

Group Standards of the People's Republic of China, Phase I Clinical Trial

T/CGCPU 006-2023 Specification for competency assessment of phase I clinical trials
T/CGCPU 006-2019 Phase I Clinical Trial Capacity Evaluation Criteria
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

Korean Agency for Technology and Standards (KATS), Phase I Clinical Trial

KS P 8429-2015(2020) General requirements for clinical laboratory automation system information
KS P 8428-2015(2020) General requirements for clinical laboratory automation system performance
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 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 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 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 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
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

ASHRAE - American Society of Heating@ Refrigerating and Air-Conditioning Engineers@ Inc., Phase I Clinical Trial

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

AENOR, Phase I Clinical Trial

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, Phase I Clinical Trial

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

US-HHS, Phase I Clinical Trial

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

Zhejiang Provincial Standard of the People's Republic of China, Phase I Clinical Trial

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

司法部, Phase I Clinical Trial

SF/T 0112-2021 Standards for implementation of forensic clinical imaging examinations

US-CLSI, Phase I Clinical Trial

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

American National Standards Institute （ANSI), Phase I Clinical Trial

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

US-FCR, Phase I Clinical Trial

FCR FED H-08-3 316-1-1988 RESEARCH AND CLINICAL LABORATORY GAS AND VACUUM SYSTEMS
FCR FED SPEC PUB 729-1987 NATIONAL EARTHQUAKE ENGINEERING EXPERIMENTAL FACILITY STUDY PHASE ONE - LARGE SCALE TESTING NEEDS

American Society for Testing and Materials (ASTM), Phase I Clinical Trial

ASTM E2045-99 Standard Practice for Detailed Clinical Observations of Test Animals
ASTM E2045-99(2003) Standard Practice for Detailed Clinical Observations of Test Animals
ASTM E1466-92(1999) Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory
ASTM E2045-99(2009) Standard Practice for Detailed Clinical Observations of Test Animals
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 E2045-22 Standard Practice for Detailed Clinical Observations of Test Animals
ASTM E2045-99(2014) Standard Practice for Detailed Clinical Observations of Test Animals
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

国家卫生计生委, Phase I Clinical Trial

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

Professional Standard - Agriculture, Phase I Clinical Trial

农业部1247号公告-4-2009 Guiding Principles for Phase II and Phase III Clinical Drug Efficacy Evaluation Trials of Antibacterial Drugs

British Standards Institution (BSI), Phase I Clinical Trial

DD ENV 13728-2001 Health informatics. Clinical analyser interfaces to laboratory information systems
DD ENV 1614-1995 Healthcare informatics. Structure for nomenclature, classification and coding of properties in clinical laboratory science
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, Phase I Clinical Trial

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

Association Francaise de Normalisation, Phase I Clinical Trial

NF EN ISO 18812:2003 Informatique de santé - Interfaces d'analyseur clinique pour systèmes d'information de laboratoire - Profils d'utilisation
NF S94-801:2007 Vaginal reinforcement implant for stress urinary incontinence and/or pelvic organ prolapse repair surgery through vaginal approach - Pre-clinical and clinical tests.
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

国家市场监督管理总局、中国国家标准化管理委员会, Phase I Clinical Trial

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), Phase I Clinical Trial

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/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 17593:2007 Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
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

German Institute for Standardization, Phase I Clinical Trial

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 ISO 20776-1:2007 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 antim

KR-KS, Phase I Clinical Trial

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

国家市场监督管理总局, Phase I Clinical Trial

RB/T 060.2-2021 Forensic Identification/Forensic Science Proficiency Testing Implementation Guide Part 2: Forensic Clinical Identification

European Committee for Standardization (CEN), Phase I Clinical Trial

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

Indonesia Standards, Phase I Clinical Trial

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

Danish Standards Foundation, Phase I Clinical Trial

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

Lithuanian Standards Office , Phase I Clinical Trial

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

Professional Standard - Medicine, Phase I Clinical Trial

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

US-CFR-file, Phase I Clinical Trial

CFR 42-405.209-2013 Public Health. Part405:Federal health insurance for the aged and disabled. Section405.209:Payment for a non-experimental/investigational (Category B)device.