Phase I Clinical Trial

Phase I Clinical Trial, Total:89 items.

The international standard classification for "Phase I Clinical Trial" includes: Laboratory medicine , Medical Sciences and health care facilities in general .

The Chinese standard classification for "Phase I Clinical Trial" includes: Sanitation in general , Legal medical expert .

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

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

Professional Standard - Hygiene

WS/T 489-2015 Clinical Microbiological Laboratory Diagnosis of Urinary Tract Infection
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 420-2013 Verification of analytical performance of quantitative kits by clinical laboratory
WS/T 230-2024 Real-time fluorescence polymerase chain reaction clinical laboratory application guide
WS/T 418-2013 Guidelines for the ion of referral clinical laboratories
WS/T 251-2005 Guidelines for Clinical Laboratory Safety
WS/T 250-2005 Requirements of Quality Assurance for Clinical Laboratories
WS/T 489-2016 Laboratory diagnosis of urinary tract infections
WS/T 255-2005 Clinical laboratory medicine-Requirements for reference measurement laboratories
WS/T 249-2005 Clinical Laboratory Waste Management
WS/T 402-2024 Establishment of reference intervals for quantitative test items in clinical laboratories
WS/T 442-2024 Clinical Laboratory Biosafety Guidelines
WS/T 442-2014 Guideline for clinical laboratory biosafety

中华人民共和国国家卫生和计划生育委员会

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

Group Standards of the People's Republic of China

T/SAME 003-2021 Norm for establishment of clinical laboratory of measurement integrity
T/CGCPU 006-2023 Specification for competency assessment of phase I clinical trials
T/SAME 001-2022 Management requirements for level II biosafety cabinets in clinical laboratories
T/CADHOH 0006-2024 Specification for clinical diagnosis and treatment of tinnitus
T/CAS 819-2024 General technical requirements for clinical laboratory automation system
T/CGCPU 006-2019 Phase I Clinical Trial Capacity Evaluation Criteria

卫生健康委员会

WS/T 574-2018 Purified reagent water in the clinical laboratory
WS/T 616-2018 Autoverification of Clinical Laboratory Quantitative Test Results

Zhejiang Provincial Standard of the People's Republic of China

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

司法部

SF/T 0112-2021 Implemental specification of clinical forensic imaging examination

Anhui Provincial Standard of the People's Republic of China

DB34/T 4619-2023 Guidelines for the Construction of Intelligent Research Laboratory for Drug Phase I Clinical Trials

国家卫生计生委

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

Professional Standard - Agriculture

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

RU-GOST R

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 ISO 14155-2014 Clinical investigation. Good clinical practice
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

GOST R 70355-2022 Specialized food products. General requirements for preclinical tests on laboratory animals
GOST R ISO 14155-2022 Clinical investigation of medical devices for human subjects. Good clinical practice

Korean Agency for Technology and Standards (KATS)

KS P 8429-2015(2020) General requirements for clinical laboratory automation system information
KS P ISO 14155:2019 Clinical investigation of medical devices for human subjects — Good clinical practice
KS P 8428-2020 General requirements for clinical laboratory automation system performance
KS P 8429-2020 General requirements for clinical laboratory automation system information
KS P 8428-2015(2020) General requirements for clinical laboratory automation system performance

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

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

US-HHS

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

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.
UNE-EN ISO 14155:2021 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

GSO

OS GSO ISO 14155:2015 Clinical investigation of medical devices for human subjects -- Good clinical practice
GSO ASTM F3108:2022 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
BH GSO ASTM F3108:2023 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
GSO ISO 14155:2015 Clinical investigation of medical devices for human subjects -- Good clinical practice

KR-KS

KS P ISO 14155-2022 Clinical investigation of medical devices for human subjects — Good clinical practice
KS P ISO 14155-2019 Clinical investigation of medical devices for human subjects — Good clinical practice

SCC

AAMI/ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
DANSK DS/ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good clinical practice
ISO 14155:2020 Plus Redline Clinical investigation of medical devices for human subjects - Good clinical practice
DANSK DS/EN ISO 14155/AC:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
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)
NS-EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
DANSK DS/EN ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2020)
AENOR UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
NS-EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
ASTM STP 1008-89 Femoral Intramedullary Rods: Clinical Performance and Related Laboratory Testing
DIN EN ISO 14155 E:2018 Draft Document - Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2018); German and English version prEN ISO 14155:2018

International Organization for Standardization (ISO)

ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
ISO 14155:2011/cor 1:2011 Clinical investigation of medical devices for human subjects - Good clinical practice; Technical Corrigendum 1

US-CLSI

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

American National Standards Institute （ANSI)

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

US-FCR

FCR FED H-08-3 316-1-1988 RESEARCH AND CLINICAL LABORATORY GAS AND VACUUM SYSTEMS

American Society for Testing and Materials (ASTM)

ASTM E2045-99 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(2003) Standard Practice for Detailed Clinical Observations of Test Animals
ASTM F3108-19 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
ASTM E2045-99(2009) Standard Practice for Detailed Clinical Observations of Test Animals
ASTM F3448-20 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Hip Reconstructive Surgery
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

German Institute for Standardization

DIN EN ISO 14155:2024 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2024); German and English version prEN ISO 14155:2024
DIN EN ISO 14155:2021-05 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020
DIN EN ISO 14155 E:2018-08 Good Clinical Practice for Clinical Investigation of Medical Devices in Anthropology (Draft)

British Standards Institution (BSI)

18/30344902 DC BS EN ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice
BS EN ISO 14155:2020 Clinical investigation of medical devices for human subjects. Good clinical practice