Clinical Trial Central Laboratory
Clinical Trial Central Laboratory, Total:36 items.
The international standard classification for "Clinical Trial Central Laboratory" includes: Medical Sciences and health care facilities in general , Laboratory medicine .
The Chinese standard classification for "Clinical Trial Central Laboratory" includes: Sanitation in general .
卫生健康委员会
- WS/T 616-2018 Autoverification of Clinical Laboratory Quantitative Test Results
- WS/T 574-2018 Purified reagent water in the clinical laboratory
Zhejiang Provincial Standard of the People's Republic of China
- DB33/T 903-2013 Classification and coding of clinical laboratory test items
Professional Standard - Hygiene
- WS/T 250-2005 Requirements of Quality Assurance for Clinical Laboratories
- WS/T 489-2016 Laboratory diagnosis of urinary tract infections
- WS/T 402-2012 Define and determine the reference intervals in clinical laboratory
- WS/T 489-2015 Clinical Microbiological Laboratory Diagnosis of Urinary Tract Infection
- WS/T 420-2013 Verification of analytical performance of quantitative kits by clinical laboratory
- WS/T 251-2005 Guidelines for Clinical Laboratory Safety
- WS/T 418-2013 Guidelines for the ion of referral clinical laboratories
- WS/T 442-2024 Clinical Laboratory Biosafety Guidelines
- WS/T 442-2014 Guideline for clinical laboratory biosafety
- WS/T 249-2005 Clinical Laboratory Waste Management
- WS/T 255-2005 Clinical laboratory medicine-Requirements for reference measurement laboratories
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 20468-2006 Guideline for internal quality control for quantitative measurements in clinical laboratory
- GB/T 20470-2006 Requirements of external quality assessment for clinical laboratories
中华人民共和国国家卫生和计划生育委员会
- WS/T 496-2017 Quality indicators in clinical laboratories
Group Standards of the People's Republic of China
- T/CGCPU 002-2023 Evaluation standard of centralized management of clinical investigational product
- T/SHDSGY 066-2023 Inspection service specification of clinical trial research center
- T/CGCPU 029-2023 Evaluation requirements of follow-up centers for primary clinical trials
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
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 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 53133.1-2008 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 53022.2-2008 Clinical laboratory technologies. Requirements for quility of clinical laboratory tests. Part 2. Assessment of methods analytical reliability (accuracy, censitivity, specificity)
US-HHS
- HHS 21 CFR PART 58-2011 GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
ASHRAE - American Society of Heating@ Refrigerating and Air-Conditioning Engineers@ Inc.
- ASHRAE NO-94-29-1994 Validation of Pharmaceutical Clinical Supply Laboratories
US-CLSI
- 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
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.
SCC
- 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)
- ASTM STP 1008-89 Femoral Intramedullary Rods: Clinical Performance and Related Laboratory Testing
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