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preclinical trial

preclinical trial, Total:496 items.

In the international standard classification, preclinical trial involves: Medical sciences and health care facilities in general, Quality, Medical equipment, Pharmaceutics, Test conditions and procedures in general, Dentistry, Laboratory medicine, Birth control. Mechanical contraceptives, ENVIRONMENT. HEALTH PROTECTION. SAFETY, Veterinary medicine, Terminology (principles and coordination), First aid, Lubricants, industrial oils and related products, Hospital equipment, Applications of information technology, AIRCRAFT AND SPACE VEHICLE ENGINEERING, Thermodynamics and temperature measurements, Nuclear energy engineering, Food products in general, Industrial automation systems, Construction materials, Machine tools, Protection against fire, Furniture, Woodworking equipment, Elements of buildings, Vocabularies, Vibrations, shock and vibration measurements, Chipless working equipment, Equipment for entertainment, Mechanical testing, Software development and system documentation, Construction equipment, Transport, Equipment for children.

Group Standards of the People's Republic of China, preclinical trial

T/CGCPU 015-2020 Requirements for Subjects Risk Monitoring system in clinical trials
T/CGCPU 014-2020 The practices of chemicals for clinical trials in clinical trial institutions
T/CGCPU 008-2019 General Auditing Standards for Clinical Trials
T/CGCPU 024-2023 Specification for training management of practitioners in clinical trial institution
T/CGCPU 003-2023 Specification for capacity evaluation of clinical trial institutions
T/CGCPU 006-2023 Specification for competency assessment of phase I clinical trials
T/CGCPU 024-2022 Specification for training management of practitioners in clinical trial institution
T/CGCPU 003-2019 Clinical Trial Institution Capacity Evaluation Standards
T/CGCPU 006-2019 Phase I Clinical Trial Capacity Evaluation Criteria
T/CGCPU 012-2020 File management standards for clinical trial institutions
T/CGCPU 022-2022 Evaluation criteria for information management of clinical trials
T/CGCPU 005-2023 Specification for competency assessment of the clinical trial professional group
T/CGCPU 022-2023 Evaluation criteria for information management of clinical trials
T/CGCPU 005-2019 Clinical Trial Professional Group Competence Evaluation Criteria
T/CHSA 006-2019 Clinical practice specification for metal prefabricated crown restoration of deciduous teeth
T/CGCPU 012-2023 Evaluation specifications for archives management of clinical trial institutions
T/CGCPU 023-2022 Evaluation standard for clinical trial management system document
T/SHDSGY 066-2023 Inspection service specification of clinical trial research center
T/CGCPU 023-2023 Evaluation standard for clinical trial management system document
T/CGCPU 020-2022 Guidelines for the management of pain in clinical trial subjects in the pediatric population
T/CAV 003-2023 Guidelines for visiting site setting of prophylactic vaccine clinical research
T/CGCPU 013-2020 Ethical Considerations for Subject Pain Management in Clinical Trials
T/CGCPU 002-2023 Evaluation standard of centralized management of clinical investigational product
T/SHQAP 001-2023 Guidelines for the Construction of Quality Management Systems for Drug Clinical Trial Sponsors
T/ZSBT 001-2021 Acceptance Standards for clinical blood use management in Zhejiang Province
T/QDAS 108-2023 Technical specification for mobile intelligent clinical examination platform
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
T/CGCPU 016-2021 Technical requirements for clinical trials of new drugs for oral inhalation of respiratory system in pediatric populations
T/CGSS 008-2019 Clinical application guidelines for laboratory indicators of blood stasis syndrome in senile coronary heart disease
T/CACM 1351-2021 Standards for collection, preservation and transportation of fecal microbial samples in clinical trials of TCM
T/CACM 1353-2021 Technical guidelines for clinical trial design and evaluation of traditional Chinese medicine in the treatment of carotid atherosclerosis
T/CACM 1333.1-2019 Technical guidelines for the design and evaluation of traditional Chinese medicine clinical trials for common diseases in the pediatric system Part 1: Anorexia
T/CACM 1333.4-2019 Technical guidelines for the design and evaluation of traditional Chinese medicine clinical trials for pediatric series of common diseases Part 4: Diarrhea in children
T/CACM 1333.3-2019 Technical guidelines for the design and evaluation of traditional Chinese medicine clinical trials for pediatric common diseases Part 3: Functional abdominal pain
T/CACM 1333.2-2019 Technical guidelines for the design and evaluation of traditional Chinese medicine clinical trials for common diseases in the pediatric system Part 2: functional constipation

RU-GOST R, preclinical 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 52379-2005 Good clinical practice (GCP)
GOST R 51352-1999 Kits of reagents for clinical laboratory diagnostics. Test methods
GOST R 51088-1997 Kits of reagents for clinical laboratory diagnostics. General specifications
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 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 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 ISO 16037-2014 Rubber condoms for clinical trials. Determination of physical properties
GOST R 54328-2011 Dentistry. Preclinical evaluation of dental implant systems. Animal test methods
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)
GOST R 56377-2015 Clinical recommendations (protocols for patients cure). Prevention of thromboembolic syndromes
GOST R 57106-2016 Products diet therapeutic and preventive nutrition diet. Complexes vitamin-mineral in clinical nutrition. Specification
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 ISO 230-4-2015 Test code for machine tools. Part 4. Circular tests for numerically controlled machine tools
GOST R 55991.7-2014 In vitro diagnostics medical devices. Part 7. Automatic analyzers for general clinical tests. Technical requirements for public procurement
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
GOST R ISO 16256-2015 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
GOST 30210-1994 Furniture. Methods for testing bunk beds

American Society for Testing and Materials (ASTM), preclinical trial

ASTM F3108-19 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
ASTM F3448-20 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Hip Reconstructive Surgery
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 E2045-99(2009) Standard Practice for Detailed Clinical Observations of Test Animals
ASTM F3037-15 Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs)
ASTM D3829-20 Standard Test Method for Predicting the Borderline Pumping Temperature of Engine Oil
ASTM D3829-93(1998) Standard Test Method for Predicting the Borderline Pumping Temperature of Engine Oil
ASTM D3829-18 Standard Test Method for Predicting the Borderline Pumping Temperature of Engine Oil
ASTM D3829-17 Standard Test Method for Predicting the Borderline Pumping Temperature of Engine Oil
ASTM D3829-20a Standard Test Method for Predicting the Borderline Pumping Temperature of Engine Oil
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 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 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 E1246-88(1995) Standard Practice for Reporting Reliability of Clinical Laboratory Computer Systems
ASTM E1590-01 Standard Test Method for Fire Testing of Mattresses
ASTM E1590-99 Standard Test Method for Fire Testing of Mattresses
ASTM E1381-95 Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems
ASTM E1590-02 Standard Test Method for Fire Testing of Mattresses
ASTM E1590-12 Standard Test Method for Fire Testing of Mattresses
ASTM E1590-23 Standard Test Method for Fire Testing of Mattresses
ASTM E1590-22 Standard Test Method for Fire Testing of Mattresses
ASTM E1590-13 Standard Test Method for Fire Testing of Mattresses
ASTM E1590-16 Standard Test Method for Fire Testing of Mattresses
ASTM E1590-17 Standard Test Method for Fire Testing of Mattresses
ASTM E2080-06 Standard Guide for Clinical Psychophysiological Detection of Deception (PDD) Examinations for Sex Offenders
ASTM F2385-04 Standard Test Method for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs
ASTM F2385-04(2010) Standard Test Method for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs
ASTM F1566-09 Standard Test Methods for Evaluation of Innersprings, Boxsprings, Mattresses or Mattress Sets

Professional Standard - Medicine, preclinical trial

YY/T 0991-2015 Clinical trial guideline for orthodontic brackets
YY/T 1305-2015 Clinical trial guideline for titanium and titanium alloy dental implant
YY/T 0990-2015 Clinical trial guideline for polymer-based dental restorative materials
YY/T 1227-2014 In vitro diagnostic reagent (kit) nomenclature for clinical chemistry
YY/T 0522-2009 Dentistry Preclinical evaluation of dental implant systems Animal test methods
YY/T 0127.11-2001 Dentistry----Preclinical evaluation of biocompatibility of medical devices used in dentistry----Part 2:Biological evaluation test method of dental materials----Pulp capping test
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
YY/T 0268-2001 Dentistry----Preclinical evaluation of biocompatibility of medical devices used in dentistry----Part 1:Evaluation and test methods selection

US-AAMI, preclinical trial

ANSI/AAMI/ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
ANSI/AAMI/ISO 14155:2020 Clinical investigation of medical devices for human subjects-Good clinical practice

Danish Standards Foundation, preclinical trial

DS/EN ISO 14155:2013 Clinical investigation of medical devices for human subjects - Good clinical practice
DS/ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties
DS/ISO 230-4:2007 Test code for machine tools - Part 4: Circular tests for numerically controlled machine tools
DS 13081:1959 Prestressed reinforcing wire. Testing
DS 2338:1987 Hospital beds and cots. Safety sides. Requirements and testing
DS/EN 747-2:2012 Furniture - Bunk beds and high beds - Part 2: Test methods
DS/ISO 23767:2021 Children's furniture – Mattresses for cots and cribs – Safety requirements and test methods
DS/EN 16890:2021 Children's furniture – Mattresses for cots and cribs – Safety requirements and test methods

IT-UNI, preclinical trial

UNI EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
EC 1-2020 UNI EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
UNI ISO 3875:2021 Machine tools — Test conditions for external cylindrical centreless grinding machines — Testing of the accuracy

Association Francaise de Normalisation, preclinical trial

NF S99-201*NF EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
NF S97-045*NF ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties
NF ISO 16037:2002 Préservatifs masculins en caoutchouc destinés aux essais cliniques - Mesurage des propriétés physiques
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 S12-112*NF EN ISO 8596:2018 Ophthalmic optics - Visual acuity testing - Standard and clinical optotypes and their presentation
NF E60-125*NF ISO 3875:2020 Machine tools - Test conditions for external cylindrical centreless grinding machines - Testing of the accuracy
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
NF E60-139*NF ISO 19744:2022 Test conditions for numerically controlled broaching machines - Testing of the accuracy - Vertical surface type broaching machines
NF EN ISO 18812:2003 Informatique de santé - Interfaces d'analyseur clinique pour systèmes d'information de laboratoire - Profils d'utilisation
NF E60-096:1998 Test code for machine-tools. Part 4 : circular tests for numerically controlled machine tools.
NF E60-100-4*NF ISO 230-4:2022 Test code for machine tools - Part 4 : circular tests for numerically controlled machine tools
NF E60-125:2004 Machine tools - Test conditions for external cylindrical centreless grinding machines - Testing of the accuracy.
NF P20-526:1983 Doors. Prepainting test.
NF E60-126*NF ISO 4703:2001 Test conditions for surface grinding machines with two columns - Machines for grinding slideways - Testing of the accuracy
NF E60-127:2017 Machine tools - Vertical grinding machines - Acceptance conditions - Testing of accuracy
NF E60-163*NF ISO 8636-1:2000 Machine tools - Test conditions for bridge-type milling machines - Testing of the accuracy - Part 1 : fixed bridge (portal-type) machines
NF S12-112/A1*NF EN ISO 8596/A1:2020 Ophthalmic optics - Visual acuity testing - Standard and clinical optotypes and their presentation - Amendment 1
NF E60-141*NF ISO 6480:2019 Test conditions for horizontal internal type broaching machines - Testing of accuracy
NF E60-133*NF ISO 2772:2019 Test conditions for box type vertical drilling machines - Testing of the accuracy
NF E60-142*NF ISO 6779:2019 Test conditions for vertical internal type broaching machines - Testing of accuracy
NF E60-143*NF ISO 6481:2019 Test conditions for vertical surface type broaching machines - Testing of accuracy
NF S92-053-2*NF EN ISO 20776-2:2022 Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2 : evaluation of performance of antimicrobial susceptibility
NF E60-140:2000 Machine tools - Test conditions for wire electrical discharge machines (wire EDM) - Terminology and testing of the accuracy.
NF E60-111-1*NF ISO 1701-1:2005 Test conditions for milling machines with table of variable height - Testing of the accuracy - Part 1 : machines with horizontal spindle
NF E60-124*NF ISO 2433:2000 Machines tools - Test conditions for external cylindrical and universal grinding machines with a movable table - Testing of the accuracy.
NF E60-401:1986 GRINDERS. GRINDING WHEEL GUARDS. STRENGTH TESTS.
NF E60-415:1989 MACHINES TOOLS. LATHES AND TURNING CENTRES. STRENGTH TESTS FOR GUARDS.
NF E62-154:1985 Machine tools. Hack sawing machines. Acceptance conditions. Testing of accuracy.
NF E60-116-2:2008 Machines tools - Test conditions for testing the accuracy of boring and milling machines with horizontal spindle - Part 2 : machines with movable column and fixed table.
NF ISO 3070-1:2008 Machines-outils - Conditions d'essai pour le contrôle de l'exactitude des machines à aléser et à fraiser à broche horizontale - Partie 1 : machines à montant fixe et à table mobile
NF E60-164:1988 Machine-tools. Plano-milling machines, portal type. Acceptance conditions and testing of accuracy.
NF P93-501-3*NF EN 12811-3:2003 Temporary works equipment - Part 3 : load testing
NF D62-015-2:2012 Furniture - Bunk beds and high beds - Part 2 : test methods.
NF D64-501:1965 Domestic interior sprung mattrenesses. Characteristics. Tests.
NF E60-114:1985 Machine tools. Removable tables of boring and milling machines. Acceptance conditions. Testing of accuracy.

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, preclinical trial

GB/T 30224-2013 Clinical use of tests for Toxoplasma gondii
GB/T 20469-2006 General guideline of the clinical laboratory design
GB/T 26124-2011 In vitro diagnostic reagent(kit) for clinical chemistry
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
GB/T 43000-2023 Test methods for household cribs and folding cots for furniture

卫生健康委员会, preclinical trial

WS/T 574-2018 Purified water for clinical laboratory reagents
WS/T 644-2018 Clinical laboratory quality evaluation
WS/T 662-2020 Technical requirements for clinical body fluid testing
WS/T 804-2022 Basic technical standards for clinical chemistry testing
WS/T 616-2018 Automated review of quantitative test results in clinical laboratories
WS/T 641-2018 Clinical laboratory quantitative measurement indoor quality control
WS/T 780-2021 Reference intervals for commonly used clinical biochemical tests in children
WS/T 640-2018 Collection and transportation of samples for clinical microbiology testing

British Standards Institution (BSI), preclinical trial

BS EN ISO 14155:2011 Clinical investigation of medical devices for human subjects. Good clinical practice
BS EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Clinical investigation plans
BS EN ISO 14155:2020 Clinical investigation of medical devices for human subjects. Good clinical practice
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 EN 12470-3:2000+A1:2009 Clinical thermometers. Performance of compact electrical thermometers (non-predictive and predictive) with maximum device
BS ISO 230-4:1997 Test code for machine tools - Circular tests for numerically controlled machine tools
BS EN ISO 8596:2018+A1:2020 Ophthalmic optics. Visual acuity testing. Standard and clinical optotypes and their presentation
DD ENV 13728-2001 Health informatics. Clinical analyser interfaces to laboratory information systems
BS ISO/IEC 10373-7:2008 Identification cards - Test methods - Vicinity cards
DD ENV 1614-1995 Healthcare informatics. Structure for nomenclature, classification and coding of properties in clinical laboratory science
BS ISO 3070-2:1999 Test conditions for boring and milling machines with horizontal spindle - Testing of the accuracy - Table-type machines
BS EN 13453-2:2004 Bunk beds and high beds for non-domestic use - Test methods
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 EN 747-2:2007 Furniture - Bunk beds and high beds for domestic use - Part 2: Test methods
BS EN 747-2:2012 Furniture. Bunk beds and high beds. Test methods
BS EN 747-2:2008 Furniture. Bunk beds and high beds for domestic use. Test methods
BS ISO 230-4:2022 Tracked Changes. Test code for machine tools. Circular tests for numerically controlled machine tools
BS ISO 8636-2:2008 Machine tools - Test conditions for bridge-type milling machines - Testing of the accuracy - Travelling bridge (gantry-type) machines
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 6155:1998 Machine tools - Test conditions for horizontal spindle turret and single spindle automatic lathes - Testing of the accuracy
BS ISO 1985:1998 Machine tools - Test conditions for surface grinding machines with vertical grinding wheel spindle and reciprocating table - Testing of the accuracy
BS EN 1725:1998 Domestic furniture - Beds and mattresses - Safety requirements and test methods
19/30378401 DC BS EN ISO 8596 AMD1. Ophthalmic optics. Visual acuity testing. Standard and clinical optotypes and their presentation
BS ISO 14137:2000 Machine tools - Test conditions for wire electrical-discharge machines (wire EDM) - Terminology and testing of the accuracy
BS ISO 1985:2015 Machine tools — Test conditions for surface grinding machines with vertical grinding wheel spindle and reciprocating table — Testing of the accuracy
BS EN ISO 20776-2:2007 Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices. Evaluation of performance of antimicrobial susceptibility test device
BS ISO 3070-1:2007 Machine tools - Test conditions for testing the accuracy of boring and milling machines with horizontal spindle - Machines with fixed column and movable table
BS ISO 3070-3:2007 Machine tools - Test conditions for testing the accuracy of boring and milling machines with horizontal spindle - Machines with movable column and movable table
BS ISO 4703:2001 Test conditions for surface grinding machines with two columns - Machines for grinding slideways - Testing of the accuracy
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
BS ISO 3070-4:1999 Test conditions for boring and milling machines with horizontal spindle - Testing of the accuracy - Planer type machines with movable column
BS ISO 3070-2:2016 Machine tools. Test conditions for testing the accuracy of boring and milling machines with horizontal spindle. Machines with movable column along the X-axis (floor type)
BS EN 716-2:2008+A1:2013 Furniture - Children's cots and folding cots for domestic use - Test methods
BS EN 716-2:1996 Furniture - Children's cots and folding cots for domestic use - Test methods
BS 4656-10:1975 Specification for the accuracy of machine tools and methods of test - Drilling machines, radial type
16/30325091 DC BS ISO 3875. Machine tools. Test conditions for external cylindrical centreless grinding machines. Testing of the accuracy
18/30361448 DC BS ISO 3875. Machine tools. Test conditions for external cylindrical centreless grinding machines. Testing of the accuracy
BS EN 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 of fungi involved in infectious diseases
14/30264453 DC BS ISO 16782. Clinical laboratory testing. Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing

European Committee for Standardization (CEN), preclinical trial

EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
EN ISO 14155-2:2003 Clinical Investigation of Medical Devices for Human Subjects - Part 2: Clinical Investigation Plans ISO 14155-2:2003
EN 12470-3:2000 Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device Incorporates Amendment A1: 2009
EN ISO 81060-2:2019 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type (ISO 81060-2:2018)
prEN ISO 20776-2:2021 Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test - Part 2: Evaluation of performance of antimicrobial susceptibility test devi
EN 747-2:2012+A1:2015 Furniture - Bunk beds and high beds - Part 2: Test methods
EN 747-2:2012 Furniture - Bunk beds and high beds - Part 2: Test methods (Incorporates Amendment A1: 2015)
EN 747-2:1993 Furniture - Bunk Beds for Domestic Use - Part 2: Test Methods
prEN 747-2 Furniture - Bunk beds and high beds - Part 2: Test methods
EN ISO 7405:1997 Dentistry - Preclinical Evaluation of Biocompatibility of Medical Devices Used in Dentistry - Test Methods for Dental Materials ISO 7405: 1997
EN ISO 81060-2:2014 Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type
EN 12811-3:2002 Temporary works equipment - Part 3: Load testing
EN 1957:2000 Domestic Furniture - Beds and Mattresses - Test Methods for the Determination of Functional Characteristics
EN 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 (ISO 16256:2021)
EN 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 of fungi involved in infectious diseases (ISO 16256:2012)

AT-ON, preclinical trial

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

Lithuanian Standards Office , preclinical trial

LST EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
LST EN 12470-3-2001+A1-2009 Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device
LST EN 747-2-2012 Furniture - Bunk beds and high beds - Part 2: Test methods

PL-PKN, preclinical trial

PN-EN ISO 14155-2021-02 E Clinical investigation of medical devices for human subjects -- Good clinical practice (ISO 14155:2020)
PN M55650-1964 Machin? tool test cod?

AENOR, preclinical trial

UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
UNE 129001:1997 CLINICAL LABORATORY REPORTS. PREPARING REQUIREMENTS.
UNE 129002:2000 IN Glossary of recommended terms in clinical laboratory sciences.
UNE-ISO 230-4:2008 Test code for machine tools - Part 4: Circular test for numerically controlled machine tools.
UNE-ISO 8636-2:2009 Machine tools -- Test conditions for bridge-type milling machines -- Testing of the accuracy - Part 2: Travelling bridge (gantry-type) machines
UNE-EN ISO 20776-2:2008 Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2: Evaluation of performance of antimicrobial susceptibility t
UNE-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

German Institute for Standardization, preclinical trial

DIN EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
DIN EN ISO 8596:2020-05 Ophthalmic optics - Visual acuity testing - Standard and clinical optotypes and their presentation (ISO 8596:2017 + Amd.1:2019); German version EN ISO 8596:2018 + A1:2020
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
DIN ISO 2407:1999 Machine tools - Test conditions for internal cylindrical grinding machines with horizontal spindle - Testing of accuracy (ISO 2407:1997)
DIN 6875-3:2008-03 Special radiotherapy equipments - Part 3: Intensity-modulated radiation therapy - Characteristics, test methods and rules for clinical application
DIN 58937-7:1994 General laboratory medicine (clinical pathology); part 7: listing of features of in vitro diagnostic systems
DIN EN 1725:1998 Domestic furniture - Beds and mattresses - Safety requirements and test methods; German version EN 1725:1998
DIN EN 747-2:2012 Furniture - Bunk beds and high beds - Part 2: Test methods; German version EN 747-2:2012
DIN EN 747-2:2022 Furniture - Bunk beds and high beds - Part 2: Test methods; German and English version prEN 747-2:2022
DIN 6875-3:2008 Special radiotherapy equipments - Part 3: Intensity-modulated radiation therapy - Characteristics, test methods and rules for clinical application
DIN 81208-18:2006 Manoeuvring of ships - Part 18: Critical speed trial
DIN EN 12811-3:2003 Temporary works equipment - Part 3: Load testing; German version EN 12811-3:2002

Zhejiang Provincial Standard of the People's Republic of China, preclinical 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

Professional Standard - Certification and Accreditation, preclinical trial

RB/T 192-2015 Forensic clinical examination specification
RB/T192-2015

司法部, preclinical trial

SF/T 0111-2021 Forensic Clinical Examination Standards
SF/T 0112-2021 Standards for implementation of forensic clinical imaging examinations

ZA-SANS, preclinical trial

SANS 16037:2003 Rubber condoms for clinical trials - Measurement of physical properties
SANS 10373-7:2004 Identification cards - Test methods - Part 7: Vicinity cards

Professional Standard - Meteorology, preclinical trial

QX/T 204-2013 Nowcast Verification

Professional Standard - Hygiene , preclinical 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 102-1998 Classification and codes of clinical laboratory tests item
WS/T 420-2013 Verification of analytical performance of quantitative kits by clinical laboratory
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 402-2012 Define and determine the reference intervals in clinical laboratory
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 225-2002 Collection and processing of blood specimens for clinical chemistry
WS/T 406-2012 Analytical quality specifications for routine tests in clinical hematology
WS/T 403-2012 Analytical quality specifications for routine analytes in clinical biochemistry
WS/T 492-2016 Performance verification of precision and correctness of quantitative determination items in clinical laboratory
WS/T 492-2015 Performance verification of precision and correctness of quantitative determination items in clinical laboratory
WS/T 404.3-2012 Reference intervals for common clinical biochemistry tests.Part 3:Serum potassium,sodium and chloride
WS/T 404.8-2015 Reference intervals for commonly used clinical biochemical test items Part 8: Serum amylase
WS/T 404.2-2012 Reference intervals for common clinical biochemistry tests.Part 2:Serum total protein and albumin

中华人民共和国国家卫生和计划生育委员会, preclinical trial

WS/T 496-2017 Quality indicators in clinical laboratories
WS/T 124-1999 Inspection criteria of the quality of clinical chemistry in vitro diagnostic kits.General guideline
WS/T 227-2002 Requirement for the technical procedure manual in clinical laboratory
WS/T 228-2002 Preliminary evaluation of quantitative clinical laboratory methods
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
WS/T 404.5-2015 Reference intervals for common clinical biochemistry tests.Part 5: Serum urea and creatinine

Professional Standard - Public Safety Standards, preclinical trial

GA/T 1970-2021 Standards for forensic clinical examination

Canadian General Standards Board （CGSB), preclinical trial

CAN/CGSB-191.1-2013 Research ethics oversight of biomedical clinical trials
CGSB 191.1-2013-CAN/CGSB-2013 Surveillance de l掗thique de recherches comportant des essais cliniques biom閐icaux

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

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

Professional Standard - Agriculture, preclinical trial

农业部1247号公告-6-2009 Guiding principles for preclinical toxicology evaluation tests of veterinary drugs
农业部1596号公告-1-2011 Technical guidelines for clinical trials of traditional Chinese medicines and natural medicines for veterinary use
农业部1247号公告-3-2009 Guiding principles for clinical pharmacokinetic tests of veterinary chemical drugs
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
农业部1596号公告-2-2011 Writing principles of clinical trial reports of traditional Chinese medicine and natural medicine for veterinary use
CNAS-GL037-2019 Guidelines for performance verification of quantitative assay procedures in clinical chemistry
农业部1247号公告-2-2009 Guiding principles for non-clinical pharmacokinetic tests of veterinary chemical drugs

Hunan Provincial Standard of the People's Republic of China, preclinical trial

DB43/T 2135-2021 Technical Service Specifications for the Recruitment and Management of Drug Clinical Trial Subjects

BE-NBN, preclinical trial

NBN-EN 540-1993 Clinical investigation of medical devices for human subjects

Korean Agency for Technology and Standards (KATS), preclinical trial

KS M ISO 16037:2008 Rubber condoms for clinical trials-Measurement of physical properties
KS P ISO 14155-2:2007 Clinical investigation of medical devices for human subjects－Part 2：Clinical investigation plans
KS M ISO 16037:2018 Rubber condoms for clinical trials — Measurement of physical properties
KS P ISO TS 22911:2010 Dentistry-Preclinical evaluation of dental implant systems-Animal test methods
KS P ISO TS 22911:2014 Dentistry－Preclinical evaluation of dental implant systems－Animal test methods
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 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 8430-2015(2020) Management and safety requirements for clinical laboratory pre-analytical automation system
KS B ISO 8636-2:2014 Machine tools — Test conditions for bridge-type milling machines — Testing of the accuracy — Part 2: Travelling bridge(gantry-type) machines
KS B ISO 8636-2:2009 Machine tools-Test conditions for bridge-type milling machines-Testing of the accuracy-Part 2:Travelling bridge(gantry-type) machines
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 B ISO 3875:2014 Machine tools — Test conditions for external cylindrical centreless grinding machines — Testing of the accuracy
KS B ISO 3875:2013 External cylindrical centerless grinding machines-Testing of the accuracy
KS B 4917-1997(2004) MACHINE TOOLS-GENERAL REQUIREMENTS FOR TESTING
KS B ISO 6155:2013 Machine tools-Test conditions for horizontal spindle turret andsingle spindle automatic lathes-Testing of the accuracy
KS B ISO 6155:2014 Machine tools — Test conditions for horizontal spindle turret and single spindle automatic lathes — Testing of the accuracy
KS B 4917-1995 Machine tools-general requirements for testing
KS X ISO 18812-2016(2021) Health informatics — Clinical analyser interfaces to laboratory information systems — Use profiles
KS B 4224-2007 Test code for performance and accuracy of numerically controlled external cylindrical and universal grinding machines
KS B 4224-1987 Test code for performance and accuracy of numerically controlled external cylindrical and universal grinding machines
KS B 4918-1995 Machine tools-geometric accuracy tests and practical tests-Test methods
KS B ISO 3875:2019 Machine tools — Test conditions for external cylindrical centreless grinding machines — Testing of the accuracy
KS B 4207-2007 Test code for performance and accuracy of numerically controlled lathes
KS B 4219-2002 Test conditions for high accuracy turret and single spindle coordinate drilling andboring machines with table of fixed height with vertical spindle-Testing of the accuracy-Part 1:Single column type machines
KS B 4207-1981 Test code for performance and accuracy of numerically controlled lathes
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 B ISO 4703:2014 Test conditions for surface grinding machines with two columns — Machines for grinding slideways — Testing of the accuracy
KS B ISO 4703:2010 Test conditions for surface grinding machines with two columns-Machines for grinding slideways-Testing of the accuracy
KS B 0077-1994(2009) Machine tools-Test codes-Vocabulary
KS B ISO 1984-1:2018 Bed type milling machines — Testing of the accuracy — Part 1: Milling machines with horizontal spindle
KS B ISO 1984-2:2018 Bed type milling machines — Testing of the accuracy — Part 2: Milling machines with vertical spindle
KS B 4213-2002 Test conditions for milling machines with table of variable height－Testing of accuracy－Part 3：Machines with vertical spindle
KS B 4045-2007(2012) Test code for performance and accuracy of multispindle automatic lathes
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 B ISO 3070-2:2013 Machine tools-Test conditions for testing the accuracy of boring and milling machines with horizontal spindle-Part 2:Machines with movable column and fixed table
KS B ISO 3070-2:2014 Machine tools — Test conditions for testing the accuracy of boring and milling machines with horizontal spindle — Part 2: Machines with movable column and fixed table
KS B 4201-2014 Test code for performance and accuracy of veneer lathes
KS B 4107-2014 Wide belt sanders — Test and inspection methods
KS B 4102-2014 Test methods for performance and accuracy of vertical wood milling machines
KS B 4107-2007 Wide belt sanders-Test and inspection methods
KS B 4102-2007 Test methods for performance and accuracy of vertical wood milling machines
KS B 4201-2007 Test code for performance and accuracy of veneer lathes
KS B 4207-2007(2012) Test code for performance and accuracy of numerically controlled lathes
KS B 4107-1982 Wide belt sanders-Test and inspection methods
KS B 4102-1985 Test methods for performance and accuracy of vertical wood milling machines
KS B 4201-1986 Test code for performance and accuracy of veneer lathes
KS G 7175-2-2014(2019) Children's cots and folding cots for domestic use ― Part 2: Test methods
KS B 4064-2014 Test code for performance and accuracy of wood working machinery
KS B 4064-1985 Test code for performance and accuracy of wood working machinery

International Organization for Standardization (ISO), preclinical trial

ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties
ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plants
ISO/TS 22911:2016 Dentistry - Preclinical evaluation of dental implant systems - Animal test methods
ISO/TS 22911:2005 Dentistry - Preclinical evaluation of dental implant systems - Animal test methods
ISO 16037:2002/Amd 1:2011 Rubber condoms for clinical trials — Measurement of physical properties — Amendment 1
ISO 8596:2017/Amd 1:2019 Ophthalmic optics — Visual acuity testing — Standard and clinical optotypes and their presentation — Amendment 1
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 81060-2:2009 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type
ISO 81060-2:2013 Non-invasive sphgmomanometers-Part 2:Clinical investigation of automated measurement type
ISO 3070-1:1975 Test conditions for boring and milling machines with horizontal spindle — Testing of the accuracy — Part 1: Table type machines
ISO 8596:2017 Ophthalmic optics - Visual acuity testing - Standard and clinical optotypes and their presentation
ISO 4703:1977 Test conditions for surface grinding machines with two columns — Machines for grinding slideways — Testing of accuracy
ISO 230-4:2022 Test code for machine tools — Part 4: Circular tests for numerically controlled machine tools
ISO 3875:2004 Machine tools - Test conditions for external cylindrical centreless grinding machines - Testing of the accuracy
ISO 19744:2020 Test conditions for numerically controlled broaching machines — Testing of accuracy — Vertical surface type broaching machines
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
ISO 6779:2019 Test conditions for vertical internal type broaching machines — Testing of accuracy
ISO/PRF 6779:2018 Test conditions for vertical internal type broaching machines — Testing of accuracy
ISO 6779:2023 Test conditions for vertical internal type broaching machines — Testing of accuracy
ISO/DIS 6779 Test conditions for vertical internal type broaching machines — Testing of accuracy
ISO 2772:2019 Test conditions for box type vertical drilling machines — Testing of the accuracy
ISO 6481:2019 Test conditions for vertical surface type broaching machines — Testing of accuracy
ISO 3875:2020 Machine tools — Test conditions for external cylindrical centreless grinding machines — Testing of the accuracy
ISO 4703:1984 Acceptance conditions for surface grinding machines with two columns; Machines for grinding slideways; Testing of accuracy
ISO 3070-2:2007 Machine tools - Test conditions for testing the accuracy of boring and milling machines with horizontal spindle - Part 2: Machines with movable column and fixed table
ISO/DIS 8636-2 Machine tools — Test conditions for bridge-type milling machines — Part 2: Testing of the accuracy of travelling bridge (gantry-type) machines
ISO 2407:1973 Test conditions for internal cylindrical grinding machines with horizontal spindle — Testing of accuracy
ISO/DIS 2773 Test conditions for pillar type vertical drilling machines — Testing of the accuracy
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 81060-2:2009/Cor 1:2011 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type; Technical Corrigendum 1
ISO 3070-1:1987 Acceptance conditions for boring and milling machines with horizontal spindle; Testing of the accuracy; Part 1 : Table-type machines
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 6480:2019 Test conditions for horizontal internal type broaching machines — Testing of accuracy

Shanghai Provincial Standard of the People's Republic of China, preclinical trial

DB31/T 138-1-1994 General rules for assay kits for clinical chemistry
DB31/T 138-10-1994 Transaminase Assay Kit for Clinical Chemistry (Rei's Method)
DB31/T 138-9-1994 Total protein assay kit for clinical chemistry (biuret colorimetric method)
DB31/T 138-3-1994 Burea Nitrogen Determination Kit for Clinical Chemistry (Diacetyl-Oxime Colorimetric Method)
DB31/T 138-4-1994 Urease Nitrogen Determination Kit for Clinical Chemistry (Urease--Berthelot Endpoint Colorimetric Method)
DB31/T 138-5-1994 Creatinine Determination Kit for Clinical Chemistry (Picric Acid Endpoint Colorimetric Method)
DB31/T 138-8-1994 Total Bilirubin Determination Kit for Clinical Chemistry (Caffeine Colorimetric Method)
DB31/T 138-2-1994 Calcium Determination Kit for Clinical Chemistry (Methyl Thymol Blue Colorimetric Method)
DB31/T 138-6-1994 Glucose Assay Kit for Clinical Chemistry (Glucose Oxidase Endpoint Colorimetric Method)

未注明发布机构, preclinical trial

DIN EN 540:1993 Clinical testing of medical devices on humans
WS/T 514-2017 Establishment and verification of detection capability for clinical laboratory measurement procedures
DIN EN 540 Berichtigung 1:1998 Clinical testing of medical devices on humans; German version EN 540: 1993
BS EN ISO 8597:1996*BS 4274-3-1996)(1999 Visual acuity test types — Method for correlating optotypes used for non - clinical purposes

KR-KS, preclinical trial

KS M ISO 16037-2018 Rubber condoms for clinical trials — Measurement of physical properties
KS P ISO TS 22911-2014 Dentistry－Preclinical evaluation of dental implant systems－Animal test methods
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 B ISO 230-4-2018(2023) Test code for machine tools — Part 4: Circular tests for numerically controlled machine tools
KS B ISO 4703-2022 Test conditions for surface grinding machines with two columns — Machines for grinding slideways — Testing of the accuracy
KS P ISO 15198-2017 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
KS B ISO 1701-2-2016 Test conditions for milling machines with table of variable hight — Testing of accuracy — Part 2: Machines with vertical spindle
KS B ISO 2407-2012 Test conditions for internal cylindrical grinding machines with horizontal spindle－Testing of the accuracy
KS B ISO 3875-2019 Machine tools — Test conditions for external cylindrical centreless grinding machines — Testing of the accuracy
KS B ISO 1984-1-2018 Bed type milling machines — Testing of the accuracy — Part 1: Milling machines with horizontal spindle
KS B ISO 1984-2-2018 Bed type milling machines — Testing of the accuracy — Part 2: Milling machines with vertical spindle
KS P ISO 16256-2022 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 infec
KS P ISO 15198-2017(2022) Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
KS X ISO 18812-2016 Health informatics — Clinical analyser interfaces to laboratory information systems — Use profiles

National Health Commission of the People's Republic of China, preclinical trial

WS/T 805-2022 Basic Technical Standards for Clinical Microbiological Examination
WS/T 806-2022 Basic technical standards for clinical blood and body fluid testing
Pharma-Guidelines-Nanodrug003 Technical Guiding Principles for Non-clinical Safety Research of Nanomedicines (Trial Implementation)
WS/T 807-2022 Performance Validation of Clinical Microbial Culture, Identification and Antimicrobial Susceptibility Testing Systems
Pharma-Guidelines-Nanodrug002 Technical Guiding Principles for Nonclinical Pharmacokinetic Research of Nanomedicines (Trial Implementation)

未注明发布机构, preclinical trial

DIN EN 540:1993 Clinical testing of medical devices on humans
WS/T 514-2017 Establishment and verification of detection capability for clinical laboratory measurement procedures
DIN EN 540 Berichtigung 1:1998 Clinical testing of medical devices on humans; German version EN 540: 1993
BS EN ISO 8597:1996*BS 4274-3-1996)(1999 Visual acuity test types — Method for correlating optotypes used for non - clinical purposes

US-HHS, preclinical trial

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

Military Standards (MIL-STD), preclinical trial

DOD A-A-51827-1987 THERMOMETER, CLINICAL, HUMAN, (DISPOSABLE)
DOD A-A-54898-1993 THERMOMETER, LIQUID CRYSTAL, CLINICAL, DISPOSABLE
DOD A-A-54885-1993 CHART SET, VISION ACUITY TESTING, CLINICAL AND SCREENING, DISTANT VISION

US-CLSI, preclinical 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

US-FCR, preclinical trial

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

国家卫生计生委, preclinical trial

WS/T 503-2017 Blood culture operating procedures in clinical microbiology laboratories
WS/T 494-2017 Analysis quality requirements for important routine items in clinical qualitative immunoassay testing

国家市场监督管理总局、中国国家标准化管理委员会, preclinical 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

American Nuclear Society (ANS), preclinical trial

ANS 1-2000 Conduct of Critical Experiments

American National Standards Institute （ANSI), preclinical trial

ANSI/ANS 1-2000 Conduct of Critical Experiments
ANSI/HL7 V3 PORT, R 1-2004 HL7 Version 3 Standard: Regulated Studies - Periodic Reporting of Clinical Trials Laboratory Results, , Release 1
ANSI/ASTM E1590:2013 Test Method for Fire Testing of Mattresses
ANSI/HL7 CMSAPP, R 1-2008 HL7 Clinical Context Management Specification (CCOW) Application Protection Package, Release 1
ANSI/HL7 CMSCMPP, R 1-2008 HL7 Clinical Context Management Specification (CCOW) Context Manager Protection Package, Release 1

CU-NC, preclinical trial

NC 57-50-7-1985 Clinical Methods and Aids Sodium Tungsten Reagent Solution. Quality Specifications
NC 57-50-16-1986 Clinical Methods and Aids Mercury Nitrato Reagent Solution. Quality Speeifications
NC 57-50-14-1986 Clinical Methods and Aids. Sodium Citrate Reagent Solution. Quality Specifications
NC 57-50-15-1986 Clinical Methods and Aids Sodium Carbonate Reagent Solution. Quality Specifications

CN-GJB-H, preclinical trial

GJB 5515/5-2006 Detail specification for clinical laboratory shelter of field mobile medical system
GJB 7125.3-2011 Model selection technique requirements for military medical equipments.Part 3:Clinical laboratory equipments

ES-UNE, preclinical trial

UNE-EN ISO 8596:2018 Ophthalmic optics - Visual acuity testing -- Standard and clinical optotypes and their presentation (ISO 8596:2017)
UNE-EN ISO 8596:2018/A1:2020 Ophthalmic optics - Visual acuity testing - Standard and clinical optotypes and their presentation - Amendment 1 (ISO 8596:2017/Amd1:2019)

Guangdong Provincial Standard of the People's Republic of China, preclinical trial

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

Japanese Industrial Standards Committee (JISC), preclinical trial

JIS T 6001:2005 Preclinical evaluation of biocompatibility of medical devices used in dentistry -- Test methods for dental materials
JIS B 6220:2021 Machine tools -- Test conditions for external cylindrical centreless grinding machines -- Testing of the accuracy
JIS B 6520:1994 Machines planing -- Test and inspection methods
JIS B 6211:1986 Test code for performance and accuracy of internal cylindrical grinding machines
JIS B 6212:1986 Test code for performance and accuracy of external cylindrical and universal grinding machines
JIS B 6202:1986 Test code for performance and accuracy of lathes
JIS B 6224:1978 Jig boring machines -- Test conditions for accuracy
JIS B 0182:1993 Machine tools -- Test codes -- Vocabulary
JIS B 6003:1993 Machine tools -- Test methods for vibration
JIS B 6191:1999 Machine tools -- Geometric accuracy tests and practical tests -- Test methods
JIS B 6360:2006 Machine tools -- Test conditions for wire electrical-discharge machines (wire EDM) -- Testing of the accuracy
JIS B 6190-4:2008 Test code for machine tools -- Part 4: Circular tests for numerically controlled machine tools
JIS B 6194:1997 Machine tool -- Test code for circular movement of numerically controlled machine tools
JIS B 6191:1993 Machine tools -- Geometric accuracy tests and practical tests -- Tests methods
JIS B 6203:1986 Test code for performance and accuracy of knee type horizontal and universal milling machines
JIS B 6190:1993 Machine tools -- General requirements for testing
JIS B 6360:1999 Machine tools -- Test conditions for wire electrical discharge machines (wire EDM) -- Terminology and testing of the accuracy
JIS B 6210:1986 Test code for performance and accuracy of horizontal boring machines (table type)
JIS B 6543:1991 Veneer knife grinders -- Test and inspection methods
JIS B 6208:1993 Radial drilling machines -- Test conditions for geometric accuracy and rigidity
JIS B 6209:1993 Upright drilling machines -- Test conditions for geometric accuracy and rigidity
JIS B 6201:1993 Machine tools -- Running tests and rigidity tests -- General requirements
JIS B 6203-1:2007 Test conditions for milling machines with table of variable height - Testing of the accuracy - Part 1: Machines with horizontal spindle
JIS B 6330:1980 Test code for performance and accuracy of numerically controlled machine tools
JIS B 6230:1995 Gantry-type plano-milling machines -- Testing of the accuracy

Indonesia Standards, preclinical trial

SNI ISO 81060-2:2012 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type

Shanxi Provincial Standard of the People's Republic of China, preclinical trial

DB14/T 2254-2020 Regulations on cold storage and freezing management of clinical in vitro diagnostic reagents in medical institutions

The American Road & Transportation Builders Association, preclinical trial

AASHTO DIVISION II 18.7 Testing and Acceptance Interim 1997

Underwriters Laboratories (UL), preclinical trial

UL 1895-1991 Fire tests of mattresses

Professional Standard - Forestry, preclinical trial

LY/T 1043-1991 Test method for bed building machine

林业部, preclinical trial

LY 1043-1991 Test methods for machine tools

GOSTR, preclinical trial

GOST R ISO 15198-2009 Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user control procedures by the manufacturer
GOST R ISO 20776-2-2010 Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices. Part 2. Evaluation of performance of antimicrobial susceptibility tes

YU-JUS, preclinical trial

JUS B.Z1.156-1987 Vetnilation of mine openings. Provisional dams for testing of leakage

IN-BIS, preclinical trial

VN-TCVN, preclinical trial

TCVN 7679-2007 Machine tools.Test conditions for horizontal spindle turret and single spidle automatic lathes.Testing of the accuracy
TCVN 7689-2007 Machine tools.Test conditions for surface grindingmachines with vertical grinding wheel spindle and reciprocating table.Testing of the accuracy
TCVN 7011-4-2013 Test code for machine tools.Part 4: Circular tests for numerically controlled machine tools
TCVN 7691-2007 Test conditions for surface grinding machines with two columns.Machines for grinding slideways.Testing of the accuracy

NO-SN, preclinical trial

NS 5026-1982 Test conditions for vertical turning and boring lathes with one or two columns - Testing of accuracy
NS 5025-1982 Test conditions for vertical turning and boring lathes with one or two columns - Testing of accuracy - General introduction

PK-PSQCA, preclinical trial

PS 882-1972 ACCURACY OF MACHINE TOOLS AND METHODS OF TESTING BROACHING MACHINES HORIZONTAL TYPE

Standard Association of Australia （SAA）, preclinical trial

AS 4420.1:1996 Windows - Methods of test - Test sample, preparation for tests, and test sequence

Taiwan Provincial Standard of the People's Republic of China, preclinical trial

CNS 9562-1982 Testbar for Automatic Lathes

National Association of Pipe Fabricators (NAPF), preclinical trial

PFI ES-4-2006 Hydrostatic Testing of Fabricated Piping

国家市场监督管理总局, preclinical trial

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

Professional Standard - Machinery, preclinical trial

JB/T 2322.1-2002 Horizontal lathe-performance test method

CH-SNV, preclinical trial

SN EN 16890+A1-2021 Children's furniture - Mattresses for cots and cribs - Safety requirements and test methods