ZH
RU
ES

European Clinical Trials

European Clinical Trials, Total:268 items.

In the international standard classification, European Clinical Trials 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, Veterinary medicine, Protective equipment, Integrated circuits. Microelectronics, Terminology (principles and coordination), Valves, Construction materials, Welding, brazing and soldering, Products of the textile industry, Earthworks. Excavations. Foundation construction. Underground works, Construction industry, Adhesives, Elements of buildings, Testing of metals, Applications of information technology, Aids for disabled or handicapped persons, Thermodynamics and temperature measurements, Burners. Boilers, Building accessories, Sports equipment and facilities, Pipeline components and pipelines, Products of the chemical industry, Corrosion of metals, Protection against crime, Air quality, Pumps, Company organization and management, Electromechanical components for electronic and telecommunications equipment, Iron and steel products, Electric traction equipment, Railway rolling stock, Materials and articles in contact with foodstuffs, Acoustics and acoustic measurements, Measurement of volume, mass, density, viscosity.

RU-GOST R, European Clinical Trials

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 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 53133.3-2008 Medical laboratory technologies. Quality control of clinical laboratory tests. Description of materials for quality control of clinical laboratory investigations
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 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

Group Standards of the People's Republic of China, European 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/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 015-2020 Requirements for Subjects Risk Monitoring system in clinical trials
T/CGCPU 020-2022 Guidelines for the management of pain in clinical trial subjects in the pediatric population
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/CGCPU 016-2021 Technical requirements for clinical trials of new drugs for oral inhalation of respiratory system in pediatric populations
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

European Committee for Standardization (CEN), European Clinical Trials

DD ENV 13728-2000 Health Informatics - Clinical Analyser Interfaces to Laboratory Information Systems Ratified European Text
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 1245:1998 Adhesives - Determination of pH - Test Method Ratified European Text
EN 1985:1998 Walking aids - General requirements and test methods
EN 1523:1998 Windows, doors, shutters and blinds - Bullet resistance - Test method
EN 1933:1998 Exterior blinds - Resistance to load due to water accumulation - Test method
EN 50215:1999 Railway Applications Testing of Rolling Stock After Completion of Construction and Before Entry into Service
EN 1150:1999 Protective clothing - Visibility clothing for non-professional use - Test methods and requirements
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 ISO 7405:1997 Dentistry - Preclinical Evaluation of Biocompatibility of Medical Devices Used in Dentistry - Test Methods for Dental Materials ISO 7405: 1997
EN 140:1998 Respiratory protective devices - Half masks and quarter masks - Requirements, testing, marking
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)
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 t

American Society for Testing and Materials (ASTM), European Clinical Trials

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 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 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 D7109-04 Standard Test Method for Shear Stability of Polymer Containing Fluids Using a European Diesel Injector Apparatus at 30 and 90 Cycles

IX-EU/EC, European Clinical Trials

2004/9/EC-2004 DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the inspection and verification of good laboratory practice (GLP) (Codified version; Text with EEA relevance)
2001/20/EC-2001 Directive of the European Parlament and of the Council on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Relating to the Implementation of Good Clinical Practice in the Conduct of Clinical Trials on Medicinal
COM(2002) 529 FINAL-2002 Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the inspection and verification of good laboratory practice (GLP)(codified version)
COM(1999) 193 FINAL-1999 Amended Proposal for a European Parliament and Council Directive on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Relating to the Implementation of Good Clinical Parctice in the Conduct of Clinical Trials on
2005/28/EC-2005 COMMISSION DIRECTIVE laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products
2004/10/EC-2004 DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests
COM(2002) 530 FINAL-2002 Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applicat
1999/11/EC-1999 Commission Directive Adapting to Technical Progress the Principles of Good Laboratory Practice as Specified in Council Directive 87/18/EEC on the Harmonisation of Laws, Regulations and Administrative Provisions Relating to the Application of the Principle
78/1999-1999 Decision of the EEA Joint Committee Amending Annex II (Technical Regulations, Standards, Testing and Certification) to the EEA Agreement
NO 668/2009-2009 COMMISSION REGULATION implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of quality and non-clinical data relating to advanced therapy medicinal products developed by mic
NO 139/2007-2007 DECISION OF THE EEA JOINT COMMITTEE amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement
NO 140/2007-2007 DECISION OF THE EEA JOINT COMMITTEE amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement
NO 141/2007-2007 DECISION OF THE EEA JOINT COMMITTEE amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement
93/1999-1999 Decision of the EEA Joint Committee Amending Annex II (Technical Regulations, Standards, Testing and Certification) to the EEA Agreement
91/1999-1999 Decision of the EEA Joint Committee Amending Annex II (Technical Regulations, Standards, Testing and Certification) to the EEA Agreement
46/1999-1999 Decision of the EEA Joint Committee Amending Annex II (Technical Regulations, Standards, Testing and Certification) to the EEA Agreement
47/1999-1999 Decision of the EEA Joint Committee Amending Annex II (Technical Regulations, Standards, Testing and Certification) to the EEA Agreement
72/96-1996 Decision of the EEA Joint Committee Amending Annex II (Technical Regulations, Standards, Testing and Certification) to the EEA Agreement
73/96-1996 Decision of the EEA Joint Committee Amending Annex II (Technical Regulations, Standards, Testing and Certification) to the EEA Agreement
74/96-1996 Decision of the EEA Joint Committee Amending Annex II (Technical Regulations, Standards, Testing and Certification) to the EEA Agreement
75/96-1996 Decision of the EEA Joint Committee Amending Annex II (Technical Regulations, Standards, Testing and Certification) to the EEA Agreement
2007/C 141/04-2007 List of approved laboratories that according to Article 8(2) of Regulation (EC) No 648/2004 of the European Parliament and of the Council on detergents are competent to carry out the tests required by the Regulation

Professional Standard - Medicine, European Clinical Trials

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 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, European Clinical Trials

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, European Clinical Trials

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/ETS 300 176:1993 Radio Equipment and Systems (RES) - Digital European Cordless Telecommunications (DECT) -Approval test specification
DS/ETS 300323-5:1994 Radio Equipment and Systems (RES) - Digital European Cordless Telecommunications (DECT) Public Access Profile (PAP) test specification - Part 5:FT Abstract Test Suite (ATS)
DS/ETS 300 175-8:1993 Radio Equipment and Systems (RES) - Digital European Cordless Telecommunications (DECT) -Common interface - Part 8: Speech coding and transmission

IT-UNI, European Clinical Trials

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

Association Francaise de Normalisation, European Clinical Trials

NF S99-201*NF EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
NF S72-508:1995 Headforms for use in the testing of protective helmets.
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 A89-210:1996 Destructive tests on welds in metallic materials. Fracture test.
NF G35-023:1995 Textile floor coverings. Castor chair test.
NF T54-083*NF EN 28233:1991 Thermoplastics valves. Torque. Test method.
NF P36-302:1997 BRACKETS FOR EAVES GUTTERS. REQUIREMENTS AND TESTING. (EUROPEAN STANDARD EN 1462).
NF A03-005:1992 Metallic materials. Tensile testing. Part 5 : method of testing at elevated temperature.
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 E17-401-5:1997 Heat meters. Part 5 : initial verification tests.
NF E17-401-4:1997 Heat meters. Part 4 : pattern approval tests.
NF E31-310:1991 ATOMIZING OIL BURNERS OF MONOBLOC TYPE. TESTING. (EUROPEAN STANDARD EN 267).
NF S74-521:1995 Abrasion resistance of protective clothing materiel. Test methods.
NF T54-084:1991 Thermoplastics valves. Fatigue strength. Test method.
NF P26-321:1998 Building hardware. Cylinders for locks. Requirements and test methods.
NF S52-348:1997 Mountaineering equipment. Pitons. Safety requirements and test methods.
NF S52-347:1997 Mountaineering equipment. Ice anchors. Safety requirements and test methods.
NF S52-343:1997 Mountaineering equipment. Rope clamps. Safety requirements and test methods.
NF S52-341:1997 Mountaineering equipment. Slings. Safety requirements and test methods.
NF A89-204-2:1996 Destructive tests on welds in metallic materials. Hardness test. Part 2 : micro hardness testing on welded joints.
NF E29-443*NF EN 26948:1992 Automatic steam traps. Production and performance characteristics tests.
NF S53-503:1991 Propellants for commercial ammunition. Requirements and test methods.
NF S71-511*NF EN 364:1993 Personal protective equipment against falls from a height. Test mthods.
NF A89-211:1996 Destructive tests on welds in metallic materials. Macroscopic and microscopic examination of welds.
NF P31-307*NF EN 538:1994 Clay roofing tiles for discontinuous laying. Flexural strength test.
NF P26-316*NF EN 1154:1997 Building hardware. controlled door closing devices. Requirements and test methods.
NF P26-320*NF EN 1158:1997 Building hardware. Door coordinator devices. Requirements and test methods.
NF S52-339:1997 Mountaineering equipment. Accessory cord. Safety requirements and test methods.
NF S76-022:1991 RESPIRATORY PROTECTIVE DEVICES. PARTICLE FILTERS. REQUIREMENTS,TESTING,MARKING. (EUROPEAN STANDARD EN 143).
NF A05-402:1995 Metals and alloys. Atmospheric corrosion testing. General requirements for field tests.
NF D90-216-1*NF EN 12132-1:1998 Feather and down. Methods of testing the down proof properties of fabrics. Part 1 : rubbing test.
NF E29-445*NF EN 27842:1992 Automatic steam traps. Determination of discharge capacity. Test methods.
NF P15-472:1995 Methods of testing cement. Part 2 : chemical analysis of cement.
NF P85-507:1991 Building construction. Jointing products. Sealants. Determination of tensile properties.
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 X43-282:1997 Workplace atmospheres. Pumps for personal sampling of chemical agents. Requirements and test methods.
NF S93-042*NF EN 1618:1997 Catheters other than intravascular catheters. Test methods for common properties.
NF S52-305:1997 Gymnastic equipment. Horses and bucks. Functional and safety requirements, test methods.
NF H00-040:1993 PACKAGING. COMPLETE, FILLED TRANSPORT PACKAGES. CONDITIONING FOR TESTING. (EUROPEAN STANDARD EN 2233).
NF P85-508:1991 Building construction. Jointing products. Sealants. Determination of tensile properties at maintained extension.
NF G07-019-6*NF EN ISO 105-X06:1997 Textiles. Tests for colour fastness. Part X06 : colour fastness to soda boiling.
NF S76-014:1991 Respiratory protective devices. Filtering half masks to protect against particles. Requirements, testing, marking.
NF G07-013-9:1997 Textiles. Tests for colour fastness. Part E09 : colour fastness to potting.
NF G07-019-4*NF EN ISO 105-X04:1997 Textiles.Tests for colour fastness. Part X04 : colour fastness to mercerizing.
NF S99-505:1994 BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 5 : TESTS FOR CYTOTOXICITY : IN VITRO METHODS. (EUROPEAN STANDARD EN 30993-5).
NF G07-013-5:1997 Textiles. Tests for colour fastness. Part E05 : colour fastness to spotting : acid.
NF G07-013-7:1997 Textiles.Tests for colour fastness. Part E07 : colour fastness to spotting : water.
NF C93-471-14:1997 ELECTROMECHANICAL COMPONENTS FOR ELECTRONIC EQUIPMENT. BASIC TESTING PROCEDURES AND MEASURING METHODS. PART 11 : CLIMATIC TESTS. SECTION 14 : TEST 11P. FLOWING SINGLE GAS CORROSION TEST. (EUROPEAN STANDARD EN 60 512-11-14).
NF P18-163*NF EN 524-3:1997 Steel strip sheaths for prestressing tendons. Test methods. Part 3 : to-and-fro bending test.
NF G07-071-3*NF EN ISO 105-G03:1997 Textiles. Tests for colour fastness. Part G03 : colour fastness to ozone in the atmosphere.
NF D21-623*NF EN 1183:1997 Materials and articles in contact with foodstuffs. Test methods for thermal shock and thermal shock endurance.
NF G07-013-6:1997 Textiles.Tests for colour fastness. Part E06 : colour fastness to spotting : alkali.
NF G07-019-7*NF EN ISO 105-X07:1997 Textiles.Tests for colour fastness. Part X07 : colour fastness to cross-dyeing : wool.
NF EN ISO 20623:2018 Pétrole et produits connexes - Détermination des propriétés extrême pression et anti-usure des lubrifiants - Essai quatre billes (conditions Européennes)
NF G07-012-4*NF EN ISO 105-B04:1997 Textiles.Tests for colour fastness. Part B04 : colour fastness to artificial weathering : xenon arc fading lamp test.
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 P26-319*NF EN 1155:1997 Building hardware. Electrically powered hold-open devices for swing doors. Requirements and test methods.
NF S76-021:1991 RESPIRATORY PROTECTIVE DEVICES. GASFILTERS AND COMBINED FILTERS. REQUIREMENTS,TESTING,MARKING. (EUROPEAN STANDARD EN 141).
NF G07-071-2*NF EN ISO 105-G02:1997 Textiles. Tests for colour fastness. Part G02 : colour fastness to burnt-gas fumes.
NF B40-334*NF EN 993-4:1995 Methods of test for dense shaped refractory products. Part 4 : determination of permeability to gases.
NF E44-402*NF EN ISO 5198:1999 Centrifugal, mixed flow and axial pumps. Code for hydraulic performance tests. Precision grade.
NF S31-400:1997 Acoustics. Noise emitted by machinery and equipment. Rules for the drafting and presentation of a noise test code.
NF T54-908:1997 Thermoplastics pipes for the conveyance of fluids. Determination of resistance to rapid crack propagation (RCP). Full-scale test (FST).
NF G07-012-3:1997 Textiles.Tests for colour fastness. Part B03 : colour fastness to weathering : outdoor exposure.
NF S97-121-1*NF EN 1644-1:1997 Test methods for nonwoven compresses for medical use. Part 1 : nonwovens used in the manufacture of compresses.
NF P93-321*NF EN 1065:1999 Adjustable telescopic steel props. Product specifications, design and assessment by calculation and tests.
NF S74-509-8:1997 Protective clothing for users of hand-held chain saws. Part 8 : test methods for chain saw protective gaiters.
NF G07-093-6:1997 Textiles - Tests for colour fastness - Part C06 : colour fastness to domestic and commercial laundering.
NF G07-171-4:1997 Textiles. Test methods for nonwovens. Part 4 : determination of tear resistance.
NF S92-053-2*NF 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 - Part 2 : evaluation of performance of antimicrobial susceptibility

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, European Clinical Trials

GB/T 30224-2013 Clinical use of tests for Toxoplasma gondii

卫生健康委员会, European Clinical Trials

WS/T 574-2018 Purified water for clinical laboratory reagents

British Standards Institution (BSI), European Clinical Trials

BS EN ISO 14155:2011 Clinical investigation of medical devices for human subjects. Good clinical practice
PD 6598-1996 Measurement techniques for the characterization of the European mini test chip
DD ENV 50219-1996 Description of the reliability test structures of the European mini test chip
DD ENV 50218-1996 Description of a parametrized European mini test chip
PD 6595-1996 Parameter extraction techniques for the European mini test chip
PD 6682-9-2003 Aggregates. Guidance on the use of European test method standards
PD 6621-1998 Guidance on the new European test method standards for thermal insulation materials
BIP 0113-2012 Guide to European Medical Device Trials and BS EN ISO 14155
BS PD ISO/TS 16782:2016 Clinical laboratory testing. Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
DD ENV 1997-2-2000 Eurocode 7. Geotechnical design. Design assisted by laboratory testing
DD ENV 1997-3-2000 Eurocode 7. Geotechnical design. Design assisted by fieldtesting
BS PD CEN/TS 16920:2016 Environmental influence testing methodology for operational deployments of European ABC systems
BS CWA 16073-4:2010 Business interoperability interfaces for public procurement in Europe - Evaluation guidelines for testing and piloting
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
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 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 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 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

AT-ON, European Clinical Trials

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

Lithuanian Standards Office , European Clinical Trials

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

PL-PKN, European Clinical Trials

PN-EN ISO 14155-2021-02 E Clinical investigation of medical devices for human subjects -- Good clinical practice (ISO 14155:2020)

AENOR, European Clinical Trials

UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
UNE-ENV 1997-2:2001 EUROCODE 7: GEOTECHNICAL DESIGN. PART 2: DESIGN ASSISTED BY LABORATORY TESTING.
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, European Clinical Trials

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 6875-3:2008-03 Special radiotherapy equipments - Part 3: Intensity-modulated radiation therapy - Characteristics, test methods and rules for clinical application
DIN 6875-3:2008 Special radiotherapy equipments - Part 3: Intensity-modulated radiation therapy - Characteristics, test methods and rules for clinical application

Zhejiang Provincial Standard of the People's Republic of China, European Clinical Trials

DB33/T 903-2013 Classification and coding of clinical laboratory test items
DB33/T 697.2-2015 Inspection and testing of valves Part 2: European series

ZA-SANS, European Clinical Trials

SANS 16037:2003 Rubber condoms for clinical trials - Measurement of physical properties

Canadian General Standards Board （CGSB), European Clinical Trials

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

Professional Standard - Agriculture, European Clinical Trials

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
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, European Clinical Trials

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

Korean Agency for Technology and Standards (KATS), European Clinical Trials

KS M ISO 16037:2008 Rubber condoms for clinical trials-Measurement of physical properties
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 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 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 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 Clinical laboratory testing and in vitro medical devices－Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
KS P ISO 20776-2:2009 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 test d

International Organization for Standardization (ISO), European Clinical Trials

ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties
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 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 17593:2007 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 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 - Part 2: Evaluation of performance of antimicrobial susceptibility t

中华人民共和国国家卫生和计划生育委员会, European Clinical Trials

WS/T 124-1999 Inspection criteria of the quality of clinical chemistry in vitro diagnostic kits.General guideline

Professional Standard - Hygiene , European Clinical Trials

WS/T 420-2013 Verification of analytical performance of quantitative kits by clinical laboratory

KR-KS, European Clinical Trials

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 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

European Committee for Electrotechnical Standardization（CENELEC）, European Clinical Trials

HD 1/160-1984 General Introductory Document on European (or CEN) Methods of Test for Wood Preservatives

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

GB/T 40672-2021 Clinical laboratory testing—Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing

BE-NBN, European Clinical Trials

NBN B 16-517-1986

American National Standards Institute （ANSI), European Clinical Trials

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

Japanese Industrial Standards Committee (JISC), European Clinical Trials

JIS T 6001:2005 Preclinical evaluation of biocompatibility of medical devices used in dentistry -- Test methods for dental materials

CEN - European Committee for Standardization, European Clinical Trials

DD ENV 1997-2-1999 Eurocode 7: Geotechnical Design - Part 2: Design Assisted by Laboratory Testing
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 - Part 2: Evaluation of performance of antimicrobial susceptibility t

European Telecommunications Standards Institute (ETSI), European Clinical Trials

ETSI ETR 184-1995 Methods for Testing and Specification (MTS); Overview of Validation Techniques for European Telecommunication Standards (ETSs) Containing SDL
ETSI TS 102 172-2003 Services and Protocols for Advanced Networks (SPAN); Minimum requirements for interoperability of European ENUM trials V1.1.1

ETSI - European Telecommunications Standards Institute, European Clinical Trials

ETR 184-1995 Methods for Testing and Specification (MTS); Overview of Validation Techniques for European Telecommunication Standards (ETSs) Containing SDL
TS 102 172-2003 Services and Protocols for Advanced Networks (SPAN); Minimum requirements for interoperability of European ENUM trials (V1.1.1)
PRETS 300 414-1995 Methods for Testing and Specification (MTS); Use of SDL in European Telecommunication Standards Rules for Testability and Facilitating Validation
PRETS 300 414-1994 Methods for Testing and Specification (MTS); Use of SDL in European Telecommunication Standards Rules for Testability and Facilitating Validation

GOSTR, European Clinical Trials

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