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Clinical Trial Equipment

Clinical Trial Equipment, Total:193 items.

In the international standard classification, Clinical Trial Equipment involves: Laboratory medicine, Medical sciences and health care facilities in general, Applications of information technology, ENVIRONMENT. HEALTH PROTECTION. SAFETY, Medical equipment, Hospital equipment, Quality, Pharmaceutics, Test conditions and procedures in general, Dentistry, Terminology (principles and coordination), Construction equipment, Birth control. Mechanical contraceptives, Veterinary medicine, Waxes, bituminous materials and other petroleum products, Construction materials, Protective equipment, Sports equipment and facilities, Construction technology, Machine tools, Electrical and electronic testing, Lamps and related equipment, Environmental testing, ELECTRICAL ENGINEERING, Linear and angular measurements.


British Standards Institution (BSI), Clinical Trial Equipment

  • 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
  • BS EN ISO 14155:2011 Clinical investigation of medical devices for human subjects. Good clinical practice
  • BS EN ISO 14155-1:2003 Clinical investigation of medical devices for human subjects - General requirements
  • BS EN 12811-3:2002 Temporary works equipment - Load testing
  • BS EN 13398:2003 Methods of test for petroleum and its products - BS 2000-516:Bitumen and bituminous binders - Determination of the elastic recovery of modified bitumen
  • BS EN 13399:2003 Methods of test for petroleum and its products - BS 2000-517:Bitumen and bituminous binders - Determination of storage stability of modified bitumen
  • BS EN 13374:2004 Temporary edge protection systems - Product specification, test methods
  • BS EN 13375:2004 Flexible sheets for waterproofing-Waterproofing of concrete bridge decks and other concrete surfaces trafficable by vehicles-Specimen preparation
  • BS EN 1263-1:2014 Temporary works equipment. Safety nets. Safety requirements, test methods
  • BS ISO 15198:2004 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
  • 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 13219:2008 Gymnastic equipment - Trampolines - Functional and safety requirements, test methods
  • BS EN 13219:2001 Gymnastic equipment - Trampolines - Functional and safety requirements, test methods
  • BS ISO 20916:2019 In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice
  • PD CEN/TR 17538:2020 Furniture. Common test equipment. Test foams and mattresses
  • 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 61180-2:1995 High-voltage test techniques for low-voltage equipment - Test equipment

US-FCR, Clinical Trial Equipment

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

  • KS P ISO 14155:2019 Clinical investigation of medical devices for human subjects — Good clinical practice
  • KS P ISO 14155-2:2007 Clinical investigation of medical devices for human subjects-Part 2:Clinical investigation plans
  • KS C 1221-1989 Polygraphs for clinical use
  • KS P ISO 14155-1:2007 Clinical investigation of medical devices for human subjects-Part 1:General requirements
  • 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 15198:2006 Clinical laboratory medicine-In vitro diagnostic medical devices-Validation of user quality control procedures by the manufacturer
  • KS P ISO 15198:2017 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
  • KS P ISO 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 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 C IEC 60598-2-25:2015 Luminaires — Part 2-25: Particular requirements — Luminaires for use in clinical areas of hospitals and health care buildings
  • KS C IEC 60598-2-25:2003 Luminaires-Part 2-25:Particular requirements-Luminaires for use in clinical areas of hospitals and health care buildings
  • KS K ISO 22610:2018 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment — Test method to determine the resistance to wet bacterial penetration
  • KS K ISO 22610:2021 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment — Test method to determine the resistance to wet bacterial penetration

KR-KS, Clinical Trial Equipment

  • KS P ISO 14155-2019 Clinical investigation of medical devices for human subjects — Good clinical practice
  • KS P ISO 15198-2017(2022) Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
  • 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 K ISO 22610-2021 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment — Test method to determine the resistance to wet bacterial penetration

International Organization for Standardization (ISO), Clinical Trial Equipment

  • ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice
  • ISO 14155:1996 Clinical investigation of medical devices
  • ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plants
  • ISO/CD 12487:2023 Medical electrical equipment — Clinical investigation of clinical thermometers
  • ISO 14155-1:2003 Clinical investigation of medical devices for human subjects - Part 1: General requirements
  • 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 15198:2004 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
  • ISO 16037:2002/Amd 1:2011 Rubber condoms for clinical trials — Measurement of physical properties — Amendment 1
  • 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 20916:2019 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
  • 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

RU-GOST R, Clinical Trial Equipment

  • 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 56437-2015 Gymnastic equipment. Trampolines. Functional requirements, safety requirements and test methods
  • GOST R 53133.3-2008 Medical laboratory technologies. Quality control of clinical laboratory tests. Description of materials for quality control of clinical laboratory investigations

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

  • GB/T 42204-2022 Communication specification for clinical medical equipment—Imaging equipment
  • GB/T 20469-2006 General guideline of the clinical laboratory design
  • GB/T 30224-2013 Clinical use of tests for Toxoplasma gondii
  • GB/T 5170.20-2022 Inspection methods for environmental testing equipments—Part 20:Water testing equipments

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

  • T/CGCPU 014-2020 The practices of chemicals for clinical trials in clinical trial institutions
  • T/CGCPU 015-2020 Requirements for Subjects Risk Monitoring system in clinical trials
  • 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/SHQAP 001-2023 Guidelines for the Construction of Quality Management Systems for Drug Clinical Trial Sponsors
  • 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 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/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/CAAM 0010-2020 Specifications for recording data of equipment used in real-world acupuncture and moxibustion clinical research
  • T/CAAM 0011-2020 Specifications for use record sheets of various instruments and equipment used in real-world acupuncture and moxibustion clinical research
  • 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
  • T/CGCPU 016-2021 Technical requirements for clinical trials of new drugs for oral inhalation of respiratory system in pediatric populations

AT-ON, Clinical Trial Equipment

  • ONORM EN 540-1993 Clinical investigation of medical devices for human subjects
  • OENORM EN ISO 14155:2021 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

RO-ASRO, Clinical Trial Equipment

  • SR EN 540-1996 Clinical investigation of medical devices for human subjects

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

  • 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 F3037-15 Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs)
  • ASTM E1394-97 Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems
  • 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 E2045-22 Standard Practice for Detailed Clinical Observations of Test Animals
  • ASTM E2045-99(2014) Standard Practice for Detailed Clinical Observations of Test Animals

AENOR, Clinical Trial Equipment

Professional Standard - Hygiene , Clinical Trial Equipment

  • WS/T 408-2012 Guide to linearity evaluation of clinical chemistry analyzers
  • WS/T 420-2013 Verification of analytical performance of quantitative kits by clinical laboratory

Professional Standard - Medicine, Clinical Trial Equipment

  • 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 0688.2-2010 Clinical laboratory testing and in vitro diagnostic test systems.Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility devices.Part 2 : Evaluation of performance of antimicrobial susceptibility test devi
  • YY/T 0522-2009 Dentistry Preclinical evaluation of dental implant systems Animal test methods

PT-IPQ, Clinical Trial Equipment

  • NP EN 540-2001 Clinical investigation of medical devices for human subjects

US-AAMI, Clinical Trial Equipment

Danish Standards Foundation, Clinical Trial Equipment

IT-UNI, Clinical Trial Equipment

Association Francaise de Normalisation, Clinical Trial Equipment

  • NF S99-201*NF EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
  • NF P93-501-3*NF EN 12811-3:2003 Temporary works equipment - Part 3 : load testing
  • 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 S52-369*NF EN 13219:2009 Gymnastic equipment - Trampolines - Functional and safety requirements, test methods.
  • NF P93-311-1*NF EN 1263-1:2015 Temporary works equipment - Safety nets - Part 1 : safety requirements, test methods
  • 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 EN 12811-3:2003 Équipements temporaires de chantiers - Partie 3 : essais de charges
  • NF P93-355/A1:2012 Équipements de chantier - Protection périphérique temporaire pour travaux d'étanchéité en toiture - Spécification du produit, méthode d'essai
  • NF P93-355:2010 Équipements de chantier - Protection périphérique temporaire pour travaux d'étanchéité en toiture - Spécification du produit, méthode d'essai

卫生健康委员会, Clinical Trial Equipment

US-CFR-file, Clinical Trial Equipment

  • CFR 21-862.1-2013 Food and Drugs. Part862:Clinical chemistry and clinical toxicology devices. Section862.1:Scope.
  • CFR 42-405.203-2013 Public Health. Part405:Federal health insurance for the aged and disabled. Section405.203:FDA categorization of investigational devices.

European Committee for Standardization (CEN), Clinical Trial Equipment

  • 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 12811-3:2002 Temporary works equipment - Part 3: Load testing
  • EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects - Part 1: General requirements
  • EN 1263-1:2014 Temporary works equipment - Safety nets - Part 1: Safety requirements@ test methods
  • EN 12811-3:2002/AC:2004 Temporary works equipment - Part 3: Load testing
  • EN 13219:2001 Gymnastic Equipment - Trampolines - Functional and Safety Requirements, Test Methods
  • CEN/TR 17538:2020 Furniture - Common test equipment - Test foams and mattresses
  • EN ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements ISO 14155-1: 2003; Supersedes EN 540: 1993

Lithuanian Standards Office , Clinical Trial Equipment

PL-PKN, Clinical Trial Equipment

  • PN-EN ISO 14155-2021-02 E Clinical investigation of medical devices for human subjects -- Good clinical practice (ISO 14155:2020)
  • PN M55679-1958 Machine tools -- Grinding machines for tools -- Testing of accuracy

German Institute for Standardization, Clinical Trial Equipment

  • DIN EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
  • DIN EN 12811-3:2003 Temporary works equipment - Part 3: Load testing; German version EN 12811-3:2002
  • DIN 6875-3:2008-03 Special radiotherapy equipments - Part 3: Intensity-modulated radiation therapy - Characteristics, test methods and rules for clinical application
  • DIN EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011 + Cor. 1:2011); German version EN ISO 14155:2011 + AC:2011
  • DIN 6875-3:2008 Special radiotherapy equipments - Part 3: Intensity-modulated radiation therapy - Characteristics, test methods and rules for clinical application
  • DIN EN 12811-3:2003-02 Temporary works equipment - Part 3: Load testing; German version EN 12811-3:2002
  • 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 13219:2009 Gymnastic equipment - Trampolines - Functional and safety requirements, test methods; German version EN 13219:2008
  • 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

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

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

Japanese Industrial Standards Committee (JISC), Clinical Trial Equipment

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

ZA-SANS, Clinical Trial Equipment

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

Canadian General Standards Board (CGSB), Clinical Trial Equipment

Professional Standard - Agriculture, Clinical Trial Equipment

CN-GJB-H, Clinical Trial Equipment

  • GJB 7125.3-2011 Model selection technique requirements for military medical equipments.Part 3:Clinical laboratory equipments

Hunan Provincial Standard of the People's Republic of China, Clinical Trial Equipment

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

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

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

Jiangsu Provincial Standard of the People's Republic of China, Clinical Trial Equipment

  • DB32/T 4451.10-2023 Clinical use management and quality control specifications for medical imaging equipment Part 10: Ultrasound imaging equipment
  • DB32/T 4451.6-2023 Clinical use management and quality control specifications for medical imaging equipment Part 6: Medical magnetic resonance imaging equipment (MRI)

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

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

VN-TCVN, Clinical Trial Equipment

  • TCVN 7689-2007 Machine tools.Test conditions for surface grindingmachines with vertical grinding wheel spindle and reciprocating table.Testing of the accuracy

Standard Association of Australia (SAA), Clinical Trial Equipment

American National Standards Institute (ANSI), Clinical Trial Equipment

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

工业和信息化部, Clinical Trial Equipment

  • JB/T 13634-2020 Technical conditions for acceptance of machine tool electrical equipment and systems CNC sawing machine control system

Association of German Mechanical Engineers, Clinical Trial Equipment





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