ZH

KR

JP

ES

RU

DE

Domestic Clinical Trials

Domestic Clinical Trials, Total:191 items.

In the international standard classification, Domestic Clinical Trials involves: Medical sciences and health care facilities in general, Quality, Medical equipment, Pharmaceutics, Test conditions and procedures in general, Dentistry, Laboratory medicine, ENVIRONMENT. HEALTH PROTECTION. SAFETY, Birth control. Mechanical contraceptives, Veterinary medicine, Machine tools, Terminology (principles and coordination), Construction materials, Furniture, Freight distribution of goods, Applications of information technology.


Group Standards of the People's Republic of China, Domestic 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/CQAP 3013-2023 Key points for quality inspection of clinical trial data management
  • T/CGCPU 029-2023 Evaluation requirements of follow-up centers for primary clinical trials
  • 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/CGCPU 027-2023 Design specifications for clinical research protocol of immunotherapy
  • T/SHSPS 002-2024 Standards for the management and competency evaluation of clinical trial monitors (Shanghai)
  • T/SHSPS 001-2024 Standards for Management and Competency Assessment of Clinical Trial Coordinators (Shanghai)
  • T/SHQAP 001-2023 Guidelines for the Construction of Quality Management Systems for Drug Clinical Trial Sponsors
  • T/CGCPU 026-2023 Design specifications for clinical trial protocol of cardiovascular interventional medical devices
  • 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

RU-GOST R, Domestic 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 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 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 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

GSO, Domestic Clinical Trials

  • GSO ASTM F3108:2022 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
  • BH GSO ASTM F3108:2023 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
  • OS GSO 1647:2002 Methods of testing and verification for Clinical electrical thermometers with maximum device
  • GSO ISO 2407:2013 Test conditions for internal cylindrical grinding machines with horizontal spindle -- Testing of accuracy
  • GSO ASTM F3037:2021 Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs)
  • BH GSO ASTM F3037:2022 Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs)
  • BH GSO ISO 2407:2016 Test conditions for internal cylindrical grinding machines with horizontal spindle -- Testing of accuracy
  • OS GSO ISO 16037:2009 Rubber condoms for clinical trials – Measurement of physical properties
  • BH GSO ISO/TS 22911:2017 Dentistry -- Preclinical evaluation of dental implant systems -- Animal test methods
  • OS GSO ISO/TS 22911:2015 Dentistry -- Preclinical evaluation of dental implant systems -- Animal test methods
  • GSO ISO/TS 22911:2015 Dentistry -- Preclinical evaluation of dental implant systems -- Animal test methods
  • BH GSO 2184:2012 Test methodes forspring interior mattresses for domestic bedding for adult use
  • OS GSO 2184:2011 Test methodes forspring interior mattresses for domestic bedding for adult use

SCC, Domestic Clinical Trials

  • ASTM STP 1008-89 Femoral Intramedullary Rods: Clinical Performance and Related Laboratory Testing
  • DANSK DS/ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties
  • BS EN ISO 8596:1996 Visual acuity test types. Specification for Landolt ring optotype for non-clinical purposes
  • DIN EN ISO 8596 E:2016 Draft Document - Ophthalmic optics - Visual acuity testing - Standard and clinical optotypes and their presentation (ISO/DIS 8596:2016); German and English version prEN ISO 8596:2016
  • CSA Z316.8-2018(R2023) Requirements for the design, development, and validation of laboratory-developed tests used for the screening, diagnosis, and management of clinical conditions

GOST, Domestic Clinical Trials

  • GOST R ISO 14155-2-2008 Clinical investigation of medical devices for human subjects. Part 2. Clinical investigation plans
  • GOST R 70355-2022 Specialized food products. General requirements for preclinical tests on laboratory animals
  • GOST R ISO 14155-1-2008 Clinical investigation of medical devices for human subjects. Part 1. General requirements
  • GOST R 59786-2021 Clinical laboratory testing. Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
  • GOST ISO 81060-2-2021 Non-invasive sphygmomanometers (measuring devices of arterial pressure). Part 2. Clinical investigation of intermittent automated measurement type

American Society for Testing and Materials (ASTM), Domestic 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 F1566-09 Standard Test Methods for Evaluation of Innersprings, Boxsprings, Mattresses or Mattress Sets
  • ASTM F1566-14 Standard Test Methods for Evaluation of Innersprings, Boxsprings, Mattresses or Mattress Sets
  • 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

卫生健康委员会, Domestic Clinical Trials

  • WS/T 641-2018 Clinical laboratory quantitative measurement indoor quality control
  • WS/T 574-2018 Purified water for clinical laboratory reagents

Professional Standard - Medicine, Domestic 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

US-AAMI, Domestic Clinical Trials

Danish Standards Foundation, Domestic 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

IT-UNI, Domestic Clinical Trials

Association Francaise de Normalisation, Domestic Clinical Trials

  • NF S99-201*NF EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
  • NF E60-141*NF ISO 6480:2019 Test conditions for horizontal internal type broaching machines - Testing of accuracy
  • NF E60-142*NF ISO 6779:2019 Test conditions for vertical internal type broaching machines - Testing of accuracy
  • 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 E60-123*NF ISO 2407:2000 Test conditions for internal cylindrical grinding machines with horizontal spindle - Testing of accuracy.
  • NF E60-123/A1*NF ISO 2407/A1:2016 Test conditions for internal cylindrical grinding machines with horizontal spindle - Testing of accuracy -Amendment 1
  • 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 ISO 2407:2000 Test conditions for horizontal spindle internal surface grinding machines - Precision control
  • 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

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

  • GB/T 30224-2013 Clinical use of tests for Toxoplasma gondii
  • GB/T 20468-2006 Guideline for internal quality control for quantitative measurements in clinical laboratory

Professional Standard - Hygiene , Domestic Clinical Trials

  • WS/T 834-2024 Clinical application of Toxoplasma gondii test
  • WS/T 420-2013 Verification of analytical performance of quantitative kits by clinical laboratory

British Standards Institution (BSI), Domestic Clinical Trials

  • BS EN ISO 14155:2011 Clinical investigation of medical devices for human subjects. Good clinical practice
  • BS ISO 6779:2019 Test conditions for vertical internal type broaching machines. Testing of accuracy
  • BS ISO 6480:2019 Test conditions for horizontal internal type broaching machines. Testing of accuracy
  • BS ISO 6779:2023 Test conditions for vertical internal type broaching machines. Testing of accuracy
  • BS ISO 2407:1997 Test conditions for internal cylindrical grinding machines with horizontal spindle - Testing of accuracy
  • BS ISO 2407:1998 Test conditions for internal cylindrical grinding machines with horizontal spindle. Testing of accuracy
  • 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 IEC 60601-2-19:2021+A1:2023 Medical electrical equipment - Particular requirements for the basic safety and essential performance of infant incubators
  • BS ISO 2407:1997+A1:2016 Test conditions for internal cylindrical grinding machines with horizontal spindle. Testing of accuracy

European Committee for Standardization (CEN), Domestic Clinical Trials

  • 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)

AT-ON, Domestic Clinical Trials

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

Lithuanian Standards Office , Domestic Clinical Trials

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

PL-PKN, Domestic Clinical Trials

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

German Institute for Standardization, Domestic Clinical Trials

  • DIN EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
  • DIN ISO 2407:1999 Machine tools - Test conditions for internal cylindrical grinding machines with horizontal spindle - Testing of accuracy (ISO 2407:1997)
  • 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 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

AENOR, Domestic Clinical Trials

  • UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
  • UNE-EN 1725:1998 DOMESTIC FURNITURE. BEDS AND MATTRESSES. SAFETY REQUIREMENTS AND TEST METHODS.
  • UNE 15325:1993 CONDITIONS OF ACCEPTANCE FOR HORIZONTAL INTERNAL BROACHING MACHINES. TESTING OF THE ACCURACY.
  • UNE 15327:1993 ACCEPTANCE CONDITIONS FOR BROACHING MACHINES OF VERTICAL INTERNAL TYPE. TESTING OF THE ACCURACY.

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

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

ZA-SANS, Domestic Clinical Trials

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

Canadian General Standards Board (CGSB), Domestic Clinical Trials

International Organization for Standardization (ISO), Domestic Clinical Trials

  • 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/FDIS 2407:2023 Test conditions for internal cylindrical grinding machines with horizontal spindle
  • ISO/DIS 6779 Test conditions for vertical internal type broaching machines — Testing of accuracy
  • ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties
  • ISO 2407:1973 Test conditions for internal cylindrical grinding machines with horizontal spindle — Testing of accuracy
  • ISO 6480:2019 Test conditions for horizontal internal type broaching machines — Testing of accuracy
  • ISO/TS 22911:2016 Dentistry - Preclinical evaluation of dental implant systems - Animal test methods
  • ISO 2407:1984 Acceptance conditions for internal cylindrical grinding machines with horizontal spindle; Testing of accuracy
  • ISO/TS 22911:2005 Dentistry - Preclinical evaluation of dental implant systems - Animal test methods
  • ISO/DIS 2407 Test conditions for internal cylindrical grinding machines with horizontal spindle — Testing of accuracy
  • ISO 16037:2002/Amd 1:2011 Rubber condoms for clinical trials — Measurement of physical properties — Amendment 1
  • ISO/TR 10353:1992 Plastics; survey of ignition sources used for national and international fire tests
  • 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

Professional Standard - Agriculture, Domestic Clinical Trials

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

  • KS B 4055-1978 Test code for performance of interna1 cylindrical grinding machines
  • KS M ISO 16037:2008 Rubber condoms for clinical trials-Measurement of physical properties
  • KS M ISO 16037-2023 Rubber condoms for clinical trials — Measurement of physical properties
  • KS M ISO 16037:2018 Rubber condoms for clinical trials — Measurement of physical properties
  • KS B ISO 6779:2013 Acceptance conditions for broaching machines of vertical internal type-Testing of accuracy
  • KS B ISO 6480:2010 Conditions of acceptance for horizontal internal broaching machines-Testing of the accuracy
  • KS B ISO 6480:2013 Conditions of acceptance for horizontal internal broaching machines-Testing of the accuracy
  • 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 22911-2020 Dentistry-Preclinical evaluation of dental implant systems-Animal test methods
  • KS B 4037-1975(2007) Test code for performance and accuracy of interna1 cylindrical grinding machines
  • KS B 4037-1981 Test code for performance and accuracy of interna1 cylindrical grinding machines
  • KS T 3202-1997(2012) Test method of insulated containers for domestic trade
  • KS T 3202-1997 Test method of insulated containers for domestic trade
  • 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

KR-KS, Domestic Clinical Trials

  • KS B ISO 2407-2012 Test conditions for internal cylindrical grinding machines with horizontal spindle-Testing of the accuracy
  • KS M ISO 16037-2018(2023) Rubber condoms for clinical trials — Measurement of physical properties
  • KS B ISO 6480-2010 Conditions of acceptance for horizontal internal broaching machines-Testing of the accuracy
  • 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

Hunan Provincial Standard of the People's Republic of China, Domestic Clinical Trials

  • DB43/T 2135-2021 Technical Service Specifications for the Recruitment and Management of Drug Clinical Trial Subjects
  • DB43/T 2896-2023 Standards for the construction and operation management of practical training bases for principal investigators in drug clinical trials

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

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

Anhui Provincial Standard of the People's Republic of China, Domestic Clinical Trials

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

VN-TCVN, Domestic Clinical Trials

  • TCVN 2002-2008 Conditions of acceptance for horizontal internal broaching machines.Testing of the accuracy
  • TCVN 7688-2007 Test conditions for internal cylindrical grinding machines with horizontal spindle.Testing of accuracy

Professional Standard - Post and Telecommunication, Domestic Clinical Trials

  • YD/T 766-1995 Test method for domestic mail bag tags
  • WBH 45-1994 Test specification and acceptance of NO 7 signal mode in domestic telephone network in China.

Standard Association of Australia (SAA), Domestic Clinical Trials

  • ISO 2407:1997/Amd.1:2016 Test conditions for internal cylindrical grinding machines with horizontal spindle — Testing of accuracy AMENDMENT 1

Japanese Industrial Standards Committee (JISC), Domestic Clinical Trials

  • JIS B 6211:2006 Test conditions for internal cylindrical grinding machines with horizontal spindle -- Testing of the accuracy
  • JIS T 6001:2005 Preclinical evaluation of biocompatibility of medical devices used in dentistry -- Test methods for dental materials

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

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

IN-BIS, Domestic Clinical Trials

  • IS 10352-1992 Test charts for internal cylindrical grinding machines with horizontal spindle (First Revision)

Jiangsu Provincial Standard of the People's Republic of China, Domestic Clinical Trials

  • DB32/T 4652-2024 Guidelines for the development of multi-center drug clinical trial management systems based on blockchain technology

American National Standards Institute (ANSI), Domestic Clinical Trials

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

未注明发布机构, Domestic Clinical Trials

  • CSA Z316.8-2018 Requirements for the design, development, and validation of laboratory-developed tests used for the screening, diagnosis, and management of clinical conditions

CZ-CSN, Domestic Clinical Trials

  • CSN ISO 2407:1992 Acceptance conditions for internal cylindrical grinding machines with horizontal spendle. Testing of accuracy




Copyright ©2007-2023 ANTPEDIA, All Rights Reserved