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Evaluation of non-clinical trials

Evaluation of non-clinical trials, Total:64 items.

In the international standard classification, Evaluation of non-clinical trials involves: Pharmaceutics, ENVIRONMENT. HEALTH PROTECTION. SAFETY, Dentistry, Medical sciences and health care facilities in general, Terminology (principles and coordination), Test conditions and procedures in general, Furniture, Machine tools, Laboratory medicine, Microbiology, Testing of metals, Rubber, Industrial automation systems, Medical equipment, Pesticides and other agrochemicals, Products of the textile industry, Quality.


RU-GOST R, Evaluation of non-clinical trials

  • GOST R 57147-2016 Medicine for medical application. Nonclinical evaluation for anticancer pharmaceuticals
  • GOST R 54328-2011 Dentistry. Preclinical evaluation of dental implant systems. Animal test methods
  • GOST R 53022.3-2008 Clinical laboratory technologies. Requirements of quality of clinical laboratory tests. Part 3. Assessment of laboratory tests clinical significance
  • GOST R 53022.2-2008 Clinical laboratory technologies. Requirements for quility of clinical laboratory tests. Part 2. Assessment of methods analytical reliability (accuracy, censitivity, specificity)
  • 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 53204-2008 Non-destructive testing. Alternating stress evaluation by ultrasound. General requirements

卫生健康委员会, Evaluation of non-clinical trials

Professional Standard - Agriculture, Evaluation of non-clinical trials

中华人民共和国国家卫生和计划生育委员会, Evaluation of non-clinical trials

  • WS/T 228-2002 Preliminary evaluation of quantitative clinical laboratory methods

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Evaluation of non-clinical trials

  • GB/T 20470-2006 Requirements of external quality assessment for clinical laboratories
  • GB/T 31270.19-2014 Test guidelines on environmental safety assessment for chemical pesticides.Part 19:Effects on non-target plants
  • GB/T 27408-2010 Quality control in laboratories.Evaluating validity of non-standard test method.Practice for a linear relationship

Professional Standard - Medicine, Evaluation of non-clinical trials

  • YY/T 0522-2009 Dentistry Preclinical evaluation of dental implant systems Animal test methods
  • YY/T 0268-2001 Dentistry----Preclinical evaluation of biocompatibility of medical devices used in dentistry----Part 1:Evaluation and test methods selection
  • 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 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

KR-KS, Evaluation of non-clinical trials

Group Standards of the People's Republic of China, Evaluation of non-clinical trials

  • 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 003-2019 Clinical Trial Institution Capacity Evaluation Standards
  • T/CGCPU 006-2019 Phase I Clinical Trial Capacity Evaluation Criteria
  • 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/CGCPU 023-2023 Evaluation standard for clinical trial management system document
  • 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/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

AENOR, Evaluation of non-clinical trials

  • 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

GOSTR, Evaluation of non-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
  • GOST R ISO 20776-1-2010 Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices. Part 1. Reference method for testing the in vitro activity of antimic

Association Francaise de Normalisation, Evaluation of non-clinical trials

  • 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 E60-160-8*NF ISO 13041-8:2004 Test conditions for numerically controlled turning machines and turning centres - Part 8 : evaluation of thermal distortions

American Society for Testing and Materials (ASTM), Evaluation of non-clinical trials

  • ASTM F1566-09 Standard Test Methods for Evaluation of Innersprings, Boxsprings, Mattresses or Mattress Sets
  • ASTM E1326-98 Standard Guide for Evaluating Nonconventional Microbiological Tests Used for Enumerating Bacteria
  • ASTM E1326-15 Standard Guide for Evaluating Non-culture Microbiological Tests Used for Enumerating Bacteria
  • ASTM E1326-08 Standard Guide for Evaluating Nonconventional Microbiological Tests Used for Enumerating Bacteria

International Organization for Standardization (ISO), Evaluation of non-clinical trials

  • ISO/TS 22911:2016 Dentistry - Preclinical evaluation of dental implant systems - Animal test methods
  • ISO 14955-3:2020 Machine tools — Environmental evaluation of machine tools — Part 3: Principles for testing metal-cutting machine tools with respect to energy efficiency
  • ISO/TS 22911:2005 Dentistry - Preclinical evaluation of dental implant systems - Animal test methods
  • ISO/TR 12134:2010 Rubber - Estimation of uncertainty for test methods - Non-functional parameters
  • ISO 13041-8:2004 Test conditions for numerically controlled turning machines and turning centres - Part 8: Evaluation of thermal distortions

European Committee for Standardization (CEN), Evaluation of non-clinical trials

  • 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

Korean Agency for Technology and Standards (KATS), Evaluation of non-clinical trials

British Standards Institution (BSI), Evaluation of non-clinical trials

  • 21/30425530 DC BS EN ISO 20776-2. 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 susc...
  • BS ISO 13041-8:2004 Test conditions for numerically controlled turning machines and turning centres - Evaluation of thermal distortions
  • BS EN ISO 20776-2:2021 Tracked Changes. 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 suscep...
  • 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

Japanese Industrial Standards Committee (JISC), Evaluation of non-clinical trials

  • JIS T 6001:2005 Preclinical evaluation of biocompatibility of medical devices used in dentistry -- Test methods for dental materials
  • JIS B 6331-8:2006 Test conditions for numerically controlled turning machines and turning centres -- Part 8: Evaluation of thermal distortions

German Institute for Standardization, Evaluation of non-clinical trials

  • 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

国家食品药品监督管理局, Evaluation of non-clinical trials

  • YY/T 1536-2017 Standard test model for evaluation of surface sliding properties of non-intravascular catheters

国家市场监督管理总局、中国国家标准化管理委员会, Evaluation of non-clinical trials

  • GB/T 40181-2021 Test method and evaluation for flushability of disposable sanitary nonwoven materials




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