animal clinical trials

animal clinical trials, Total:141 items.

The international standard classification for "animal clinical trials" includes: Dental materials , Medical Sciences and health care facilities in general , Laboratory medicine .

The Chinese standard classification for "animal clinical trials" includes: Stomatologic device, equipment and material , Sanitation in general , Legal medical expert .

Professional Standard - Agriculture

农业部1247号公告-2-2009 Guiding principles for non-clinical pharmacokinetic tests of veterinary chemical drugs
12 OIE陆生动物诊断试验和疫苗手册-2005 Avian mycoplasma disease (Mycoplasma gallisepticum) 2. Serological test item c: enzyme-linked immunosorbent assay (ELISA)
14 OIE陆生动物诊断试验和疫苗手册-2005 Chicken infectious laryngotracheitis 2. Item d in serological test: enzyme-linked immunosorbent assay
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
第1．1．3章OIE陆生动物诊断试验和疫苗手册-第七版 General standard - Introduction - Biosafety and biosecurity for veterinary microbiology laboratories and animal facilities
9 OIE陆生动物诊断试验和疫苗手册-2005 Pig brucellosis enzyme-linked immunosorbent assay (designated test for international trade)
农业部1247号公告-3-2009 Guiding principles for clinical pharmacokinetic tests of veterinary chemical drugs
2 OIE陆生动物诊断试验和疫苗手册-2005 Foot-and-mouth disease non-structural protein antibody test
16 OIE陆生动物诊断试验和疫苗手册-2005 Swine Influenza B 2: ELISA
3 OIE陆生动物诊断试验和疫苗手册-2005 Bovine brucellosis enzyme-linked immunosorbent assay (international trade designated test) indirect ELISA competition ELISA
1 OIE陆生动物诊断试验和疫苗手册-2005 Foot and Mouth Disease Enzyme-Linked Immunosorbent Assay (ELISA)
7 OIE陆生动物诊断试验和疫苗手册-2005 Pathogen Isolation and Identification of Hemorrhagic Septicemia Nucleic Acid Identification a Pasteurella Specific PCR
农业部1596号公告-1-2011 Technical guidelines for clinical trials of traditional Chinese medicines and natural medicines for veterinary use
11 OIE陆生动物诊断试验和疫苗手册-2005 1. Pathogen Identification in Marek's Disease by Polymerase Chain Reaction
6 OIE陆生动物诊断试验和疫苗手册-2005 Isolation and Identification of Pathogen of Hemorrhagic Septicemia
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
10 OIE陆生动物诊断试验和疫苗手册-2005 Infectious bursal disease (Gambrow disease) 1. Item e in pathogen identification: molecular technology identification

Professional Standard - Medicine

YY/T 1305-2015 Clinical trial guideline for titanium and titanium alloy dental implant
YY/T 0991-2015 Clinical trial guideline for orthodontic brackets
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

Group Standards of the People's Republic of China

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 005-2023 Specification for competency assessment of the clinical trial professional group
T/CGCPU 025-2023 Guideline of contract research organization
T/SSFSIDC 015-2023 Clinical trial data collection requirements
T/CGCPU 006-2019 Phase I Clinical Trial Capacity Evaluation Criteria
T/CGCPU 012-2020 File management standards for clinical trial institutions
T/SHDSGY 066-2023 Inspection service specification of clinical trial research center
T/CGCPU 022-2023 Evaluation criteria for information management of clinical trials
T/QDAS 108-2023 Technical specification for mobile intelligent clinical examination platform
T/CGCPU 023-2022 Evaluation standard for clinical trial management system document
T/CGCPU 003-2019 Clinical Trial Institution Capacity Evaluation Standards
T/CQAP 3013-2023 Key points for quality inspection of clinical trial data management
T/CGCPU 024-2022 Specification for training management of practitioners in clinical trial institution
T/SHQAP 001-2023 Guidelines for the Construction of Quality Management Systems for Drug Clinical Trial Sponsors
T/SAME 001-2022 Management requirements for level II biosafety cabinets in clinical laboratories
T/CGCPU 005-2019 Clinical Trial Professional Group Competence Evaluation Criteria
T/CGCPU 029-2023 Evaluation requirements of follow-up centers for primary clinical trials
T/CGCPU 023-2023 Evaluation standard for clinical trial management system document
T/CGCPU 003-2023 Specification for capacity evaluation of clinical trial institutions
T/CAS 819-2024 General technical requirements for clinical laboratory automation system
T/CGCPU 012-2023 Evaluation specifications for archives management of clinical trial institutions
T/CGCPU 025-2022 Guideline of contract research organization
T/CGCPU 006-2023 Specification for competency assessment of phase I clinical trials
T/CGCPU 022-2022 Evaluation criteria for information management of clinical trials
T/CGCPU 024-2023 Specification for training management of practitioners in clinical trial institution

National Health Commission of the People's Republic of China

Pharma-Guidelines-Nanodrug002 Technical Guiding Principles for Nonclinical Pharmacokinetic Research of Nanomedicines (Trial Implementation)
WS/T 805-2022 Basic technical standard for clinical microbiology laboratory

Professional Standard - Hygiene

WS/T 249-2005 Clinical Laboratory Waste Management
WS/T 489-2015 Clinical Microbiological Laboratory Diagnosis of Urinary Tract Infection
WS/T 442-2014 Guideline for clinical laboratory biosafety
WS/T 442-2024 Clinical Laboratory Biosafety Guidelines
WS/T 489-2016 Laboratory diagnosis of urinary tract infections
WS/T 834-2024 Clinical application of tests for Toxoplasma gondii
WS/T 251-2005 Guidelines for Clinical Laboratory Safety
WS/T 489-2024 Guidelines for clinical microbiology laboratory testing of urine specimens

Shandong Provincial Standard of the People's Republic of China

DB37/T 3606-2019 Technical regulations for clinical diagnosis and treatment of animal diseases

Anhui Provincial Standard of the People's Republic of China

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

Hunan Provincial Standard of the People's Republic of China

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

卫生健康委员会

WS/T 616-2018 Autoverification of Clinical Laboratory Quantitative Test Results
WS/T 574-2018 Purified reagent water in the clinical laboratory
WS/T 640-2018 Specimen collection and transport in clinical microbiology

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

GB/T 30224-2013 Clinical Use of Tests for Toxoplasma Gondii
GB/T 20469-2006 General guideline of the clinical laboratory design

Jiangxi Provincial Standard of the People's Republic of China

DB36/T 1622-2022 Technical specifications for clinical diagnosis of aquatic animal diseases

Zhejiang Provincial Standard of the People's Republic of China

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

国家卫生计生委

WS/T 503-2017 Blood culture operating procedures in clinical microbiology laboratories

司法部

SF/T 0111-2021 Specification of examination in forensic clinical medicine

Professional Standard - Certification and Accreditation

RB/T 192-2015 Guideline for clinical forensic examination
RB/T192-2015 Forensic Clinical Examination Standards

Professional Standard - Public Safety Standards

GA/T 1970-2021 Specifications for clinical forensic examination

中华人民共和国国家卫生和计划生育委员会

WS/T 496-2017 Quality indicators in clinical laboratories

GOST

GOST R 70355-2022 Specialized food products. General requirements for preclinical tests on laboratory animals
GOST R ISO 14155-2-2008 Clinical investigation of medical devices for human subjects. Part 2. Clinical investigation plans

American Society for Testing and Materials (ASTM)

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 E2045-99(2014) Standard Practice for Detailed Clinical Observations of Test Animals
ASTM E2045-22 Standard Practice for Detailed Clinical Observations of Test Animals
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

RU-GOST R

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 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 52379-2005 Good clinical practice (GCP)
GOST ISO 16037-2014 Rubber condoms for clinical trials. Determination of physical properties
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 51352-1999 Kits of reagents for clinical laboratory diagnostics. 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

International Organization for Standardization (ISO)

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 Rubber condoms for clinical trials - Measurement of physical properties
ISO 16037:2002/Amd 1:2011 Rubber condoms for clinical trials — Measurement of physical properties — Amendment 1

GSO

OS GSO ISO/TS 22911:2015 Dentistry -- Preclinical evaluation of dental implant systems -- Animal test methods
BH GSO ISO/TS 22911:2017 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 ASTM F3108:2023 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
GSO ASTM F3108:2022 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
OS GSO ISO 16037:2009 Rubber condoms for clinical trials – Measurement of physical properties

Korean Agency for Technology and Standards (KATS)

KS P ISO TS 22911-2020 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 22911:2010 Dentistry-Preclinical evaluation of dental implant systems-Animal test methods
KS M ISO 16037-2023 Rubber condoms for clinical trials — Measurement of physical properties
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 11953:2018 Dentistry — Implants — Clinical performance of hand torque instruments
KS P 8428-2020 General requirements for clinical laboratory automation system performance
KS P 8429-2020 General requirements for clinical laboratory automation system information
KS P 8428-2015(2020) General requirements for clinical laboratory automation system performance

KR-KS

KS P ISO TS 22911-2014 Dentistry－Preclinical evaluation of dental implant systems－Animal test methods
KS M ISO 16037-2018(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 P ISO 11953-2018 Dentistry — Implants — Clinical performance of hand torque instruments

ZA-SANS

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

Canadian General Standards Board （CGSB)

CAN/CGSB-191.1-2013 Research ethics oversight of biomedical clinical trials
CGSB 191.1-2013-CAN/CGSB-2013 Oversight of research ethics involving biomedical clinical trials

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

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

Association Francaise de Normalisation

NF S97-045*NF ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties
NF S99-201*NF EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
NF ISO 16037:2002 Préservatifs masculins en caoutchouc destinés aux essais cliniques - Mesurage des propriétés physiques
NF S91-154:1995 Clinical evaluation of dental implants.

SCC

DANSK DS/ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties
BS ISO 81060-2:2009 Non-invasive sphygmomanometers-Clinical validation of automated measurement type

Danish Standards Foundation

DS/ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties
DS/EN ISO 14155:2013 Clinical investigation of medical devices for human subjects - Good clinical practice

US-AAMI

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

IT-UNI

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

British Standards Institution (BSI)

BS EN ISO 14155:2011 Clinical investigation of medical devices for human subjects. Good clinical practice
BS EN IEC 60601-2-19:2021+A1:2023 Medical electrical equipment - Particular requirements for the basic safety and essential performance of infant incubators

European Committee for Standardization (CEN)

EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

PL-PKN

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

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

Lithuanian Standards Office

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

AT-ON

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

AENOR

UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

GOSTR

GOST R 58090-2018 Clinical examination of unproductive animals. General requirements

Standard Association of Australia （SAA）

AS 3816:2018 Management of clinical and related wastes

Others: animal testing,Clinical Trials,Clinical Trial Testing,Analyzing Clinical Trials,Animal Clinical Trial Standards,clinical trial quality,drug clinical trial,Clinical Trial Pre-Trial,Clinical Trial Equipment,Product Clinical Trials,clinical trial design,medical clinical trial,Clinical Trial Report,Clinical Trial Review,clinical + animal,animal testing,Clinical + Trial,animal clinical trials,Animals for Clinical Trials