European Clinical Trials

European Clinical Trials, Total:144 items.

The international standard classification for "European Clinical Trials" includes: Dental materials , Laboratory medicine , Medical Sciences and health care facilities in general .

The Chinese standard classification for "European Clinical Trials" includes: Stomatologic device, equipment and material , Sanitation in general , Medical laboratory equipment , Codification , Legal medical expert .

Group Standards of the People's Republic of China

T/CAQI 366-2024 Clinical testing quantitative project method confirmation
T/CGCPU 003-2019 Clinical Trial Institution Capacity Evaluation Standards
T/CGCPU 015-2020 Requirements for Subjects Risk Monitoring system in clinical trials
T/CGCPU 023-2023 Evaluation standard for clinical trial management system document
T/CGCPU 023-2022 Evaluation standard for clinical trial management system document
T/CGCPU 005-2023 Specification for competency assessment of the clinical trial professional group
T/CGCPU 003-2023 Specification for capacity evaluation of clinical trial institutions
T/CGCPU 002-2023 Evaluation standard of centralized management of clinical investigational product
T/CGCPU 006-2019 Phase I Clinical Trial Capacity Evaluation Criteria
T/CGCPU 022-2023 Evaluation criteria for information management of clinical trials
T/CGCPU 024-2023 Specification for training management of practitioners in clinical trial institution
T/JPMA 023-2024 Specification for safety follow-up of vaccine clinical trials
T/CGCPU 022-2022 Evaluation criteria for information management of clinical trials
T/SHSPS 002-2024 Standards for the management and competency evaluation of clinical trial monitors (Shanghai)
T/CGCPU 008-2019 General Auditing Standards for Clinical Trials
T/CGCPU 013-2020 Ethical Considerations for Subject Pain Management in Clinical Trials
T/SHQAP 016-2024 Drug clinical trial management system — Dataset specification
T/SHDSGY 066-2023 Inspection service specification of clinical trial research center
T/CGCPU 024-2022 Specification for training management of practitioners in clinical trial institution
T/CGCPU 029-2023 Evaluation requirements of follow-up centers for primary clinical trials
T/CGCPU 014-2020 The practices of chemicals for clinical trials in clinical trial institutions
T/CGCPU 027-2023 Design specifications for clinical research protocol of immunotherapy
T/CGCPU 012-2023 Evaluation specifications for archives management of clinical trial institutions
T/CGCPU 005-2019 Clinical Trial Professional Group Competence Evaluation Criteria
T/CAV 007-2024 Guidelines for site selection of prophylactic vaccine clinical trial
T/CGCPU 020-2022 Guidelines for the management of pain in clinical trial subjects in the pediatric population
T/CGCPU 006-2023 Specification for competency assessment of phase I clinical trials
T/SHSPS 001-2024 Standards for Management and Competency Assessment of Clinical Trial Coordinators (Shanghai)
T/CGCPU 012-2020 File management standards for clinical trial institutions
T/SSFSIDC 015-2023 Clinical trial data collection requirements
T/CQAP 3013-2023 Key points for quality inspection of clinical trial data management
T/CAV 009-2024 Quality control standards for on-site implementation of vaccine clinical trials

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

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

GB/T 20469-2006 General guideline of the clinical laboratory design
GB/T 26124-2011 In vitro diagnostic reagent(kit) for clinical chemistry
GB/T 30224-2013 Clinical Use of Tests for Toxoplasma Gondii

Professional Standard - Hygiene

WS/T 834-2024 Clinical application of tests for Toxoplasma gondii
WS/T 249-2005 Clinical Laboratory Waste Management
WS/T 251-2005 Guidelines for Clinical Laboratory Safety
WS/T 420-2013 Verification of analytical performance of quantitative kits by clinical laboratory
WS/T 102-1998 Classification and codes of clinical laboratory tests item
WS/T 442-2024 Clinical Laboratory Biosafety Guidelines
WS/T 442-2014 Guideline for clinical laboratory biosafety
WS/T 250-2005 Requirements of Quality Assurance for Clinical Laboratories
WS/T 418-2013 Guidelines for the ion of referral clinical laboratories

卫生健康委员会

WS/T 662-2020 Technical requirements for clinical body fluids analysis
WS/T 804-2022 Basic technical standard for clinical chemistry laboratory
WS/T 574-2018 Purified reagent water in the clinical laboratory
WS/T 644-2018 Clinical laboratory quality evaluation

Gansu Provincial Standard of the People's Republic of China

DB62/T 2055-2011 Cultivation Technical Regulations of European Sweet Prune in Linxia Prefecture

Zhejiang Provincial Standard of the People's Republic of China

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

司法部

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

Professional Standard - Certification and Accreditation

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

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 124-1999 Inspection criteria of the quality of clinical chemistry in vitro diagnostic kits - General guideline
WS/T 496-2017 Quality indicators in clinical laboratories
WS/T 227-2002 Requirement for the technical procedure manual in clinical laboratory

Professional Standard - Agriculture

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

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

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

RU-GOST R

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 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 ISO 14155-2014 Clinical investigation. Good clinical practice
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 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)

GSO

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 1647:2002 Methods of testing and verification for Clinical electrical thermometers with maximum device
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)

GOST

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

European Committee for Standardization (CEN)

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)

American Society for Testing and Materials (ASTM)

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

IX-EU/EC

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(96) 10 FINAL-1996 Communication from the Commission the Challenges Facing the European Defence-Related Industry, a Contribution for Action at European Level
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

Association Francaise de Normalisation

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 D90-205:1998 Feather and down. Sampling in view of tests.

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

Danish Standards Foundation

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

EC 1-2020 UNI EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
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
PAS 8812:2016 Temporary works. Application of European Standards in design. Guide
PD 6598-1996 Measurement techniques for the characterization of the European mini test chip
BS EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Clinical investigation plans
BS PAS 83:2012 Developing human cells for clinical applications in the European Union and the United States of America. Guide
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
BS EN ISO 14155:2020 Clinical investigation of medical devices for human subjects. Good clinical practice
PD 6682-9-2003 Aggregates. Guidance on the use of European test method standards

PL-PKN

PN-EN ISO 14155-2021-02 E 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)

German Institute for Standardization

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

Spanish Association for Standardization (UNE)

UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
UNE 129001:1997 CLINICAL LABORATORY REPORTS. PREPARING REQUIREMENTS.
UNE 129002:2000 IN Glossary of recommended terms in clinical laboratory sciences.

CEPT - Conference Europeenne des Administrations des Postes et des Telecommunications

CEPT T/R 01-05 E-1993 Transposition of National Standards to Enable Introduction of European Standards Relating to the Implementation by CEPT Members of European Telecommunication Standards and Interim European Telecommunication Standards

SCC

BS PAS 8812:2016 Temporary works. Application of European Standards in design. Guide
DANSK DS/ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties
ASTM STP 1008-89 Femoral Intramedullary Rods: Clinical Performance and Related Laboratory Testing
AWWA ACE99395 European DAF Experiences and Optimization
AWWA ACE91156 European Ozone Design Experiences
BS BIP 0113:2012 Guide to European medical device trials and BS EN ISO 14155

South African Bureau of Standard

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
ASHRAE CH-03-1-2-2003 Secondary Refrigeration - European Experiences

International Organization for Standardization (ISO)

ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties
ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plants

KR-KS

KS M ISO 16037-2018(2023) Rubber condoms for clinical trials — Measurement of physical properties

Korean Agency for Technology and Standards (KATS)

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 P ISO 14155-2:2007 Clinical investigation of medical devices for human subjects－Part 2：Clinical investigation plans

BE-NBN

NBN-EN 540-1993 Clinical investigation of medical devices for human subjects