currently in clinical trials

currently in clinical trials, Total:84 items.

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

The Chinese standard classification for "currently in clinical trials" includes: Codification , Sanitation in general , Stomatologic device, equipment and material .

Group Standards of the People's Republic of China

T/SSFSIDC 015-2023 Clinical trial data collection requirements
T/CACM 1260-2019 Clinical guidelines for diagnosis and treatment of gynecology in TCM Premenstrual syndrome
T/CAQI 366-2024 Clinical testing quantitative project method confirmation
T/CGCPU 006-2019 Phase I Clinical Trial Capacity Evaluation Criteria
T/CGCPU 003-2019 Clinical Trial Institution Capacity Evaluation Standards
T/CGCPU 006-2023 Specification for competency assessment of phase I clinical trials
T/CACM 1245-2019 Clinical guidelines for diagnosis and treatment of ophthalmology in TCM anterior uveitis
T/CAAM 0010-2019 Evidence-based acupuncture and moxibustion clinical practice guidelines: red eyes and pain
T/CIATCM 071-2020 Data element dictionary of clinical pathway of Tradtitional Chinese Medicine
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 024-2022 Specification for training management of practitioners in clinical trial institution
T/CGCPU 005-2019 Clinical Trial Professional Group Competence Evaluation Criteria
T/CGCPU 024-2023 Specification for training management of practitioners in clinical trial institution
T/CAV 001-2023 Terms used in vaccine preclinical research
T/CACM 1165-2019 Clinical guidelines for diagnosis and treatment of proctology in TCM Rectocele
T/CGCPU 022-2022 Evaluation criteria for information management of clinical trials
T/SDHCST 003-2023 Pre-dose Quality Testing of Test Substances in Non-clinical Studies of the Cell Therapy Medical Products
T/CGCPU 012-2020 File management standards for clinical trial institutions
T/CGCPU 003-2023 Specification for capacity evaluation of clinical trial institutions

Zhejiang Provincial Standard of the People's Republic of China

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

Professional Standard - Agriculture

农业部1247号公告-6-2009 Guiding principles for preclinical toxicology evaluation tests of veterinary drugs

Professional Standard - Hygiene

WS/T 406-2024 Quality Standards for Analysis of Common Items in Clinical Blood Tests
WS/T 403-2012 Analytical quality specifications for routine analytes in clinical biochemistry
WS/T 402-2024 Establishment of reference intervals for quantitative test items in clinical laboratories
WS/T 406-2012 Analytical quality specifications for routine tests in clinical hematology
WS/T 402-2012 Define and determine the reference intervals in clinical laboratory
WS/T 834-2024 Clinical application of tests for Toxoplasma gondii
WS/T 102-1998 Classification and codes of clinical laboratory tests item
WS/T 460-2015 Clinical practice of PSA test in prostatic cancer
WS/T 403-2024 Analytical quality standards for common items in clinical chemistry tests
WS/T 492-2016 Verification of performance for precision and trueness of quantitative measurements in clinical laboratories
WS/T 227-2024 Requirements for writing standard operating procedures for clinical laboratory tests
WS/T 492-2015 Performance verification of precision and correctness of quantitative determination items in clinical laboratory

Professional Standard - Medicine

YY/T 0522-2009 Dentistry Preclinical evaluation of dental implant systems Animal test methods
YY/T 0991-2015 Clinical trial guideline for orthodontic brackets
YY/T 0268-2001 Dentistry--Preclinical evaluation of biocompatibility of medical devices used in dentistry--Part 1:Evaluation and test methods selevtion

卫生健康委员会

WS/T 780-2021 Reference intervals of clinical biochemistry tests commonly used for children
WS/T 574-2018 Purified reagent water in the clinical laboratory

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

国家卫生计生委

WS/T 494-2017 Guideline for performance characteristics of immunological qualitative test

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

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

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
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
GSO ISO 14155:2015 Clinical investigation of medical devices for human subjects -- Good clinical practice
BH GSO ASTM F2884:2022 Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion
GSO ASTM F2884:2021 Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion

Korean Agency for Technology and Standards (KATS)

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 P 8430-2015(2020) Management and safety requirements for clinical laboratory pre-analytical automation system

KR-KS

KS P ISO TS 22911-2014 Dentistry－Preclinical evaluation of dental implant systems－Animal test methods

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 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

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 F2884-12 Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion
ASTM F2884-21 Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion

Society of Automotive Engineers (SAE)

SAE J600-2009 Headlamp Aim Test Machines
SAE J600-2011 Headlamp Aim Test Machines (Stabilized Type)

Association Francaise de Normalisation

NF S99-201*NF EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
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.

US-CLSI

CLSI C28-A3c-2008 Defining, Establishing, and Verifying Reference Intervals in the Clinical laboratory

US-AAMI

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

Danish Standards Foundation

DS/EN ISO 14155:2013 Clinical investigation of medical devices for human subjects - Good clinical practice

European Committee for Standardization (CEN)

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)

British Standards Institution (BSI)

BS EN ISO 14155:2011 Clinical investigation of medical devices for human subjects. Good clinical practice

AENOR

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

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)

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