medical clinical trial

medical clinical trial, Total:84 items.

The international standard classification for "medical clinical trial" includes: Protection against crime , Occupational safety. Industrial hygiene , Radiation protection , Health care technology (Vocabularies) .

The Chinese standard classification for "medical clinical trial" includes: Crime judging technology , Legal medical expert , Sanitation in general , Radiological sanitation protection , Pharmaceutical in general , Medical apparatus and devices in general .

Professional Standard - Public Safety Standards

GA/T 1970-2021 Specifications for clinical forensic examination
GA/T 1588-2019 Forensic sciences - Specifications for construction of forensic clinical examination laboratory
GA/T 1194-2014 Guideline for forensic clinical examination in sexual assault case

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/CACM 1063~1064-2018 Acupuncture Medicine Clinical Basic Terminology Acupuncture Medicine Clinical General Requirements
T/CACM 1064-2018 Acupotomology clinic-General requirements
T/CACM 1063-2018 Acupotomology clinic-Basic terminologies

司法部

SF/T 0112-2021 Implemental specification of clinical forensic imaging examination
SF/T 0111-2021 Specification of examination in forensic clinical medicine

Professional Standard - Hygiene

WS/T 255-2005 Clinical laboratory medicine-Requirements for reference measurement laboratories

Professional Standard - Certification and Accreditation

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

未注明发布机构

WS 533-2017 Clinical nuclear medicine patient protection requirements

Occupational Health Standard of the People's Republic of China

GBZ 120-2006 Radiological protection standards for clinical nuclear medicine

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

GB/T 42467.8-2023 Clinical terminology of traditional Chinese medicine—Part 8:Ophthalmology
GB/T 42467.1-2023 Clinical terminology of traditional Chinese medicine—Part 1：Internal medicine
GB/T 42467.5-2023 Clinical terminology of traditional Chinese medicine—Part 5:Orthopaedics and traumatology
GB/T 42467.2-2023 Clinical terminology of traditional Chinese medicine—Part 2：External medicine
GB 16360-1996 Radiological protection standard for clinical nuclear medicine
GB/T 42467.7-2023 Clinical terminology of traditional Chinese medicine—Part 7:Pediatrics
GB/T 42467.3-2023 Clinical terminology of traditional Chinese medicine—Part 3：Dermatology
GB/T 42467.6-2023 Clinical terminology of traditional Chinese medicine—Part 6:Gynecology

中华人民共和国国家卫生和计划生育委员会

GBZ 120-2002 Radiological protection standard For clinical nuclear medicine

Professional Standard - Medicine

YY/T 0297-1997 Clinical investigation of medical devices

Canadian General Standards Board （CGSB)

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

British Standards Institution (BSI)

BS EN ISO 14155:2011 Clinical investigation of medical devices for human subjects. Good clinical practice
BS EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Clinical investigation plans
PD ISO/TS 16277-1:2015 Health informatics. Categorial structures of clinical findings in traditional medicine. Traditional Chinese, Japanese and Korean medicine
BS EN ISO 21549-4:2006 Health informatics - Patient healthcard data - Extended clinical data

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)
EN ISO 14155-2:2003 Clinical Investigation of Medical Devices for Human Subjects - Part 2: Clinical Investigation Plans ISO 14155-2:2003

International Organization for Standardization (ISO)

ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plants
ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice
ISO/TS 22990:2019 Traditional Chinese medicine — Categories of clinical terminological system to support the integration of clinical terms from traditional Chinese medicine and Western medicine
ISO 19465:2017 Traditional Chinese medicine - Categories of traditional Chinese medicine (TCM) clinical terminological systems

Korean Agency for Technology and Standards (KATS)

KS P ISO 14155-2:2007 Clinical investigation of medical devices for human subjects－Part 2：Clinical investigation plans
KS P ISO 14155:2019 Clinical investigation of medical devices for human subjects — Good clinical practice

CN-QIYE

Q/BYYYY 1993-2023 1+X Medical Clinical Guide

GOST

GOST R ISO 14155-2-2008 Clinical investigation of medical devices for human subjects. Part 2. Clinical investigation plans
GOST R 59921.1-2022 Artificial intelligence systems in clinical medicine. Part 1. Clinical evaluation
GOST R 59921.9-2022 Artificial intelligence systems in clinical medicine. Algorithms for data analysis in clinical physiology. Testing methods. General requirements
GOST R 59921.7-2022 Artificial Intelligence systems in clinical medicine. Algorithms of medical images analysis. Test methods. General requirements
GOST R 56429-2021 Medical devices. Clinical еvaluation

KR-KS

KS P ISO 14155-2019 Clinical investigation of medical devices for human subjects — Good clinical practice
KS P ISO TS 22911-2014 Dentistry－Preclinical evaluation of dental implant systems－Animal test methods
KS P ISO 14155-2022 Clinical investigation of medical devices for human subjects — Good clinical practice
KS P ISO 15198-2017 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
KS X ISO TS 16277-1-2017 Health informatics ― Categorial structures of clinical findings in traditional medicine ― Part 1: Traditional Chinese, Japanese and Korean medicine

Association Francaise de Normalisation

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

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

Danish Standards Foundation

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

RO-ASRO

SR EN 540-1996 Clinical investigation of medical devices for human subjects

PH-BPS

PNS ISO 19465:2021 Traditional Chinese medicine - Categories of traditional Chinese medicine (TCM) clinical terminological systems

RU-GOST R

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 53022.3-2008 Clinical laboratory technologies. Requirements of quality of clinical laboratory tests. Part 3. Assessment of laboratory tests clinical significance
GOST R ISO 14155-2014 Clinical investigation. Good clinical practice
GOST R 56429-2015 Medical devices. Clinical evaluation

German Institute for Standardization

DIN EN ISO 14155 E:2018-08 Good Clinical Practice for Clinical Investigation of Medical Devices in Anthropology (Draft)
DIN EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
DIN EN 540:1993 Clinical testing of medical devices on humans

AT-ON

OENORM EN ISO 14155:2021 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)

PL-PKN

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

US-FCR

FCR 21 CFR PART 862-2014 CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
FCR 21 CFR PART 862-2015 CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
FCR 21 CFR PART 862-2013 CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

BE-NBN

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

Military Standards (MIL-STD)

DOD A-A-53345-1988 THERMOMETER, CLINICAL, VETERINARY

GOSTR

GOST R ISO 15198-2009 Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user control procedures by the manufacturer

GSO

OS GSO ISO 14155:2015 Clinical investigation of medical devices for human subjects -- Good clinical practice
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

SCC

BS EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects-Clinical investigation plans
DANSK DS/EN ISO 14155/AC:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
ISO 14155:2020 Plus Redline Clinical investigation of medical devices for human subjects - Good clinical practice
AAMI/ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
DANSK DS/ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good clinical practice

Standard Association of Australia （SAA）

AS ISO 14155:2002 Clinical investigation of medical devices