Clinical Phase I

Clinical Phase I, Total:101 items.

The international standard classification for "Clinical Phase I" includes: Birth control. Mechanical contraceptives , Medical Sciences and health care facilities in general .

The Chinese standard classification for "Clinical Phase I" includes: Other special devices , Medical science , Medical apparatus and devices in general .

Inner Mongolia Provincial Standard of the People's Republic of China

DB15/T 1899-2020 Judgment of primary subclinical ketosis in postpartum dairy cows

Group Standards of the People's Republic of China

T/CACM 1126-2018 Traditional Chinese medicine guidelines for the diagnosis and treatment of mental diseases- Premenstrual mental disorder
T/CACM 010-2017 Clinical practice guidelines for the treatment of common infectious diseases with traditional Chinese medicine alone/combined with antibiotics for pelvic inflammatory disease
T/CACM 1127-2018 Traditional Chinese medicine guidelines for the diagnosis and treatment of mental diseases- Perimenopausal mental disorder
T/CACM 1263-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Dengue Fever
T/GDACM 0125-2024 Traditional Chinese medicine external therapy guidelines for adverse reactions of early-stage breast cancer （Ru Yan disease）
T/CACM 1309-2019 Clinical guidelines for diagnosis and treatment of gynecology in TCM Irregular Menstrual Cycle
T/CACM 1133-2018 Traditional Chinese medicine guidelines for the diagnosis and treatment of mental diseases- Tic disorder
T/GDACM 0107-2022 Guidelines for Clinical Diagnosis and Treatment of Early Breast Cancer (Ruyan) with Integrated Traditional Chinese and Western Medicine
T/CACM 1265-2019 TCM Gynecology Clinical Diagnosis and Treatment Guidelines for Prolonged Menstrual Period
T/CACM 1260-2019 Clinical guidelines for diagnosis and treatment of gynecology in TCM Premenstrual syndrome
T/CACM 1063~1064-2018 Acupuncture Medicine Clinical Basic Terminology Acupuncture Medicine Clinical General Requirements
T/SHZSAQS 00078-2022 Judgment of primary subclinical ketosis in postpartum dairy and meat cattle
T/CHSA 005-2020 Clinical guidelines for restoration of tooth defects with gold alloys
T/CSCO 2-2022 Standard Datasets for Breast Cancer Clinical Scientific Research
T/CGCPU 006-2019 Phase I Clinical Trial Capacity Evaluation Criteria
T/CACM 1239-2019 Clinical guidelines for diagnosis and treatment of gynecology in TCM Advanced Menstruation
T/CACM 1289-2019 Clinical guidelines for diagnosis and treatment of ophthalmology in TCM Primary angle closure glaucoma
T/CACM 1300-2019 Clinical guidelines for diagnosis and treatment of gynecology in TCM Ovulation Bleeding
T/CGCPU 025-2023 Guideline of contract research organization
T/DALN 024-2022 Judgment of primary subclinical ketosis in postpartum dairy and meat cattle
T/CGCPU 006-2023 Specification for competency assessment of phase I clinical trials
T/CGCPU 025-2022 Guideline of contract research organization

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

Professional Standard - Agriculture

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

Beijing Provincial Standard of the People's Republic of China

DB11/T 2275.3-2024 Malignant Tumor Clinical Research Dataset Part 3: Lung Cancer

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

GB/T 42168.1-2022 Condoms—Guidance on clinical studies—Part 1: Male condoms, clinical function studies based on self reports

Professional Standard - Hygiene

WS 392-2012 Clinical application of ventilator

Professional Standard - Medicine

YY/T 0297-1997 Clinical investigation of medical devices

Professional Standard - Certification and Accreditation

RB/T 192-2015 Guideline for clinical forensic examination

US-FCR

FCR 21 CFR PART 862-2014 CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
FCR 21 CFR PART 862-2013 CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
FCR 21 CFR PART 862-2015 CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
FCR AF I44-119-2001 CLINICAL PERFORMANCE IMPROVEMENT
FCR FED H-08-9 CHAP 214-1979 CLINICAL SERVICES ADMINISTRATION

GSO

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

SCC

CAN/HSO 1003:2023 Clinical Governance
BS EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects-Clinical investigation plans
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
ISO 14155:2020 Plus Redline Clinical investigation of medical devices for human subjects - Good clinical practice
DANSK DS/EN ISO 14155/AC:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
08/30116059 DC BS ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice
NS-EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
DANSK DS/EN ISO 14155:2020 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)
NS-EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
BS 691:1953 Clinical maximum thermometers
BS 691:1961 Clinical maximum thermometers
BS 691:1966 Clinical maximum thermometers
BS 691:1936 Clinical maximum thermometers
DIN EN ISO 14155 E:2018 Draft Document - Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2018); German and English version prEN ISO 14155:2018
ADA 1000-2010(R2020) Standard Clinical Data Architecture

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

KR-KS

KS P ISO 14155-2022 Clinical investigation of medical devices for human subjects — Good clinical practice
KS P ISO 14155-2019 Clinical investigation of medical devices for human subjects — Good clinical practice

Military Standards (MIL-STD)

DOD A-A-51709-1986 THERMOMETER, CLINICAL, HUMAN
DOD A-A-53345-1988 THERMOMETER, CLINICAL, VETERINARY
DOD A-A-54736-1992 THERMOMETER, CLINICAL, HUMAN
DOD A-A-54437-1991 PITCHER, CLINICAL SOLUTIONS (ALUMINUM)

Spanish Association for Standardization (UNE)

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

International Organization for Standardization (ISO)

ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
ISO 14155:2011/cor 1:2011 Clinical investigation of medical devices for human subjects - Good clinical practice; Technical Corrigendum 1
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

Korean Agency for Technology and Standards (KATS)

KS P ISO 14155:2019 Clinical investigation of medical devices for human subjects — Good clinical practice
KS P 1208-1987 Direct Blood-Pressure Meters for Clinical Use
KS P ISO 14155-2-2007(2012) Clinical investigation of medical devices for human subjects－Part 2：Clinical investigation plans
KS C 1222-1989 Clinical electronic spirometers
KS C 1221-2014 Polygraphs for clinical use
KS P ISO 14155-2-2019 Clinical investigation of medical devices for human subjects－Part 2：Clinical investigation plans
KS C 1222-2014 Clinical electronic spirometers
KS C 1221-1989(2009) Polygraphs for clinical use

AR-IRAM

IRAM 9020-1962 clinical thermometer

German Institute for Standardization

DIN EN ISO 14155:2024 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2024); German and English version prEN ISO 14155:2024
DIN EN ISO 14155:2021-05 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020
DIN EN ISO 14155 E:2018-08 Good Clinical Practice for Clinical Investigation of Medical Devices in Anthropology (Draft)

British Standards Institution (BSI)

24/30467406 DC BS EN ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice
18/30344902 DC BS EN ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice

GOST

GOST R 59921.1-2022 Artificial intelligence systems in clinical medicine. Part 1. Clinical evaluation
GOST R ISO 14155-2022 Clinical investigation of medical devices for human subjects. Good clinical practice
GOST R 56429-2021 Medical devices. Clinical еvaluation

Standard Association of Australia （SAA）

AS 2190:1978 Clinical maximum thermometers
AS ISO 14155:2002 Clinical investigation of medical devices

SE-SIS

SIS 64 41 50-1969 Clinical maximum thermometer

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 ISO 14155-2014 Clinical investigation. Good clinical practice

Japanese Industrial Standards Committee (JISC)

JIS T 1140:1998 Clinical electrical thermometers

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.

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

Indonesia Standards

SNI 16-4941-1998 Enclosed-scale clinical thermometers

CN-QIYE

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