/ Phase II clinical

/ Phase II clinical, Total:128 items.

The international standard classification for "/ Phase II clinical" includes: Medical Sciences and health care facilities in general .

The Chinese standard classification for "/ Phase II clinical" includes: Medical science , Nutrition sanitation , Legal medical expert .

Group Standards of the People's Republic of China

T/CACM 1265-2019 TCM Gynecology Clinical Diagnosis and Treatment Guidelines for Prolonged Menstrual Period
T/CGCPU 025-2022 Guideline of contract research organization
T/CACM 1300-2019 Clinical guidelines for diagnosis and treatment of gynecology in TCM Ovulation Bleeding
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/CACM 1239-2019 Clinical guidelines for diagnosis and treatment of gynecology in TCM Advanced Menstruation
T/CACM 1127-2018 Traditional Chinese medicine guidelines for the diagnosis and treatment of mental diseases- Perimenopausal mental disorder
T/DALN 024-2022 Judgment of primary subclinical ketosis in postpartum dairy and meat cattle
T/CACM 1126-2018 Traditional Chinese medicine guidelines for the diagnosis and treatment of mental diseases- Premenstrual mental disorder
T/CGCPU 006-2019 Phase I Clinical Trial Capacity Evaluation Criteria
T/CGCPU 006-2023 Specification for competency assessment of phase I clinical trials
T/CGCPU 025-2023 Guideline of contract research organization
T/CACM 1260-2019 Clinical guidelines for diagnosis and treatment of gynecology in TCM Premenstrual syndrome
T/GDACM 0107-2022 Guidelines for Clinical Diagnosis and Treatment of Early Breast Cancer (Ruyan) with Integrated Traditional Chinese and Western Medicine
T/SAME 001-2022 Management requirements for level II biosafety cabinets in clinical laboratories
T/CGCPU 014-2020 The practices of chemicals for clinical trials in clinical trial institutions
T/CAPA 12-2024 Clinical treatment and long-term management of melasma
T/CACM 1309-2019 Clinical guidelines for diagnosis and treatment of gynecology in TCM Irregular Menstrual Cycle
T/GDACM 0125-2024 Traditional Chinese medicine external therapy guidelines for adverse reactions of early-stage breast cancer （Ru Yan disease）

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

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

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

Professional Standard - Hygiene

WS/T 427-2013 Nutritional risk screening
WS 392-2012 Clinical application of ventilator

Professional Standard - Judicatory

SF/Z JD0103003-2011 Specifications for Forensic Clinical Examination
SF/T 0111-2021 Specification of examination in forensic clinical medicine

Professional Standard - Certification and Accreditation

RB/T192-2015 Forensic Clinical Examination Standards

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

American National Standards Institute （ANSI)

ANSI/ASTM E2210:2012 Specification for Guideline Elements Model Version 2 (GEM II) Document Model for Clinical Practice Guidelines
ANSI/ADA 1000-2010(2020) Standard Clinical Data Architecture
ANSI/ADA 1000-2010 Standard Clincal Data Architecture

Kingdom of Bahrain Testing and Metrology Directorate

BH GSO ASTM F3108:2023 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery

Clinical and Laboratory Standards Institute

CLSI GP46-R-2003 Report on the Challenges of Planning Clinical Laboratory Operations During Disasters

GCC Standardization Organization

GSO ASTM F3108:2022 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

SCC

CAN/HSO 1003:2023 Clinical Governance
AAMI/ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
AAMI/ISO 14155-2:2003(R2008) Clinical Investigation of Medical Devices for Human Subjects - Part 2: Clinical Investigation Plans

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 E2210-06 Standard Specification for Guideline Elements Model version 2 (GEM II)-Document Model for Clinical Practice Guidelines

The Directorate General of Specifications and Metrology (DGSM)

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

Bureau of Indian Standards

IS/ISO 14155-2011 Clinical Investigation of Medical Devices for Human Subjects-Good Clinical Practice

British Standards Institution (BSI)

BS EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects-Clinical investigation plans
08/30116059 DC BS ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice
24/30467406 DC BS EN ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice
BS EN ISO 14155:2020+A11:2024 Clinical investigation of medical devices for human subjects. Good clinical practice
24/30506234 DC BS EN ISO 12487 Medical electrical equipment — Clinical performance evaluation of clinical thermometers
BS 691:1966 Clinical maximum thermometers
BS 691:1936 Clinical maximum thermometers
BS 691:1953 Clinical maximum thermometers
18/30344902 DC BS EN ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice
BS 691:1961 Clinical maximum thermometers
BS EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Clinical investigation plans

Spanish Association for Standardization (UNE)

UNE-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)

International Organization for Standardization (ISO)

ISO 14155:2020 Plus Redline Clinical investigation of medical devices for human subjects - Good clinical practice
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

Danish Standards Foundation

DANSK DS/ISO 14155:2020 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
DANSK DS/EN ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2020)
DS/EN ISO 14155:2013 Clinical investigation of medical devices for human subjects - Good clinical practice

Ente Nazionale Italiano di Unificazione

UNI 7792:1977 Clinical thermometers.
EC 1-2011 UNI EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
UNI EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice
UNI EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
UNI EN ISO 14155-2:2004 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
UNI EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
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

Korean Agency for Technology and Standards (KATS)

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
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 P ISO 14155-2-2019 Clinical investigation of medical devices for human subjects － Part 2: Clinical investigation plans
KS C 1221-2014 Polygraphs for clinical use
KS C 1222-1989 Clinical electronic spirometers
KS C 1222-2014 Clinical electronic spirometers
KS C 1221-1989(2009) Polygraphs for clinical use
KS P 1208-2013 Direct Blood-Pressure Meters for Clinical Use

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)

German Institute for Standardization

DIN EN ISO 14155:2020-12 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
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)
DIN EN ISO 14155 E:2024-09 Draft Document - 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 14155:2018-08 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
DIN EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
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

Standards Norway

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

AR-IRAM

IRAM 9020-1962 clinical thermometer

Gosstandart of Russia

GOST R ISO 14155-2022 Clinical investigation of medical devices for human subjects. Good clinical practice
GOST R 59921.1-2022 Artificial intelligence systems in clinical medicine. Part 1. Clinical evaluation
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 ISO 14155-2-2008 Clinical investigation of medical devices for human subjects. Part 2. Clinical investigation plans
GOST R 56429-2021 Medical devices. Clinical еvaluation
GOST R 56429-2015 Medical devices. Clinical evaluation

SE-SIS

SIS 64 41 50-1969 Clinical maximum thermometer

Association Francaise de Normalisation

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

Japanese Industrial Standards Committee (JISC)

JIS T 1140:1998 Clinical electrical thermometers
JIS T 1170:1987 Clinical electronics spirometers

Standard Association of Australia （SAA）

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

Association for the Advancement of Medical Instrumentation

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

Swedish Institute for Standards

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

European Committee for Standardization (CEN)

EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
prEN ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2024)