Clinical phase 2

Clinical phase 2, Total:175 items.

The international standard classification for "Clinical phase 2" includes: Health care technology (Vocabularies) , Medical Sciences and health care facilities in general .

The Chinese standard classification for "Clinical phase 2" includes: Pharmaceutical in general , Sanitation in general , Medical science , Nutrition sanitation , Medical apparatus and devices in general , Legal medical expert .

Group Standards of the People's Republic of China

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/SHPPA 023-2023 Long term follow-up study guidance for CAR-T cell therapy products
T/CACM 1127-2018 Traditional Chinese medicine guidelines for the diagnosis and treatment of mental diseases- Perimenopausal mental disorder
T/HNMA 1-2019 MRI clinical function evaluation specification
T/CACM 1063~1064-2018 Acupuncture Medicine Clinical Basic Terminology Acupuncture Medicine Clinical General Requirements
T/DALN 024-2022 Judgment of primary subclinical ketosis in postpartum dairy and meat cattle
T/GDACM 0125-2024 Traditional Chinese medicine external therapy guidelines for adverse reactions of early-stage breast cancer （Ru Yan disease）
T/CACM 1126-2018 Traditional Chinese medicine guidelines for the diagnosis and treatment of mental diseases- Premenstrual mental disorder
T/CHAS 20-2-14-2024 Pharmacy administration and Pharmacy practice in Healthcare institutions——Part 2-14: Pharmacy practice—Perioperative pharmacy practice
T/CGCPU 006-2019 Phase I Clinical Trial Capacity Evaluation Criteria
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 1239-2019 Clinical guidelines for diagnosis and treatment of gynecology in TCM Advanced Menstruation
T/CGCPU 014-2020 The practices of chemicals for clinical trials in clinical trial institutions
T/HNMA 3-2019 MRI Clinical Functional Evaluation Guidelines
T/CACM 1300-2019 Clinical guidelines for diagnosis and treatment of gynecology in TCM Ovulation Bleeding
T/CGCPU 006-2023 Specification for competency assessment of phase I clinical trials
T/CACM 1309-2019 Clinical guidelines for diagnosis and treatment of gynecology in TCM Irregular Menstrual Cycle
T/GDACM 0107-2022 Guidelines for Clinical Diagnosis and Treatment of Early Breast Cancer (Ruyan) with Integrated Traditional Chinese and Western Medicine
T/SHZSAQS 00078-2022 Judgment of primary subclinical ketosis in postpartum dairy and meat cattle

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

国家市场监督管理总局、中国国家标准化管理委员会

GB/T 16751.2-2021 Clinic terminology of traditional Chinese medical diagnosis and treatment—Part 2:Syndromes/patterns

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 42467.2-2023 Clinical terminology of traditional Chinese medicine—Part 2：External medicine

Professional Standard - Hygiene

WS 387.2-2012 Clinical common techniques of first aid—Part 2:Emetic and gastric lavage
WS/T 251-2005 Guidelines for Clinical Laboratory Safety
WS/T 427-2013 Nutritional risk screening
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/T192-2015 Forensic Clinical Examination Standards
RB/T 192-2015 Guideline for clinical forensic examination

司法部

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

中华人民共和国国家卫生和计划生育委员会

WS/T 496-2017 Quality indicators in clinical laboratories

Zhejiang Provincial Standard of the People's Republic of China

DB33/T 855-2011 Clinical disease classification and code

Professional Standard - Public Safety Standards

GA/T 1970-2021 Specifications for clinical forensic examination

Beijing Provincial Standard of the People's Republic of China

DB11/T 2275.2-2024 Malignant tumor clinical research dataset Part 2: Breast cancer

Korean Agency for Technology and Standards (KATS)

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 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
KS P 1208-1987 Direct Blood-Pressure Meters for Clinical Use
KS C 1221-2014 Polygraphs for clinical use
KS C 1222-1989 Clinical electronic spirometers
KS X ISO HL7 27932-2023 Data exchange standards — HL7 clinical document architecture, Release 2
KS C 1222-2014 Clinical electronic spirometers
KS X ISO HL7 27932:2018 Data exchange standards — HL7 clinical document architecture, Release 2
KS C 1221-1989(2009) Polygraphs for clinical use
KS P 1208-2013 Direct Blood-Pressure Meters for Clinical Use

SCC

NS-EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans (ISO 14155-2:2003)
CAN/HSO 1003:2023 Clinical Governance
NS-EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
DANSK DS/EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
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
NS-EN 12470-2:2000 Clinical thermometers — Part 2: Phase change type (dot matrix) thermometers
NS-EN 12470-2:2000+A1:2009 Clinical thermometers — Part 2: Phase change type (dot matrix) thermometers
AENOR UNE-EN 12470-2+A1:2009 Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers
08/30176648 DC BS ISO HL7 27932. Health informatics. Clinical document architecture, release 2
CAN/CGSB-14.1-M87-1987 Mercury-in-Glass Clinical Thermometers
AAMI/ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (Includes Erratum, 2011)
DANSK DS/EN 14822-2:2005 Health informatics - General purpose information components - Part 2: Non-clinical
DANSK DS/EN ISO 81060-2:2014 Non-invasive sphygmomanometers – Part 2: Clinical investigation of automated measurement type
NS-EN 14822-2:2005 Health informatics — General purpose information components — Part 2: Non-clinical
BS ISO /HL7 27932:2009 Data exchange standards. HL7 clinical document architecture, release 2 CD-ROM

Spanish Association for Standardization (UNE)

UNE-EN ISO 14155-2:2004 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
UNE-EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
UNE-EN ISO 14155:2021 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
UNE-EN 12470-2:2001 Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers.
UNE-EN 12470-2:2001+A1:2009 Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers
UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
UNE-EN 14822-2:2005 Health informatics - General purpose information components - Part 2: Non-clinical (Endorsed by AENOR in December of 2005.)

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

VN-TCVN

TCVN 7740-2-2007 Clinical investigation of medical devices for human subjects.Part 2: Clinical investigation plans

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 ISO 14155-2022 Clinical investigation of medical devices for human subjects. Good clinical practice
GOST R 56429-2021 Medical devices. Clinical еvaluation

European Committee for Standardization (CEN)

EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
EN ISO 14155-2:2003 Clinical Investigation of Medical Devices for Human Subjects - Part 2: Clinical Investigation Plans ISO 14155-2:2003
EN 12470-2:2000+A1:2009 Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers

German Institute for Standardization

DIN EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
DIN EN ISO 14155-2 E:2001-08 Clinical Studies of Medical Devices for Human Use Part 2: Clinical Study Protocol (Draft)
DIN EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003); English version of DIN EN ISO 14155-2:2009-11
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 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
DIN EN 14822-2:2006 Health informatics - General purpose information components - Part 2: Non-clinical; English version EN 14822-2:2005
DIN EN 14822-2:2006-05 Health informatics - General purpose information components - Part 2: Non-clinical; English version EN 14822-2:2005
DIN 13902-3:2007 Dentistry - Terminology of oral implantology - Part 3: Clinical terms

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 29943-2:2017 Condoms - Guidance on clinical studies - Part 2: Female condoms, clinical function studies based on self-reports
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/HL7 27932:2009 Data Exchange Standards - HL7 Clinical Document Architecture, Release 2
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 14155:1996 Clinical investigation of medical devices

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 29943-2:2021 Condoms — Guidance on clinical studies — Part 2: Female condoms, clinical function studies based on self-reports
GSO ISO 14155:2015 Clinical investigation of medical devices for human subjects -- Good clinical practice

NATO - North Atlantic Treaty Organization

STANAG 2348-1984 Basic Military Hospital (Clinical) Records (ED 2 AMD 2)

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
KS X ISO HL7 27932-2018 Data exchange standards — HL7 clinical document architecture, Release 2
KS X ISO HL7 27932-2018(2023) Data exchange standards — HL7 clinical document architecture, Release 2

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)
DOD A-A-54861-1993 INDICATOR, CLINICAL CHART HOLDER, METAL
DOD A-A-54778-1993 ANALYZER, CLINICAL CHEMISTRY, DRY

AR-IRAM

IRAM 9020-1962 clinical thermometer

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
BS EN ISO 14155:2020 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

Standard Association of Australia （SAA）

AS 2190:1978 Clinical maximum thermometers
AS ISO 14155:2002 Clinical investigation of medical devices
AS T33:1966 Specification for clinical maximum thermometers

SE-SIS

SIS 64 41 50-1969 Clinical maximum thermometer

Japanese Industrial Standards Committee (JISC)

JIS T 1140:1998 Clinical electrical thermometers
JIS T 1170:1987 Clinical electronics spirometers
JIS T 1116:1985 Direct blood-pressure meters for clinical use

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
GOST R 56429-2015 Medical devices. Clinical evaluation
GOST R 52379-2005 Good clinical practice (GCP)

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
DS/ISO/HL7 27932:2010 Data Exchange Standards - HL7 Clinical Document Architecture, Release 2
DS/EN 12470-2+A1:2009 Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers
DS/EN 14822-2:2005 Health informatics - General purpose information components - Part 2: Non-clinical

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

American National Standards Institute （ANSI)

ANSI/ADA 1000-2010 Standard Clincal Data Architecture
ANSI/ADA 1000-2010(2020) Standard Clinical Data Architecture
ANSI/HL7 CDA,R 2-2005 HL7 Version 3 Standard: Clinical Document Architecture, Release 2

Lithuanian Standards Office

LST EN 12470-2-2002+A1-2009 Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers
LST EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
LST EN 14822-2-2005 Health informatics - General purpose information components - Part 2: Non-clinical

AT-ON

OENORM EN ISO 14155:2021 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
ONORM S 5234-3-2001 Clinical dosimetry - lonization chamber dosimetry

PL-PKN

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

IX-EU/EC

MEDDEV 2.12-2-2004 GUIDELINES ON POST MARKET CLINICAL FOLLOW-UP