Phase I clinical trial conditions

Phase I clinical trial conditions, Total:162 items.

The international standard classification for "Phase I clinical trial conditions" includes: Dental materials , Medical Sciences and health care facilities in general , Laboratory medicine .

The Chinese standard classification for "Phase I clinical trial conditions" includes: Stomatologic device, equipment and material , Sanitation in general .

Group Standards of the People's Republic of China

T/CGCPU 024-2022 Specification for training management of practitioners in clinical trial institution
T/CGCPU 024-2023 Specification for training management of practitioners in clinical trial institution
T/CGCPU 023-2023 Evaluation standard for clinical trial management system document
T/CGCPU 023-2022 Evaluation standard for clinical trial management system document
T/CGCPU 006-2023 Specification for competency assessment of phase I clinical trials
T/CGCPU 014-2020 The practices of chemicals for clinical trials in clinical trial institutions
T/CGCPU 005-2023 Specification for competency assessment of the clinical trial professional group
T/CGCPU 006-2019 Phase I Clinical Trial Capacity Evaluation Criteria
T/CGCPU 022-2022 Evaluation criteria for information management of clinical trials
T/CGCPU 012-2020 File management standards for clinical trial institutions
T/CGCPU 008-2019 General Auditing Standards for Clinical Trials
T/CGCPU 005-2019 Clinical Trial Professional Group Competence Evaluation Criteria
T/CGCPU 022-2023 Evaluation criteria for information management of clinical trials
T/CGCPU 003-2019 Clinical Trial Institution Capacity Evaluation Standards
T/SSFSIDC 015-2023 Clinical trial data collection requirements
T/CGCPU 003-2023 Specification for capacity evaluation of clinical trial institutions

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 - Medicine

YY/T 0991-2015 Clinical trial guideline for orthodontic brackets

卫生健康委员会

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

Professional Standard - Hygiene

WS/T 834-2024 Clinical application of tests for Toxoplasma gondii

Zhejiang Provincial Standard of the People's Republic of China

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

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 51352-1999 Kits of reagents for clinical laboratory diagnostics. Test methods

NO-SN

NS 5026-1982 Test conditions for vertical turning and boring lathes with one or two columns - Testing of accuracy
NS 5025-1982 Test conditions for vertical turning and boring lathes with one or two columns - Testing of accuracy - General introduction

AT-ON

ONORM M 9034 Beib.1-2000 Machine tools - Acceptance conditions for external cylindrical centreless grinding machines - Generality, terms in foreign languages
ONORM M 9016 Beib.1-1996 Machine tools - Acceptance conditions for lathes - General introduction, terms in foreign languages
ONORM M 9025-1980 Machine tools; acceptance conditions for lathes with central drive and normal accuracy Machine-outils; conditions de reception pour tpurs avec entrainement central et precision normale
ONORM M 9030 Beib.1-1998 Machine tools - Acceptance conditions for external cylindrical grinding machines - General introduction, terms in foreign languages
ONORM M 9016-1996 Machine tools - Acceptance conditions for lathes of normal accuracy - Swing up to 800 mm
ONORM M 9030-1998 Machine tools - Acceptance conditions for external cylindrical grinding machines
OENORM EN ISO 14155:2021 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

German Institute for Standardization

DIN 8609-1:1979 Machine tools; vertical turning and boring lathes, acceptance conditions, general introduction
DIN ISO 2407:1999 Machine tools - Test conditions for internal cylindrical grinding machines with horizontal spindle - Testing of accuracy (ISO 2407:1997)
DIN 69051-3:1989 Machine tools; ball screws; acceptance conditions and acceptance tests
DIN 8660-1:1981 Machine tools; Planing machines; Single-column planing machines; Acceptance conditions
DIN EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
DIN 8660-2:1981 Machine tools; Planing machines; Two-column planing machines; Acceptance conditions
DIN 8626-2:1976 Machine Tools; Vertical Drilling Machines; Pillar Type Drilling Machines; Acceptance Conditions
DIN 8626-1:1976 Machine Tools; Vertical Drilling Machines; Box Type Drilling Machines; Acceptance Conditions

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
BH GSO ISO 3875:2017 Machine tools -- Test conditions for external cylindrical centreless grinding machines -- Testing of the accuracy
OS GSO ISO 3875:2015 Machine tools -- Test conditions for external cylindrical centreless grinding machines -- Testing of the accuracy
GSO ISO 3875:2015 Machine tools -- Test conditions for external cylindrical centreless grinding machines -- Testing of the accuracy
GSO ISO 2407:2013 Test conditions for internal cylindrical grinding machines with horizontal spindle -- Testing of accuracy
BH GSO ISO 2407:2016 Test conditions for internal cylindrical grinding machines with horizontal spindle -- Testing of accuracy
BH GSO ISO 2433:2016 Machine tools -- Test conditions for external cylindrical and universal grinding machines with a movable table -- Testing of accuracy
OS GSO ISO 2433:2015 Machine tools -- Test conditions for external cylindrical and universal grinding machines with a movable table -- Testing of accuracy
GSO ISO 3089:2008 Machine tools - Test conditions for self-centring, manually operated chucks with one-piece jaws
OS GSO ISO 3089:2008 Machine tools - Test conditions for self-centring, manually operated chucks with one-piece jaws
GSO ISO 2773-1:2013 Test conditions for pillar type vertical drilling machines -- Testing of the accuracy -- Part 1: Geometrical tests

IT-UNI

UNI ISO 3875:2021 Machine tools — Test conditions for external cylindrical centreless grinding machines — Testing of the accuracy
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

GOST

GOST R ISO 14155-2-2008 Clinical investigation of medical devices for human subjects. Part 2. Clinical investigation plans
GOST R 70355-2022 Specialized food products. General requirements for preclinical tests on laboratory animals
GOST R ISO 14155-1-2008 Clinical investigation of medical devices for human subjects. Part 1. General requirements

Korean Agency for Technology and Standards (KATS)

KS B ISO 2772-2006 Test conditions for box type vertical drilling machines - Testing of the accuracy - Part I Geometrical tests
KS B ISO 3875:2013 External cylindrical centerless grinding machines-Testing of the accuracy
KS B ISO 3875:2014 Machine tools — Test conditions for external cylindrical centreless grinding machines — Testing of the accuracy
KS B ISO 8636-2:2014 Machine tools — Test conditions for bridge-type milling machines — Testing of the accuracy — Part 2: Travelling bridge(gantry-type) machines
KS B ISO 8636-2:2009 Machine tools-Test conditions for bridge-type milling machines-Testing of the accuracy-Part 2:Travelling bridge(gantry-type) machines
KS B ISO 3875:2019 Machine tools — Test conditions for external cylindrical centreless grinding machines — Testing of the accuracy
KS B ISO 4703:2014 Test conditions for surface grinding machines with two columns — Machines for grinding slideways — Testing of the accuracy
KS B ISO 4703:2010 Test conditions for surface grinding machines with two columns-Machines for grinding slideways-Testing of the accuracy
KS B ISO 6480:2010 Conditions of acceptance for horizontal internal broaching machines-Testing of the accuracy
KS P ISO TR 18112:2009 Clinical laboratory testing and in vitro diagnostic test systems-In vitro diagnostic medical devices for professional use-Summary of regulatory requirements for information supplied by the manufacturer
KS B ISO 6480:2013 Conditions of acceptance for horizontal internal broaching machines－Testing of the accuracy
KS B ISO 6779:2013 Acceptance conditions for broaching machines of vertical internal type-Testing of accuracy
KS B ISO 6481:2010 Acceptance conditions for vertical surface type broaching machines-Testing of accuracy
KS B ISO 5734-2006(2011) Acceptance conditions of mechanical dividing heads for machine tools－Testing of accuracy

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 E1466-92(1999) Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory

Association Francaise de Normalisation

NF E60-125*NF ISO 3875:2020 Machine tools - Test conditions for external cylindrical centreless grinding machines - Testing of the accuracy
NF E60-139*NF ISO 19744:2022 Test conditions for numerically controlled broaching machines - Testing of the accuracy - Vertical surface type broaching machines
NF E60-125:2004 Machine tools - Test conditions for external cylindrical centreless grinding machines - Testing of the accuracy.
NF E60-127:2017 Machine tools - Vertical grinding machines - Acceptance conditions - Testing of accuracy
NF S99-201*NF EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
NF E60-142*NF ISO 6779:2019 Test conditions for vertical internal type broaching machines - Testing of accuracy
NF E60-141*NF ISO 6480:2019 Test conditions for horizontal internal type broaching machines - Testing of accuracy
NF E60-143*NF ISO 6481:2019 Test conditions for vertical surface type broaching machines - Testing of accuracy
NF E60-133*NF ISO 2772:2019 Test conditions for box type vertical drilling machines - Testing of the accuracy
NF E60-126*NF ISO 4703:2001 Test conditions for surface grinding machines with two columns - Machines for grinding slideways - Testing of the accuracy
NF E62-154:1985 Machine tools. Hack sawing machines. Acceptance conditions. Testing of accuracy.
NF E60-123*NF ISO 2407:2000 Test conditions for internal cylindrical grinding machines with horizontal spindle - Testing of accuracy.
NF ISO 19744:2022 Test conditions for numerically controlled broaching machines - Checking accuracy - Vertical exterior broaching machines
NF ISO 3875:2020 Machine tools - Test conditions for centerless external surface grinding machines - Checking accuracy

SCC

NS 5026:1982 Test conditions for vertical turning and boring lathes with one or two columns — Testing of accuracy (ISO 3655-1:1976)
NS 5025:1982 Test conditions for vertical turning and boring lathes with one or two columns — Testing of accuracy — General introduction
UNE 15309:2002 Machine-tools. Test conditions for boring and milling machines with horizontal spindle. Testing of the accuracy. Planer type machines with movable column.
UNE 15305:1989 ACCEPTANCE CONDITIONS FOR BORING AND MILLING MACHINES WITH HORIZONTAL SPINDLE. TESTING OF THE ACCURACY. PART 0: GENERAL INTRODUCTION.
BS ISO 3070-4:1998 Test conditions for boring and milling machines with horizontal spindle. Testing of the accuracy-Planer type machines with movable column
BS ISO 3070-2:1997 Test conditions for boring and milling machines with horizontal spindle. Testing of the accuracy-Table-type machines

International Organization for Standardization (ISO)

ISO 6779:2019 Test conditions for vertical internal type broaching machines — Testing of accuracy
ISO/PRF 6779:2018 Test conditions for vertical internal type broaching machines — Testing of accuracy
ISO 6779:2023 Test conditions for vertical internal type broaching machines — Testing of accuracy
ISO 3875:2004 Machine tools - Test conditions for external cylindrical centreless grinding machines - Testing of the accuracy
ISO/FDIS 2407:2023 Test conditions for internal cylindrical grinding machines with horizontal spindle
ISO 4703:1977 Test conditions for surface grinding machines with two columns — Machines for grinding slideways — Testing of accuracy
ISO 2772:2019 Test conditions for box type vertical drilling machines — Testing of the accuracy
ISO/DIS 6779 Test conditions for vertical internal type broaching machines — Testing of accuracy
ISO 6481:2019 Test conditions for vertical surface type broaching machines — Testing of accuracy
ISO 2773:2023 Test conditions for pillar type vertical drilling machines
ISO 2407:1973 Test conditions for internal cylindrical grinding machines with horizontal spindle — Testing of accuracy
ISO 3070-1:1975 Test conditions for boring and milling machines with horizontal spindle — Testing of the accuracy — Part 1: Table type machines
ISO 19744:2020 Test conditions for numerically controlled broaching machines — Testing of accuracy — Vertical surface type broaching machines
ISO 2773:2024 Test conditions for pillar type vertical drilling machines — Testing of accuracy
ISO/DIS 2773 Test conditions for pillar type vertical drilling machines — Testing of the accuracy
ISO 6480:2019 Test conditions for horizontal internal type broaching machines — Testing of accuracy
ISO 3875:2020 Machine tools — Test conditions for external cylindrical centreless grinding machines — Testing of the accuracy
ISO 4703:1984 Acceptance conditions for surface grinding machines with two columns; Machines for grinding slideways; Testing of accuracy
ISO/FDIS 2773:2018 Test conditions for pillar type vertical drilling machines — Testing of the accuracy
ISO 3875:1980 Conditions of acceptance for external cylindrical centreless grinding machines — Testing of the accuracy
ISO 2407:1984 Acceptance conditions for internal cylindrical grinding machines with horizontal spindle; Testing of accuracy
ISO 5734:1978 Test conditions of mechanical dividing heads for machine tools — Testing of the accuracy
ISO 1708:1983 Acceptance conditions for general purpose parallel lathes — Testing of the accuracy

RO-ASRO

STAS 2266-1951 machine tool. slotting machine. Acceptance conditions

Japanese Industrial Standards Committee (JISC)

JIS B 6220:2021 Machine tools -- Test conditions for external cylindrical centreless grinding machines -- Testing of the accuracy
JIS B 6223:1993 Vertical turning and boring lathes -- Test conditions for accuracy
JIS B 6360:1999 Machine tools -- Test conditions for wire electrical discharge machines (wire EDM) -- Terminology and testing of the accuracy
JIS B 6229:1993 Universal tool grinding machines -- Test conditions for accuracy
JIS B 6225:1993 Bed type vertical milling machines -- Test conditions for accuracy
JIS B 6226:1993 Bed type horizontal milling machines -- Test conditions for accuracy
JIS B 6360:2006 Machine tools -- Test conditions for wire electrical-discharge machines (wire EDM) -- Testing of the accuracy
JIS B 6211:2006 Test conditions for internal cylindrical grinding machines with horizontal spindle -- Testing of the accuracy

KR-KS

KS B ISO 2407-2012 Test conditions for internal cylindrical grinding machines with horizontal spindle－Testing of the accuracy
KS B ISO 4703-2022 Test conditions for surface grinding machines with two columns — Machines for grinding slideways — Testing of the accuracy
KS B ISO 6480-2010 Conditions of acceptance for horizontal internal broaching machines－Testing of the accuracy
KS B ISO 6481-2010 Acceptance conditions for vertical surface type broaching machines－Testing of accuracy
KS B ISO 3875-2019 Machine tools — Test conditions for external cylindrical centreless grinding machines — Testing of the accuracy
KS B ISO 1708-2022 Acceptance conditions for general purpose parallel lathes — Testing of the accuracy
KS B ISO 1701-2-2016 Test conditions for milling machines with table of variable hight — Testing of accuracy — Part 2: Machines with vertical spindle
KS B ISO 8636-1-2019(2024) Machine tools — Test conditions for bridge-type milling machines — Testing of the accuracy — Part 1: Fixed bridge(portal-type) machines

British Standards Institution (BSI)

BS 3800-3:1990 General tests for machine tools - Method of testing performance of machines operating under loaded conditions in respect of thermal distortion
BS EN ISO 14155:2011 Clinical investigation of medical devices for human subjects. Good clinical practice
BS ISO 6779:2023 Test conditions for vertical internal type broaching machines. Testing of accuracy
BS ISO 6480:2019 Test conditions for horizontal internal type broaching machines. Testing of accuracy
BS ISO 6779:2019 Test conditions for vertical internal type broaching machines. Testing of accuracy
BS ISO 4703:2001 Test conditions for surface grinding machines with two columns - Machines for grinding slideways - Testing of the accuracy
BS ISO 8636-2:2008 Machine tools - Test conditions for bridge-type milling machines - Testing of the accuracy - Travelling bridge (gantry-type) machines
BS ISO 3070-2:1999 Test conditions for boring and milling machines with horizontal spindle - Testing of the accuracy - Table-type machines
BS ISO 2407:1997 Test conditions for internal cylindrical grinding machines with horizontal spindle - Testing of accuracy
BS ISO 2407:1998 Test conditions for internal cylindrical grinding machines with horizontal spindle. Testing of accuracy
BS ISO 1985:2015 Machine tools — Test conditions for surface grinding machines with vertical grinding wheel spindle and reciprocating table — Testing of the accuracy
BS ISO 2772:2019 Test conditions for box type vertical drilling machines. Testing of the accuracy

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

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)

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)

Lithuanian Standards Office

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

VN-TCVN

TCVN 2002-2008 Conditions of acceptance for horizontal internal broaching machines.Testing of the accuracy
TCVN 7691-2007 Test conditions for surface grinding machines with two columns.Machines for grinding slideways.Testing of the accuracy
TCVN 7688-2007 Test conditions for internal cylindrical grinding machines with horizontal spindle.Testing of accuracy

Standard Association of Australia （SAA）

ISO 2407:1997/Amd.1:2016 Test conditions for internal cylindrical grinding machines with horizontal spindle — Testing of accuracy AMENDMENT 1

Others: Phase I clinical trial,Phase I clinical trial conditions,Phase I Drug Clinical Trials,Phase I Clinical Trial Design