single-arm clinical trial

single-arm clinical trial, Total:158 items.

The international standard classification for "single-arm clinical trial" includes: Dental materials , Drilling machines , Laboratory medicine , Boring and milling machines , Planing machines , Medical Sciences and health care facilities in general .

The Chinese standard classification for "single-arm clinical trial" includes: Stomatologic device, equipment and material , Drilling, boring and milling machine , Sanitation in general , Slotting, broaching, planing and sawing machines , Legal medical expert .

Group Standards of the People's Republic of China

T/CGCPU 022-2023 Evaluation criteria for information management of clinical trials
T/CGCPU 002-2023 Evaluation standard of centralized management of clinical investigational product
T/CGCPU 013-2020 Ethical Considerations for Subject Pain Management in Clinical Trials
T/CGCPU 008-2019 General Auditing Standards for Clinical Trials
T/CGCPU 029-2023 Evaluation requirements of follow-up centers for primary clinical trials
T/CGCPU 005-2019 Clinical Trial Professional Group Competence Evaluation Criteria
T/CGCPU 006-2019 Phase I Clinical Trial Capacity Evaluation Criteria
T/SSFSIDC 015-2023 Clinical trial data collection requirements
T/CGCPU 014-2020 The practices of chemicals for clinical trials in clinical trial institutions
T/CGCPU 012-2020 File management standards for clinical trial institutions
T/CGCPU 020-2022 Guidelines for the management of pain in clinical trial subjects in the pediatric population
T/CGCPU 006-2023 Specification for competency assessment of phase I clinical trials
T/CGCPU 022-2022 Evaluation criteria for information management of clinical trials
T/CGCPU 023-2022 Evaluation standard for clinical trial management system document
T/CGCPU 005-2023 Specification for competency assessment of the clinical trial professional group
T/CAV 007-2024 Guidelines for site selection of prophylactic vaccine clinical trial
T/CGCPU 024-2022 Specification for training management of practitioners in clinical trial institution
T/CQAP 3013-2023 Key points for quality inspection of clinical trial data management
T/CGCPU 024-2023 Specification for training management of practitioners in clinical trial institution
T/CGCPU 012-2023 Evaluation specifications for archives management of clinical trial institutions
T/SAME 003-2021 Norm for establishment of clinical laboratory of measurement integrity
T/CGCPU 015-2020 Requirements for Subjects Risk Monitoring system in clinical trials
T/CGCPU 023-2023 Evaluation standard for clinical trial management system document
T/SHDSGY 066-2023 Inspection service specification of clinical trial research center
T/CGCPU 003-2023 Specification for capacity evaluation of clinical trial institutions
T/CGCPU 003-2019 Clinical Trial Institution Capacity Evaluation Standards

Professional Standard - Medicine

YY/T 0990-2015 Clinical trial guideline for polymer-based dental restorative materials
YY/T 1305-2015 Clinical trial guideline for titanium and titanium alloy dental implant
YY/T 0991-2015 Clinical trial guideline for orthodontic brackets

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
GB/T 20469-2006 General guideline of the clinical laboratory design
GB/T 4017-1997 Radial drilling machines--Testing of the accuracy

Professional Standard - Machinery

JB/T 9897-2011 Nothingness-bed-type universal radial drilling machines — Testing of the accuracy
JB/T 2732.2-2008 Cantilever and portal-type planers—Part 2：Testing of the accurary
JB/T 9898-1999 Slide Block Universal Radial Drilling Machines Accuracy Inspection
JB/T 8333.1-2011 Portable cantilever and portal-type planers — Part 1：Testing of the accuracy
JB/T 3697.1-2011 Radial milling machine — Part 1：Testing of accuracy
JB/T 9898-2013 Traveling-type universal radial drilling machines-Testing of the accuracy
JB/T 3697.1-1999 Radial milling machine Accuracy inspection
JB/T 9899-2014 Portable Universal Radial Drilling Machines - Testing of the Accuracy
JB/T 9897-1999 Baseless universal radial drilling machines Accuracy inspection
JB/T 9899-1999 Portable Universal Radial Drilling Machines - Testing of the Accuracy

Professional Standard - Hygiene

WS/T 250-2005 Requirements of Quality Assurance for Clinical Laboratories
WS/T 420-2013 Verification of analytical performance of quantitative kits by clinical laboratory
WS/T 402-2012 Define and determine the reference intervals in clinical laboratory
WS/T 834-2024 Clinical application of tests for Toxoplasma gondii
WS/T 251-2005 Guidelines for Clinical Laboratory Safety

卫生健康委员会

WS/T 574-2018 Purified reagent water in the clinical laboratory
WS/T 662-2020 Technical requirements for clinical body fluids analysis
WS/T 644-2018 Clinical laboratory quality evaluation

Zhejiang Provincial Standard of the People's Republic of China

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

司法部

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

Professional Standard - Certification and Accreditation

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

Professional Standard - Public Safety Standards

GA/T 1970-2021 Specifications for clinical forensic examination

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
WS/T 228-2002 Preliminary evaluation of quantitative clinical laboratory methods

Taiwan Provincial Standard of the People's Republic of China

CNS 96-1993 Test Code for Performance and Accuracy of Radial Drilling Machines

Professional Standard - Agriculture

农业部1247号公告-6-2009 Guiding principles for preclinical toxicology evaluation tests of veterinary drugs
农业部1596号公告-2-2011 Writing principles of clinical trial reports of traditional Chinese medicine and natural medicine for veterinary use

未注明发布机构

DIN EN 540:1993 Clinical testing of medical devices on humans

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
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 ISO 14155-2014 Clinical investigation. Good clinical practice
GOST R 53022.4-2008 Medical laboratory technologies. Requirement of quality of clinical laboratory tests. Part 4. Rules for development of requirements to timeliness of laboratory information submitting
GOST R 56701-2015 Medicines for medical applications. Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals
GOST ISO 16037-2014 Rubber condoms for clinical trials. Determination of physical properties
GOST R 54328-2011 Dentistry. Preclinical evaluation of dental implant systems. Animal test methods
GOST R 51088-1997 Kits of reagents for clinical laboratory diagnostics. General specifications
GOST R 53079.2-2008 Medical laboratory technologies. Quality assurance of clinical laboratory tests. Part 2. Guidelines for improvements of quality in clinical-diagnostic laboratory. Typical model
GOST R 53022.2-2008 Clinical laboratory technologies. Requirements for quility of clinical laboratory tests. Part 2. Assessment of methods analytical reliability (accuracy, censitivity, specificity)
GOST R 53133.1-2008 Clinical laboratory technologies. Quality control of clinical laboratory tests. Part 1. Limits of allowable errors of the results of the analyte measurements in clinical-diagnostics laboratories

Japanese Industrial Standards Committee (JISC)

JIS B 6208:1993 Radial drilling machines -- Test conditions for geometric accuracy and rigidity
JIS B 6208:1998 Radial drilling machines -- Testing of the accuracy

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

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 E2045-99 Standard Practice for Detailed Clinical Observations of Test Animals
ASTM E2045-99(2003) Standard Practice for Detailed Clinical Observations of Test Animals
ASTM E2045-99(2009) Standard Practice for Detailed Clinical Observations of Test Animals
ASTM F3037-15 Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs)

German Institute for Standardization

DIN 8625-1:1976 Machine Tools; Radial Drilling Machines with Adjustable Arm; Acceptance conditions
DIN EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

Association Francaise de Normalisation

NF E60-131*NF ISO 2423:1996 Acceptance conditions for radial drilling machines with arm adjustable in height. Testing of accuracy.
NF S99-201*NF EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
NF ISO 2423:1996 Acceptance conditions for radial drilling machines with height-movable arm - Precision control
NF S97-045*NF ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties
NF ISO 16037:2002 Préservatifs masculins en caoutchouc destinés aux essais cliniques - Mesurage des propriétés physiques

GSO

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
GSO ISO 2423:2016 Acceptance conditions for radial drilling machines with the arm adjustable in height -- Testing of accuracy
OS GSO ISO 2423:2016 Acceptance conditions for radial drilling machines with the arm adjustable in height -- Testing of accuracy
BH GSO ISO 2423:2017 Acceptance conditions for radial drilling machines with the arm adjustable in height -- Testing of accuracy
OS GSO ISO 16037:2009 Rubber condoms for clinical trials – Measurement of physical properties
OS GSO 1647:2002 Methods of testing and verification for Clinical electrical thermometers with maximum device

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

Danish Standards Foundation

DS/EN ISO 14155:2013 Clinical investigation of medical devices for human subjects - Good clinical practice
DS/ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties

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
UNI 5402-1979 Lathe acceptance regulations. Radial drilling machine
UNI 5403-1964 Lathe acceptance regulations. Portable universal radial drill press

VN-TCVN

TCVN 3587-2008 Acceptance conditions for radial drilling machines with the arm adjustable in height.Testing of accuracy

British Standards Institution (BSI)

BS EN ISO 14155:2011 Clinical investigation of medical devices for human subjects. Good clinical practice
BS 4656-10:1975 Specification for the accuracy of machine tools and methods of test - Drilling machines, radial type
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

European Committee for Standardization (CEN)

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

AT-ON

OENORM EN ISO 14155:2021 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
ONORM M 9012-1996 Machine tools - Acceptance conditions for radial drilling machines with adjustable arm

AENOR

UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
UNE 15310:1990 RADIAL DRILLING MACHINES WITH ADJUSTABLE ARM IN HEIGHT. ACCURACY CONTROL.

Korean Agency for Technology and Standards (KATS)

KS B 4035-2007 Radial drilling machines－Testing of the accuracy
KS B ISO 2423-2013 Acceptance conditions for radial drilling machines with the arm adjustable in height－Testing of the accuracy
KS B 4035-1972 Radial drilling machines－Testing of the accuracy
KS B 4035-2001(2006) Radial drilling machines－Testing of the accuracy
KS B ISO 2423:2009 Acceptance conditions for radial drilling machines with the arm adjustable in height-Testing of the accuracy
KS B ISO 2423:2013 Acceptance conditions for radial drilling machines with the arm adjustable in height－Testing of the accuracy
KS M ISO 16037-2023 Rubber condoms for clinical trials — Measurement of physical properties
KS M ISO 16037:2008 Rubber condoms for clinical trials-Measurement of physical properties
KS P ISO 14155-2:2007 Clinical investigation of medical devices for human subjects－Part 2：Clinical investigation plans
KS M ISO 16037:2018 Rubber condoms for clinical trials — Measurement of physical properties
KS P ISO 14155:2019 Clinical investigation of medical devices for human subjects — Good clinical practice

IN-BIS

IS 2199-1989 Radial Drilling Machine—Test Picture
IS 2877-1974 Single and double column planer test drawings

KR-KS

KS B ISO 2423-2009 Acceptance conditions for radial drilling machines with the arm adjustable in height－Testing of the accuracy
KS M ISO 16037-2018(2023) Rubber condoms for clinical trials — Measurement of physical properties
KS M ISO 16037-2018 Rubber condoms for clinical trials — Measurement of physical properties
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

PL-PKN

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

Canadian General Standards Board （CGSB)

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

ASHRAE - American Society of Heating@ Refrigerating and Air-Conditioning Engineers@ Inc.

ASHRAE NO-94-29-1994 Validation of Pharmaceutical Clinical Supply Laboratories

International Organization for Standardization (ISO)

ISO 2423:1982 Acceptance conditions for radial drilling machines with the arm adjustable in height; Testing of accuracy
ISO 2423:1974 Title missing - Legacy paper document
ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties
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 22911:2016 Dentistry - Preclinical evaluation of dental implant systems - Animal test methods

BE-NBN

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

ZA-SANS

SANS 16037:2003 Rubber condoms for clinical trials - Measurement of physical properties

SCC

DANSK DS/ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties
DANSK DS/ISO 14155:2020 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
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
DANSK DS/EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
ASTM STP 1008-89 Femoral Intramedullary Rods: Clinical Performance and Related Laboratory Testing

SE-SIS

SIS SS-ISO 2423:1986 Acceptance conditions for radial drilling machines with the arm adjust- able in height - Testing of accuracy

ES-UNE

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

ES-AENOR

UNE 16-148-1985 Tool durability test for single-cut lathes

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