ZH
KR
JP
ES
RU
DE

Medical Device Clinical Trial Technology

Medical Device Clinical Trial Technology, Total:100 items.

In the international standard classification, Medical Device Clinical Trial Technology involves: Medical equipment, Quality, Laboratory medicine, Dentistry, Hospital equipment, Medical sciences and health care facilities in general, Construction materials, Pulps, Sterilization and disinfection.

Professional Standard - Medicine, Medical Device Clinical Trial Technology

• YY/T 0297-1997 Clinical investigation of medical devices
• YY/T 0690-2008 Clinical laboratory testing and in vitro medical devices -- Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

RU-GOST R, Medical Device Clinical Trial Technology

• GOST R 56429-2015 Medical devices. Clinical evaluation
• GOST R ISO 14155-2014 Clinical investigation. Good clinical practice
• GOST R 55991.7-2014 In vitro diagnostics medical devices. Part 7. Automatic analyzers for general clinical tests. Technical requirements for public procurement
• 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

SCC, Medical Device Clinical Trial Technology

• AS ISO 14155:2002 Clinical investigation of medical devices
• BS EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects-Clinical investigation plans
• ISO 14155:2020 Plus Redline 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
• AAMI/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
• 08/30116059 DC BS ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice
• BS EN 540:1993 Clinical investigation of medical devices for human subjects
• NS-EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
• NS-EN 540:1993 Clinical investigation of medical devices for human subjects
• AENOR UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
• DANSK DS/EN ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2020)
• NS-EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
• BS EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects-General requirements
• 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
• DANSK DS/EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
• NS-EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans (ISO 14155-2:2003)
• UNE-EN ISO 14155-2:2004 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
• AAMI/ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (Includes Erratum, 2011)
• UNE-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 14155-1:2009 Clinical investigation of medical devices for human subjects - Part 1: General requirements
• 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/ISO 17593:2007 Clinical laboratory testing and in vitro medical devices – Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
• DANSK DS/ISO 15198:2004 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer

GOST, Medical Device Clinical Trial Technology

• GOST R ISO 14155-2-2008 Clinical investigation of medical devices for human subjects. Part 2. Clinical investigation plans
• GOST R ISO 14155-2022 Clinical investigation of medical devices for human subjects. Good clinical practice
• GOST R ISO 14155-1-2008 Clinical investigation of medical devices for human subjects. Part 1. General requirements

Association Francaise de Normalisation, Medical Device Clinical Trial Technology

• NF S99-201*NF EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
• NF S99-201:1993 Clinical investigation of medical devices for human subjects.

International Organization for Standardization (ISO), Medical Device Clinical Trial Technology

• ISO 14155:2011/cor 1:2011 Clinical investigation of medical devices for human subjects - Good clinical practice; Technical Corrigendum 1
• ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plants
• ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
• ISO 17593:2022 Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

未注明發布機構, Medical Device Clinical Trial Technology

• DIN EN 540:1993 Clinical testing of medical devices on humans
• DIN EN 540 Berichtigung 1:1998 Clinical testing of medical devices on humans; German version EN 540: 1993
• 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)

Danish Standards Foundation, Medical Device Clinical Trial Technology

• DS/EN ISO 14155:2013 Clinical investigation of medical devices for human subjects - Good clinical practice
• DS/EN 540:1993 Clinical investigation of medical devices for human subjects

IT-UNI, Medical Device Clinical Trial Technology

• 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

British Standards Institution (BSI), Medical Device Clinical Trial Technology

• BS EN ISO 14155:2011 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
• BS EN 540:1993(1998) Clinicalinvestigationof medical devices for human subjects
• BS EN ISO 14155:2020 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
• 18/30344902 DC BS EN ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice
• BS ISO 17593:2022 Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

US-AAMI, Medical Device Clinical Trial Technology

• 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

European Committee for Standardization (CEN), Medical Device Clinical Trial Technology

• 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)
• prEN 540-1992 Clinical investigation of medical devices for human subjects
• EN ISO 14155-2:2003 Clinical Investigation of Medical Devices for Human Subjects - Part 2: Clinical Investigation Plans ISO 14155-2:2003
• EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
• EN 540:1993 Clinical Investigation of Medical Devices for Human Subjects Superseded by EN ISO 14155-1:2003

GSO, Medical Device Clinical Trial Technology

• 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
• BH GSO ISO 15198:2017 Clinical laboratory medicine -- In vitro diagnostic medical devices -- Validation of user quality control procedures by the manufacturer
• GSO ISO 15198:2016 Clinical laboratory medicine -- In vitro diagnostic medical devices -- Validation of user quality control procedures by the manufacturer
• OS GSO ISO 15198:2016 Clinical laboratory medicine -- In vitro diagnostic medical devices -- Validation of user quality control procedures by the manufacturer

AT-ON, Medical Device Clinical Trial Technology

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

Lithuanian Standards Office , Medical Device Clinical Trial Technology

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

German Institute for Standardization, Medical Device Clinical Trial Technology

• DIN EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
• 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 14155:2024 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 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020

AENOR, Medical Device Clinical Trial Technology

• UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

PL-PKN, Medical Device Clinical Trial Technology

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

KR-KS, Medical Device Clinical Trial Technology

• KS P ISO 14155-2022 Clinical investigation of medical devices for human subjects — Good clinical practice
• KS P ISO 15198-2017 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer

ES-UNE, Medical Device Clinical Trial Technology

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

Korean Agency for Technology and Standards (KATS), Medical Device Clinical Trial Technology

• KS P ISO 14155-2:2007 Clinical investigation of medical devices for human subjects－Part 2：Clinical investigation plans
• 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 14155-1-2007(2012) Clinical investigation of medical devices for human subjects－Part 1：General requirements
• KS P ISO 17593-2009(2019) Clinical laboratory testing and in vitro medical devices－Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
• KS P ISO 14155-1-2019 Clinical investigation of medical devices for human subjects－Part 1：General requirements
• KS P ISO 15198-2022 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer

NL-NEN, Medical Device Clinical Trial Technology

• NEN-EN 540-1994 Clinical investigation of medical devices for human subjects

Group Standards of the People's Republic of China, Medical Device Clinical Trial Technology

• T/CGCPU 026-2023 Design specifications for clinical trial protocol of cardiovascular interventional medical devices

BE-NBN, Medical Device Clinical Trial Technology

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

Beijing Provincial Standard of the People's Republic of China, Medical Device Clinical Trial Technology

• DB11/T 1864-2021 Technical Guidelines for Clinical Nutrition in Medical Institutions
• DB11/T 1794-2020 Technical specifications for clinical blood use in medical institutions

Standard Association of Australia （SAA）, Medical Device Clinical Trial Technology

• AS ISO 14155.1:2004 Clinical investigations of medical devices for human subjects - General requirements

VN-TCVN, Medical Device Clinical Trial Technology

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

GOSTR, Medical Device Clinical Trial Technology

• GOST R ISO 15198-2009 Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user control procedures by the manufacturer

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Medical Device Clinical Trial Technology

• GB/T 16751.1-1997 Clinic terminology of traditional Chinese medical diagnosis and treatment--Disease
• GB/T 16751.2-1997 Clinic terminology of traditional Chinese medical diagnosis and treatment--Syndromes
• GB/T 16751.3-1997 Clinic terminology of traditional Chinese medical diagnosis and treatment--Therapeutic methods

國家藥監局, Medical Device Clinical Trial Technology

• YY/T 1754.1-2020 Preclinical Animal Studies for Medical Devices Part 1: General Requirements

American Society for Testing and Materials (ASTM), Medical Device Clinical Trial Technology

• ASTM D817-96(2004)e1 Standard Test Methods of Testing Cellulose Acetate Propionate and Cellulose Acetate Butyrate
• ASTM D8179-18 Standard Guide for Characterizing Detergents for the Cleaning of Clinically-used Medical Devices

Institute of Electrical and Electronics Engineers (IEEE), Medical Device Clinical Trial Technology

• Ethically Aligned Design - A Vision for Prioritizing Human Well-being with Autonomous and Intelligen Ethically Aligned Design - A Vision for Prioritizing Human Well-being with Autonomous and Intelligent Systems

Others:   Medical Device Clinical Trials, Medical Devices for Clinical Trials, Clinical Trial Requirements for Medical Devices, Medical Device Clinical Trial Technology, Medical Device Technology Development, Technical Requirements for Medical Devices, Technical Requirements for Medical Devices, Overseas clinical trials of medical devices, Class III Medical Device Clinical Trials, Medical Device Technology, Overseas clinical trials of medical devices, Frontiers of Medical Device Technology, Clinical Trial Medical Devices, Medical Device Clinical Trials, Three categories of medical device clinical trials, Clinical Trial Medical Devices, Technical Requirements for Medical Devices, Dental medical device clinical trials, for medical devices for clinical trials in vitro testing, Overseas clinical trial medical devices.