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Overseas clinical trials of medical devices

Overseas clinical trials of medical devices, Total:132 items.

In the international standard classification, Overseas clinical trials of medical devices involves: Quality, Medical equipment, Laboratory medicine, Dentistry, Hospital equipment, Medical sciences and health care facilities in general, Construction materials, Pharmaceutics, Pulps, Sterilization and disinfection.

GOST, Overseas clinical trials of medical devices

• 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

Standard Association of Australia （SAA）, Overseas clinical trials of medical devices

• AS ISO 14155:2002 Clinical investigation of medical devices
• AS ISO 14155.1:2004 Clinical investigations of medical devices for human subjects - General requirements

RU-GOST R, Overseas clinical trials of medical devices

• GOST R 56429-2015 Medical devices. Clinical evaluation
• GOST R ISO 14155-2014 Clinical investigation. Good clinical practice
• GOST R 51352-2013 In vitro diagnostic medical devices. Test methods
• GOST R 55991.7-2014 In vitro diagnostics medical devices. Part 7. Automatic analyzers for general clinical tests. Technical requirements for public procurement
• GOST ISO 10993-5-2011 Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity

Professional Standard - Medicine, Overseas clinical trials of medical devices

• 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
• YY/T 1930-2024 Medical Device Clinical Evaluation Terms and Definitions

Association Francaise de Normalisation, Overseas clinical trials of medical devices

• 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.
• NF S90-463 Medical surgical equipment. Surgical medical instruments. Scissors. Dimensions and tests.
• NF S90-463:1982 Medical and surgical equipment. Surgical instruments. Scissors. Dimensions and tests.
• NF S92-082*NF ISO 20916:2019 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice
• NF S90-481:1987 MEDICO-SURGICAL EQUIPMENT. IMPLANTS FOR SURGERY. CARDIAC PACEMAKERS. PART 2 : REPORTING OF THE CLINICAL PERFORMANCE OF POPULATIONS OF PULSE GENERATORS.

US-AAMI, Overseas clinical trials of medical devices

• 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
• AAMI TIR49-2013 Design of training and instructional materials for medical devices used in non-clinical environments

Danish Standards Foundation, Overseas clinical trials of medical devices

• 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, Overseas clinical trials of medical devices

• 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

German Institute for Standardization, Overseas clinical trials of medical devices

• DIN EN 540:1993 Clinical testing of medical devices on humans
• DIN EN ISO 14155:2020 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 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
• DIN EN 540 Berichtigung 1:1998 Clinical testing of medical devices on humans; German version EN 540: 1993
• 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 14155:2021 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020

British Standards Institution (BSI), Overseas clinical trials of medical devices

• 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 ISO 17593:2022 Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
• 24/30467406 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
• 21/30402425 DC BS ISO 17593. Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for selftesting of oral anticoagulant therapy
• 18/30344902 DC BS EN ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice

European Committee for Standardization (CEN), Overseas clinical trials of medical devices

• 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)
• 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, Overseas clinical trials of medical devices

• OS GSO ISO 14155:2015 Clinical investigation of medical devices for human subjects -- Good clinical practice
• OS GSO ISO 17593:2016 Clinical laboratory testing and in vitro medical devices -- Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
• GSO ISO 17593:2016 Clinical laboratory testing and in vitro medical devices -- Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
• 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
• BH GSO ISO 15198:2017 Clinical laboratory medicine -- In vitro diagnostic medical devices -- Validation of user quality control procedures by the manufacturer
• GSO ISO 14155:2015 Clinical investigation of medical devices for human subjects -- Good clinical practice

Lithuanian Standards Office , Overseas clinical trials of medical devices

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

AT-ON, Overseas clinical trials of medical devices

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

PL-PKN, Overseas clinical trials of medical devices

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

Spanish Association for Standardization (UNE), Overseas clinical trials of medical devices

• UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
• UNE-EN ISO 14155:2021 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
• 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)

SCC, Overseas clinical trials of medical devices

• BS EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects-Clinical investigation plans
• DANSK DS/EN ISO 14155/AC:2011 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
• 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
• 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
• 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 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 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)
• DANSK DS/ISO 15198:2004 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
• 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
• AAMI ST35:2003 Safe Handling and Biological Decontamination of Reusable Medical Devices in Health Care Facilities and in Nonclinical Settings
• NS-EN ISO 14155-2:2003 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)
• 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)

KR-KS, Overseas clinical trials of medical devices

• 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
• KS P ISO 20916-2022 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice

International Organization for Standardization (ISO), Overseas clinical trials of medical devices

• ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plants
• ISO 17593:2022 Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
• 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

Korean Agency for Technology and Standards (KATS), Overseas clinical trials of medical devices

• KS P ISO 14155-2:2007 Clinical investigation of medical devices for human subjects－Part 2：Clinical investigation plans
• 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 14155-2-2007(2012) Clinical investigation of medical devices for human subjects－Part 2：Clinical investigation plans
• KS P ISO 17593-2019 Clinical laboratory testing and in vitro medical devices－Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
• KS P ISO 15198-2022 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
• KS P ISO 14155-2-2019 Clinical investigation of medical devices for human subjects－Part 2：Clinical investigation plans
• KS P ISO TR 18112-2009(2014) 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 manufacture
• KS P ISO 14155-1-2007(2012) Clinical investigation of medical devices for human subjects－Part 1：General requirements
• KS P ISO 14155-1-2019 Clinical investigation of medical devices for human subjects－Part 1：General requirements
• KS P ISO TR 18112-2020 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

NL-NEN, Overseas clinical trials of medical devices

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

GOSTR, Overseas clinical trials of medical devices

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

Group Standards of the People's Republic of China, Overseas clinical trials of medical devices

• T/CGCPU 026-2023 Design specifications for clinical trial protocol of cardiovascular interventional medical devices
• T/CACM 1205-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM impotence disease
• T/CACM 1199-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM fibroadenoma of breast
• T/CACM 1247-2019 Guidelines for clinical diagnosis and treatment of surgery in Chinese medicine—Intestinal obstruction
• T/CACM 1236-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Pressure Ulcers
• T/CACM 1235-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Chilblain
• T/CACM 1153-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Sinus
• T/CACM 1206-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Stone gonorrhea
• T/CACM 1304-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Intestinal abscess
• T/CACM 1185-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Flesh goiter
• T/CACM 1277-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Burn
• T/CACM 1207-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Gynecomastia
• T/CACM 1312-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Cholelithiasis
• T/CACM 1242-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM GuZhong disease
• T/CACM 1150-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Headed Carbuncle
• T/CACM 1139-2018 Traditional Chinese medicine guidelines for the diagnosis and treatment of mental diseases- Dysthymia
• T/CACM 1302-2019 Guidelines for ophthalmology clinical diagnosis and treatment in Chinese medicine—External ophthalmoplegia
• T/CACM 1186-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Comedomastitis
• T/CACM 1202-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Chronic Leg Ulcer
• T/CACM 1287-2019 Clinical guidelines for diagnosis and treatment of gynecology in TCM White Lesions of the Vulva

BE-NBN, Overseas clinical trials of medical devices

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

VN-TCVN, Overseas clinical trials of medical devices

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

Indonesia Standards, Overseas clinical trials of medical devices

• SNI ISO 15198:2009 Clinical laboratory medicine - In vitro diagnostic medical devices - validation of user quality control procedures by the manufacturer

國家藥監局, Overseas clinical trials of medical devices

• YY/T 1808-2021 In vitro skin irritation test for medical devices
• YY/T 1754.1-2020 Preclinical Animal Studies for Medical Devices Part 1: General Requirements

American Society for Testing and Materials (ASTM), Overseas clinical trials of medical devices

• 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

Shanxi Provincial Standard of the People's Republic of China, Overseas clinical trials of medical devices

• DB14/T 2254-2020 Regulations on cold storage and freezing management of clinical in vitro diagnostic reagents in medical institutions

Institute of Electrical and Electronics Engineers (IEEE), Overseas clinical trials of medical devices

• 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

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