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Clinical Trial Requirements for Medical Devices

Clinical Trial Requirements for Medical Devices, Total:136 items.

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

GOST, Clinical Trial Requirements for Medical Devices

• GOST R ISO 14155-1-2008 Clinical investigation of medical devices for human subjects. Part 1. General requirements
• 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

SCC, Clinical Trial Requirements for Medical Devices

• BS EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects-General requirements
• DANSK DS/EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects - Part 1: General requirements
• 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/EN ISO 14155/AC:2011 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
• 08/30116059 DC BS ISO 14155. 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
• 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)
• NS-EN ISO 14155-1:2003 Clinical investigation of medical devices for human subjects — Part 1: General requirements (ISO 14155-1:2003)
• 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)
• NS-EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
• AAMI/ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (Includes Erratum, 2011)
• 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 15198:2004 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
• DANSK DS/EN 556-1/AC:2006 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
• AENOR UNE-EN 556-2:2016 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
• NS-EN 556-2:2003 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 2: Requirements for aseptically processed medical devices
• NS-EN 556-2:2015 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 2: Requirements for aseptically processed medical devices
• NS-EN 556-1:2001 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1: Requirements for terminally sterilized medical devices
• DANSK DS/EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
• DANSK DS/EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices

Standard Association of Australia （SAA）, Clinical Trial Requirements for 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

Professional Standard - Medicine, Clinical Trial Requirements for 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 91056-1999 Evaluating requirements for corrosion test of electroplated metallic coatings of medical instruments

RU-GOST R, Clinical Trial Requirements for Medical Devices

• 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

Association Francaise de Normalisation, Clinical Trial Requirements for 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 EN 50637:2017 Electromedical devices - Special basic safety and essential performance requirements of medical beds for children
• NF EN 556-1:2002 Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage STERILE - Partie 1 : exigences relatives aux dispositifs médicaux stérilisés au stade terminal

IT-UNI, Clinical Trial Requirements for 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

Danish Standards Foundation, Clinical Trial Requirements for 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

US-AAMI, Clinical Trial Requirements for 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

German Institute for Standardization, Clinical Trial Requirements for 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 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)
• 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
• DIN EN 556-2:2015-11 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2015 / Note: To be replaced by DIN EN 556-2 (2023-02).
• DIN EN 556-1:2023-02 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German and English version prEN 556-1:2023 / Note: Date of issue 2023-01-06*Intended as r...
• DIN EN 556-1:2002-03 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001 / Note: To be replaced by DIN EN 556-1 (2023-02).
• DIN EN 556-1 Berichtigung 1:2006-12 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001, Corrigenda to DIN EN 556-1:2002-03; German version EN 556-1...
• DIN EN 556-2:2023-02 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: requirements for aseptically processed medical devices; German and English version prEN 556-2:2023 / Note: Date of issue 2023-01-06*Intended as r...
• DIN EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices

British Standards Institution (BSI), Clinical Trial Requirements for 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
• BS EN ISO 14155-1:2003 Clinical investigation of medical devices for human subjects - General requirements
• BS EN 556-1:2024 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for terminally sterilized medical devices
• BS EN 556-2:2015 Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'. Requirements for aseptically processed medical devices
• BS EN 60598-2-25:1995 Luminaires - Particular requirements - Luminaires for use in clinical areas of hospitals and health care buildings
• BS EN 556-1:2001(2006) Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1 : Requirements for terminally sterilized medical devices

European Committee for Standardization (CEN), Clinical Trial Requirements for 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, Clinical Trial Requirements for 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 14155:2015 Clinical investigation of medical devices for human subjects -- Good clinical practice
• OS GSO ISO 15198:2016 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
• BH GSO ISO 15198:2017 Clinical laboratory medicine -- In vitro diagnostic medical devices -- Validation of user quality control procedures by the manufacturer

AT-ON, Clinical Trial Requirements for Medical Devices

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

Lithuanian Standards Office , Clinical Trial Requirements for Medical Devices

• LST EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
• LST EN 556-1-2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
• LST EN 556-2-2004 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices

PL-PKN, Clinical Trial Requirements for Medical Devices

• PN-EN ISO 14155-2021-02 E Clinical investigation of medical devices for human subjects -- Good clinical practice (ISO 14155:2020)
• PN Z54058-1990 Medical instruments Needle holders Re?uirements and tests
• PN Z54032-1989 Medical instruments Haemostatic forceps Re?uirements and tests

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

• KS P ISO 14155-1-2007(2012) Clinical investigation of medical devices for human subjects－Part 1：General requirements
• KS P ISO 14155-2:2007 Clinical investigation of medical devices for human subjects－Part 2：Clinical investigation plans
• KS P ISO 14155-1-2019 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 14155-2-2007(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 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 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 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
• KS P ISO 15198-2022 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer

Spanish Association for Standardization (UNE), Clinical Trial Requirements for 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 14155-1:2009 Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
• UNE-EN ISO 14155-1:2003 Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
• 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 556-1:2002/AC:2007 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
• UNE-EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
• UNE-EN 556-2:2016 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices

KR-KS, Clinical Trial Requirements for 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

International Organization for Standardization (ISO), Clinical Trial Requirements for 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

國家藥監局, Clinical Trial Requirements for Medical Devices

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

NL-NEN, Clinical Trial Requirements for Medical Devices

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

Group Standards of the People's Republic of China, Clinical Trial Requirements for Medical Devices

• T/CGCPU 026-2023 Design specifications for clinical trial protocol of cardiovascular interventional medical devices
• T/CACM 1063~1064-2018 Acupuncture Medicine Clinical Basic Terminology Acupuncture Medicine Clinical General Requirements

BE-NBN, Clinical Trial Requirements for Medical Devices

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

VN-TCVN, Clinical Trial Requirements for Medical Devices

• TCVN 7740-1-2007 Clinical investigation of medical devices for human subjects.Part 1: General requirements
• TCVN 7740-2-2007 Clinical investigation of medical devices for human subjects.Part 2: Clinical investigation plans

GOSTR, Clinical Trial Requirements for Medical Devices

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

US-FCR, Clinical Trial Requirements for Medical Devices

• FCR 21 CFR PART 821-2015 MEDICAL DEVICE TRACKING REQUIREMENTS

American Society for Testing and Materials (ASTM), Clinical Trial Requirements for 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

Institute of Electrical and Electronics Engineers (IEEE), Clinical Trial Requirements for 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

Professional Standard - Hygiene , Clinical Trial Requirements for Medical Devices

• WS/T 255-2005 Clinical laboratory medicine Reguirements for reference measurement laboratories

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