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Medical devices must be clinically

Medical devices must be clinically, Total:81 items.

In the international standard classification, Medical devices must be clinically involves: Medical equipment, Quality, Dentistry, Hospital equipment, Laboratory medicine, Pulps, Sterilization and disinfection, Medical sciences and health care facilities in general.

SCC, Medical devices must be clinically

• 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
• NS-EN 540:1993 Clinical investigation of medical devices for human subjects
• 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)
• 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)
• AENOR UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
• 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
• UNE-EN ISO 14155-2:2004 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
• 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
• DANSK DS/EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans

Professional Standard - Medicine, Medical devices must be clinically

• YY/T 0297-1997 Clinical investigation of medical devices

RU-GOST R, Medical devices must be clinically

• GOST R 56429-2015 Medical devices. Clinical evaluation
• GOST R ISO 14155-2014 Clinical investigation. Good clinical practice

GSO, Medical devices must be clinically

• 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

European Committee for Standardization (CEN), Medical devices must be clinically

• prEN 540-1992 Clinical investigation of medical devices for human subjects
• EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
• EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
• EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
• EN ISO 14155-2:2003 Clinical Investigation of Medical Devices for Human Subjects - Part 2: Clinical Investigation Plans ISO 14155-2:2003
• EN 540:1993 Clinical Investigation of Medical Devices for Human Subjects Superseded by EN ISO 14155-1:2003

Association Francaise de Normalisation, Medical devices must be clinically

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

British Standards Institution (BSI), Medical devices must be clinically

• BS EN 540:1993(1998) Clinicalinvestigationof medical devices for human subjects
• 24/30467406 DC BS EN ISO 14155 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
• 18/30344902 DC BS EN ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice
• BS EN ISO 14155:2011 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

KR-KS, Medical devices must be clinically

• KS P ISO 14155-2022 Clinical investigation of medical devices for human subjects — Good clinical practice

ES-UNE, Medical devices must be clinically

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

未注明發(fā)布機(jī)構(gòu), Medical devices must be clinically

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

NL-NEN, Medical devices must be clinically

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

Danish Standards Foundation, Medical devices must be clinically

• DS/EN 540:1993 Clinical investigation of medical devices for human subjects
• DS/EN ISO 14155:2013 Clinical investigation of medical devices for human subjects - Good clinical practice
• DS/ISO 17664-2:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Non-critical medical devices

GOST, Medical devices must be clinically

• GOST R ISO 14155-2022 Clinical investigation of medical devices for human subjects. Good clinical practice
• GOST R ISO 14155-2-2008 Clinical investigation of medical devices for human subjects. Part 2. Clinical investigation plans
• GOST R 56429-2021 Medical devices. Clinical еvaluation

German Institute for Standardization, Medical devices must be clinically

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

Korean Agency for Technology and Standards (KATS), Medical devices must be clinically

• 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 14155-2:2007 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 14155-1-2019 Clinical investigation of medical devices for human subjects－Part 1：General requirements

International Organization for Standardization (ISO), Medical devices must be clinically

• ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
• ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plants
• ISO 14155:2011/cor 1:2011 Clinical investigation of medical devices for human subjects - Good clinical practice; Technical Corrigendum 1
• ISO 14155:1996 Clinical investigation of medical devices

US-AAMI, Medical devices must be clinically

• 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

IT-UNI, Medical devices must be clinically

• 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

VN-TCVN, Medical devices must be clinically

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

Standard Association of Australia （SAA）, Medical devices must be clinically

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

Lithuanian Standards Office , Medical devices must be clinically

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

AT-ON, Medical devices must be clinically

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

AENOR, Medical devices must be clinically

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

PL-PKN, Medical devices must be clinically

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

BE-NBN, Medical devices must be clinically

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

國家藥監(jiān)局, Medical devices must be clinically

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

American Society for Testing and Materials (ASTM), Medical devices must be clinically

• 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 devices must be clinically

• 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

Group Standards of the People's Republic of China, Medical devices must be clinically

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

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