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Class II medical device clinical research

Class II medical device clinical research, Total:49 items.

In the international standard classification, Class II medical device clinical research involves: Dentistry, Medical equipment, Hospital equipment, Laboratory medicine.

European Committee for Standardization (CEN), Class II medical device clinical research

• prEN 540-1992 Clinical investigation of medical devices for human subjects
• EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
• 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)
• EN 540:1993 Clinical Investigation of Medical Devices for Human Subjects Superseded by EN ISO 14155-1:2003
• prEN ISO 20916:2021 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)
• FprEN ISO 20916 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)

Association Francaise de Normalisation, Class II medical device clinical research

• 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
• NF S92-082*NF ISO 20916:2019 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice
• NF ISO 20916:2019 Dispositifs médicaux de diagnostic in vitro - Études des performances cliniques utilisant des prélèvements de sujets humains - Bonnes pratiques d'étude

未注明发布机构, Class II medical device clinical research

• BS EN 540:1993(1998) Clinicalinvestigationof medical devices for human subjects

Korean Agency for Technology and Standards (KATS), Class II medical device clinical research

• KS P ISO 14155-2-2007(2012) 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

NL-NEN, Class II medical device clinical research

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

ES-UNE, Class II medical device clinical research

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

KR-KS, Class II medical device clinical research

• KS P ISO 14155-2022 Clinical investigation of medical devices for human subjects — Good clinical practice
• KS P ISO 20916-2022 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice

Danish Standards Foundation, Class II medical device clinical research

• 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

RU-GOST R, Class II medical device clinical research

• GOST R ISO 14155-2014 Clinical investigation. Good clinical practice

VN-TCVN, Class II medical device clinical research

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

British Standards Institution (BSI), Class II medical device clinical research

• 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
• 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 ISO 20916:2019 In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice

International Organization for Standardization (ISO), Class II medical device clinical research

• 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

German Institute for Standardization, Class II medical device clinical research

• 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 14155:2020 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
• DIN EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003); English version of DIN EN ISO 14155-2:2009-11
• DIN EN ISO 20916:2021-05 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019); German and English version prEN ISO 20916:2021 / Note: Date of issue 2021-04-09

US-AAMI, Class II medical device clinical research

• 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, Class II medical device clinical research

• UNI EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
• EC 1-2020 UNI EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice

AT-ON, Class II medical device clinical research

• OENORM EN ISO 14155:2021 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
• OENORM EN ISO 20916:2021 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)

Lithuanian Standards Office , Class II medical device clinical research

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

PL-PKN, Class II medical device clinical research

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

AENOR, Class II medical device clinical research

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

国家药监局, Class II medical device clinical research

• YY/T 1754.1-2020 Preclinical Animal Studies for Medical Devices Part 1: General Requirements
• YY/T 1754.2-2020 Medical Device Preclinical Animal Studies Part 2: Induced Diabetic Rat Skin Defect Model

IX-EU/EC, Class II medical device clinical research

• MEDDEV 2.7.2-2008 GUIDELINES ON MEDICAL DEVICES GUIDE FOR COMPETENT AUTHORITIES IN MAKING AN ASSESSMENT OF CLINICAL INVESTIGATION NOTIFICATION

Standard Association of Australia （SAA）, Class II medical device clinical research

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

Professional Standard - Medicine, Class II medical device clinical research

• YY/T 1754.3-2023 Preclinical Animal Studies of Medical Devices Part 3: An Animal Incisional Hernia Model for Evaluation of Mesh Histological Response and Biomechanical Properties

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