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Device clinical

Device clinical, Total:36 items.

In the international standard classification, Device clinical involves: Quality, Medical equipment, Laboratory medicine, Dentistry, Hospital equipment.

RU-GOST R, Device clinical

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

Professional Standard - Medicine, Device clinical

• YY/T 0297-1997 Clinical investigation of medical devices
• YY/T 1281-2015 Dentistry.Implants.Clinical performance of hand torque instruments

Danish Standards Foundation, Device clinical

• 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

International Organization for Standardization (ISO), Device clinical

• 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), Device clinical

• 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

European Committee for Standardization (CEN), Device clinical

• EN 540:1993 Clinical Investigation of Medical Devices for Human Subjects Superseded by EN ISO 14155-1:2003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

国家药监局, Device clinical

• 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

VN-TCVN, Device clinical

• 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

PL-PKN, Device clinical

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

Association Francaise de Normalisation, Device clinical

• NF S99-201:1993 Clinical investigation of medical devices for human subjects.
• NF EN ISO 11953:2010 Médecine bucco-dentaire - Implants - Performances cliniques des instruments de serrage
• NF S99-201*NF EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice

未注明发布机构, Device clinical

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

NL-NEN, Device clinical

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

EU/EC - European Union/Commission Legislative Documents, Device clinical

• MEDDEV 2.7/3-2010 GUIDELINES ON MEDICAL DEVICES CLINICAL INVESTIGATIONS: SERIOUS ADVERSE EVENT REPORTING UNDER DIRECTIVES 90/385/EEC AND 93/42/EEC.
• MEDDEV 2.7/1-2016 GUIDELINES ON MEDICAL DEVICES CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC (Rev 4)
• MEDDEV 2.7.1 APP 1-2008 GUIDELINES ON MEDICAL DEVICES EVALUATION OF CLINICAL DATA - A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES - Appendix 1 : Clinical Evaluation of Coronary Stents (Rev 3)

ES-UNE, Device clinical

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

KR-KS, Device clinical

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

Standard Association of Australia （SAA）, Device clinical

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

German Institute for Standardization, Device clinical

• 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 14155:2021-05 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020

US-AAMI, Device clinical

• 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, Device clinical

• 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

British Standards Institution (BSI), Device clinical

• 18/30344902 DC BS EN ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice

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