ZH
KR
JP
ES
RU
DE

Phase I Clinical Study of Medical Devices

Phase I Clinical Study of Medical Devices, Total:65 items.

In the international standard classification, Phase I Clinical Study of Medical Devices involves: Laboratory medicine, Dentistry, Medical equipment, Hospital equipment.

SCC, Phase I Clinical Study of Medical Devices

• 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
• BS EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects-General requirements
• 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
• 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
• 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 14155-2:2003 Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans (ISO 14155-2:2003)
• UNE-EN ISO 14155-2:2004 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
• 08/30116059 DC BS ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice
• DANSK DS/EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects - Part 1: General requirements
• NS-EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
• AENOR UNE-EN ISO 14155:2012 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)
• DANSK DS/EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
• 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 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
• NS-EN ISO 14155-2:2009 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)

European Committee for Standardization (CEN), Phase I Clinical Study of Medical Devices

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• EN 540:1993 Clinical Investigation of Medical Devices for Human Subjects Superseded by EN ISO 14155-1:2003

British Standards Institution (BSI), Phase I Clinical Study of Medical Devices

• 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 14155:2020 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

Korean Agency for Technology and Standards (KATS), Phase I Clinical Study of Medical Devices

• 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 14155-1-2007(2012) Clinical investigation of medical devices for human subjects－Part 1：General requirements

Association Francaise de Normalisation, Phase I Clinical Study of Medical Devices

• 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

NL-NEN, Phase I Clinical Study of Medical Devices

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

GSO, Phase I Clinical Study of Medical Devices

• OS GSO ISO 14155:2015 Clinical investigation of medical devices for human subjects -- Good clinical practice

KR-KS, Phase I Clinical Study of Medical Devices

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

ES-UNE, Phase I Clinical Study of Medical Devices

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

Danish Standards Foundation, Phase I Clinical Study of Medical Devices

• 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

VN-TCVN, Phase I Clinical Study of Medical Devices

• 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

未注明發(fā)布機構, Phase I Clinical Study of Medical Devices

• 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)

German Institute for Standardization, Phase I Clinical Study of Medical Devices

• 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

International Organization for Standardization (ISO), Phase I Clinical Study of Medical Devices

• 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

GOST, Phase I Clinical Study of Medical Devices

• GOST R ISO 14155-2022 Clinical investigation of medical devices for human subjects. Good clinical practice

IT-UNI, Phase I Clinical Study 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

RU-GOST R, Phase I Clinical Study of Medical Devices

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

US-AAMI, Phase I Clinical Study 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

Lithuanian Standards Office , Phase I Clinical Study of Medical Devices

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

AT-ON, Phase I Clinical Study of Medical Devices

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

AENOR, Phase I Clinical Study of Medical Devices

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

PL-PKN, Phase I Clinical Study of Medical Devices

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

國家藥監(jiān)局, Phase I Clinical Study of Medical Devices

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

Others:   Preclinical Research Medical Devices, Clinical investigation of medical devices used in medical research subjects - good clinical trials of pharmaceuticals, Nonclinical Research Medical Devices, Medical device non-clinical research, Medical Device Clinical Research, Clinical investigation of medical devices intended for use in humans. Good clinical practice, Clinical research on medical devices for human use, Medical device non-clinical research, Preclinical research Phase I clinical Phase II clinical, Phase I and Phase II of clinical research, Clinical Phase I Study, Class II medical device clinical research, Class II medical device clinical research requirements, Class II medical device clinical research, Clinical Phase I of Class III Medical Devices, Phase I Clinical Study of Medical Devices, The first phase of safety and pharmacokinetic clinical research.