Clinical Evaluation of Medical Devices

Clinical Evaluation of Medical Devices, Total:53 items.

The international standard classification for "Clinical Evaluation of Medical Devices" includes: Dental materials , Implants for surgery, prosthetics and orthotics .

The Chinese standard classification for "Clinical Evaluation of Medical Devices" includes: Medical apparatus and devices in general , Stomatologic device, equipment and material , Extracorporeal circulation, artificial organ and prosthesis device .

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Professional Standard - Medicine

• YY/T 0127.11-2014 Biological evaluation of medical devices used in dentistry―Part 11:Pulp capping test
• YY/T 0268-2001 Dentistry--Preclinical evaluation of biocompatibility of medical devices used in dentistry--Part 1:Evaluation and test methods selevtion
• YY/T 0268-2008 Dentistry - Biological evaluation of medical devices used in dentistry Part1: Evaluation and test
• YY/T 1930-2024 Medical Device Clinical Evaluation Terms and Definitions
• YY/T 0297-1997 Clinical investigation of medical devices

国家药监局

• YY/T 1679-2021 Tissue engineering medical device products-Bone-Standard guide for pre-clinical in vivo evaluation in critical size segmental bone defects

RU-GOST R

• GOST R 56429-2015 Medical devices. Clinical evaluation
• GOST ISO 10993-1-2011 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
• GOST R ISO 14155-2014 Clinical investigation. Good clinical practice

Standard Association of Australia （SAA）

• AS ISO 14155:2002 Clinical investigation of medical devices

GSO

• 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

SCC

• 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
• 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)

European Committee for Standardization (CEN)

• prEN 540-1992 Clinical investigation of medical devices for human subjects

KR-KS

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

Association Francaise de Normalisation

• 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)

• 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

Spanish Association for Standardization (UNE)

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

GOST

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

NL-NEN

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

German Institute for Standardization

• DIN EN 540:1993 Clinical testing of medical devices on humans
• 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 ISO 10993-18:2009 Biological assessment of medical devices

Danish Standards Foundation

• 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

Korean Agency for Technology and Standards (KATS)

• 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

International Organization for Standardization (ISO)

• 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/CD 10993-1.2:2023 Biological evaluation of medical devices
• ISO 14155:2011/cor 1:2011 Clinical investigation of medical devices for human subjects - Good clinical practice; Technical Corrigendum 1

IT-UNI

• 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

US-AAMI

• 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

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