Medical device non-clinical research

Medical device non-clinical research, Total:64 items.

The international standard classification for "Medical device non-clinical research" includes: Medical equipment in general .

The Chinese standard classification for "Medical device non-clinical research" includes: Medical apparatus and devices in general .

国家药监局

YY/T 1754.1-2020 Preclinical animal study of medical devices—Part 1:General considerations

Standard Association of Australia （SAA）

AS ISO 14155:2002 Clinical investigation of medical devices

SCC

BS EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects-Clinical investigation plans
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
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
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)
08/30116059 DC BS ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice
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)
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)
BS EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects-General requirements
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
DANSK DS/EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects - Part 1: General requirements
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)

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)

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)

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

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

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

GSO

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

KR-KS

KS P ISO 14155-2022 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)
UNE-EN ISO 14155-2:2004 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
UNE-EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

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

German Institute for Standardization

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 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 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

VN-TCVN

TCVN 7740-2-2007 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 14155:2011/cor 1:2011 Clinical investigation of medical devices for human subjects - Good clinical practice; Technical Corrigendum 1

GOST

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

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

RU-GOST R

GOST R ISO 14155-2014 Clinical investigation. 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

Lithuanian Standards Office

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

AT-ON

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

PL-PKN

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

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