ivd in vitro diagnostic device

ivd in vitro diagnostic device, Total:121 items.

The international standard classification for "ivd in vitro diagnostic device" includes: Laboratory medicine , Industrial process measurement and control .

The Chinese standard classification for "ivd in vitro diagnostic device" includes: Medical laboratory equipment , Industrial automation and control device in general , Infrared device .

Professional Standard - Medicine

YY 0648-2008 Safety requirements for electrical equipment for measurement control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

GB/T 29791.5-2013 In vitro diagnostic medical devices―Information supplied by the manufacturer (labelling)―Part 5:In vitro diagnostic instruments for selftesting
GB/T 18268.26-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 26:Particular requirements—In vitro diagnostic (IVD) medical equipment

未注明发布机构

DS/EN 61326-2-6:2013 Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment
DIN EN 592:2002 Instructions for use for devices for in-vitro diagnostic examinations for personal use
CSA C22.2 No.61010-2-101-2019 Safety requirements for electrical equipment for measurement, control and laboratory use — Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

未注明发布机构

DIN EN 592:2002 Instructions for use for devices for in-vitro diagnostic examinations for personal use
DS/EN 61326-2-6:2013 Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment
CSA C22.2 No.61010-2-101-2019 Safety requirements for electrical equipment for measurement, control and laboratory use — Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

Group Standards of the People's Republic of China

T/CAMDI 125-2024 Reliability test methods for in vitro diagnostic (IVD) medical equipment

国家药品监督管理局

YY/T 1579-2018 In vitro diagnostic medical devices—Evaluation of stability of in vitro diagnostic reagents

Professional Standard - Electricity

DL/T 664-2008 Application rules of infrared diagnosis for live electrical equipment
DL/T 664-2016 Application rules of infrared diagnosis for live electrical equipment
DL/T 664-2016(英文版) Specification for application of infrared diagnosis of live equipment

British Standards Institution (BSI)

BS EN ISO 23640:2015 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
BS EN IEC 61326-2-6:2021 Electrical equipment for measurement, control and laboratory use. EMC requirements. Particular requirements. In vitro diagnostic (IVD) medical equipment
BS EN IEC 61010-2-101:2022+A11:2022 Safety requirements for electrical equipment for measurement, control, and laboratory use - Safety requirements for in vitro diagnostic (IVD) medical equipment
BS EN 61010-2-101:2017 Safety requirements for electrical equipment for measurement, control and laboratory use. Particular requirements for in vitro diagnostic (IVD) medical equipment
BS EN 61326-2-6:2013 Electrical equipment for measurement, control and laboratory use. EMC requirements. Particular requirements. In vitro diagnostic (IVD) medical equipment
BS EN ISO 23640:2011 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
BS EN ISO 23640:2013 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
18/30374801 DC BS EN 61326-2-6. Electrical equipment for measurement, control and laboratory use. EMC requirements. Part 2-6. Particular requirements. In vitro diagnostic (IVD) medical equipment
21/30416033 DC BS EN ISO 18113-2. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - Part 2. In vitro diagnostic reagents for professional use
21/30416037 DC BS EN ISO 18113-3. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - Part 3. In vitro diagnostic instruments for professional use

International Organization for Standardization (ISO)

ISO 20916:2019 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
ISO 23640:2011 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents

Association Francaise de Normalisation

NF EN IEC 61326-2-6:2021 Electrical measurement, control and laboratory equipment - EMC requirements - Part 2-6: special requirements - In vitro diagnostic (IVD) medical equipment
NF C46-050-2-6*NF EN IEC 61326-2-6:2021 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6 : particular requirements - In vitro diagnostic (IVD) medical equipment
NF C46-050-2-6*NF EN 61326-2-6:2013 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6 : particular requirements - In vitro diagnostic (IVD) medical equipment
NF EN IEC 61010-2-101/A11:2022 Safety requirements for electrical measuring, regulating and laboratory equipment - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
NF EN IEC 61010-2-101:2022 Safety requirements for electrical measuring, regulating and laboratory apparatus - Part 2-101: special requirements for in vitro diagnostic (IVD) medical equipment
NF C42-020-2-101*NF EN 61010-2-101:2017 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101 : particular requirements for in vitro diagnostic (IVD) medical equipment
NF EN ISO 23640:2015 In vitro diagnostic medical devices - Assessment of the stability of in vitro diagnostic reagents
NF S92-032*NF EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
NF S92-032:2014 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
NF S92-017:1995 IN VITRO DIAGNOSTIC SYSTEMS. REQUIREMENTS FOR USER MANUALS FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR HOME USE. (EUROPEAN STANDARD EN 592).

European Committee for Electrotechnical Standardization（CENELEC）

EN IEC 61326-2-6:2021 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
EN IEC 61010-2-101:2022/prAB Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101 Particular requirements for in vitro diagnostic (IVD) medical equipment
EN IEC 61010-2-101:2022/A11:2022 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment
EN IEC 61010-2-101:2022 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment

SCC

CEI EN 61326-2-6:2014 Electrical equipment for measurement, control and laboratory use - EMC requirements Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
DANSK DS/EN IEC 61326-2-6:2021 Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment
CEI EN IEC 61326-2-6:2022 Electrical equipment for measurement, control and laboratory use - EMC requirements Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
DANSK DS/EN 61326-2-6:2013 Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment
BS EN ISO 18113-2:2009 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling)-In vitro diagnostic reagents for professional use
BS EN ISO 18113-4:2009 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling)-In vitro diagnostic reagents for self-testing
BS EN ISO 18113-3:2009 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling)-In vitro diagnostic instruments for professional use
CAN/CSA-C22.2 No.61010-2-101-2004(C2014) Safety rules for electrical measuring, regulating and laboratory devices - Part 2-101: Special requirements for in vitro diagnostic (IVD) medical devices
CEI EN IEC 61010-2-101:2023 Safety requirements for electrical equipment for measurement, control and laboratory use Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
BS EN ISO 18113-5:2009 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling)-In vitro diagnostic instruments for self-testing
DANSK DS/EN IEC 61010-2-101:2022 Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment
CAN/CSA-C22.2 No.61010-2-101-2004(R2014) Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use - Part 2-101: Particular Requirements for In Vitro Diagnostic (IVD) Medical Equipment
DANSK DS/EN 61010-2-101:2017 Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
AENOR UNE-EN 61010-2-101:2018 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
CEI EN 61010-2-101:2017 Safety requirements for electrical equipment for measurement, control and laboratory use Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
CAN/CSA C22.2 No.61010-2-101-2015 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment (Adopted IEC 61010-2-101:2015, second edition, 2015-01, with Canadian deviati...
UNE-EN 61326-2-6:2006 Electrical equipment for measurement, control and laboratory use - EMC requirements -- Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment (IEC 61326-2-6:2005).
UNE-EN 12376:1999 IN VITRO DIAGNOSTIC MEDICAL DEVICES. INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR STAINING IN BIOLOGY.
DIN EN IEC 61010-2-101/A11 E:2023 Draft Document - Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment; German version EN IEC 61010-2-101:2022/A11:2022
DIN EN IEC 61326-2-6:2022 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment (IEC 61326-2-6:2020); German version EN IEC 61326-2-6:2021
10/30216029 DC BS EN 61326-2-6. Electrical equipment for measurement, control and laboratory use . EMC requirements. Part 2-6. Particular requirements. In vitro diagnostic (IVD) medical equipment
IEC 61326-2-6:2005/COR1:2007 Corrigendum 1 - Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
NS-EN 375:1992 In vitro diagnostic systems — Requirements for labelling of in vitro diagnostic reagents for professional use
NS-EN 376:1992 In vitro diagnostic systems — Requirements for labelling of in vitro diagnostic reagents for self-testing
DANSK DS/EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
NS-EN 592:1994 In vitro diagnostic systems — Requirements for user manual for in vitro diagnostic instruments for home use
12/30269739 DC BS EN 61010-2-101. Safety requirements for electrical equipment for measurement, control and laboratory use. Part 2-101. Particular requirements for laboratory equipment for in vitro diagnostic (IVD) medical equipment
DIN EN 61010-2-101:2017 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment (IEC 61010-2-101:2015); German version EN 61010-2-101:2017
DIN IEC 61326-2-6 E:2010 Draft Document - Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment (IEC 65A/568/CD:2010)
DIN EN 61326-2-6 E:2018 Draft Document - Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment (IEC 65A/863/CD:2018); Text in German and English

ES-UNE

UNE-EN 61326-2-6:2013 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment (Endorsed by AENOR in June of 2013.)
UNE-EN IEC 61010-2-101:2023 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment
UNE-EN IEC 61010-2-101:2023/A11:2023 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment
UNE-EN 61010-2-101:2018 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
UNE-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

Japanese Industrial Standards Committee (JISC)

JIS C 61326-2-6:2023 Electrical equipment for measurement, control and laboratory use -- EMC requirements -- Part 2-6: Particular requirements -- In vitro diagnostic (IVD) medical equipment
JIS C 1010-2-101:2017 Safety requirements for electrical equipment for measurement, control and laboratory use -- Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
JIS C 1010-2-101:2013 Safety requirements for electrical equipment for measurement, control and laboratory use -- Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
JIS C 61326-2-6:2019 Electrical equipment for measurement, control and laboratory use -- EMC requirements -- Part 2-6: Particular requirements -- In vitro diagnostic (IVD) medical equipment
JIS C 1806-2-6:2012 Electrical equipment for measurement, control and laboratory use -- EMC requirements -- Part 2-6: Particular requirements -- In vitro diagnostic (IVD) medical equipment

Danish Standards Foundation

DS/EN IEC 61326-2-6:2021 Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment
DS/EN 375:1993 In vitro diagnostic systems. Requirements for labelling of in vitro diagnostic reagents for professional use

GSO

GSO ISO 19001:2015 In vitro diagnostic medical devices -- Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
OS GSO IEC 61326-2-6:2012 ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE – EMC REQUIREMENTS – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment
GSO IEC 61010-2-101:2014 Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
BH GSO IEC 61010-2-101:2016 Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

German Institute for Standardization

DIN EN 61010-2-101:2003 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment (IEC 61010-2-101:2002, modified); German version EN 61010-2-101:2002
DIN EN ISO 23640:2015-12 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2015 / Note: DIN EN ISO 23640 (2013-09) remains valid alongside this standard until 2018-06-30.

International Electrotechnical Commission (IEC)

IEC 61326-2-6:2020 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
IEC 61010-2-101:2018 RLV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
IEC 61010-2-101:2015 RLV Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
IEC 61326-2-6:2020 RLV Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment

AENOR

UNE-EN 61010-2-101:2004 Safety requirements for electrical equipment for measurement, control and laboratory use -- Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

RU-GOST R

GOST IEC 61010-2-101-2013 Safety requirements for electrical equipment for measurement, control and laboratory use. Part 2-101. Particular requirements for in vitro diagnostic (IVD) medical equipment
GOST R IEC 61326-2-6-2014 Electrical equipment for measurement, control and laboratory use. EMC requirements. Part 2-6. Particular requirements. In vitro diagnostic (IVD) medical equipment

IEC - International Electrotechnical Commission

IEC 61326-2-6/COR:2007 Electrical equipment for measurement control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment (Edition 1.0)

IX-EU/EC

MEDDEV 2.14/3-2007 GUIDELINES ON MEDICAL DEVICES IVD GUIDANCES: Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD) Medical Devices A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES

Lithuanian Standards Office

LST EN 61326-2-6-2006 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment (IEC 61326-2-6:2005)
LST EN IEC 61326-2-6:2021 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment (IEC 61326-2-6:2020)

VDE - VDE Verlag GmbH@ Berlin@ Germany

VDE 0843-20-2-6-2013 Electrical equipment for measurement@ control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment (IEC 61326-2-6:2012); German version EN 61326-2-6:2013
VDE 0843-2-6-2018 Electrical equipment for measurement@ control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment (IEC 65A/863/CD:2018); Text in German and English
VDE 0411-2-101-2017 Safety requirements for electrical equipment for measurement@ control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment (IEC 61010-2-101:2015); German version EN 61010-2-101:2017
VDE 0411-2-101-2018 Safety requirements for electrical equipment for measurement@ control@ and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment (IEC 66/644/CDV:2017); German and English version prEN 61010-2-101:2017
VDE 0411-2-101-2013 Safety requirements for electrical equipment for measurement@ control and laboratory use - Part 2-101: Particular requirements for laboratory equipment for in vitro diagnostic (IVD) medical equipment (IEC 66/487/CDV:2012); German version FprEN 61010-2-101

DIN

DIN EN 61326-2-6:2006 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment (IEC 61326-2-6:2005); German version EN 61326-2-6:2006

PL-PKN

PN-EN IEC 61326-2-6-2021-11 E Electrical equipment for measurement, control and laboratory use -- EMC requirements -- Part 2-6: Particular requirements -- In vitro diagnostic (IVD) medical equipment (IEC 61326-2-6:2020)

Korean Agency for Technology and Standards (KATS)

KS P ISO 18113-4-2015(2020) In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 4: In vitro diagnostic reagents for self-testing
KS P ISO 18113-2:2018 In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 2: In vitro diagnostic reagents for professional use
KS P ISO 23640:2019 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
KS P ISO 18113-5-2015(2020) In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 5: In vitro diagnostic instruments for self-testing
KS P ISO 23640:2013 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents

Underwriters Laboratories (UL)

UL 61010-2-101-2019 UL Standard for Safety Safety Requirements for Electrical Equipment for Measurement Control and Laboratory Use – Part 2-101: Particular Requirements for In Vitro Diagnostic (IVD) Medical Equipment

KR-KS

KS P ISO 18113-2-2018 In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 2: In vitro diagnostic reagents for professional use
KS P ISO 23640-2019 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents

AT-ON

ONORM EN 375-1993 In vitro diagnostic Systems - Requirements for labelling of in vitro diagnostic reagents for professional use
ONORM EN 376-1993 In vitro diagnostic Systems - Requirements for labelling of in vitro diagnostic reagents for serf-testing

BE-NBN

NBN EN 592-1995 In vitro diagnostic systems - Requirements for user manual for in vitro diagnostic instruments for home use
NBN EN 591-1995 In vitro diagnostic systems - Requirements for user manuals for in vitro diagnostic instruments for professional use
NBN-EN 376-1992 In vitro diagnostic systems - Requirements for labelling of in vitro diagnostic reagents for self-testing

European Committee for Standardization (CEN)

EN ISO 23640:2011 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents [Superseded: CEN EN 13640]
EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents

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