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Class III in vitro diagnostic reagents for medical devices

Class III in vitro diagnostic reagents for medical devices, Total:82 items.

In the international standard classification, Class III in vitro diagnostic reagents for medical devices involves: Medical sciences and health care facilities in general, Laboratory medicine, Analytical chemistry, Medical equipment.

Korean Agency for Technology and Standards (KATS), Class III in vitro diagnostic reagents for medical devices

KS P ISO 23640:2019 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
KS P ISO 23640:2013 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
KS P ISO TR 18112-2009(2014) Clinical laboratory testing and in vitro diagnostic test systems－In vitro diagnostic medical devices for professional use－Summary of regulatory requirements for information supplied by the manufacture

KR-KS, Class III in vitro diagnostic reagents for medical devices

KS P ISO 23640-2019 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
KS P ISO 19001-2017(2022) In virto diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
KS P 2201-2022 In vitro diagnostic medical devices: Lateral flow immunoassay for infectious disease — General requirements for test performance

ES-UNE, Class III in vitro diagnostic reagents for medical devices

UNE-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

Association Francaise de Normalisation, Class III in vitro diagnostic reagents for medical devices

NF EN ISO 23640:2015 Dispositifs médicaux de diagnostic in vitro - Évaluation de la stabilité des réactifs de diagnostic in vitro
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 S92-040*NF EN ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
NF EN ISO 19001:2013 Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant avec les réactifs de coloration de diagnostic in vitro utilisés en biologie
NF S92-010-4:2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4 : in vitro diagnostic reagents for self-testing.
NF S92-010-4*NF EN ISO 18113-4:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4 : in vitro diagnostic reagents for self-testing
NF S92-010-2:2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2 : in vitro diagnostic reagents for professional use.
NF EN ISO 18113-2:2012 Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 2 : réactifs de diagnostic in vitro à usage professionnel
NF S92-010-2*NF EN ISO 18113-2:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2 : in vitro diagnostic reagents for professional use
NF EN ISO 18113-4:2012 Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 4 : réactifs de diagnostic in vitro pour auto-tests
NF EN 13975:2003 Procédures d'échantillonnage utilisées pour l'acceptation des essais des dispositifs médicaux de diagnostic in vitro - Aspects statistiques
NF EN ISO 6717:2021 Dispositifs médicaux de diagnostic in vitro - Récipients à usage unique pour le prélèvement d'échantillons d'origine humaine autres que le sang

German Institute for Standardization, Class III in vitro diagnostic reagents for medical devices

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.
DIN EN ISO 23640:2012 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2011
DIN EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2015
DIN EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2013
DIN EN ISO 19001:2013-07 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013); German version EN ISO 19001:2013 / Note: DIN EN 12376 (1999-04) remains valid alongside this stan...
DIN EN ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013); German version EN ISO 19001:2013
DIN EN 13975:2003-11 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects; German version EN 13975:2003, German and English texts
DIN EN ISO 18113-4:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009); German version EN ISO 18113-4:2011
DIN EN ISO 18113-2:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009); German version EN ISO 18113-2:2011
DIN EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects; German version EN 13975:2003, German and English texts

国家药品监督管理局, Class III in vitro diagnostic reagents for medical devices

YY/T 1579-2018 In vitro diagnostic medical devices and in vitro diagnostic reagent stability evaluation

European Committee for Standardization (CEN), Class III in vitro diagnostic reagents for medical devices

EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
EN ISO 23640:2011 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents [Superseded: CEN EN 13640]
EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
EN ISO 18113-4:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
EN ISO 18113-2:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
prEN ISO 18113-2:2021 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO/DIS 18113-2:2021)
FprEN ISO 18113-2 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO/FDIS 18113-2:2022)
EN ISO 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)
prEN ISO 18113-4:2021 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/DIS 18113-4:2021)
FprEN ISO 18113-4 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/FDIS 18113-4:2022)

AENOR, Class III in vitro diagnostic reagents for medical devices

UNE-EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
UNE-EN ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013)
UNE-EN ISO 18113-2:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
UNE-EN ISO 18113-4:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
UNE-EN 14254:2004 In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans
UNE-EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects

RU-GOST R, Class III in vitro diagnostic reagents for medical devices

GOST R ISO 23640-2015 In vitro medical devices. Evaluation of stability of in vitro diagnostic reagents
GOST R 51352-2013 In vitro diagnostic medical devices. Test methods
GOST R ISO 19001-2013 In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
GOST R ISO 18113-4-2015 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 4. In vitro diagnostic reagents for self-testing
GOST R ISO 18113-2-2015 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 2. In vitro diagnostic reagents for professional use
GOST EN 13975-2016 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects
GOST R 51088-2013 In vitro diagnostic medical devices. Reagents, kits, the test-systems, control materials, culture media. Requirements to devices and to supporting documentation
GOST R 55991.4-2014 In vitro diagnostics medical devices. Part 4. Automatic analyzers for coagulation tests. Technical requirements for public procurement
GOST R ISO 15194-2013 In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for certified reference materials and the content of supporting documentation
GOST R 55991.6-2014 In vitro diagnostics medical devices. Part 6. Automatic analyzers for hematology tests. Technical requirements for public procurement
GOST R 55991.7-2014 In vitro diagnostics medical devices. Part 7. Automatic analyzers for general clinical tests. Technical requirements for public procurement

British Standards Institution (BSI), Class III in vitro diagnostic reagents for medical devices

BS EN ISO 18113-4:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for self-testing
BS EN ISO 18113-2:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for professional use
BS EN ISO 18113-5:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for self-testing

Professional Standard - Medicine, Class III in vitro diagnostic reagents for medical devices

YY/T 0639-2008 In vitro diagnostic medical devices.Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

国家药监局, Class III in vitro diagnostic reagents for medical devices

YY/T 0639-2019 In vitro diagnostic medical devices.Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

Danish Standards Foundation, Class III in vitro diagnostic reagents for medical devices

DS/EN ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

International Organization for Standardization (ISO), Class III in vitro diagnostic reagents for medical devices

ISO 18113-4:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
ISO 18113-2:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
ISO 18113-2:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
ISO 18113-4:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
ISO 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood
ISO 21474-1:2020 In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluation
ISO 21474-2:2022 In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verification
ISO 15193:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Class III in vitro diagnostic reagents for medical devices

GB/T 29791.4-2013 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 4:In vitro diagnostic reagents for selftesting
GB/T 29791.2-2013 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 2:In vitro diagnostic reagents for professional use

CEN - European Committee for Standardization, Class III in vitro diagnostic reagents for medical devices

EN ISO 18113-4:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
EN ISO 18113-2:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use

Lithuanian Standards Office , Class III in vitro diagnostic reagents for medical devices

LST EN ISO 18113-4:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
LST EN ISO 18113-2:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
LST EN ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013)

AT-ON, Class III in vitro diagnostic reagents for medical devices

OENORM EN ISO 18113-2:2021 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO/DIS 18113-2:2021)
OENORM EN ISO 18113-4:2021 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/DIS 18113-4:2021)

GOSTR, Class III in vitro diagnostic reagents for medical devices

GOST R EN 14254-2010 In vitro diagnostic medical devices. Single-use receptacles for the collection of specimens, other than blood, from humans