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Foreign medical instrument testing

Foreign medical instrument testing, Total:32 items.

In the international standard classification, Foreign medical instrument testing involves: Medical equipment, Laboratory medicine, Metrology and measurement in general, Microbiology.

海关总署, Foreign medical instrument testing

SN/T 5473.3-2022 Technical Requirements for Inspection of Export Medical Devices Part 3: Infrared Thermometer

Professional Standard - Medicine, Foreign medical instrument testing

YY/T 1454-2016 General requirements for in vitro diagnostic medical devices for self-testing

European Committee for Standardization (CEN), Foreign medical instrument testing

EN ISO 18113-5:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
prEN ISO 18113-5:2021 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/DIS 18113-5:2021)
FprEN ISO 18113-5 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/FDIS 18113-5:2022)
EN ISO 18113-5:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing [Superseded: CEN EN 592]

American Society for Testing and Materials (ASTM), Foreign medical instrument testing

ASTM F2401-16 Standard Practice for Security Checkpoint Metal Detector Screening of Persons with Medical Devices
ASTM F3276-19 Standard Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to Clean the External Surface of a Medical Device
ASTM F3276-22 Standard Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to Clean the External Surface of a Medical Device

RU-GOST R, Foreign medical instrument testing

GOST R 8.901-2015 State system for ensuring the uniformity of measurements. Instruments of measurement of characteristic of ultraviolet radiation for medical sources. Verification procedure
GOST R ISO 18113-5-2015 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 5. In vitro diagnostic instruments for self-testing
GOST R 55991.1-2014 In vitro diagnostics medical devices. Part 1. Automatic analyzers for biochemical assays. Technical requirements for public procurement
GOST R 55991.2-2014 In vitro diagnostics medical devices. Part 2. Automatic analyzer for immunoassays. Technical requirements for public procurement
GOST R 8.658-2009 State system for ensuring the uniformity of measurements Instruments measuring the characteristics of ultraviolet radiation of solar bad Verification procedure
GOST R 55991.3-2014 In vitro diagnostics medical devices. Part 3. Automatic analyzers for biomolecular assays. Technical requirements for public procurement
GOST R 8.705-2010 State system for ensuring the uniformity of measurements. Embedded and external photometers for high-energy laser medical apparatus. Verification procedure
GOST 8.627-2013 State system for ensuring the traceability of measurements. In vitro diagnostics medicine test systems for measurement of quantities in biological samples. Part 1. Haematology analyzers. Verification procedure

Association Francaise de Normalisation, Foreign medical instrument testing

NF EN ISO 18113-5:2012 Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 5 : instruments de diagnostic in vitro pour auto-tests
NF S92-010-5:2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5 : in vitro diagnostic instruments for self-testing.
NF S92-010-5*NF EN ISO 18113-5:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5 : in vitro diagnostic instruments for self-testing
NF ISO 21474-2:2022 Dispositifs médicaux de diagnostic in vitro - Tests moléculaires multiplex pour les acides nucléiques - Partie 2 : validation et vérification
NF S92-021*NF EN ISO 17511:2004 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
NF S92-022*NF EN ISO 18153:2004 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials.

German Institute for Standardization, Foreign medical instrument testing

DIN 6855-1:1992 Quality control of nuclear medicine instruments; radiation counting systems for measurements in vivo and in vitro
DIN EN ISO 18113-5:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009); German version EN ISO 18113-5:2011

International Organization for Standardization (ISO), Foreign medical instrument testing

ISO 18113-5:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
ISO 18113-5:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Foreign medical instrument testing

GB/T 29791.5-2013 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 5:In vitro diagnostic instruments for selftesting

Korean Agency for Technology and Standards (KATS), Foreign medical instrument testing

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

AENOR, Foreign medical instrument testing

UNE-EN ISO 18113-5:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)

British Standards Institution (BSI), Foreign medical instrument testing

21/30416045 DC BS EN ISO 18113-5. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - Part 5. In vitro diagnostic instruments for self-testing

IT-UNI, Foreign medical instrument testing

UNI ISO 21474-1:2021 In vitro diagnostic medical devices - Multiplex molecular testing for nucleic acids - Part 1: Terminology and general requirements for nucleic acid quality evaluation