Complete list of the Harmonized Standards for 98/79/ec
List of European Harmonized Standards For Directive 98/79/EC for In vitro diagnostic medical devices (with links to the Official English Language Edition of each)
EN-ISO-18113-1In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) 2011 EDITION. Issued: OCT. 31, 2011. 60 pages. CURRENT Show EN-ISO-18113-1 revision history |
$317.50 |
|
EN-ISO-18113-2In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) 2011 EDITION. Issued: NOV. 30, 2011. 24 pages. CURRENT Show EN-ISO-18113-2 revision history |
$236.60 |
|
EN-ISO-18113-3In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) 2011 EDITION. Issued: NOV. 30, 2011. 22 pages. CURRENT Show EN-ISO-18113-3 revision history |
$169.00 |
|
EN-ISO-18113-4In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) 2011 EDITION. Issued: NOV. 30, 2011. 24 pages. CURRENT Show EN-ISO-18113-4 revision history |
$236.60 |
|
EN-ISO-18113-5In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) 2011 EDITION. Issued: NOV. 30, 2011. 22 pages. CURRENT Show EN-ISO-18113-5 revision history |
$169.00 |
|
EN-ISO-18153In 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 2003 EDITION. Issued: AUG. 19, 2003. 20 pages. CURRENT |
$169.00 |
|
EN-ISO-20776-1Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices 2020 EDITION. Issued: JULY 7, 2020. 30 pages. CURRENT Show EN-ISO-20776-1 revision history |
$236.60 |
|
EN-61010-2-101Safety requirements for electrical equipment for measurement, control and laboratory use Show EN-61010-2-101 revision history |
||
EN-61326-2-6Electrical equipment for measurement, control and laboratory use. EMC requirements Show EN-61326-2-6 revision history |
||
EN-62304Medical device software. Software life-cycle processes 2006/A1 EDITION. Issued: NOV. 1, 2015. 88 pages. CURRENT Show EN-62304 revision history |
$342.50 |
|
EN-62366Medical devices. Application of usability engineering to medical devices Show EN-62366 revision history |