In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009, IDT)
This Malaysian Standard specifies requirements for information supplied by the manufacturer of IVD instruments for self-testing.
This Malaysian Standard also applies to apparatus and equipment intended to be used with IVD instruments for self-testing.
This Malaysian Standard can also be applied to accessories.
?This Malaysian Standard does not apply to
a) instructions for instrument servicing or repair,
b) IVD reagents, including calibrators and control materials for use in control of the reagent,
c) IVD instruments for professional use.
Published
• (none) / (none) / (none)
PDF
21/01/2021
18
NSC 18 - Medical Devices and Facilities for Healthcare
