In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009, IDT)
This Malaysian Standard specifies requirements for information supplied by the manufacturer of IVD instruments for professional use.
This Malaysian Standard also applies to apparatus and equipment intended to be used with IVD instruments for professional use.
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 self-testing.
Published
• (none) / (none) / (none)
PDF
17/01/2021
19
NSC 18 - Medical Devices and Facilities for Healthcare
