In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009, IDT)
This Malaysian Standard specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing.
This Malaysian Standard also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing.
This Malaysian Standard can also be applied to accessories.
?This Malaysian Standard applies to the labels for outer and immediate containers and to the instructions for use.
This Malaysian Standard does not apply to:
a) IVD instruments or equipment,
b) IVD reagents for professional use.
Published
• (none) / (none) / (none)
PDF
21/01/2021
19
NSC 18 - Medical Devices and Facilities for Healthcare
