In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009, IDT)
This Malaysian Standard defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of IVD medical devices.
This standard does not address language requirements, since that is the domain of national laws and regulations. This standard does not apply to
a) IVD devices for performance evaluation (e.g., for investigational use only),
b) instrument marking,
c) material safety data sheets.
Published
• (none) / (none) / (none)
PDF
17/01/2021
59
NSC 18 - Medical Devices and Facilities for Healthcare
