In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
This part of ISO 18113 defines concepts, establishes general principles and specifies essential requirements
for information supplied by the manufacturer of IVD medical devices.
This part of ISO 18113 does not address language requirements, since that is the domain of national laws and
regulations.
This part of ISO 18113 does not apply to
a) IVD devices for performance evaluation (e.g., for investigational use only),
b) instrument marking,
c) material safety data sheets.
ΚΩΔΙΚΟΣ ΠΡΟΪΟΝΤΟΣ:
CYS EN ISO 18113-1:2011
This part of ISO 18113 defines concepts, establishes general principles and specifies essential requirements
for information supplied by the manufacturer of IVD medical devices.
This part of ISO 18113 does not address language requirements, since that is the domain of national laws and
regulations.
This part of ISO 18113 does not apply to
a) IVD devices for performance evaluation (e.g., for investigational use only),
b) instrument marking,
c) material safety data sheets.