ISO 18113-2:2009

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use

Synopsis

ISO 18113-2:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for professional use.

ISO 18113-2:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use.

ISO 18113-2:2009 can also be applied to accessories.

ISO 18113-2:2009 applies to the labels for outer and immediate containers and to the instructions for use.

Comments

General Information

Status Current
Edition 2009
No. of Pages 10
ICS Classification 11.100.10 In vitro diagnostic test systems
Committee ISO/TC 212
Available for Purchase For sale in Singapore only
Adoption ISO