KS P ISO TR 18112:2009
Clinical laboratory testing and in vitro diagnostic test systems-In vitro diagnostic medical devices for professional use-Summary of regulatory requirements for information supplied by the manufacturer

Standard No.

KS P ISO TR 18112:2009

Release Date

2009

Published By

Korean Agency for Technology and Standards (KATS)

Status

Withdraw

Replace By

KS P ISO TR 18112-2009(2014)

Latest

KS P ISO TR 18112-2020

Scope

This technical report provides regulatory guidance on information provided by manufacturers regarding IVD medical devices for professional use.

KS P ISO TR 18112:2009 history

• 2020 KS P ISO TR 18112-2020 Clinical laboratory testing and in vitro diagnostic test systems－In vitro diagnostic medical devices for professional use－Summary of regulatory requirements for information supplied by the manufacturer
• 0000 KS P ISO TR 18112-2009(2014)
• 2009 KS P ISO TR 18112:2009 Clinical laboratory testing and in vitro diagnostic test systems-In vitro diagnostic medical devices for professional use-Summary of regulatory requirements for information supplied by the manufacturer