ISO 18113-4:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for self-testing.
ISO 18113-4:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing.
ISO 18113-4:2009 can also be applied to accessories, where appropriate.
ISO 18113-4:2009 applies to the labels for outer and immediate containers and to the instructions for use.
Document published on: 2009-12-15 Edition: 1 (Monolingual) ICS: 11.100.10 Status: Published Stage: 90.60 (2015-03-18) TC/SC: ISO/TC 212 Number of Pages: 10
No revision information available