SR EN ISO 18113-3:2012

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)

ISO 18113-3:2009 specifies requirements for information supplied by the manufacturer of in vitro dignostic (IVD) instruments for professional use. ISO 18113-3:2009 also applies to apparatus and equipment intended to be used with IVD instruments for professional use. ISO 18113-3:2009 can also be applied to accessories, where appropriate.

General information

Status : Valid
Approval date : 3/30/2012
Withdrawal date : 6/30/2027
Number of pages : 16
ICS : 11.100.10 In vitro diagnostic test systems
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR EN ISO 18113-3:2010
Normative reference SR EN 62366:2008
Normative reference SR EN ISO 18113-1:2010
Normative reference SR EN 61326-2-6:2006
Normative reference SR EN 61010-1:2011
Normative reference SR EN 980:2008
Normative reference SR EN ISO 14971:2009
Normative reference SR EN 61010-2-101:2003
Replaced by SR EN ISO 18113-3:2024