SR EN ISO 18113-5:2010

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)

ISO 18113-5:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments for self-testing. ISO 18113-5:2009 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing. ISO 18113-5:2009 can also be applied to accessories.

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General information

Status : Withdrawn
Approval date : 5/31/2010
Publish date : 6/2/2010
Withdrawal date : 3/30/2012
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 592:2003
Normative reference SR EN 980:2008
Normative reference SR EN ISO 14971:2009
Normative reference SR EN 61010-1:2011
Normative reference SR EN ISO 18113-1:2010
Normative reference SR EN 61326-2-6:2006
Normative reference SR EN 62366:2008
Normative reference SR EN 61010-2-101:2003
Replaced by SR EN ISO 18113-5:2012