RO
SR EN ISO 18113-5:2012
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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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
- Replaces SR EN ISO 18113-5:2010
- Normative reference SR EN 980:2008
- Normative reference SR EN 61326-2-6:2006
- Normative reference SR EN ISO 18113-1:2012
- Normative reference SR EN 61010-1:2011
- Normative reference SR EN ISO 14971:2009
- Normative reference SR EN 62366:2008
- Normative reference SR EN 61010-2-101:2003
- Replaced by SR EN ISO 18113-5:2024