RO
SR EN ISO 18113-4:2012
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
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.
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Status :
Valid
Approval date : 3/30/2012
Withdrawal date : 6/30/2027
Number of pages : 18
ICS : 11.100.10 In vitro diagnostic test systems
Technical Committee : 377 - Medical devices
- Replaces SR EN ISO 18113-4:2010
- Normative reference SR EN 980:2008
- Normative reference SR EN ISO 14971:2009
- Normative reference SR EN ISO 18113-1:2012
- Replaced by SR EN ISO 18113-4:2024