<p>ISO 18113-4:2009 specifies requirements for information supplied by the manufacturer of <i>in vitro</i> diagnostic (IVD) reagents for self-testing.</p>
<p>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.</p>
<p>ISO 18113-4:2009 can also be applied to accessories, where appropriate.</p>
<p>ISO 18113-4:2009 applies to the labels for outer and immediate containers and to the instructions for use.</p>
Registration number (WIID)
40987
Scope
<p>ISO 18113-4:2009 specifies requirements for information supplied by the manufacturer of <i>in vitro</i> diagnostic (IVD) reagents for self-testing.</p>
<p>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.</p>
<p>ISO 18113-4:2009 can also be applied to accessories, where appropriate.</p>
<p>ISO 18113-4:2009 applies to the labels for outer and immediate containers and to the instructions for use.</p>
