<p><i>IEC 60601-1:2005+A1:2012, 1.1 is replaced by: </i></p>
<p>This document applies to the <i>basic</i> <i>safety</i> and <i>essential</i> <i>performance</i> of <i>medical</i> <i>supply</i> <i>units</i>, hereafter also referred to as <i>ME</i> <i>equipment</i>.</p>
<p>This document applies to <i>medical</i> <i>supply</i> <i>units</i> manufactured within a factory or assembled on site, including cabinetry and other <i>enclosures</i>, which incorporate <i>patient</i> care services. </p>
<p>NOTE 1 A party that assembles on site various components intended for <i>patient</i> care services into an <i>enclosure</i> is considered the <i>manufacturer</i> of the <i>medical</i> <i>supply</i> <i>unit</i>.</p>
<p><i>Hazards</i> inherent in the intended function of <i>ME</i> <i>equipment</i> or <i>ME</i> <i>systems</i> within the scope of this document are not covered by specific requirements in this standard, except in of IEC 60601-1:2005+A1:2012, 7.2.13 and 8.4.1 (see 201.1.4).</p>
<p>NOTE 2 Refer to IEC 60601-1:2005+A1:2012, 4.2.</p>
Registration number (WIID)
74384
Scope
<p><i>IEC 60601-1:2005+A1:2012, 1.1 is replaced by: </i></p>
<p>This document applies to the <i>basic</i> <i>safety</i> and <i>essential</i> <i>performance</i> of <i>medical</i> <i>supply</i> <i>units</i>, hereafter also referred to as <i>ME</i> <i>equipment</i>.</p>
<p>This document applies to <i>medical</i> <i>supply</i> <i>units</i> manufactured within a factory or assembled on site, including cabinetry and other <i>enclosures</i>, which incorporate <i>patient</i> care services. </p>
<p>NOTE 1 A party that assembles on site various components intended for <i>patient</i> care services into an <i>enclosure</i> is considered the <i>manufacturer</i> of the <i>medical</i> <i>supply</i> <i>unit</i>.</p>
<p><i>Hazards</i> inherent in the intended function of <i>ME</i> <i>equipment</i> or <i>ME</i> <i>systems</i> within the scope of this document are not covered by specific requirements in this standard, except in of IEC 60601-1:2005+A1:2012, 7.2.13 and 8.4.1 (see 201.1.4).</p>
<p>NOTE 2 Refer to IEC 60601-1:2005+A1:2012, 4.2.</p>
