<p><em>IEC 60601-1:2005+A1:2012, 1.1 is replaced by: </em></p>
<p>This document applies to the <em>basic</em> <em>safety</em> and <em>essential</em> <em>performance</em> of <em>medical</em> <em>supply</em> <em>units</em>, hereafter also referred to as <em>ME</em> <em>equipment</em>.</p>
<p>This document applies to <em>medical</em> <em>supply</em> <em>units</em> manufactured within a factory or assembled on site, including cabinetry and other <em>enclosures</em>, which incorporate <em>patient</em> care services.</p>
<p>NOTE 1 A party that assembles on site various components intended for <em>patient</em> care services into an <em>enclosure</em> is considered the <em>manufacturer</em> of the <em>medical</em> <em>supply</em> <em>unit</em>.</p>
<p><em>Hazards</em> inherent in the intended function of <em>ME</em> <em>equipment</em> or <em>ME</em> <em>systems</em> 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)
85403
Scope
<p><em>IEC 60601-1:2005+A1:2012, 1.1 is replaced by: </em></p>
<p>This document applies to the <em>basic</em> <em>safety</em> and <em>essential</em> <em>performance</em> of <em>medical</em> <em>supply</em> <em>units</em>, hereafter also referred to as <em>ME</em> <em>equipment</em>.</p>
<p>This document applies to <em>medical</em> <em>supply</em> <em>units</em> manufactured within a factory or assembled on site, including cabinetry and other <em>enclosures</em>, which incorporate <em>patient</em> care services.</p>
<p>NOTE 1 A party that assembles on site various components intended for <em>patient</em> care services into an <em>enclosure</em> is considered the <em>manufacturer</em> of the <em>medical</em> <em>supply</em> <em>unit</em>.</p>
<p><em>Hazards</em> inherent in the intended function of <em>ME</em> <em>equipment</em> or <em>ME</em> <em>systems</em> 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>
