Project No.ISO 19223:2019
Title<p>This document establishes a vocabulary of terms and semantics for all fields of respiratory care involving <i>mechanical ventilation,</i> such as intensive-care <i>ventilation</i>, anaesthesia <i>ventilation</i>, emergency and transport <i>ventilation</i> and home-care <i>ventilation,</i> including <i>sleep-apnoea</i> <i>breathing</i>-<i>therapy equipment</i>. It is applicable</p> <p>— in <i>lung ventilator</i> and <i>breathing</i>-therapy device standards,</p> <p>— in health informatics standards,</p> <p>— for labelling on <i>medical electrical equipment</i> and <i>medical electrical systems,</i></p> <p>— in <i>medical electrical equipment</i> and <i>medical electrical system</i> instructions for use and <i>accompanying documents,</i></p> <p>— for <i>medical electrical equipment</i> and <i>medical electrical systems</i> interoperability, and</p> <p>— in electronic health records.</p> <p>This document is also applicable to those accessories intended by their <i>manufacturer</i> to be connected to a <i>ventilator</i> <i>breathing system</i> or to a <i>ventilator</i>, where the characteristics of those accessories can affect the basic safety or essential performance of the <i>ventilator</i> and <i>ventilator</i> <i>breathing system</i>.</p> <p>NOTE This document can also be used for other applications relating to <i>lung</i> <i>ventilation</i>, including non-electrical devices and equipment, research, description of critical events, forensic analysis and adverse event (vigilance) reporting systems.</p> <p>This document does not specify terms specific to <i>breathing</i>-therapy equipment, or to physiologic closed-loop <i>ventilation</i>, high-frequency <i>ventilation</i> or <i>negative-pressure ventilation</i>; nor to respiratory support using liquid <i>ventilation</i> or extra-corporeal gas exchange, or oxygen, except where it has been considered necessary to establish boundaries between bordering concepts.</p>
Registration number (WIID)51164
Scope<p>This document establishes a vocabulary of terms and semantics for all fields of respiratory care involving <i>mechanical ventilation,</i> such as intensive-care <i>ventilation</i>, anaesthesia <i>ventilation</i>, emergency and transport <i>ventilation</i> and home-care <i>ventilation,</i> including <i>sleep-apnoea</i> <i>breathing</i>-<i>therapy equipment</i>. It is applicable</p> <p>— in <i>lung ventilator</i> and <i>breathing</i>-therapy device standards,</p> <p>— in health informatics standards,</p> <p>— for labelling on <i>medical electrical equipment</i> and <i>medical electrical systems,</i></p> <p>— in <i>medical electrical equipment</i> and <i>medical electrical system</i> instructions for use and <i>accompanying documents,</i></p> <p>— for <i>medical electrical equipment</i> and <i>medical electrical systems</i> interoperability, and</p> <p>— in electronic health records.</p> <p>This document is also applicable to those accessories intended by their <i>manufacturer</i> to be connected to a <i>ventilator</i> <i>breathing system</i> or to a <i>ventilator</i>, where the characteristics of those accessories can affect the basic safety or essential performance of the <i>ventilator</i> and <i>ventilator</i> <i>breathing system</i>.</p> <p>NOTE This document can also be used for other applications relating to <i>lung</i> <i>ventilation</i>, including non-electrical devices and equipment, research, description of critical events, forensic analysis and adverse event (vigilance) reporting systems.</p> <p>This document does not specify terms specific to <i>breathing</i>-therapy equipment, or to physiologic closed-loop <i>ventilation</i>, high-frequency <i>ventilation</i> or <i>negative-pressure ventilation</i>; nor to respiratory support using liquid <i>ventilation</i> or extra-corporeal gas exchange, or oxygen, except where it has been considered necessary to establish boundaries between bordering concepts.</p>
StatusStandarts spēkā
ICS group01.040.11
99.010
11.040.10