ISO/TC 121/SC 3

Project No.ISO 10651-4:2023
Title<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document specifies requirements for <em style="mso-bidi-font-style: normal;">user-powered resuscitators</em> intended for use with all age groups and which are intended to provide <em style="mso-bidi-font-style: normal;">lung</em> ventilation to <em style="mso-bidi-font-style: normal;">patients</em> whose breathing is inadequate. <em style="mso-bidi-font-style: normal;">User-powered resuscitators</em> are designated according to ideal body mass range.</span></p> <p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">Example <em style="mso-bidi-font-style: normal;">user-powered resuscitators</em> include:</span></p> <p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;">    </span>self-inflating bag <em style="mso-bidi-font-style: normal;">resuscitators</em> intended to be squeezed by the <em style="mso-bidi-font-style: normal;">user’s</em> hand and refilled by elastic recoil; and</span></p> <p class="Note" style="tab-stops: 19.85pt 39.7pt 48.25pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">NOTE 1<span style="mso-tab-count: 1;">    </span>Self-inflating bag <em style="mso-bidi-font-style: normal;">resuscitators</em> are generally <em style="mso-bidi-font-style: normal;">transit-operable</em> and can be used in a wide range of environmental and emergency situations.</span></p> <p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;">    </span>flow-inflating bag <em style="mso-bidi-font-style: normal;">resuscitators</em> intended to be squeezed by the <em style="mso-bidi-font-style: normal;">user’s</em> hand and refilled by a flow from a medical gas source.</span></p> <p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document is also applicable to those <em style="mso-bidi-font-style: normal;">accessories</em> that are intended for use with <em style="mso-bidi-font-style: normal;">resuscitators</em> where the characteristics of those <em style="mso-bidi-font-style: normal;">accessories</em> can affect the <em style="mso-bidi-font-style: normal;">safety</em> of the <em style="mso-bidi-font-style: normal;">user-powered resuscitator.</em></span></p> <p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">Examples of such <em style="mso-bidi-font-style: normal;">accessories</em> include face <em style="mso-bidi-font-style: normal;">masks</em>, <em style="mso-bidi-font-style: normal;">PEEP</em> valves, capnometric indicators, manometers, metronomes, flow restrictors, filters, gas refill valves, oxygen gas mixers, connectors, electronic feedback devices, electronic sensors and transmission of data to other equipment.</span></p> <p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document is also applicable to point-of-use packaging.</span></p> <p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document does not specify the requirements for:</span></p> <p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;">    </span>gas-powered emergency resuscitators, which are given in <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">10651</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">5</span></span></span>;</span></p> <p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;">    </span>electrically-powered resuscitators;</span></p> <p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;">    </span>gas powered resuscitators for <em style="mso-bidi-font-style: normal;">professional healthcare facilities</em>; and</span></p> <p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;">    </span>anaesthetic reservoir bags, which are given in <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">5362</span></span></span>.</span></p> <p class="Note" style="tab-stops: 19.85pt 39.7pt 48.25pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">NOTE 2<span style="mso-tab-count: 1;">    </span>This document has been prepared to address the relevant <em style="mso-bidi-font-style: normal;">essential principles</em><sup>[<span class="citebib"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">24</span></span></span>]</sup> and labelling<sup>[<span class="citebib"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">25</span></span></span>]</sup> guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in <span class="citeapp"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">Annex D</span></span></span>.</span></p> <p class="Note" style="tab-stops: 19.85pt 39.7pt 48.25pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">NOTE 3<span style="mso-tab-count: 1;">    </span>This document has been prepared to address the relevant <em style="mso-bidi-font-style: normal;">essential principles of safety and performance</em> of <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">16142</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">1</span></span></span>:<span class="stdyear"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">2016</span></span></span> as indicated in <span class="citeapp"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">Annex E</span></span></span>.</span></p> <p class="Note" style="tab-stops: 19.85pt 39.7pt 48.25pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">NOTE 4<span style="mso-tab-count: 1;">    </span>This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745<sup>[<span class="citebib"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">23</span></span></span>]</sup> as indicated in <span class="citeapp"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">Annex F</span></span></span>.</span></p>
Registration number (WIID)77803
Scope<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document specifies requirements for <em style="mso-bidi-font-style: normal;">user-powered resuscitators</em> intended for use with all age groups and which are intended to provide <em style="mso-bidi-font-style: normal;">lung</em> ventilation to <em style="mso-bidi-font-style: normal;">patients</em> whose breathing is inadequate. <em style="mso-bidi-font-style: normal;">User-powered resuscitators</em> are designated according to ideal body mass range.</span></p> <p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">Example <em style="mso-bidi-font-style: normal;">user-powered resuscitators</em> include:</span></p> <p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;">    </span>self-inflating bag <em style="mso-bidi-font-style: normal;">resuscitators</em> intended to be squeezed by the <em style="mso-bidi-font-style: normal;">user’s</em> hand and refilled by elastic recoil; and</span></p> <p class="Note" style="tab-stops: 19.85pt 39.7pt 48.25pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">NOTE 1<span style="mso-tab-count: 1;">    </span>Self-inflating bag <em style="mso-bidi-font-style: normal;">resuscitators</em> are generally <em style="mso-bidi-font-style: normal;">transit-operable</em> and can be used in a wide range of environmental and emergency situations.</span></p> <p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;">    </span>flow-inflating bag <em style="mso-bidi-font-style: normal;">resuscitators</em> intended to be squeezed by the <em style="mso-bidi-font-style: normal;">user’s</em> hand and refilled by a flow from a medical gas source.</span></p> <p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document is also applicable to those <em style="mso-bidi-font-style: normal;">accessories</em> that are intended for use with <em style="mso-bidi-font-style: normal;">resuscitators</em> where the characteristics of those <em style="mso-bidi-font-style: normal;">accessories</em> can affect the <em style="mso-bidi-font-style: normal;">safety</em> of the <em style="mso-bidi-font-style: normal;">user-powered resuscitator.</em></span></p> <p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">Examples of such <em style="mso-bidi-font-style: normal;">accessories</em> include face <em style="mso-bidi-font-style: normal;">masks</em>, <em style="mso-bidi-font-style: normal;">PEEP</em> valves, capnometric indicators, manometers, metronomes, flow restrictors, filters, gas refill valves, oxygen gas mixers, connectors, electronic feedback devices, electronic sensors and transmission of data to other equipment.</span></p> <p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document is also applicable to point-of-use packaging.</span></p> <p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document does not specify the requirements for:</span></p> <p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;">    </span>gas-powered emergency resuscitators, which are given in <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">10651</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">5</span></span></span>;</span></p> <p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;">    </span>electrically-powered resuscitators;</span></p> <p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;">    </span>gas powered resuscitators for <em style="mso-bidi-font-style: normal;">professional healthcare facilities</em>; and</span></p> <p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;">    </span>anaesthetic reservoir bags, which are given in <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">5362</span></span></span>.</span></p> <p class="Note" style="tab-stops: 19.85pt 39.7pt 48.25pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">NOTE 2<span style="mso-tab-count: 1;">    </span>This document has been prepared to address the relevant <em style="mso-bidi-font-style: normal;">essential principles</em><sup>[<span class="citebib"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">24</span></span></span>]</sup> and labelling<sup>[<span class="citebib"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">25</span></span></span>]</sup> guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in <span class="citeapp"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">Annex D</span></span></span>.</span></p> <p class="Note" style="tab-stops: 19.85pt 39.7pt 48.25pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">NOTE 3<span style="mso-tab-count: 1;">    </span>This document has been prepared to address the relevant <em style="mso-bidi-font-style: normal;">essential principles of safety and performance</em> of <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">16142</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">1</span></span></span>:<span class="stdyear"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">2016</span></span></span> as indicated in <span class="citeapp"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">Annex E</span></span></span>.</span></p> <p class="Note" style="tab-stops: 19.85pt 39.7pt 48.25pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">NOTE 4<span style="mso-tab-count: 1;">    </span>This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745<sup>[<span class="citebib"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">23</span></span></span>]</sup> as indicated in <span class="citeapp"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">Annex F</span></span></span>.</span></p>
StatusStandarts spēkā
ICS group11.040.10