ISO 80601-2-80:2018

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Norsk tittel: Medical electrical equipment — Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
Engelsk tittel: Medical electrical equipment — Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
Varetype: Standard
Språk: Engelsk
Utgave: 1 (2018-07-18)
Erstatter: ISO 10651-6:2004 Alert Tilbaketrukket
Antall sider: 85

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Omfang: <p><std><std-ref>IEC 60601-1:2005+AMD1:2012</std-ref>, Clause 1</std>, applies, except as follows:</p><sec id="sec_201.1.1"><label>201.1.1</label><title>* Scope</title><p><italic>Replacement:</italic></p><p>This document applies to the <sc>basic safety</sc> and <sc>essential performance</sc> of <sc>ventilatory support equipment</sc>, as defined in <xref ref-type="sec" rid="sec_201.3.205">201.3.205</xref>, for <sc>ventilatory insufficiency</sc>, as defined in <xref ref-type="sec" rid="sec_201.3.204">201.3.204</xref>, hereafter also referred to as <sc>me equipment</sc>, in combination with its <sc>accessories</sc>:</p><list list-type="bullet"><list-item><label>—</label><p>intended for use in the <sc>home healthcare environment</sc>;</p></list-item><list-item><label>—</label><p>intended for use by a <sc>lay operator</sc>;</p></list-item><list-item><label>—</label><p>intended for use with <sc>patients</sc> who have <sc>ventilatory insufficiency</sc> or failure, the most fragile of which would likely experience injury with the loss of this artificial ventilation;</p></list-item><list-item><label>—</label><p>intended for <sc>transit-operable</sc> use;</p></list-item><list-item><label>—</label><p>not intended for <sc>patients</sc> who are dependent on artificial ventilation for their immediate life support.</p></list-item></list><non-normative-example><label>EXAMPLE 1</label><p>P<sc>atients</sc> with moderate to severe chronic obstructive pulmonary disease (COPD), moderate amyotrophic lateral sclerosis (ALS), severe bronchopulmonary dysplasia or muscular dystrophy.</p></non-normative-example><non-normative-note><label>NOTE 1</label><p>In the <sc>home healthcare environment</sc>, the <sc>supply mains</sc> is often not reliable.</p></non-normative-note><non-normative-note><label>NOTE 2</label><p>Such <sc>ventilatory support equipment</sc> can also be used in non-critical care applications of professional health care facilities.</p></non-normative-note><p>This document is also applicable to those <sc>accessories</sc> intended by their <sc>manufacturer</sc> to be connected to the <sc>ventilator breathing system</sc> of <sc>ventilatory support equipment</sc> for <sc>ventilatory insufficiency</sc>, where the characteristics of those <sc>accessories</sc> can affect the <sc>basic safety</sc> or <sc>essential performance</sc> of the <sc>ventilatory support equipment</sc>for <sc>ventilatory insufficiency</sc>.</p><non-normative-example><label>EXAMPLE 2</label><p>Breathing sets, connectors, water traps, expiratory valve, <sc>humidifier</sc>, <sc>breathing system filter</sc>, external electrical power source, <sc>distributed alarm system</sc>. </p></non-normative-example><p>If a clause or subclause is specifically intended to be applicable to <sc>me equipment</sc> only, or to <sc>me systems</sc> only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to <sc>me equipment</sc> and to <sc>me systems</sc>, as relevant.</p><p>H<sc>azards</sc> inherent in the intended physiological function of <sc>me equipment</sc> or <sc>me systems</sc> within the scope of this document are not covered by specific requirements in this document except in <std><std-ref>IEC 60601-1:2005 +AMD1:2012</std-ref>, 7.2.13 and 8.4.1</std>.</p><non-normative-note><label>NOTE 3</label><p>Additional information can be found in <std><std-ref>IEC 60601-1:2005 +AMD1:2012</std-ref>, 4.2</std>.</p></non-normative-note><p>This document does not specify the requirements for:</p><list list-type="bullet"><list-item><label>—</label><p><sc>ventilators</sc> or <sc>accessories</sc> for <sc>ventilator-dependent patients</sc> intended for critical care applications, which are given in <std><std-ref>ISO 80601-2-12</std-ref></std>;</p></list-item><list-item><label>—</label><p><sc>ventilators</sc> or <sc>accessories</sc> intended for anaesthetic applications, which are given in <std std-id="iso:std:iso:80601:-2-13:en" type="undated"><std-ref>ISO 80601-2-13</std-ref></std><xref ref-type="bibr" rid="biblref_5"><sup>[5]</sup></xref>;</p></list-item><list-item><label>—</label><p><sc>ventilators</sc> or <sc>accessories</sc> intended for the emergency medical services environment, which are given in <std><std-ref>ISO 80601-2-84</std-ref></std><xref ref-type="bibr" rid="biblref_6"><sup>[6]</sup></xref><xref ref-type="fn" rid="fn_4"><sup>4</sup></xref> , the future replacement for <std std-id="iso:std:iso:10651:-3:en" type="undated"><std-ref>ISO 10651-3</std-ref></std><xref ref-type="bibr" rid="biblref_7"><sup>[7]</sup></xref>;</p></list-item><list-item><label>—</label><p><sc>ventilators</sc> or <sc>accessories</sc> intended for <sc>ventilator-dependent patients</sc> in the <sc>home healthcare environment</sc>, which are given in <std std-id="iso:std:iso:80601:-2-72:en" type="undated"><std-ref>ISO 80601-2-72</std-ref></std>;</p></list-item><list-item><label>—</label><p><sc>ventilatory support equipment</sc> or <sc>accessories</sc> intended for <sc>ventilatory impairment</sc>, which are given in <std std-id="iso:std:iso:80601:-2-79:en" type="undated"><std-ref>ISO 80601-2-79</std-ref></std><xref ref-type="bibr" rid="biblref_1"><sup>[1]</sup></xref>;</p></list-item><list-item><label>—</label><p>sleep apnoea therapy <sc>me equipment</sc>, which are given in <std std-id="iso:std:iso:80601:-2-70:en" type="undated"><std-ref>ISO 80601-2-70</std-ref></std><xref ref-type="bibr" rid="biblref_8"><sup>[8]</sup></xref>;</p></list-item><list-item><label>—</label><p>continuous positive airway pressure (CPAP) <sc>me equipment</sc>;</p></list-item><list-item><label>—</label><p>high-frequency jet <sc>ventilators</sc> (HFJVs);</p></list-item><list-item><label>—</label><p>high-frequency oscillatory <sc>ventilators</sc> (HFOVs)<xref ref-type="bibr" rid="biblref_9"><sup>[9]</sup></xref>;</p></list-item><list-item><label>—</label><p>oxygen therapy constant flow <sc>me equipment</sc>;</p></list-item><list-item><label>—</label><p>cuirass or “iron-lung” ventilation equipment.</p></list-item></list><p>This document is a particular standard in the <std std-id="iso:std:iec:tr:60601:en" type="undated"><std-ref>IEC 60601</std-ref></std> and <std><std-ref>IEC/ISO 80601</std-ref></std> series of documents.</p></sec><sec id="sec_201.1.2"><label>201.1.2</label><title>Object</title><p><italic>Replacement</italic>:</p><p>The object of this document is to establish particular <sc>basic safety</sc> and <sc>essential performance</sc> requirements for <sc>ventilatory support equipment</sc>, as defined in <xref ref-type="sec" rid="sec_201.3.205">201.3.205</xref>, and its <sc>accessories</sc>.</p><non-normative-note><label>NOTE</label><p>A<sc>ccessories</sc> are included because the combination of the <sc>ventilatory support equipment</sc> and the <sc>accessories</sc> needs to be adequately safe. A<sc>ccessories</sc> can have a significant impact on the <sc>basic safety</sc> or <sc>essential performance</sc> of the <sc>ventilatory support equipment</sc>.</p></non-normative-note></sec><sec id="sec_201.1.3"><label>201.1.3</label><title>Collateral standards</title><p><italic>Addition</italic>:</p><p>This document refers to those applicable collateral standards that are listed in Clause 2 of the general standard and <xref ref-type="sec" rid="sec_201.2">Clause 201.2</xref> of this document.</p><p><std><std-ref>IEC 60601-1-2:2014</std-ref></std>, <std><std-ref>IEC 60601-1-6:2010 +AMD1:2013</std-ref></std>, <std><std-ref>IEC 60601-1-8:2006 +AMD1:2012</std-ref></std> and <std std-id="iso:std:iec:60601:-1-11:ed-2:en" type="dated"><std-ref>IEC 60601-1-11:2015</std-ref></std> apply as modified in <xref ref-type="sec" rid="sec_202">Clauses 202</xref>, <xref ref-type="sec" rid="sec_206">206</xref>, <xref ref-type="sec" rid="sec_208">208</xref> and <xref ref-type="sec" rid="sec_211">211</xref> respectively. <std><std-ref>IEC 60601-1-3 :2008</std-ref></std><xref ref-type="bibr" rid="biblref_10"><sup>[10]</sup></xref> does not apply. All other published collateral standards in the <std><std-ref>IEC 60601-1</std-ref></std> series apply as published.</p></sec><sec id="sec_201.1.4"><label>201.1.4</label><title>Particular standards</title><p><italic>Replacement</italic>:</p><p>In the <std std-id="iso:std:iec:tr:60601:en" type="undated"><std-ref>IEC 60601</std-ref></std> series, particular standards may modify, replace or delete requirements contained in the general standard, including the collateral standards as appropriate for the particular <sc>me equipment</sc> under consideration, and may add other <sc>basic safety</sc> or <sc>essential performance</sc> requirements.</p><p>A requirement of a particular standard takes priority over the general standard.</p><p>For brevity, <std><std-ref>IEC 60601-1:2005 +AMD1:2012</std-ref></std> is referred to in this particular document as the general standard. Collateral standards are referred to by their document number.</p><p>The numbering of clauses and subclauses of this document corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix “2xx”, where xx is the final digits of the collateral standard document number (e.g. 202.4 in this document addresses the content of <std>Clause 4 of the <std-ref>IEC 60601-1-2</std-ref></std> collateral standard, 211.10 in this document addresses the content of <std>Clause 10 of the <std-ref>IEC 60601-1-11</std-ref></std> collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words:</p><p>"Replacement" means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text of this document.</p><p>"Addition" means that the text of this document is additional to the requirements of the general standard or applicable collateral standard.</p><p>"Amendment" means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this document.</p><p>Subclauses, figures or tables that are additional to those of the general standard are numbered starting from 201.101. However, due to the fact that definitions in the general standard are numbered 3.1 through 3.147, additional definitions in this document are numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.</p><p>Subclauses, figures or tables which are additional to those of a collateral standard are numbered starting from 20x, where “x” is the number of the collateral standard, e.g. <std>202 for <std-ref>IEC 60601-1-2</std-ref></std>, <std>203 for <std-ref>IEC 60601-1-3</std-ref></std>, etc.</p><p>The term "this document" is used to make reference to the general standard, any applicable collateral standards and this particular document taken together.</p><p>Where there is no corresponding clause or subclause in this particular document, the clause or subclause of the general standard or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the general standard or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this document.</p></sec>
Fastsatt: 2018-07-18
ICS: 11.040.10 - Anestesi, åndedretts- og gjenopplivingsutstyr