ISO 18562-2:2017

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Norsk tittel: Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter
Engelsk tittel: Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter
Varetype: Standard
Språk: Engelsk
Utgave: 1 (2017-03-13)

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Omfang: <p>This document specifies tests for the emissions of <sc>particulate matter</sc> from the <sc>gas pathways</sc> of a <sc>medical device</sc>, its parts or <sc>accessories,</sc> which are intended to provide respiratory care or supply substances via the respiratory tract to a <sc>patient</sc> in all environments. The tests of this document are intended to quantify particles from 0,2 µm <sc>diameter</sc> to 10 µm <sc>diameter</sc> that are emitted by the <sc>medical device</sc>, its parts or <sc>accessories</sc> into the respirable gas stream. This document establishes acceptance criteria for these tests. This document does not address nanoparticles. Insufficient data exist to establish exposure limits for particles less than 0,2 µm in <sc>diameter</sc>.</p><non-normative-note><label>NOTE 1</label><p>Smaller and larger particles could also present biological <sc>hazards</sc>, and additional information outside the scope of this document can be needed to meet requirements of some <sc>authorities having jurisdiction</sc>.</p></non-normative-note><p>This document therefore adopts the same approach as the US Environmental Protection Agency (EPA) in setting limits based solely on particle size and not their chemistry.</p><p>This document addresses potential contamination of the gas stream arising from the <sc>gas pathways</sc>, which is then conducted to the <sc>patient</sc>.</p><p>This document applies over the <sc>expected service life</sc> of the <sc>medical device</sc> in <sc>normal use</sc> and takes into account the effects of any intended processing or reprocessing.</p><p>This document does not address biological evaluation of the surfaces of <sc>gas pathways</sc> that are in direct contact with the <sc>patient</sc>. The requirements for direct contact surfaces are found in the <std std-id="iso:std:iso:10993:en" type="undated"><std-ref>ISO 10993</std-ref></std> series.</p><p><sc>Medical devices</sc>, parts or <sc>accessories,</sc> containing <sc>gas pathways</sc> that are addressed by this document, include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces, and any breathing <sc>accessories</sc> intended to be used with such devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be <sc>gas pathways</sc> and are also addressed by this document.</p><p>This document does not address contamination already present in the gas supplied from the gas sources while <sc>medical devices</sc> are in <sc>normal use</sc>.</p><non-normative-example><label>EXAMPLE</label><p>Contamination arriving at the <sc>medical device</sc> from gas sources such as <sc>medical gas pipeline systems</sc> (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder, or room air taken into the <sc>medical device</sc> is not addressed by <std><std-ref>ISO 18562</std-ref></std> (<std><std-ref>all parts</std-ref></std>).</p></non-normative-example><non-normative-note><label>NOTE 2</label><p>This document has been prepared to address the relevant essential principles of safety and performance as indicated in <xref ref-type="app" rid="sec_B">Annex B</xref>.</p></non-normative-note>
Fastsatt: 2017-03-13
ICS: 11.040.10 - Anestesi, åndedretts- og gjenopplivingsutstyr