ISO 18562-4:2017

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Norsk tittel: Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate
Engelsk tittel: Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate
Varetype: Standard
Språk: Engelsk
Utgave: 1 (2017-03-13)

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Omfang: <p>This document specifies tests for substances leached by liquid water condensing into <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 hazardous water-soluble substances that are leached from the <sc>medical device</sc>, its parts or <sc>accessories</sc> by condensate and then conveyed by that liquid to the <sc>patient</sc>. This document establishes acceptance criteria for these tests.</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> series.</p></non-normative-example><p>This document does not address contact with drugs or anaesthetic agents. If a <sc>medical device</sc> is intended to be used with anaesthetic agents or drugs, then additional testing can be required.</p><p>This document is intended to be read in conjunction with <std><std-ref>ISO 18562-1</std-ref></std>.</p><non-normative-note><label>NOTE</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