IEC/TR 80001-2-5:2014

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Norsk tittel: Application of risk management for IT-networks incorporating medical devices — Part 2-5: Application guidance — Guidance for distributed alarm systems
Engelsk tittel: Application of risk management for IT-networks incorporating medical devices — Part 2-5: Application guidance — Guidance for distributed alarm systems
Varetype: Standard
Språk: Engelsk
Utgave: 1 (2014-12-17)
Antall sider: 33
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Omfang: <p>This part of <std std-id="iso:std:iec:tr:80001:en" type="undated"><std-ref>IEC 80001</std-ref></std>, which is a technical report, gives guidance and practical techniques for <sc>responsible organizations, medical device</sc> manufacturers and providers of other information technology in the application of <std std-id="iso:std:iec:80001:-1:ed-1:en" type="dated"><std-ref>IEC 80001-1:2010</std-ref></std> for the <sc>risk management</sc> of <sc>distributed alarm systems</sc>. This technical report applies to the transmission of <sc>alarm conditions</sc> between <sc>sources, integrator</sc> and <sc>communicators</sc> where at least one <sc>source</sc> is a <sc>medical device</sc> and at least one communication path utilizes a <sc>medical</sc> IT-<sc>network</sc>.</p><p>This technical report provides recommendations for the integration, communication of responses and <sc>redirection</sc> (to another <sc>operator</sc>) of <sc>alarm conditions</sc> from one or more <sc>sources</sc> to ensure <sc>safety</sc> and <sc>effectiveness</sc>. D<sc>ata and systems security</sc> is an important consideration for the <sc>risk management</sc> of <sc>distributed alarm systems</sc>. <xref ref-type="fig" rid="fig_2">Figure 2</xref> illustrates the functions of a <sc>medical</sc> IT-<sc>network</sc> incorporating <sc>sources</sc>, an <sc>integrator</sc> and <sc>communicators</sc> to distribute <sc>alarm conditions</sc>.</p><fig id="fig_2"><label>Figure 2</label><caption><title>Functions of a <sc>medical</sc> IT-<sc>network</sc> incorporating <sc>sources</sc>, an <sc>integrator</sc> and <sc>communicators</sc> to distribute <sc>alarm conditions</sc></title></caption><graphic xmlns:p1="http://www.w3.org/1999/xlink" p1:href="fig_2" p1:type="simple"/><non-normative-note><label>NOTE</label><p>This is a functional diagram and does not imply that these functions are in separate components. It is possible for functionality to be provided in one or more components.</p></non-normative-note></fig><p>The following is a typical chain of events. An event is detected by a <sc>source</sc> that initiates an <sc>alarm condition</sc>. The <sc>source</sc> sends the <sc>alarm condition</sc> to the <sc>integrator</sc>. Based on the <sc>responsible organization</sc>-established assignment protocol, the <sc>integrator</sc> directs the <sc>alarm condition</sc> to the assigned <sc>communicator</sc>. The <sc>communicator</sc> generates the appropriate <sc>alarm signals</sc>. The <sc>integrator</sc> now waits for an <sc>operator</sc> response from the <sc>communicator</sc> or for the <sc>source</sc> to indicate that the <sc>alarm condition</sc> no longer exists.</p><p>If the <sc>communicator</sc> is capable of accepting a response and the <sc>operator</sc> responds, the <sc>operator</sc> indicates that it either accepts or rejects responsibility for the <sc>alarm condition</sc>. If the <sc>operator</sc> rejects the responsibility, the <sc>integrator</sc> redirects the <sc>alarm condition</sc> to a different <sc>communicator</sc> (i.e. a different <sc>operator</sc>) and might also escalate the priority of the <sc>alarm condition</sc>. Eventually an <sc>operator</sc> accepts responsibility for the <sc>alarm condition</sc>. When an <sc>operator</sc> has taken appropriate action, the <sc>alarm condition</sc> subsequently ends. Alternately, the <sc>alarm condition</sc> could end without <sc>operator</sc> action in which case when the <sc>source</sc> notifies the <sc>integrator</sc> that the <sc>alarm condition</sc> is no longer present, the <sc>integrator</sc> instructs the <sc>communicator</sc> to stop generating <sc>alarm signals</sc>. Should an <sc>alarm condition</sc> remain uncorrected for an extended period of time, the <sc>alarm system</sc> should cause the <sc>escalation</sc> of the <sc>alarm condition</sc>, notify additional <sc>operators</sc>, etc.</p><non-normative-example><label>EXAMPLE</label><p>A pulse oximeter detects a low SpO2 level in the <sc>patient</sc>, initiates an <sc>alarm condition</sc> and sends that <sc>alarm condition</sc> to the <sc>integrator</sc> via a <sc>medical</sc> IT-<sc>network</sc>. The <sc>integrator</sc> then directs that <sc>alarm condition</sc> to the <sc>communicator</sc> that is mapped to the clinical <sc>operator</sc> assigned to the <sc>patient</sc> via a <sc>medical</sc> IT-<sc>network</sc>.</p><p>O<sc>perator</sc> A responds by rejecting responsibility for the <sc>alarm condition</sc>. The <sc>communicator</sc> sends this response information back to the <sc>integrator</sc>, which then redirects the <sc>alarm condition</sc> to the <sc>communicator</sc> of clinical <sc>operator</sc> B. O<sc>perator</sc> B then accepts responsibility for the <sc>alarm condition</sc>. The <sc>communicator</sc> sends this response information back to the <sc>integrator</sc>, which then sends it back to the <sc>source</sc> causing an <sc>alarm signal</sc> inactivation state (e.g. <sc>audio paused</sc>) to be generated. O<sc>perator</sc> B adjusts the oxygen concentration in the gas going to the <sc>patient</sc> and the <sc>alarm condition</sc> ceases (e.g. the event ends).</p></non-normative-example>
Fastsatt: 2014-12-17
ICS: 35.240.80 - Anvendelse av IT innenfor helsevesenet
11.040.01 - Medisinsk utstyr generelt