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| 02424cam 2200385zi 4500 |
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| 001 | 9.873919 |
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| 003 | CaOODSP |
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| 005 | 20221107164043 |
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| 006 | m o d f |
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| 007 | cr ||||||||||| |
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| 008 | 190530t20192019onc |ob f000 0 eng d |
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| 020 | |a9780660311173 |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH164-278/2019E-PDF |
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| 245 | 00|aGuidance document : |bpre-market requirements for medical device cybersecurity. |
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| 264 | 1|a[Ottawa] : |bHealth Canada = Santé Canada, |c2019. |
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| 264 | 4|c©2019 |
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| 300 | |a1 online resource (24 pages) |
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| 336 | |atext|btxt|2rdacontent |
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| 337 | |acomputer|bc|2rdamedia |
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| 338 | |aonline resource|bcr|2rdacarrier |
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| 500 | |aIssued also in French under title: Ligne directrice sur les exigences relatives à la cybersécurité des instrument médicaux avant leur mise en marché. |
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| 500 | |aTitle from cover. |
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| 500 | |a"Date adopted: 2019/06/17; effective date: 2019/06/26." |
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| 500 | |a"Publication date: June 2019." |
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| 500 | |aIssued also in HTML format. |
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| 504 | |aIncludes bibliographical references (page 19). |
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| 520 | |a"Health Canada considers the inclusion of cybersecurity risk control measures an important consideration in issuing medical device licenses. Therefore, this guidance document provides medical device manufacturers advice on the practices, responses and mitigation measures that can improve the cybersecurity of their device. This guidance also outlines the information to be submitted as part of a medical device licence or licence amendment application to demonstrate that a medical device, consisting of or containing software, is sufficiently secure from threats that may exploit a vulnerability within a medical device possibly causing harm"--Policy objectives, pages 5-6. |
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| 650 | 0|aMedical instruments and apparatus|xSafety regulations|zCanada. |
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| 710 | 1 |aCanada. |bHealth Canada, |eissuing body. |
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| 775 | 08|tLigne directrice sur les exigences relatives à la cybersécurité des instrument médicaux avant leur mise en marché.|w(CaOODSP)9.873920 |
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| 856 | 40|qPDF|s347 KB|uhttps://publications.gc.ca/collections/collection_2020/sc-hc/H164-278-2019-eng.pdf |
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| 856 | 4 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/cybersecurity/document.html |
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