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| 02171cam 2200373zi 4500 |
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| 001 | 9.873314 |
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| 003 | CaOODSP |
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| 005 | 20221107163859 |
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| 006 | m o d f |
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| 007 | cr cn||||||||| |
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| 008 | 190521t20202020onc ob f000 0 eng d |
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| 020 | |a9780660309828 |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH14-327/2019E-PDF |
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| 245 | 00|aRisk classification guide for medical device establishment inspections. |
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| 264 | 1|aOttawa, ON : |bHealth Canada = Santé Canada, |c2020. |
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| 264 | 4|c©2020 |
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| 300 | |a1 online resource (28 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: Guide de classification des risques pour les inspections d'établissements d'instruments médicaux. |
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| 500 | |a"GUI-0079." |
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| 500 | |a"January 31, 2020." |
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| 500 | |aIssued also in HTML format. |
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| 504 | |aIncludes bibliographical references (pages 27-28). |
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| 520 | |a"This document is intended to help ensure consistency among Health Canada inspectors during medical device establishment inspections when: classifying observations of deviations, deficiencies or failures according to risk; assigning an overall compliance rating to an inspection. It also informs anyone with a medical device establishment licence (MDEL) of the situations Health Canada considers unacceptable that may result in a non-compliant (NC) rating and/or compliance and enforcement actions"--page 5. |
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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|tGuide de classification des risques pour l'inspection des établissements de instruments médicaux.|w(CaOODSP)9.873316 |
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| 856 | 40|qPDF|s1.46 MB|uhttps://publications.gc.ca/collections/collection_2020/sc-hc/H14-327-2019-eng.pdf |
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| 856 | 4 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/medical-devices/guidance-risk-classification-medical-device-observations-0079.html |
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