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MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
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Available format(s): Hardcopy, PDF
Withdrawn date: 30-07-2021
Language(s): English
Published date: 01-01-2014
Publisher: Canadian Standards Association
FOREWORDINTRODUCTION1 Scope2 Normative references3 Terms and definitions4 Principles5 USABILITY ENGINEERING PROCESS6 ACCOMPANYING DOCUMENT7 Training and materials for trainingAnnex A (informative) - General guidance and rationaleAnnex B (informative) - Categories of USER actionAnnex C (informative) - Examples of USE ERRORS, ABNORMAL USE and possible causesAnnex D (informative) - Guidance on the USABILITY ENGINEERING PROCESSANNEX E (informative) - Questions that can be used to identify MEDICAL DEVICE characteristics associated with USABILITY that could impact on SAFETYANNEX F (informative) - Examples of possible USABILITY related HAZARDOUS SITUATIONSAnnex G (informative) - USABILITY goals: Illustrative example for a home parenteral infusion pumpANNEX H (informative) - Sample USABILITY SPECIFICATION and its inputsAnnex I (informative) - Recommended reading listAnnex J (informative) - Reference to the essential principlesBibliographyIndex of defined terms
Defines a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to SAFETY of a MEDICAL DEVICE.
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