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MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
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Available format(s): Hardcopy, PDF
Superseded date: 13-01-2016
Language(s): English
Published date: 01-01-2009
Publisher: National Standards Authority of Ireland
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.Only cited Standards give presumption of conformance to New Approach Directives/Regulations.Dates of withdrawal of national standards are available from NSAI.
FOREWORDINTRODUCTION1 Scope2 Normative references3 Terms and definition4 Principals5 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 principlesAnnex K (normative) - Evaluation of a USER INTERFACE OF UNKNOWN PROVENANCE (UOUP)Annex ZA (normative) - Normative references to international publications with their corresponding European publicationsAnnex ZZ (informative) - Coverage of Essential Requirements of EC DirectivesBibliographyIndex of defined terms
Describes 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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