Medical Electrical Equipment
Author: Asociación Española de Normalización y Certificación
Publisher:
Published: 2015
Total Pages: 0
ISBN-13:
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Author: Asociación Española de Normalización y Certificación
Publisher:
Published: 2015
Total Pages: 0
ISBN-13:
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Publisher:
Published: 2020
Total Pages: 0
ISBN-13: 9782832287064
DOWNLOAD EBOOK"IEC 60601-1-6 specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to basic safety and essential performance of medical electrical equipment. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, e.g., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use. If the usability engineering process detailed in this collateral standard has been complied with and the acceptance criteria documented in the usability validation plan have been met (see 5.9 of IEC 62366:2007), then the residual risks, as defined in ISO 14971, associated with usability of me equipment are presumed to be acceptable, unless there is objective evidence to the contrary (see 4.1.2 of IEC 62366:2007). The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards. This document cancels and replaces the second edition of IEC 60601-1-6 which has been technically revised. It was revised to align with the usability engineering process in IEC 62366."--Techstreet.com.
Author: Polska. Polski Komitet Normalizacyjny
Publisher:
Published: 2021
Total Pages:
ISBN-13:
DOWNLOAD EBOOKAuthor: International Electrotechnical Commission
Publisher:
Published: 2020
Total Pages: 254
ISBN-13: 9782832287200
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Publisher:
Published: 2008
Total Pages: 60
ISBN-13: 9788325157562
DOWNLOAD EBOOKAuthor: British Standards Institute Staff
Publisher:
Published: 1915-06-30
Total Pages: 58
ISBN-13: 9780580751448
DOWNLOAD EBOOKElectrical equipment, Electrical medical equipment, Health and safety requirements, Performance, Emergency services, Environmental testing
Author: British Standards Institute Staff
Publisher:
Published: 2007-11
Total Pages: 78
ISBN-13: 9780580563713
DOWNLOAD EBOOKElectrical medical equipment, Medical equipment, Electrical equipment, Electronic equipment and components, Equipment safety, Electrical safety, Risk assessment, Ergonomics, Design
Author: Polska. Polski Komitet Normalizacyjny
Publisher:
Published: 2015
Total Pages:
ISBN-13:
DOWNLOAD EBOOKAuthor: British Standards Institute Staff
Publisher:
Published: 1915-06-30
Total Pages: 70
ISBN-13: 9780580856624
DOWNLOAD EBOOKMedical equipment, Electrical medical equipment, Electrical equipment, Electronic equipment and components, Electrical safety, Safety measures, Domestic, Domestic facilities, Nursing homes, Instructions for use, Marking, Environment (working), Cleaning, Strength of materials
Author: Polska. Polski Komitet Normalizacyjny
Publisher:
Published: 2011
Total Pages: 55
ISBN-13: 9788326674235
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