BS EN 62366 Medical devices. Application of usability engineering to medical devices

BS EN 62366:2008

Medical devices. Application of usability engineering to medical devices

Status : Superseded, Withdrawn   Published : April 2008 Replaced By : BS EN 62366:2008+A1:2015

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What is BS EN 62366:2008?

BS EN 62366 looks at the application of usability engineering to medical devices. Health practices today are heavily dependent on the use of medical equipment, medical instruments and medical technology for both the observation and treatment of patients. Many of these medical devices are developed without applying a usability engineering process or instructions for use, so they’re non intuitive and difficult to master. The usability engineering process is specifically developed to reduce everyday errors, lessen risks and ensure general equipment safety.

How does it work?

BS EN 62366 not only describes the usability engineering process, but also gives guidance on how to implement and execute this method to ensure safety in medical devices – from design, right though to usage. It’s specifically intended for manufacturers and other technical committees who are responsible for the development of the standards for medical equipment. Set out clearly, this standard makes it easy for manufacturers to follow, analyse, specify, design, verify and validate the usability engineering process.

Who should buy it?

  • Manufacturers responsible for medical equipment
  • Ergonomic designers
  • Organizations providing medical devices
  • Health care professionals and specialists
  • Medical equipment engineers
  • Medical equipment suppliers

Why BSI?

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Standard NumberBS EN 62366:2008
TitleMedical devices. Application of usability engineering to medical devices
StatusSuperseded, Withdrawn
Publication Date30 April 2008
Withdrawn Date17 July 2018
Normative References(Required to achieve compliance to this standard)ISO 14971:2007, EN ISO 14971:2007
Informative References(Provided for Information)IEC 60601-1-8:2006, ISO/IEC Guide 51:1999, IEC/TR 61258:1994, ISO 13485:2003, ISO/TR 16142:2006, ANSI/AAMI HE 48:1993, ISO 9000:2005, 93/42/EEC, ANSI/AAMI HE 74:2001, IEC 60601-1:2005, 98/79/EC, ISO 9001:2000, EN 1041:1998, ISO 9241-11:1998
Replaced ByBS EN 62366:2008+A1:2015
International RelationshipsIEC 62366:2007,EN 62366:2008
DescriptorsMedical technology, Instructions for use, Medical equipment, Equipment safety, Hazards, Medical instruments, Design, Ergonomics
Title in FrenchDispositifs médicaux. Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs médicaux
Title in GermanMedizinprodukte. Anwendung der Gebrauchstauglichkeit auf Medizinprodukte
ISBN978 0 580 54371 5
File Size1.227 MB

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