Skip to main content
  • 1469 Accesses

Samenvatting

Doordat risicomanagement wereldwijd ruim aandacht krijgt, bestaat nu de kans dat ook zorgorganisaties op managementniveau het belang gaan inzien van het sluiten van de ‘organisatorische lus’. Het komt erop neer dat, ook na ingebruikname van een apparaat of installatie, risico’s geëvalueerd moeten worden, wat dan eventueel weer kan leiden tot verbeteracties (figuur 31.1).

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 169.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Literatuur

  • Europese Richtlijn 93/42/EEG voor Medische Hulpmiddelen. Het is van belang de geconsolideerde versie te gebruiken waarin ook het Amendement 2007/47/EG van 5 september 2007 is opgenomen. Google op: 1993L0042 - NL -11.10.2007. In plaats van ‘NL’ kan ook ‘EN’ of ‘FR’ worden ingevuld.

    Google Scholar 

  • IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance, Third edition, 2005-12.

    Google Scholar 

  • IEC 60601-1-2:2007 Medical electrical equipment – Part 1-6: General requirements for safety – Collateral standard: Electromagnetic Compatibility (EMC).

    Google Scholar 

  • IEC 60601-1-6:2006 Medical electrical equipment – Part 1-6: General requirements for safety – Collateral standard: Usability.

    Google Scholar 

  • IEC 60601-1-8:2006 Medical electrical equipment – Part 1-8: General requirements for safety – Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.

    Google Scholar 

  • IEC 62353:2007 Medical electrical equipment – Recurrent test and test after repair of medical electrical equipment.

    Google Scholar 

  • IEC/TR 60513:1994, Fundamental aspects of safety standards for medical electrical equipment. Technical Report.

    Google Scholar 

  • IEC/TR 60930:1988 (2nd edition expected 2009): Guidelines for administrative, medical and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems. Technical Report.

    Google Scholar 

  • ISO 14971:2000, Medical devices – Application of risk management to medical devices.

    Google Scholar 

  • ISO/IEC Guide 51:1999, Safety aspects – Guidelines for their inclusion in standards.

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2009 Bohn Stafleu van Loghum, onderdeel van Springer Uitgeverij

About this chapter

Cite this chapter

Hensbroek, R. (2009). 31 Risicomanagement. In: Broeders, I., Kalisingh, S.S. (eds) Handboek endoscopische chirurgie. Bohn Stafleu van Loghum, Houten. https://doi.org/10.1007/978-90-313-6559-3_31

Download citation

  • DOI: https://doi.org/10.1007/978-90-313-6559-3_31

  • Publisher Name: Bohn Stafleu van Loghum, Houten

  • Print ISBN: 978-90-313-5082-7

  • Online ISBN: 978-90-313-6559-3

  • eBook Packages: Dutch language eBook collection

Publish with us

Policies and ethics