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Article

Technical standards for micro sensors in surgery and minimally invasive therapy

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Pages 110-113 | Published online: 10 Jul 2009

References

  • IS=1173-20101 (Draft Standard) Health Informatics – Point-of care medical device communication, Applica- tion profles – Base standard.
  • MDD 93/42/EWG in Europe, Medical Device Directive.
  • EN 45502-1, Active implantable medical devices – Part 1, General requirements for safety, marking and information to be provided by the manufacturer, 1997.
  • EN 45502-2-1, Active implantable medical devices – Part 2-1, Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (Cardiac pacemakers), 1998.
  • EN 45502-2-2, Active implantable medical devices – Part 2-2, Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defbrillators), 1998.
  • EN 45502-2-x, Active implantable medical devices – cochlear implants (under consideration).
  • ISO 10993-1:2003, Biological evaluation of medical devices – Part 1: Evaluation and testing.
  • ENV 13734, Health informatics – Vital signs information representation.
  • DICOM http://www.iso.ch/iso/en/CombinedQueryResult. CombinedQueryResult?queryString=DICOM.

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