Biomedical Engineering Reference
In-Depth Information
monitoring, and remote access functions with the existing devices. Electrical
stimulation has been an exciting arena of research and development for six
decades, and will continue to be a field rich in new technology and therapy
development opportunities for years to come.
4.8
Acknowledgements
The authors thank Dr Warren Starkebaum for the contribution of writing the
review of gastric electrical stimulation. The authors also thank Medtronic Inc.,
for support in preparing this chapter.
4.9 Sources of further information and advice
ISO 10993:1997 Biological evaluation of medical devices Parts 1±20. 1997
ISO 11318:2002 Cardiac defibrillators ± connector assembly DF-1 for implantable
defibrillators ± dimensional and test requirements, Second Edition, 1 August 2002.
ISO 5841-3:2000 Implants for surgery ± cardiac pacemakers ± Part 3: Low-profile
connectors (IS-1) for implantable pacemakers, 15 October 2000.
ISO 27186:2010 (FDIS), Active implantable medical devices ± Four-pole connector
system for implantable cardiac rhythm management devices ± Dimensional and test
requirements, November 2009. (Note: This document is being circulated as a Final
Draft International Standard.)
CEN EN 45502-1, Active implantable medical devices ± Part 1: General requirements for
safety, marking and information to be provided by the manufacturer, 1 August
1997.
CENELEC EN 45502-2-1, Active implantable medical devices ± Part 2-1: Particular
requirements
for active implantable medical devices
intended to treat
bradyarrhythmia (cardiac pacemakers), 1 December 2003.
CENELEC EN 45502-2-2, Active implantable medical devices ± Part 2-2: Particular
requirements for active implantable medical devices intended to treat
tachyarrhythmia (includes implantable defibrillators), 1 March 2008.
ISO 14708-1:2000, Implants for surgery ± Active implantable medical devices ± Part 1:
General requirements for safety, marking and for information to be provided by the
manufacturer, 15 November 2008.
ISO 14708-2:2005, Implants for surgery ± Active implantable medical devices ± Part 2:
Cardiac pacemakers, 2nd Edition, January 2008.
ISO 14708-3:2008, Implants for surgery ± Active implantable medical devices ± Part 3:
Implantable neurostimulators, 15 November 2008.
ISO 14708-6:2010 (FDIS), Implants for surgery ± Active implantable medical devices ±
Part 6: Particular requirements for active implantable medical devices intended to
treat tachyarrhythmia (including implantable defibrillators), December 2009. (Note:
This document is being circulated as a Final Draft International Standard.)
CDRH Guidance for Industry: Guidance for the Submission of Research and Marketing
Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor
510(k) Submissions, US Department of Health and Human Services, Food and Drug
Administration, Center for Devices and Radiological Health, Interventional
Cardiology Devices Branch, Division of Cardiovascular and Respiratory Devices,
