This document is intended to be used by healthcare organisations and medical devices suppliers responsible for permanent electrical installation of medical devices and associated equipment in diagnostic imaging (including dental X-ray units) and radiotherapy rooms/suites. Its requirements are intended for application by staff with electrical knowledge.
Healthcare organisations should include as a condition of contract that 'the electrical installation shall meet the requirements of BS 7671 IEE Wiring Regulations, MEIGaN, HTM 2007 and BS EN 60601-1-1:2001.'
Version 2 has:
- new section on mechanical and engineering requirements
- additional information on over-current protection, residual current detectors, clean earth sockets, UPS and IPS systems and electrical safety checks on MR systems
- updated references.
This document may also be of use to persons installing permanently installed medical devices in other clinical areas, but has not yet been agreed by interested parties concerned with installations other than for imaging and radiotherapy.
Using the document
This guidance is for new buildings, refurbished rooms and transportable diagnostic or treatment rooms and is not retrospective.
Purchasers and suppliers shall not change the original text. Any changes shall be listed in an addendum.
For more information please email brian.mansfield@mhra.gsi.gov.uk
First edition (v1.0) published June 2005
Second edition (v2.0) published September 2007
October 2008 update:
template checklist (53Kb) - adapt for your own use
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