Archive for the ‘MHRA’ Category

MEIGaN – Medical Electrical Installation Guidance

Thursday, March 18th, 2010

MEIGaN – Medical Electrical Installation Guidance 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.

Where complied with a complete set of paper commissioning records, sufficient to show compliance with the EIGaN guidance shall be made available to the owner at handover.

This document may also be of use to persons installing permanently installed medical evices in other clinical areas, but has not yet been agreed by interested parties oncerned with installations other than for imaging and radiotherapy.

Covering the electrical wiring and installation up to the terminals of ermanently installed medical devices and to the supply outlets for other medical sevices, and is intended to improve the reliability and resilience of the power supplies sed in diagnostic imaging and radiotherapy rooms/suites as well as their electrical safety.

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.’

The guidance document supplements the following, all relevant requirements of which apply:

• BS 7671:2001 Requirements for electrical installations. IEE Wiring Regulations. Sixteenth edition, including amendment No. 1 2002 and No. 2 2004
• NHS Estates HTM 06-01 Electrical services, supply and distribution
• BS EN60601-1-1:2006 Medical electrical equipment. General requirements for safety. Collateral standard. Safety requirements for medical electrical systems.
Annex 1 of the document is based on IEC 60364-7-710 [4] and IEE Guidance Note 7 and will be incorporated in a subsequent revision of HTM 06-01.

The document document has been produced by the MHRA and representatives from the Department of Health’s Estates and Facilities Division, the Scottish, Welsh and Northern Ireland administrations, NHS electrical experts, medical device suppliers and pre-installation companies.

It is intended for new buildings, refurbished rooms and transportable diagnostic or treatment rooms and is not retrospective.

References
1 BS 7671:2001 Requirements for electrical installations. IEE Wiring Regulations.

2 Department of Health: Estates and Facilities Division. HTM 06-01 Electrical ervices supply and distribution.

3 BS EN 60601-1:2006 Medical electrical equipment. General requirements for basic safety and essential performance. BSI, 2006.

4 IEC 60364-7-710:2002 Electrical installations of buildings – Part 7-710: requirements for special installations or locations – medical locations.
Note: the MHRA and DH Estates and Facilities Division recommend that MEIGaN is used.

5 The Institution of Engineering and Technology IEE Guidance Note 7: Special locations, 2nd Edition. IEE Publications, 2004.

6 Statutory Instrument 1999 No. 3232 The Ionising Radiation Regulations 1999. MSO 1999.

7 BS 6231:2006 Electric cables. Single core PVC insulated flexible cables of rated voltage 600/1000 V for switchgear and controlgear wiring. BSI, 2006.

8 Canadian Standards Association. C22.2.127-99 Equipment and lead wires. CSA, 1999.

9 Underwriters Laboratories Inc. UL 758 Appliance wiring material, 2nd edition.

10 BS EN 60309-2:1999, IEC 60309-2:1999 Plugs, socket-outlets and couplers for industrial purposes. Dimensional interchangeability requirements for pin and contact-tube accessories. BSI, 1999.

11 Medical Devices Directives. Council of the European Communities. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. OJ L169: 1-43. 1993.
http://ec.europa.eu/enterprise/medical_devices/legislation_en.htm

12 BS EN 60601-1-4:1997, BS 5724-1.4:1997, IEC 60601-1-4:1996 Medical electrical equipment. General requirements for safety. Collateral standard. General requirements for programmable electrical medical systems. BSI, 1997.

13 IEC 61557-8 Electrical safety in low voltage distribution systems up to 1000 V a.c. and 1 500 V d.c. – Equipment for testing, measuring or monitoring of protective measures – Part 8: Insulation monitoring devices for IT systems.