© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 1 AS/NZS 3003:2011 Electrical installations  Patient areas Lawrie Knuckey IHEA seminar– July 2011

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 2 New edition Still has requirements for: body-protected electrical areas cardiac-protected electrical areas Some locations must now be Some other locations must now be Some socket-outlets and medical electrical equipment must still be protected by LPDs: high speed, high sensitivity residual current devices (RCDs), or isolation transformers with line isolation and overload monitors.

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 3 Major changes in the new edition Specific socket-outlets now require LPD protection: A circuit can no longer supply more than one room and its ensuite. A circuit can no longer supply socket-outlets for cleaning purposes and other socket-outlets. Socket-outlets within 5 m of a patient area must now be protected. UPS status indicators are now required. RCDs must now be readily accessible. Socket-outlets for cleaning purposes no longer required within

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 4 Major changes in the new edition EP terminals no longer required in New section on special locations: Specific requirements for locations with patients susceptible to self- harm. Requirements for home care use of medical electrical equipment. Practical new requirements for home dialysis installations. New section on alterations, additions and repairs: “Alterations” and “additions” range from installing a new socket- outlet to replacing a CT scanner. Routine testing must be up-to-date before alterations or additions can begin.

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 5 Major changes in the new edition New section on alterations, additions and repairs (cont): All socket-outlets must be upgraded to correct colour if total number increased >10%. EP earthing system must be upgraded/replaced for new equipment >2 Kw. New definition of “essential supply”: No longer includes generator-backed circuits subject to load shedding. Some existing red socket-outlets no longer on essential supplies.

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 6 Major changes in the new edition New section on magnetic field testing: Specifies limits for for ECG monitoring and recording. Must be applied in specified locations. New detailed requirements for routine electrical safety testing.

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 7 Scope is still predicated by the definition of “patient area”: Patient areas must be wired as body-protected or cardiac-protected electrical areas. Requirements are still limited to patient areas and locations associated with patient areas. Scope of AS/NZS 3003

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 8 Historical confusion:Which institutions: ✔✔ Hospital ✔ ?X-ray practice ✔ ?Dental surgery ✔ ?Nursing home ??Aged care facility Which locations: ?Hospital corridors ?Staff base in ICU/CCU/A&E ?Control rooms for Cath lab/CT room Further attempt to define scope: New title Amended definition of patient area Scope of AS/NZS 3003

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia editionElectrical installations in electromedical treatment areas 1985 editionElectrical installations — Patient treatment areas of hospitals and medical and dental practices 1999 editionElectrical installations — Patient treatment areas of hospitals and medical and dental practices 2003 editionElectrical installations — Patient areas of hospitals, medical and dental practices and dialyzing locations 2011 editionElectrical installations — Patient areas New title

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 10 New definition of patient area 2003Locations in hospitals and medical and dental practices in which it is intended that mains powered medical electrical equipment will be used. Locations in patients’ homes and other facilities intended for dialysis are also included. 2011Locations where it is intended that mains powered medical electrical equipment will be used on a patient. This does not include areas such as corridors and lifts where medical equipment is only used in an emergency or for transporting patients.

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 11 Extent of the patient area 2003The boundary of the cardiac-protected electrical area extends to the walls enclosing the patient location(s) or, if such walls are incomplete (e.g. entryway without a door) to the boundary formed if such walls or projections were extended.

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 12 Extent of the patient area Draft: Where the walls of a body-protected electrical area are incomplete (e.g. entryway without a door) and the opening is greater than 2 m, the adjacent area is part of the body-protected electrical area.

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia Extent of the patient area

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 14 Extent of the patient area

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 15 Extent of the patient area

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 16 Extent of the patient area 2011The boundary of the cardiac-protected electrical area extends to the walls enclosing the patient location(s) or, if such walls are incomplete (e.g. an entryway without a door) to the boundary formed if such walls or projections were extended. In this context, the following are not considered walls or boundaries: partitions, dividers, screens, benches, moveable walls or curtains.

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 17 Socket-outlets near patient areas 2003Socket-outlets within 2 m of the entrance to a patient area, if located in an area that freely communicates* with the patient area, must be: protected by an LPD, and connected to the EP earthing system if *no door

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 18 Socket-outlets near patient areas 2011Socket-outlets located within 5 m of the entrance* to a patient area, in any room, corridor, etc, opening directly off the patient area, must be: protected by an LPD, and connected to the EP earthing system if *Whether or not the entryway has a door

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 19 Extent of the patient area 2011The boundary of the cardiac-protected electrical area extends to the walls enclosing the patient location(s) or, if such walls are incomplete (e.g. an entryway without a door) to the boundary formed if such walls or projections were extended. In this context, the following are not considered walls or boundaries: partitions, dividers, screens, benches, moveable walls or curtains.

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 20 Extent of the patient area 2011The boundary of the cardiac-protected electrical area extends to the walls enclosing the patient location(s) or, if such walls are incomplete (e.g. an entryway without a door) to the boundary formed if such walls or projections were extended. In this context, the following are not considered walls or boundaries: partitions, dividers, screens, benches, moveable walls or curtains, and entryways wider than 10% of the perimeter of the patient area. (Proposed ESV ruling.)

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 21 Socket-outlets near patient areas 2011The boundary of the cardiac-protected electrical area extends to the walls enclosing the patient location(s) or, if such walls are incomplete (e.g. an entryway without a door) to the boundary formed if such walls or projections were extended. In this context, the following are not considered walls or boundaries: partitions, dividers, screens, benches, moveable walls or curtains, and entryways wider than 10% of the perimeter of the patient area. (Proposed ESV ruling.)

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 22 Socket-outlets near patient areas

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 23 New magnetic field requirements Health care facility must ensure magnetic fields do not exceed “safe” limits in areas used for sensitive monitoring or recording equipment. Maximum field strength and test methods are specified for ECG monitoring and recording. More demanding requirements are required for some other tests but neither maximum field strength nor test methods are specified. “Requirements” only apply in: -A&E departments -Cardiac cath labs -CCU -ICU -OPD rooms for diagnostic electrocardiography -Resuscitation units -Stress testing units

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 24 New magnetic field requirements “Requirements” do not apply (!) in locations such as: -Operating theatres -Procedure rooms intended for general anaesthesia -Diagnostic ECG rooms (except in OPD) -Cardiac ultrasound rooms -Imaging rooms with ECG monitoring or ECG-synchronised injectors/angiography/scanning -ECT rooms “Testing” seems to be required in any location intended for ECG monitoring or recording. But it is unclear what “testing” is required in locations where the “requirements” do not apply.

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 25 New magnetic field requirements Where the requirements do apply: New installations: -Wiring must be designed to achieve maximum specified field strength. -Installation must be tested upon completion. Alterations or additions: -Location must be tested before commencing work. -Installation must be tested again upon completion.

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 26 Socket-outlets for cleaning purposes Still required in each cardiac-protected electrical area Can be outside the room – but every part of a body- protected electrical area must be within 15 m of a socket- outlet marked for cleaning purposes MRI roomsExempt EnsuitesStill required

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 27 Routine in-service testing Must be up-to-date before starting any alteration or addition. Detailed normative requirements included in new standard. Associated report form is full of errors. We recommend: -Review contracts for routine testing of patient areas -Nominate compliance with new requirements (Section 9) -Disallow use of associated report form (Appendix G) -Disallow test stickers for alterations/additions

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 28 Routine in-service testing Disallow test stickers required by new standard:

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 29 Outstanding issues plug-in medical electrical equipment

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 30 Outstanding issues such as rooms – not roof spaces!

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 31 Outstanding issues Body-protected electrical areas of nursing homes

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 32 Outstanding issues socket-outlets in cardiac-protected electrical areas

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 33 Outstanding issues readily accessible

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 34 Outstanding issues Which requirements of AS/NZS 3009?

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 35 Outstanding issues Available: in the hospital? in the particular building of the hospital? at the switch-board supplying the UPS? in the room housing the UPS?

© 2011 Biomedical Engineering Company of Australia Pty Ltd Consulting engineers – medical device standards and regulatory affairs Biomec Australia 36 Thank you