1. AS/NZS 3003:2011 Electrical installations  Patient areas
February 2012 Seminar
AS/NZS 3003:2011 Electrical installations  Patient areas
Stuart Clifton and Lawrie Knuckey

2. Clinical engineering framework
new standard:
Still applies wherever mains powered medical electrical equipmen t is used.
S t i l l r e q u i r e s p a t i e n t a r e a s t o b e w i r e d a s :
B P A s ( b o d y - p r o t e c t e d e l e c t r i c a l a r e a s ) , o r
C P A s ( c a r d i a c - p r o t e c t e d e l e c t r i c a l a r e a s )
BPAs and CPAs
Clinical engineering framework
Physiological effects of electric current on living tissue:
Nerve and muscle stimulation
Heating
Deposition of metal ions (current with any d.c. component)
Pathological effects of electric current on living tissue:
Cardiac arrest
Respiratory arrest
Burning
Denervation
Ulceration (d.c. burns)
Risk of death/severity of injury – major factors:
Magnitude of the current
Duration of current flow
Current path

3. Clinical engineering framework
new standard:
Still applies wherever mains powered medical electrical equipmen t is used.
S t i l l r e q u i r e s p a t i e n t a r e a s t o b e w i r e d a s :
B P A s ( b o d y - p r o t e c t e d e l e c t r i c a l a r e a s ) , o r
C P A s ( c a r d i a c - p r o t e c t e d e l e c t r i c a l a r e a s )
BPAs and CPAs
Clinical engineering framework
Macroshock
Current passing through the body other than via direct cardiac contact.
Microshock
Current passing through the body via direct electrical contact with the heart.

4. Clinical engineering framework
new standard:
Still applies wherever mains powered medical electrical equipmen t is used.
S t i l l r e q u i r e s p a t i e n t a r e a s t o b e w i r e d a s :
B P A s ( b o d y - p r o t e c t e d e l e c t r i c a l a r e a s ) , o r
C P A s ( c a r d i a c - p r o t e c t e d e l e c t r i c a l a r e a s )
BPAs and CPAs
Clinical engineering framework
Macroshock
Often apparent from patient reaction ranging from sensory stimulation to violent muscular contraction.
Burning, denervation and possibly ventricular fibrillation may occur depending on the magnitude and path of the current.
(Cardiac standstill and massive burning may occur in high voltage shocks e.g. contact with 12 kV conductor; lightning strike.)
The possibility of macroelectrocution is exacerbated with the application of medical electrical equipment when:
the skin resistance is reduced or bypassed by electrodes, electrode paste or gel, or invasive conductors, or
the subject is strapped to the equipment, restrained or unconscious, thus inhibiting escape through voluntary or involuntary action.

5. Clinical engineering framework
new standard:
Still applies wherever mains powered medical electrical equipmen t is used.
S t i l l r e q u i r e s p a t i e n t a r e a s t o b e w i r e d a s :
B P A s ( b o d y - p r o t e c t e d e l e c t r i c a l a r e a s ) , o r
C P A s ( c a r d i a c - p r o t e c t e d e l e c t r i c a l a r e a s )
BPAs and CPAs
Clinical engineering framework
Microelectrocution
Risk exists when an electrical conductor is placed into direct contact with a ventricular heart muscle.
Ventricular fibrillation may be induced by current as low as 100 μa (below the threshold for feeling or visible muscle stimulation).
May occur when an electrode wire, electrolyte-filled catheter or transducer is introduced into direct contact with ventricular heart muscle.
Such procedures include:
cardiac catheterization,
intracardiac ECG,
cardiac pacing,
Swan Ganz procedure.
These are referred to in AS/NZS 2500 as cardiac-type procedures.

6. Clinical engineering framework
new standard:
Still applies wherever mains powered medical electrical equipmen t is used.
S t i l l r e q u i r e s p a t i e n t a r e a s t o b e w i r e d a s :
B P A s ( b o d y - p r o t e c t e d e l e c t r i c a l a r e a s ) , o r
C P A s ( c a r d i a c - p r o t e c t e d e l e c t r i c a l a r e a s )
BPAs and CPAs
Clinical engineering framework
Micro-electrocution
Patient must not be exposed to:
Voltages >50 mV --- need EP earthing.
Current sources >50 μA --- need intact earth wires.
Safe equipment design needed:
Medical electrical equipment/systems must comply with standards.
Safe installation needed:
Patient area must be wired as CPA.
Safe equipment application needed:
Flexible protective earthing conductors must be intact.
Hospital must control leakage currents when assembling trolley- mounted medical electrical systems.

7. Clinical engineering framework
new standard:
Still applies wherever mains powered medical electrical equipmen t is used.
S t i l l r e q u i r e s p a t i e n t a r e a s t o b e w i r e d a s :
B P A s ( b o d y - p r o t e c t e d e l e c t r i c a l a r e a s ) , o r
C P A s ( c a r d i a c - p r o t e c t e d e l e c t r i c a l a r e a s )
BPAs and CPAs
Clinical engineering framework
Safe use of electricity in medicine is maximized by following the safety triangle:
SAFE EQUIPMENT
AS/NZS 3200-series
IEC series
SAFE INSTALLATION
AS/NZS 3000 and 3003 (wiring)
X-ray protection installation codes
Surgical laser installation codes
SAFE USE
AS/NZS 2500 and AS/NZS 3551
Preventive maintenance.
Software upgrades.
Safety testing.
Performance verification.
User education.

8. Regulatory framework new standard:
Still applies wherever mains powered medical electrical equipmen t is used.
S t i l l r e q u i r e s p a t i e n t a r e a s t o b e w i r e d a s :
B P A s ( b o d y - p r o t e c t e d e l e c t r i c a l a r e a s ) , o r
C P A s ( c a r d i a c - p r o t e c t e d e l e c t r i c a l a r e a s )
BPAs and CPAs
Regulatory framework
Throughout Australia, state legislation requires:
Compliance with AS/NZS 3000 (the “Wiring Rules”).
Electrical installation work must be carried out by licensed electrical workers.
Electrical installation work includes:
Wiring a building.
Installing fixed electrical equipment.
We are consulting engineers – not lawyers. Legal questions may need to be discussed with a state electrical authority or a lawyer.

9. Regulatory framework new standard:
Still applies wherever mains powered medical electrical equipmen t is used.
S t i l l r e q u i r e s p a t i e n t a r e a s t o b e w i r e d a s :
B P A s ( b o d y - p r o t e c t e d e l e c t r i c a l a r e a s ) , o r
C P A s ( c a r d i a c - p r o t e c t e d e l e c t r i c a l a r e a s )
BPAs and CPAs
Regulatory framework
Compliance with AS/NZS 3003:
Was not a legal requirement when first published in 1974.
Became a requirement of hospital building contracts.
Became a requirement of medical and allied health professional bodies (e.g. ACHS).
Became a legal requirement in Victoria in 1999.
Became a legal requirement throughout Australia in 2007 when it was included as a requirement of AS/NZS 3000.
Formal inspection/testing of AS/NZS 3003 installation work – by a licensed electrical inspector – became a legal requirement in Victoria in 1999.
Formal inspection/testing of AS/NZS 3003 installation work – by anyone acceptable to the hospital – became a legal requirement throughout Australia in 2011 when it was included as a requirement of AS/NZS 3003.

10. Regulatory framework new standard:
Still applies wherever mains powered medical electrical equipmen t is used.
S t i l l r e q u i r e s p a t i e n t a r e a s t o b e w i r e d a s :
B P A s ( b o d y - p r o t e c t e d e l e c t r i c a l a r e a s ) , o r
C P A s ( c a r d i a c - p r o t e c t e d e l e c t r i c a l a r e a s )
BPAs and CPAs
Regulatory framework
The law does not in itself require electrical installations to be upgraded to comply with changes in AS/NZS 3003, but …
New electrical installation work must comply with current standards.
Alterations* to existing electrical installations are deemed to be new electrical installations.
Alterations* to locations used for medical electrical equipment can only be carried out if the location is a BPA or a CPA.
*Alterations from new socket-outlets to a new or replacement CT scanner.
AS/NZS 3003:2011 also requires some upgrading of patient areas when certain alterations are carried out.
Upgrading old facilities:
Is a requirement of AS/NZS 2500.
May be a duty of care under occupational health and safety legislation or common law.

11. Regulatory framework new standard:
Still applies wherever mains powered medical electrical equipmen t is used.
S t i l l r e q u i r e s p a t i e n t a r e a s t o b e w i r e d a s :
B P A s ( b o d y - p r o t e c t e d e l e c t r i c a l a r e a s ) , o r
C P A s ( c a r d i a c - p r o t e c t e d e l e c t r i c a l a r e a s )
BPAs and CPAs
Regulatory framework
Implementation of AS/NZS 3003:
AS/NZS 3003 is ignored in significant parts of the medical and allied health sectors.
Broad acceptance of legal requirements is inhibited by:
Excessive requirements in the 2011 edition of the standard.
Lack of action by state electrical authorities.

12. Regulatory framework new standard:
Still applies wherever mains powered medical electrical equipmen t is used.
S t i l l r e q u i r e s p a t i e n t a r e a s t o b e w i r e d a s :
B P A s ( b o d y - p r o t e c t e d e l e c t r i c a l a r e a s ) , o r
C P A s ( c a r d i a c - p r o t e c t e d e l e c t r i c a l a r e a s )
BPAs and CPAs
Regulatory framework
Energy Safe Victoria guidelines:
Even plug-in appliances are “fixed” electrical equipment if:
>18 kg without wheels; or
fixed in position; or
recommended to be fixed in position; or
provided with means for fixing; or
part of a number of discrete components that function as a group.
Fixed means secured, attached or connected by conduit, metal pipe-work, duct, bolt, screw, clip, other fastening device or fixed wiring.

13. Regulatory framework new standard:
Still applies wherever mains powered medical electrical equipmen t is used.
S t i l l r e q u i r e s p a t i e n t a r e a s t o b e w i r e d a s :
B P A s ( b o d y - p r o t e c t e d e l e c t r i c a l a r e a s ) , o r
C P A s ( c a r d i a c - p r o t e c t e d e l e c t r i c a l a r e a s )
BPAs and CPAs
Regulatory framework
Energy Safe Victoria guidelines:
Even plug-in appliances are “fixed” electrical equipment if:
>18 kg without wheels; or
fixed in position; or
recommended to be fixed in position; or **
provided with means for fixing; or
part of a number of discrete components that function as a group.
Fixed means secured, attached or connected by conduit, metal pipe- work, duct, bolt, screw, clip, other fastening device or fixed wiring.
**Includes plug-in medical electrical equipment such as:
Dental chairs.
Mammography units.
Wall-mounted X-ray viewing boxes.

14. Regulatory framework new standard:
Still applies wherever mains powered medical electrical equipmen t is used.
S t i l l r e q u i r e s p a t i e n t a r e a s t o b e w i r e d a s :
B P A s ( b o d y - p r o t e c t e d e l e c t r i c a l a r e a s ) , o r
C P A s ( c a r d i a c - p r o t e c t e d e l e c t r i c a l a r e a s )
BPAs and CPAs
Regulatory framework
Energy Safe Victoria guidelines:
Even plug-in appliances are “fixed” electrical equipment if:
>18 kg without wheels; or
fixed in position; or
recommended to be fixed in position; or
provided with means for fixing; or
part of a number of discrete components that function as a group.**
Fixed means secured, attached or connected by conduit, metal pipe- work, duct, bolt, screw, clip, other fastening device or fixed wiring.
**Seems to include multi-bed patient monitoring systems!

15. New edition of AS/NZS 3003 new standard:
Still applies wherever mains powered medical electrical equipmen t is used.
Still requires patient areas to be wired as:
BPAs (body- protect ed electric al areas), or
CPAs (cardia c- protect ed electric al areas)
BPAs and CPAs
New edition of AS/NZS 3003
New standard still applies in patient areas:
(Wherever mains powered medical electrical equipment is used.)
Patient areas must still be wired as:
BPAs (body-protected electrical areas), or
CPAs (cardiac-protected electrical areas)
LPDs (leakage protective devices) still required for:
Most socket-outlets.
Some high risk medical electrical equipment.
LPDs are still:
Type 1 RCDs (residual current devices), or
Isolation transformers with line isolation/overload monitors.
Socket-outlet colours unchanged except for some generator-backed circuits.
Requirements for EP (equipotential) earth wiring in CPAs similar to edition – but with better drawings.

16. Summary of major changes
Each requirement is followed by a compliance test.
New definition of essential supply.
Certain patient areas must only be BPAs.
Certain patient areas must be CPAs.
LPD protection and EP earthing of socket-outlets outside patient areas:
Has been extended from 2 m to 5 m from each entry.
Is now required with or without a door.
Final sub-circuits may only supply one BPA and its ensuite.
Final sub-circuits may no longer supply socket-outlets for cleaning purposes and other socket-outlets.
Socket-outlets requiring LPD protection clearly specified:

17. Summary of major changes
UPS status indicator now required in some patient areas.
RCDs must now be:
readily accessible,
not installed under benches, and
not positioned near some light switches.
Inaccessible socket-outlets must now have readily accessible isolating switches.
Socket-outlets for cleaning purposes now only required near BPAs.
EP terminals no longer required in CPAs.
The EPJ (equipotential junction) in a CPA may now have conveniently located nodes.

18. Summary of major changes
New commissioning and certification requirements.
New requirements for special patient areas:
Home installations for haemodialysis.
Home installations for other medical electrical equipment.
Self harm areas (e.g. psychiatric and prison wards).
New requirements for alterations, additions and repairs to electrical installations in patient areas:

19. Summary of major changes
New limitations on magnetic fields:
Maximum field strength specified for some (not all) patient areas intended for ECG monitoring and recording.
Requirements apply prior to commencing work, and on completion of work.
Requirements apply to new patient areas and to alterations.
New marking requirements for BPA and CPA area signs.
Full technical requirements for routine inspection and testing.

20. New title
Contention about the institutions covered by previous editions:
Hospital.
Dental surgery.
Day surgery.
Imaging practice.
Physiotherapy practice.
Doctors’ room.
Nursing home.
Other aged care facilities.
AS/NZS 3003 should apply in patient areas of any institution.  ?

21. New title
1976 Electrical installations in electromedical treatment areas 1985 Electrical installations — Patient treatment areas of hospitals and medical and dental practices 1999 Electrical installations — Patient treatment areas of hospitals and medical and dental practices 2003 Electrical installations — Patient areas of hospitals, medical and dental practices and dialyzing locations 2011 Electrical installations — Patient areas

22. Patient areas
2003 Locations 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.
2011 Locations 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.

23. Patient areas
2003 Locations 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 Locations 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. The standards applies wherever mains powered medical electrical equipment is used.

24. Patient areas
2003 Locations 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 Locations 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. Discourages application of the standard in areas used just for charging/storing medical electrical equipment (e.g. beds).

25. Patient areas
2003 Locations 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 Locations 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. The standard only applies in areas intended for the regular use of medical electrical equipment.

26. Patient areas
2003 Locations … in which it is intended that mains powered medical electrical equipment will be used …
2011 Locations where it is intended that mains powered medical electrical equipment will be used …
Under either standard:
Where a room is intended for medical electrical equipment that will be connected to a patient in another room, both rooms are patient areas For example:
A&E/ICU/CCU/ward/ staff base with patient monitor.
Cardiac cath lab recording room with physiological recorder.
Sleep lab recording room.
CT control room with injector control unit.

27. EXAMINATION LIGHT MUST BE PLUGGED IN HERE
Patient areas
Electrical equipment supplied by socket-outlets outside patient areas:
LPD protection required:
Socket-outlets outside BPAs or CPAs used to supply medical electrical equipment in the patient area.
EP earthing required:
Socket-outlets outside CPAs used to supply:
medical electrical equipment in the CPA, or
any electrical equipment accessible in the patient environment.
EXAMINATION LIGHT MUST BE PLUGGED IN HERE

28. Patient areas
Within a patient area:

29. “Accessible” & “readily accessible”
Readily accessible now means:
Capable of being reached quickly and without climbing over or removing obstructions, standing on a chair or using a ladder, and
Not more than 2 m above the ground, floor or platform.
RCDs must now be readily accessible and not mounted under benches, in cupboards or cabinets, or behind heavy equipment.
Socket-outlets require LPD protection if they are accessible – not just readily accessible – without a tool.
Socket-outlets that are not readily accessible must have readily accessible isolating switches or a dedicated LPD.
Permanently wired appliances protected by LPDs that also protect socket-outlets or other appliances must have readily accessible isolating switches.

30. “Group” of socket-outlets
Group of socket-outlets now means:
One or more socket-outlets contained within one surround.
No longer a group:

31. Extent of the patient area
2003 The 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.

32. Extent of the patient area
2003 Socket-outlets that are:
located within 2 m of a patient area, and
in free communication with the patient area (i.e. no door),
… must be:
protected by an LPD, and
connected to thearthing system (if CPA).

33. Extent of the patient area
First public draft: Where the walls of a BPA are incomplete (e.g. entryway without a door) and the opening is greater than 2 m, the adjacent area is part of the BPA.
IEC : Parent international standard for MEE.
Time line leading to the publication of Ed 3:
Ed 1 developed in parallel with Ed 1 of IEC (which describes the need for MEE standards).
Ed 1 of IEC published in 1976, closely followed by Ed 1 of the parent standard.
Ed 2 of IEC published 11 years later, at about the time work commenced on revising IEC
The 1st amendment to the Ed 2 of IEC was published in 1991.
Ed 2 of IEC published in 1994.
A substantive 2nd amendment to to the Ed 2 of IEC was published in 1995.
Ed 3 of the parent standard published in December 2005.

34. Extent of the patient area
IEC : Parent international standard for MEE.
Time line leading to the publication of Ed 3:
Ed 1 developed in parallel with Ed 1 of IEC (which describes the need for MEE standards).
Ed 1 of IEC published in 1976, closely followed by Ed 1 of the parent standard.
Ed 2 of IEC published 11 years later, at about the time work commenced on revising IEC
The 1st amendment to the Ed 2 of IEC was published in 1991.
Ed 2 of IEC published in 1994.
A substantive 2nd amendment to to the Ed 2 of IEC was published in 1995.
Ed 3 of the parent standard published in December 2005.

35. Extent of the patient area
IEC : Parent international standard for MEE.
Time line leading to the publication of Ed 3:
Ed 1 developed in parallel with Ed 1 of IEC (which describes the need for MEE standards).
Ed 1 of IEC published in 1976, closely followed by Ed 1 of the parent standard.
Ed 2 of IEC published 11 years later, at about the time work commenced on revising IEC
The 1st amendment to the Ed 2 of IEC was published in 1991.
Ed 2 of IEC published in 1994.
A substantive 2nd amendment to to the Ed 2 of IEC was published in 1995.
Ed 3 of the parent standard published in December 2005.

36. Extent of the patient area
IEC : Parent international standard for MEE.
Time line leading to the publication of Ed 3:
Ed 1 developed in parallel with Ed 1 of IEC (which describes the need for MEE standards).
Ed 1 of IEC published in 1976, closely followed by Ed 1 of the parent standard.
Ed 2 of IEC published 11 years later, at about the time work commenced on revising IEC
The 1st amendment to the Ed 2 of IEC was published in 1991.
Ed 2 of IEC published in 1994.
A substantive 2nd amendment to to the Ed 2 of IEC was published in 1995.
Ed 3 of the parent standard published in December 2005.

37. Extent of the patient area
2011 The 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.

38. Extent of the patient area
2003 Socket-outlets that are:
located within 2 m of a patient area, and
in free communication with the patient area (i.e. no door),
… must be:
Protected by an LPD, and
Connected to the EP earthing system (if CPA).

39. Extent of the patient area
2011 Socket-outlets that are:
located within 5 m of a patient area (door or no door),
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 CPA).

40. Extent of the patient area
2011 The 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.

41. Extent of the patient area
2011 The 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.)

42. Extent of the patient area
2011 The 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.)

43. Socket-outlets near patient areas

44. Socket-outlets near patient areas
STAFF BASE
BUSY CORRIDOR
BEDROOM
< 5m 
xxxxxxxxxxxx

45. Socket-outlets near patient areas
xxxxxxxxxxxx

46. Socket-outlets near patient areas

47. New essential supply definition
Generator-backed circuits that are subject to load shedding are no longer considered as essential supplies.
Many generator-backed outlets are no longer on essential supplies
ESV has issued exemptions allowing additional red socket-outlets on circuits subject to load shedding under programmable load shedding.
POWER
AVAILABLE
NEW SOCKET-OUTLET
POWER
AVAILABLE
EXISTING SOCKET-OUTLETS
POWER
AVAILABLE

48. Classification of patient areas
Some locations must now be CPAs:
Cardiac catheter laboratories and control rooms.
Cardiac ICU.
CCU.
ICU with regular thermodilution Swann-Ganz monitoring.
Neo natal ICU (Level 3).
Operating theatres for cardiac and thoracic surgery.
Other locations intended for regular or routine cardiac-type procedures.
(No mention of wards)

49. Classification of patient areas
Some locations must only be BPAs (unless intended for cardiac-type procedures):
Accident and emergency wards.
Plasmapherisis areas.
Blood collection areas.
Plaster rooms.
Chiropractic and physiotherapy rooms.
Recovery areas or wards associated with operating theatres and imaging rooms.
CT rooms.
Day procedure theatres.
Respiratory function laboratories.
Delivery suites.
Resuscitation bays.
Dental surgeries.
Stress test rooms.
Endoscopy theatres and procedure rooms.
Treatment rooms.
General medical and surgical wards.
Ultrasound rooms.
High dependency wards.
X-ray rooms (Except cardiac cath labs!)
MRI rooms.
Doctors consulting room.
Nurseries.
Nursing homes. (Patient areas only!)
Operating theatres for non-cardiac surgery
Patient ensuites
Patient examination rooms in outpatients.

50. Classification of patient areas
Some locations must only be BPAs:
Patient ensuite bathrooms, shower rooms, toilets … ?

51. Classification of patient areas
BPAs and CPAs still not allowed in the same room.

52. UPS status indicators
UPS status indicator now required in patient areas with:
socket-outlets or permanently wired equipment supplied from a UPS, and
continuous patient observation,
… including:
operating theatres, and nursing stations or staff bases in:
recovery wards,
intensive care units,
isolation rooms, and
other special care areas.

53. UPS status indicators UPS status indicator requirements:
Must be marked “UPS STATUS”.
Must be connected to the UPS electrical supply system.
Loss of supply to the UPS must initiate synchronized, pulsating, audible and visual alarms.
Audible alarm must continue until muted.
Visual alarm must continue until the supply is restored to the UPS or the UPS is exhausted.
New standard is not retrospective:
Existing installations do not have to be upgraded, but …
new work (one new socket-outlet) must comply with this requirement.

54. Socket-outlet protection
Socket-outlets requiring LPD protection* clearly specified:
*Except socket-outlets mounted on – and forming part of – a medical electrical system.

55. Socket-outlet protection
Intention was to treat 10 amp IEC sockets on endoscopy systems as general purpose outlets.
… except for unintended consequence:
*Except socket-outlets mounted on – and forming part of – a medical electrical system.

56. Socket-outlet protection
Socket-outlets requiring LPD protection* clearly specified.
--- another unintended consequence: 
xxxxxxxxxxxx
Special purpose industrial outlet in Pan Room

57. Magnetic field requirements
7.1 GENERAL
Health care facilities must ensure magnetic fields do not exceed safe levels in areas used for sensitive monitoring or recording equipment.
Maximum field strength and test methods are specified for locations intended for ECG monitoring and recording.
For electrophysiological measurements such as EEG, EMG and ENG:
Substantially more demanding requirements apply.
Maximum field strength and test methods are not specified.
Facility management must ensure magnetic fields are reduced to acceptable levels when specifying the wiring of such locations.

58. Magnetic field requirements
The following patient areas “where ECG monitoring and recording is expected to be carried out” must be arranged so that:
Total magnetic field flux density does not exceed 3 microtesla (μT).
No individual harmonic exceeds 1.6 μT.
Limits apply between 800 and 1200 mm above floor, over the whole area except within 300 mm of the walls.
Nominated patient areas:
Accident and emergency departments.
Cardiac catheterisation laboratories.
Coronary care units and intensive care units.
Outpatient departments for diagnostic ECG.
Resuscitation units.
Stress testing units.

59. Magnetic field requirements
Nominated patient areas:
Accident and emergency departments.
Cardiac catheterisation laboratories.
Coronary care units and intensive care units.
Outpatient departments for diagnostic ECG.
Resuscitation units.
Stress testing units.
It is unclear why these requirements do not apply in locations such as:
Cardiac ultrasound rooms.
ECG rooms (other than those in outpatient departments).
ECT rooms.
Imaging rooms with ECG monitoring or synchronised imaging.
Operating theatres.
Procedure rooms intended for general anaesthesia.

60. Magnetic field requirements
7.3 TESTING
New building:
Prior to new work: Contractor must confirm with facility management that electrical reticulation has been designed and located to achieve compliance.
After work is finished: Contractor must arrange compliance testing.
Existing building:
Prior to new work: Contractor must confirm with facility management that satisfactory testing has been carried out.
After work is finished: Contractor must arrange for compliance testing to be repeated.

61. Magnetic field requirements
7.3 TESTING
Existing building:
Prior to new work: Contractor must confirm with facility management that satisfactory testing has been carried out.
After work is finished: Contractor must arrange for compliance testing to be repeated.
Within existing buildings, these requirements apply to:
New patient areas – such as:
New cardiac cath lab. New ICU.
Alterations in existing patient areas – such as:
New $30 socket-outlet in existing ICU.
New $1,000,000 X-ray system in existing cardiac cath lab.

62. Magnetic field requirements
7.3 TESTING
Existing building:
Prior to new work: Contractor must confirm with facility management that satisfactory testing has been carried out.
After work is finished: Contractor must arrange for compliance testing to be repeated.
What about a room that has been successfully used for electrocardiography for 20 years?

63. Magnetic field requirements
7.3 TESTING
New building:
Prior to new work: Contractor must confirm with facility management that electrical reticulation has been designed and located to achieve compliance.
After work is finished: Contractor must arrange compliance testing.
What about trying out the room with an ECG machine?

64. Socket-outlets for cleaning purposes
Socket-outlet marked for cleaning purposes:
Still required in each CPA.
Can be outside a BPA if located within 15 m.
Not required in MRI rooms.
Still required in CPA ensuites.
Not required in BPA ensuites if available within 15 m.
Must still be protected by an LPD.
Must be supplied from a different circuit than other socket-outlets.
(This circuit may supply a large number of such socket-outlets.)

65. Separation of circuits
BPAs
Circuits supplying socket-outlets* must not supply electrical points in another room (except any ensuite).
CPAs
Circuits must not supply:
Socket-outlets* in more than one patient location.
Electrical points in another room.
*Except socket-outlets for cleaning purposes
Socket-outlets for cleaning purposes
Must be supplied by dedicated circuit.
Circuit may supply many patient areas.

66. 0.1  EP earthing system retained
But EP terminals no longer required.
Looping allowed providing it does not depend on pressure of single screw bearing directly on wiring.
Cpa euite
JOINING WIRES UNDER CRIMP THEN INTO SINGLE SCREW CONNECTOR IS ALLOWED
SINGLE SCREW TYPE NOT ALLOWED
SINGLE SCREW OK AS DOES NOT BEAR DIRECTLY ON WIRE

67. 0.1  EP earthing system retained
EP junction may have multiple nodes.
Nodes must be isolated from structural metal.
EP Junction
NODE
0.01 ohm connections between the EPJ and its nodes.
0.1 ohm connections to EP junction or one of its nodes.
Distribution Board

68. 0.1  EP earthing system retained
RCDs mounted in structurally connected wall boxes

69. 0.1  EP earthing system retained
RCDs mounted in non-structurally connected wall boxes

70. 0.1  EP earthing system retained
Transformer isolated supply - structurally connected wall boxes

71. 0.1  EP earthing system retained
Transformer isolated supply – non-structurally connected wall boxes

72. 0.1  EP earthing system retained
But all equipotential conductor now ≥ 4mm2.
E (SOCKET-OUTLETS)
E (ENCLOSURE)
EARTH WIRING TO PROTECTIVELY EARTHED PARTS OF THE ENCLOSURE
EARTH WIRING TO SOCKET- OUTLETS
EPJ

73. 0.1  EP earthing system retained
Special earthing required for X-ray and imaging systems:

74. 0.1  EP earthing system retained
0.1  EP earthing system still only works for building earth currents < 0.5 A.
Building earth currents > 16 A easily encountered in buildings with more than one connection between neutral bars and earth, e.g. old buildings with metal-clad wiring.
Test 1 - verify protective earthing of socket-outlets and fixed Class I electrical equipment.
Test 2 - verify EP earthing of structurally connected, non-electrical fittings in the patient environment.
Test 3 - verify <50 mV between the EP junction and:
All socket-outlets in the CPA.
Fixed electrical equipment in the patient environment.
Structurally connected, non-electrical fittings in the patient environment.

75. Marking of BPA and CPA wall signs
Person or organization that carried out the most recent electrical safety testing.
Date of test.
Report number
Date by which the next test is required.
Person and organization that carried out the required certification:
Date of certification.
Edition of AS/NZS 3003 against which the area was originally commissioned.

76. Marking of BPA and CPA wall signs
Person or organization that carried out the most recent electrical safety testing.
Date of test.
Report number
Date by which the next test is required.
Person and organization that carried out the required certification of:
The original installation?
The latest installation work?
Date of certification.
Edition of AS/NZS 3003 against which the area was originally commissioned.

77. Marking of BPA and CPA wall signs
Person or organization that carried out the most recent electrical safety testing.
Date of test.
Report number
Date by which the next test is required.
The most recent testing may be just a new socket-outlet, but the new sticker obliterates what is often the only record of the last full routine test.
Person and organization that carried out the required certification.
Date of certification.
Edition of AS/NZS 3003 against which the area was originally commissioned.

78. Marking of BPA and CPA wall signs
Person or organization that carried out the most recent electrical safety testing.
Date of test.
Report number
Date by which the next test is required.
Person and organization that carried out the required certification:
Date of certification.
Edition of AS/NZS 3003 against which the area was originally commissioned
Biomec:
Combines these two labels (saved cost and effort).
Assumes this sticker relates to certification of the original installation.

79. Marking of BPA and CPA wall signs

80. Statement by electrical contractor
The contractor must:
Certify in writing that the work has been tested to – and complies with – AS/NZS 3000.
Certify in writing that the work followed a formal specification prepared by the health care institution or practice, or
… that the number of socket-outlets has been discussed with medical or nursing personnel and the likely loading on each circuit has been checked.
Supply documentary evidence that the isolation transformer, line isolation monitor and overload monitor comply with AS/NZS 4510.
Supply a certificate of compliance or a manufacturer’s statement that each ELV supply complies with a suitable standard.

81. Special patient areas Revised requirements for home haemodialysis:
Room to be wired as BPA with following exceptions.
Dedicated circuit protected by LPD required for socket-outlets used for medical electrical equipment.
Other socket-outlets to be protected by 30 ma RCD.
Socket-outlet for cleaning purpose not required.
Supply available lights not required unless RO unit is in another room.
RCD protected labeling not required.
BPA area sign not required.
Questions now emerging from clinicians and clinical engineers about special installation requirements in:
Rental properties.
Holiday locations.

82. Special patient areas
New requirements for home use of other medical electrical equipment
No special wiring requirement if medical electrical equipment is:
Internally powered or Class II, and
Provided with Type BF or CF applied part.
Similar requirements to those for haemodialysis if:
Class I, or
Provided with Type B applied part.
Questions now emerging from clinicians and clinical engineers about the special installation requirements for the home use of:
Class I medical electrical equipment with Type BF or  CF applied parts.
Some Class II medical electrical equipment, even with Type B applied parts.

83. Special patient areas
New requirements for BPAs for self harm patients (e.g. psychiatric and prison wards)
RCDs may be located outside the room.
Amber supply available lights not required on socket-outlets.
BPA area signs may be located outside room entrance.

84. Alterations, additions and repairs
Alterations and additions
… from new socket-outlets to new or replacement CT scanners.
All new work must comply with 2011 standard.
Patient area must be upgraded if not already BPA or CPA .
Alteration cannot proceed until routine safety test is up-to-date.
All socket-outlet colours must be upgraded if necessary to 2011 standard if total number is increased by >10%.
Earthing must be upgraded if necessary to the 2011 standard if:
the EP junction is inaccessible for making new connections, or
new work involves installing fixed equipment rated above 2.0 kW.
Repairs
Standard goes close to disallowing repairs to fixed medical electrical equipment in any location not wired as a BPA or a CPA.

85. Some other outstanding problems
CPA required wherever plug-in medical electrical equipment is used for cardiac-type procedure, except X-ray and imaging systems.
plug-in medical electrical equipment

86. Some other outstanding problems
Locations that have to be wired as CPAs
such as rooms – not roof spaces!

87. Some other outstanding problems
Locations that have to be wired as BPAs
BPAs (!) in nursing homes

88. Some other outstanding problems
Circuits in CPAs
socket-outlets (!) in

89. Some other outstanding problems
Locations that have to be wired as BPAs
readily accessible (!)

90. Some other outstanding problems
Socket-outlet colours
(colour coding requirements)
Table 2.1 of AS/NZS 3009:1998

91. Some other outstanding problems
Supply to UPS that then supplies socket-outlets
Available:
in the hospital?
in the particular building of the hospital?
at the switch-board supplying the UPS?
in the room housing the UPS?

92. Routine in-service testing
Detailed inspection and testing requirements are included in the standard.
As routine testing is now a requirement in all patient areas, it has become a legal requirement throughout Australia.
Must be up-to-date before starting any alteration or addition.
Associated report form is full of errors.
Biomec recommends that hospitals and medical practices:
Review procedures or contracts for routine testing of patient areas.
Adopt the new requirements (AS/NZS 3003:2012 Section 9).
Ignore or disallow use of the associated report form (Appendix G).
Disallow test stickers for alterations/additions.

93. Routine in-service testing
COMMON REQUIREMENTS – BPAs AND CPAs
Testing interval
Maximum 12 months.
Inspection
All electrical equipment and fittings.
Labelling.
Socket-outlets
Colour.
Power-available indicator lights on RCD protected circuits.
Maximum number of protected points.
Toggle marking or “on” indicator lights.
Double-pole switches on transformer isolated supplies.
LPD protection where required.

94. Routine in-service testing
COMMON REQUIREMENTS – BPAs AND CPAs
RCDs used as LPDs
Sensitivity test – one test.
Maximum tripping time – two tests.
Test interval may be increased to 24 months based on risk management relating to the actual RCDs reliability data; but each RCD test button must then be tested each six months.
Transformer isolated supplies
Installation prospective hazard current
LIM alarm - resistive and capacitive, balanced and unbalanced faults.
Overload alarm
Uninterruptible power supplies (UPSs)
Check that (someone else?) has tested the UPS status indicators.

95. Routine in-service testing
ADDITIONAL TESTS – BPAs
Protective earthing
Reticulated metal service may be used as a reference in some circumstances.
Verify earthing resistance to:
Earth pins of socket-outlets accessible below 2.3 m.
Earth pins of socket-outlets used for electrical appliances accessible below 2.3 m.
Class I electrical appliances accessible below 2.3 m.

96. Routine in-service testing
ADDITIONAL TESTS – CPAs
Earthing
EP junction/node or medical gas/suction outlet may be used as reference in some circumstances.
Use four-wire milliohm meter to verify earthing resistance to:
Earth pins of socket-outlets accessible below 2.3 m.
Earth pins of socket-outlets used for electrical appliances accessible below 2.3 m.
Class I electrical appliances accessible below 2.3 m.
Potential difference to EP junction:
At least two socket-outlets in each patient location.
Reticulated plumbing in at least one patient location.
Permanently wired electrical equipment in patient environment.

97. Thank you

98. Thank you