Updates to the Electro-medical Standard AS 3003

Report
IHEA seminar– July 2011
AS/NZS 3003:2011
Electrical installations
 Patient areas
Lawrie Knuckey
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
1
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.
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
2
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
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
3
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 selfharm.
• 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 socketoutlet to replacing a CT scanner.
• Routine testing must be up-to-date before alterations or additions
can begin.
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
4
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.
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
5
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.
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
6
Scope of AS/NZS 3003
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.
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
7
Scope of AS/NZS 3003
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
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
8
New title
1976 edition Electrical installations in electromedical treatment areas
1985 edition Electrical installations — Patient treatment areas of
hospitals and medical and dental practices
1999 edition Electrical installations — Patient treatment areas of
hospitals and medical and dental practices
2003 edition Electrical installations — Patient areas of hospitals,
medical and dental practices and dialyzing locations
2011 edition Electrical installations — Patient areas
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
9
New definition of patient area
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.
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
10
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.
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
11
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.
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
12
Extent of the patient area
0 1 2
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
13
Extent of the patient area
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
14
Extent of the patient area
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
15
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.
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
16
Socket-outlets near patient areas
2003 Socket-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
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
17
Socket-outlets near patient areas
2011
Socket-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
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
18
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.
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
19
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.)
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
20
Socket-outlets near patient areas
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.)
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
21
Socket-outlets near patient areas
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
22
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:
Biomec
Australia
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
23
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.
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
24
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.
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
25
Socket-outlets for cleaning purposes
Still required in each cardiac-protected electrical area
Can be outside the room – but every part of a bodyprotected electrical area must be within 15 m of a socketoutlet marked for cleaning purposes
MRI rooms
Exempt
Ensuites
Still required
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
26
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
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
27
Routine in-service testing
Disallow test stickers required by new standard:
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
28
Outstanding issues
plug-in medical electrical equipment
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
29
Outstanding issues
such as rooms – not roof spaces!
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
30
Outstanding issues
Body-protected electrical areas of nursing homes
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
31
Outstanding issues
socket-outlets in cardiac-protected electrical areas
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
32
Outstanding issues
readily accessible
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
33
Outstanding issues
Which requirements of AS/NZS 3009?
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
34
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?
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
35
Thank you
Biomec
Australia
© 2011 Biomedical Engineering Company of Australia Pty Ltd
Consulting engineers – medical device standards and regulatory affairs
36

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