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Standard 6 - EQUIPMENT & INSTRUMENTATION
The equipment must be suitable for the range of
tests performed and be in good working order.
Commentary
- On installation of equipment and from time-to-time,
as defined in Standard 8, Appendix 2
and Appendix 7, quality control testing (see
Appendix 2) and compliance testing (see Appendix 7)
shall be performed. Some of these tests will be performed by an engineer
(either provided by the supplier or independent). The engineer will
be a qualified engineer who meets any requirements laid down by State
or National Regulatory Authorities, ideally one who is certified by
the Australasian
College of Physical Scientists and Engineers in Medicine (ACPSEM).
- Operating manuals for equipment shall be readily available
and staff handling such equipment must be able to check the critical
operating characteristics. They shall do so at intervals appropriate
for the type of equipment and its work-load. The manuals must include
all criteria used for assessment of Quality Assurance procedures. The
manual shall also include all communications with the manufacturer,
subsequent to installation of the machine. All software updates shall
be implemented as soon as practicable.
- Records of calibration, QC, repair and maintenance of each item of
equipment shall be kept for the life of that item.
Full details pertaining to QC requirements are described in Standard
8.
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