SmartLine RotaScope Classic Series, Инструкция по установке и эксплуатации

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RotaScope Classic Cabinet
Manual Version 1.04 Date 23 November 2021 47
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AS/NZS4187:2014 Section 7.4 States: Performance qualification shall be
performed by the HSO. PQ may be performed by suitable trained in-
house personnel or a suitable experienced and qualified external
contractor. PQ shall be undertaken in accordance with the applicable
national or international standards.
PQ shall be performed:
(a) Immediately after IQ (Install Qualification) and OQ (Operation Qualification)
for newly installed or relocated equipment.
(b) When repairs are made, or a service is changed that might adversely impact
the quality of the RMD (see Clause 10.5).
(c) When existing equipment is modified to deliver a new process.
(d) Using RMDs that are representative of the range of RMDs identified as the
most difficult to process that are in use in the HSO. Refer to clause 5.2; and
(e) When introducing new or modified RMD, packaging or loading configurations
unless equivalence to a previously qualified reference load, RMD/product
family, packaging or loading pattern has been demonstrated.
Requalification of the process shall be performed annually. Refer Clause 10.4.
Smartline Medical does offer a performance Qualification Service for the RotaScope
Cabinets in line with the requirements of AS/NZS4187:2014 and BS EN16442:2015.
Please email sales@smartlinemachinery.com or call +61 7 5478 9977 for a PQ quote or
contact your Authorised Distributor.
See Also – IQ (Installation Qualification) and OQ (Operation Qualification) –
performed upon installation by the Authorised Distributor
IQ-OQ-PQ testing methods are used to ensure that that after install or relocation of
your cabinets, that the install environment, set up, and performance is configured to
meet the required standards for drying and storage of your endoscopes.
This is a requirement.