IEC 61223-3-4:2000 pdf download

IEC 61223-3-4:2000 pdf download.Evaluation and routine testing in medicalimaging departments -Part 3-4:Acceptance tests -Imaging performance of dental x-ray equipment.
3.2 Use of terms
In this standard, terms printed in SMALL CAPITALS are used In accordance with their definitions
in IEC 60601-1. in IEC 60788, in IEC 61223-1, or in this standard, NOTE Attention is drawn to the fact that in cases where the concept addressed is not strongly confined to the
detlnltlon given In one ot the publications listed above, a corresponding term is printed in lower-case letters
An index of defined terms used in this standard is given in annex A.
3.3 Defined terms
For the purpose of this part of IEC 61223. the following additional definitions apply.
3.3.1
ARTEFACT
apparent structure visible in the image which does not represent a structure within the object.
3.3.2
LINE PAIR RESOLUTION
highest spatial frequency of the specified line-group test pattern imaged under specified conditions which Is distinguishable In the image. The unit is p/mm.
NOTE Another term tow LINE PAIP REsOLuTIoN used in literature Is spatial resolution.
3.3.3
LOW CONTRAST RESOLUTION
the lowest contrast detail object of a specified object that can be resolved from a uniform background.
3.3.4
RADIATION OUTPUT
AIR KERMA per CuRRENT TIME PROOCT (mGy/mAs) at a given distance from the FOCAL SPOT in
the primary X-RAY BEAM.
4 General aspects of ACCEPTANCE TESTS
4.1 General conditions to be considered In test procedures
The aim of an ACCEPTANCE TEST is to demonstrate that the specified characteristics of the
EOUIPMENT lie within the specified tolerances. Some requirements are enforced by legislation.
Other requirements and specifications may be in the purchase contract, in the supplier’s
brochure or in other standards, for example in the lEG 60601 series.
An inventory of the EOUIPMENT under test, the ACCOMPANYING DOCUMENTS, and the test protocols. shall be compiled before any ACCEPTANCE TESTS are carried out. Each item shall be Identilied by Its MODEL OR TYPE REFERENCE (type number) and SERIAL NUMBER, and the entire inventory shall be compared with the purchase contract.
The response of non-screen dental X-ray film (NON-SCREEN FILM, rm-32-35) to a visible-light sensitometer does not match its response to X-RA0IATION. It is therefore most practicable to assess the performance of a dedicated dental film processing system when EQUIPMENT is available for testing the X-RAY EQUIPMENT. A suitable test procedure is given in annex C.
RADIOGRAPHIC FILMS and film processing are vital parts in the imaging chain, It is the responsibility of the USER to ensure that these components perform in an acceptable way, for example with respect to sensitivity, contrast and absence of ARTEFACTS. A test of the performance of these components shall precede any ACCEPTANCE TEST measurements Involving the IRRADIATION of RADIOGRAPHIC FILMS using the dental X-RAY EQUIPMENT.
The performance of the IMAGE DISPLAY DEVICE will affect the measured performance of a digital dental imaging system. Before any ACCEPTANCE TESTS are carried out on the X-RAY EQUIPMENT, the IMAGE DISPLAY DEVICE shall be set up. by following the MANUFACTURER’S instructions and using the MANUFACTURER’S electronic test image, to deliver its specified performance.
Non-invasive measurements are preferred for ACCEPTANCE TESTS. Whenever invasive tests are part of the programme it shaft be shown that the EQUIPMENT has been restored to its pre-test condition after the test.
4.2 Documents and data for the tests The following documentation is required:
— statement of compliance with applicable parts of IEC ó0601;
— list of EQUIPMENT or EQUIPMENT parts ordered and the actual delivery list (IEC 60601.1):
— performance specification as agreed upon between the purchaser and the supplier:
— results from tests performed at the MANUFACTURER’s site or during installation covering items of importance to quality, such as NOMINAL FOCAL SPOT VALUE;
— INSTRUCTIONS FOR USE, including guidance for the operation of the EQUIPMENT;
– details of the actual operating conditions under which the dental X.RAY EQUIPMENT S to be used;
— guidance as to the extent and frequency of maintenance procedures;
— reports on previous tests where applicable:
— data on technical changes.
4.3 Test conditions
Different categories of tests can be identified:
— visual inspection;
— functional tests;
— system performance;
— check of the uncertainty in the values of variables.
The measuring arrangements which may be used for performing tests are illustrated,
a) for intra-oral application (see figures 1 and 2);
b) for panoramic application (see figures 3 and 4):
c) for cephalometric application (see figure 5).
The arrangement in figure 1 is indicative only. Not every component is needed in every test.