IEC 60580:2000 pdf download.Medical electrical equipment – Dose area product meters
1 Scope and object
This International Standard specifies the performance and testing of DOSE AREA PRODUCT METERS with IONIZATION CHAMBERS intended to measure DOSE AREA PRODUCT and/or DOSE AREA PRODUCT RATE to which the PATIENT is exposed during MEDICAL RADIOLOGICAL EXAMINATIONS . The object of this International Standard is 1) to establish requirements for a satisfactory level of performance for DOSE AREA PRODUCT METERS , and 2) to standardize the methods for the determination of compliance with this level of performance.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
IEC 60417 (all parts), Graphical symbols for use on equipment
IEC 60601-1:1988, Medical electrical equipment – Part 1: General requirements for safety
IEC 60601-1-1:1992, Medical electrical equipment – Part 1-1: General requirements for safety –
Collateral standard: Safety requirements for medical electrical systems
IEC 60601-1-2:1993, Medical electrical equipment – Part 1-2: General requirements for safety –
Collateral standard: Electromagnetic compatibility – Requirements and tests
IEC 60731:1997, Medical electrical equipment – Dosimeters with ionization chambers as used
in radiotherapy
IEC 60788:1984, Medical radiology – Terminology
IEC 60950:1999, Safety of information technology equipment
IEC 61000-4-2:1995, Electromagnetic compatibility (EMC) – Part 4-2: Testing and measure-
ment techniques – Electrostatic discharge immunity test
IEC 61000-4-3:1995, Electromagnetic compatibility (EMC) – Part 4-3: Testing and measure-
ment techniques – Radiated, radio-frequency, electromagnetic field immunity test
IEC 61000-4-4:1995, Electromagnetic compatibility (EMC) – Part 4-4: Testing and measure-
ment techniques – Electrical fast transient/burst immunity test
IEC 61000-4-5:1995, Electromagnetic compatibility (EMC) – Part 4-5: Testing and measure-
ment techniques – Surge immunity test
IEC 61000-4-6:1996, Electromagnetic compatibility (EMC) – Part 4-6: Testing and measure-
ment techniques – Immunity to conducted disturbances induced by radio frequency fields
IEC 61000-4-11:1994, Electromagnetic compatibility (EMC) – Part 4-11: Testing and measure-
ment techniques – Voltage dips, short interruptions and voltage variations immunity tests
IEC 61187:1993, Electrical and electronic measuring equipment – Documentation
ICRU 60:1998, International Commission on Radiation Units and Measurements, Fundamental
Quantities and Units for Ionizing Radiation, Report 60, ICRU Publications, Bethesda MD (1998)
ISO, International Organization for Standardization, International vocabulary of basic and
general terms in metrology, 2 nd edition, Geneva (1993)
ISO, International Organization for Standardization, Guide to the expression of uncertainty in
measurement, 1 st edition, Geneva (1993)
3 Terminology and definitions
In this International Standard the auxiliary verb
– “shall” implies that compliance with a requirement is mandatory for compliance with the
standard;
– “may” implies that compliance with a requirement is permitted to be accomplished in a
particular manner for compliance with the standard.
The definitions given in this International Standard are generally in agreement with those in
IEC 60788 and ISO: International vocabulary of basic and general terms in metrology;
uncertainties are evaluated in accordance with ISO: Guide to the expression of uncertainty in
measurement.
Terms not defined in this subclause or listed in the index of defined terms have the meanings
defined in the above publications or are assumed to be terms of general scientific usage. An
alphabetical list of defined terms is given in the index.
For the purposes of this International Standard the following definitions apply:
3.1 ACCOMPANYING DOCUMENTS
documents provided with an installation, equipment, associated equipment or accessory,
containing important information for the assembler, installer and user, particularly regarding
safety
3.4 COEFFICIENT OF VARIATION
standard deviation of a set of readings expressed as a percentage of the mean value of these
readings
3.5 CONVENTIONAL TRUE VALUE
value used instead of the TRUE VALUE when calibrating or determining the performance of an
instrument, since in practice the TRUE VALUE is unknown and unknowable (IEC 60731)
NOTE The CONVENTIONAL TRUE VALUE will usually be the value determined by the STANDARD with which the instrument under test is compared.
3.6 CORRECTION FACTOR
dimensionless multiplier which corrects the INDICATED VALUE of an instrument from its value
when operated under particular conditions to its value when operated under stated REFERENCE
CONDITIONS (IEC 60731)
3.7 DOSE AREA PRODUCT (Letter symbol K·A )
product of the area of the USEFUL BEAM and the AIR KERMA over the cross-section of the USEFUL
BEAM , both quantities being measured at the same distance from the FOCAL SPOT . The unit of
DOSE AREA PRODUCT is Gym 2 .
3.8 DOSE AREA PRODUCT METER
equipment which uses IONIZATION CHAMBERS for the measurement of DOSE AREA PRODUCT or
DOSE AREA PRODUCT RATE in the beam of an X-ray machine used for diagnostic MEDICAL
RADIOLOGICAL EXAMINATIONS
IEC 60580:2000 pdf download
