IEC 60580 pdf download – Medical electrical equipment – Dose area product meters

IEC 60580 pdf download – Medical electrical equipment – Dose area product meters
1Scope and object
This International Standard specifies the performance and testing of DoSE AREA PRODUCTMETERs with IONIZATION CHAMBERs intended to measure DOSE AREA PRODucT and/or DoSE AREAPRODUCT RATE to which the PATIENT is exposed during MEDICAL RADIOLOGICALEXAMINATIONS.
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.
2Normative 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 editionof the referenced document (including any amendments) applies.
lEC60417 (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 usedin radiotherapy
IEC 60788:1984,Medical radiology – Terminology
lEC60950:1999,Safety of information technology equipment
IEC 61000-4-2:1995,Electromagnetic compatibility (EMC) – Part 4-2: Testing and measure-ment techniques – Electrostatic discharge immunity fest
IEC 61000-4-3:1995，Electromagnetic compatibility (EMC) – Part 4-3:Testing and measure-ment techniques – Radiated, radio-frequency, electromagnetic field immunity test 1)
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 fechniques – Surge immunify test
IEC 61000-4-6:1996,Electromagnetic compatibility (EMC) – Part 4-6:Testing and measure-ment techniques – lmmunity 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， FundamentalQuantities and Units for lonizing Radiation，Report 60，ICRU Publications，Bethesda MD(1998)
lSo，International Organization for Standardization，International vocabulary of basic andgeneral terms in mefrology，2nedition, Geneva (1993,
ISO，International Organization for Standardization，Guide to the expression of uncertainty inmeasurement,1t edition, Geneva (1993y
3 Terminology and definitions
ln 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 aparticular manner for compliance with the standard.
The definitions given in this International Standard are generally in agreement with those inIEC 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 inmeasurement.
Terms not defined in this subclause or listed in the index of defined terms have the meaningsdefined in the above publications or are assumed to be terms of general scientific usage.Analphabetical 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 regardingsafety
3.2
AIR KERMA (Letter symbol K)
quotient of dEtr by dm，where dEr is the sum of the initial kinetic energies of all the chargedparticles in a mass dm of air, thus
dEtrK=m
dm
Unit: J kg-1
The special name for the unit of AIR KERMA is gray (Gy) (ICRU 60)
3.3
AIR KERMA RATE(Letter symbol k )
quotient of dK by dt, where dK is the increment of AIR KERMA in the time interval dt, thus
k _ dK
dt
Unit: J kg-1 s-1
lf the special name gray is used, the unit of AlR KERMA rate is gray per second (Gy s-1)(ICRU 60)
3.4
cOEFFICIENT OF VARIATION
standard deviation of a set of readings expressed as a percentage of the mean value of thesereadings
3.5
cONVENTIONAL TRUE VALUE
value used instead of the TRUE vALUE when calibrating or determining the performance of aninstrument, since in practice the TRUE vALUE is unknown and unknowable (IEc 60731)
NOTEThe cONVENTIONAL TRUE VALUE will usually be the value determined by the STANDARD with which theinstrument under test is compared.
3.6
cORRECTION FACTOR
dimensionless multiplier which corrects the lNDICATED vALuE of an instrument from its valuewhen operated under particular conditions to its value when operated under stated REFERENCEcONDITIONs(IEC 60731)
3.7
DOSE AREA PRODuCT (Letter symbol K-A)
product of the area of the uSEFuL BEAM and the AlR KERMA over the cross-section of the usEFuLBEAM,both quantities being measured at the same distance from the FOCAL sPOT. The unit ofDoSE AREA PRODucT is Gym2.