EN IEC 60580-2020 pdf download.Medical electrical equipment – Dose area product meters (IEC 60580:2019).
This document specifies the performance and testing of DOSE AREA PRODUCT METERS intended to measure DOSE AREA PRODUCT and/or DOSE AREA PRODUCT RATE to which the PATIENT is exposed during MEDICAL RADIOLOGICAL EXAMINATIONS .
This document is applicable to the following types of DOSE AREA PRODUCT METERS :
a) FIELD – CLASS DOSE AREA PRODUCT METERS normally used for the measurement of DOSE AREA PRODUCTS during MEDICAL RADIOLOGICAL EXAMINATIONS ;
b) REFERENCE – CLASS DOSE AREA PRODUCT METERS normally used for the CALIBRATION of FIELD – CLASS DOSIMETERS . NOTE REFERENCE – CLASS DOSE AREA PRODUCT METERS can be used as FIELD – CLASS DOSE AREA PRODUCT METERS .
The object of this document 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. Two levels of performance are specified:
– a lower level of performance applying to FIELD
– CLASS DOSE AREA PRODUCT METERS ; – a higher level of performance applying to REFERENCE
– CLASS DOSE AREA PRODUCT METERS .
2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements 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 6041 7, Graphical symbols for use on equipment (available at http://www.graphical- symbols.info/equipment) IEC 60601 -1 :2005, Medical electrical equipment
– Part 1: General requirements for basic safety and essential performance IEC 60601 -1 -2, Medical electrical equipment
– Part 1-2: General requirements for basic safety and essential performance
– Collateral Standard: Electromagnetic disturbances
– Requirements and tests IEC TR 60788:2004, Medical electrical equipment
– Glossary of defined terms IEC 62368-1 , Audio/video, information and communication technology equipment – Part 1: Safety requirements
IEC 61 000-4-2, Electromagnetic compatibility (EMC) – Part 4-2: Testing and measurement techniques – Electrostatic discharge immunity test
IEC 61 000-4-3, Electromagnetic compatibility (EMC) – Part 4-3: Testing and measurement techniques – Radiated, radio-frequency, electromagnetic field immunity test
IEC 61 000-4-4, Electromagnetic compatibility (EMC) – Part 4-4: Testing and measurement techniques – Electrical fast transient/burst immunity test
IEC 61 000-4-5, Electromagnetic compatibility (EMC) – Part 4-5: Testing and measurement techniques – Surge immunity test
IEC 61 000-4-6, Electromagnetic compatibility (EMC) – Part 4-6: Testing and measurement techniques – Immunity to conducted disturbances induced by radio-frequency fields
IEC 61 000-4-1 1 , Electromagnetic compatibility (EMC) – Part 4-11: Testing and measurement techniques – Voltage dips, short interruptions and voltage variations immunity tests
IEC 61 1 87, Electrical and electronic measuring equipment – Documentation
IEC 61 267, Medical diagnostic X-ray equipment – Radiation conditions for use in the determination of characteristics
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601 -1 :2005, IEC TR 60788:2004 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
NOTE 1 An index of defined terms is to be found at the end of the document.
NOTE 2 A searchable IEC Glossary can be found at std.iec.ch.EN IEC 60580 pdf download.