Obecné normy

Oblast zaměření: Systémy zpracování informací
Komise : CEN/TC 251 (Health informatics)
Původce: CEN
K připomínkám do: 13.05.2019
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This document specifies the common conventions required for the interchange of specific patient data (demographic, recording conditions ...), ECG signal data and metadata, ECG measurements and ECG annotations, and ECG interpretation results.

This document specifies the content and structure of the information which is to be interchanged between digital ECG electrocardiographs/devices and computer ECG management systems, as well as other computer or information systems (cloud, etc.) where ECG data can be stored.

This document defines the way to describe and encode standard and medium to long-term electrocardiogram waveforms measured in physiological laboratories, hospital wards, clinics and primary care medical check-ups, ambulatory and home care. It covers electrocardiograms such as 12-lead, 15-lead, 18-lead, Cabrera lead, Nehb lead, Frank lead, XYZ lead, Holter ECGs and exercise ECGs that are recorded, measured and analysed by equipment such as electrocardiographs, patient monitors, wearable devices. It also covers intracardiac electrograms recorded by implantable devices as well as the analysis results of ECG analysis and interpretation systems and software that are compatible with SCP-ECG.

ECG waveforms and data that are not in the scope of this technical specification include real-time ECG waveform encoding and analysis used for physiological monitors, and intra-cardiac or extra cardiac ECG mapping.

Oblast zaměření: Zkoušení materiálu obecně
Komise : CEN/TC 138 (Non-destructive testing)
Původce: CEN
K připomínkám do: 27.05.2019
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This document specifies a method for the measurement of effective focal spot dimensions above 0,1 mm of X-ray systems up to and including 1000 kV tube voltage by means of the pinhole camera method with digital evaluation. The tube voltage applied for this measurement is restricted to 200 kV for visual film evaluation.

The imaging quality and the resolution of X-ray images depend highly on the characteristics of the effective focal spot, in particular the size and the two dimensional intensity distribution as seen from the detector plane.

This test method provides instructions for determining the effective size (dimensions) of standard (macro focal spots) and mini focal spots of industrial X-ray tubes. This determination is based on the measurement of an image of a focal spot that has been radiographically recorded with a “pinhole” technique and evaluated with a digital method.

For the characterization of commercial X-ray tube types (i.e. for advertising or trade) it is advised that the specific FS values of Annex A are used.

Oblast zaměření: Prokazování kvality
Komise : CEN/CLC/JTC 1 (Criteria for conformity assessment bodies)
Původce: CEN
K připomínkám do: 28.05.2019
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This document specifies general terms and definitions relating to conformity assessment, including the accreditation of conformity assessment bodies, and to the use of conformity assessment to facilitate trade. A description of the functional approach to conformity assessment is included in Annex A, as a further aid to understanding among users of conformity assessment, conformity assessment bodies and accreditation bodies, in both voluntary and regulatory environments.

This document does not set out to provide a vocabulary for all of the concepts that may need to be used in describing particular conformity assessment activities. Terms and definitions are given only where the concept defined would not be understandable from the general language use of the term, or where an existing standard definition is not applicable.

NOTE 1       The notes appended to certain definitions offer clarification or examples to facilitate understanding of the concepts described. In certain cases, the notes may differ in different languages for linguistic reasons, or additional notes may be given.

NOTE 2       The terms and definitions are laid out in a systematic order, with an alphabetical index. A term in a definition or note that is defined in another entry is indicated by bold-face followed by its entry number in parentheses. Such terms may be replaced by their complete definition.