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BS EN 61168:1994

Current

Current

The latest, up-to-date edition.

Medical electrical equipment. Particular requirements for performance. Methods of declaring functional performance characteristics of radiotherapy simulators

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

06-15-1994

Cooperating organizations
National foreword
Foreword
Introduction
1 Scope and object
2 Normative references
3 Terminology and definitions
4 Standardized test conditions
5 Indication of DELINEATED RADIATION FIELDS
6 Indication of DELINEATED RADIATION BEAM AXIS
7 ISOCENTRE
8 Indication of the distance along the DELINEATED
    RADIATION BEAM AXIS
9 Zero position of rotation scales
10 Congruence of opposed DELINEATED RADIATION FIELDS
11 Movements of the PATIENT SUPPORT
Figure
1 RADIOTHERAPY SIMULATOR movements
Annex
A Format for presentation of functional performance
    values
Tables
1 Conditions for testing the numerical field-indicator
    and the LIGHT FIELD-INDICATOR
2 Conditions for testing reproducibility of
    DELINEATED RADIATION FIELDS
3 Conditions for testing reproducibility of the
    DELINEATOR
4 Conditions for testing the indication of the
    DELINEATED RADIATION BEAM AXIS on the ENTRANCE
    SURFACE
5 Conditions for testing the indication of the
    DELINEATED RADIATION BEAM AXIS on the exit surface
6 Conditions for testing the displacement of the
    DELINEATED RADIATION BEAM AXIS from the TEST DEVICE
    or reference pointer indicating the ISOCENTRE
7 Conditions for testing the vertical movement of the
    table top
8 Conditions for testing the ISOCENTRIC rotation of
    the PATIENT SUPPORT
9 Conditions for testing the parallelism of rotational
    axes of the PATIENT SUPPORT
10 Conditions for testing the PATIENT SUPPORT lateral
    rigidity
Annex
ZA (normative) Other international publications quoted
    in this standard with the references of the relevant
    European publications
National annex NA (informative) Committees responsible
National annex NB (informative) Cross-references

Methods of test for obtaining data.

Scope This International Standard applies to radiotherapy simulators which use diagnostic X-ray equipment to geometrically simulate a radiotherapy radiation beam so that the treatment volume to be irradiated during radiotherapy can be localized and the position and size of the therapeutic radiation field can be confirmed. This standard applies to radiotherapy simulators using high voltage generators operating at a voltage not exceeding 400kV complying with IEC601-2-7. This standard applies to radiotherapy simulators intended exclusively for radiotherapy simulation as a prelude to intended radiotherapy and not for any other purposes such as general diagnostic purposes. The requirements in this standard are based on the assumption that the radiotherapy simulator consists of: a system for producing a beam of X-radiation not exceeding 400kV which simulates the geometry of the radiotherapy radiation beam: a system for producing images of the transmitted X-ray beam, either by radiography or by radioscopy; an assembly which controls the size of the radiation beam and which delineates the intended treatment area; a mechanical structure that physically simulates the geometry and motions of a radiotherapy equipment, and which supports an imaging system; a patient support system. This standard applies to equipment intended for use under the supervision of a qualified person. Except where otherwise stated this standard assumes that the radiotherapy simulator has an isocentric gantry with no pitch or roll movement of the radiation head. This standard specifies type tests to be performed by the manufacturer at the design and construction stages of a radiotherapy simulator but does not specify site tests to be performed after installation at the user\'s site. The accompanying technical report IEC1170, however, does suggest that many of the test procedures are appropriate for site tests. During the course of any test procedure only those adjustments of the radiotherapy simulator are permissible that can be carried out using controls normally accessible to the operator and which are regarded as forming part of the normal operation of the radiotherapy simulator. 1.2 Object The object of this standard is to: identify geometric parameters which are critical for the accurate simulation of a radiotherapy treatment; recommend methods of measuring these parameters. It is recognized that inaccuracies in the test methods must be allowed for when assessing performance. However, it is not felt advisable to combine the errors into an overall performance tolerance but keep them separate in the expectation that more accurate test methods will be evolved. It is not intended that this standard should in any way inhibit the future development of new designs of equipment which may have operating modes and parameters different from those described herein. 1.3 Environmental conditions 1.3.1 General Except where other allowable environmental conditions are stated in the accompanying documents this standard applies to equipment installed, used or kept in locations where the following environmental conditions prevail: the ambient temperature falls within the range 10°C to 40°C; the relative humidity falls within the range 30%to 75%; the atmospheric pressure falls within the range 70kPa to 110kPa (700 mbar to 1100 mbar). 1.3.2 Transport and storage The allowable environmental conditions for transport and storage shall be stated in the accompanying documents.

Committee
CH/62/3
DevelopmentNote
Also numbered as BS 5724-3.129(1994) and IEC 61168 Supersedes 92/52057 DC (11/2005)
DocumentType
Standard
Pages
26
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
I.S. EN 61168:1994 Identical
SN EN 61168 : 1994 Identical
NF EN 61168 : 1994 Identical
NBN EN 61168 : 1995 Identical
DIN EN 61168:2000-01 Identical
UNE-EN 61168:1996 Identical
EN 61168 : 1994 Identical

BS 5724-1(1989) : 1989 AMD 6715 MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY
BS 6641:1985 Glossary of medical radiology terms

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