BS EN 60601-2-37-2001 pdf download.Medical electrical equipment Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.
This clause of the General Standard applies except as follows:
*1.1 Scope
Addition:
This Particular Standard specifies particular safety requirements for ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 2.1.145.
This BS EN 60601-2-37 does not cover ultrasonic therapeutic equipment: however, equipment used for the imaging of body structures by ultrasound in conjunction with therapeutic modalities is covered.
1.2 Object
Replacement:
The object of this Particular Standard is to establish particular requirements for the safety of ULTRASONIC DIAGNOSTIC EQUIPMENT and those aspects thereof which are directly related to safety.
1.3 PartIcular Standards
Addition:
This Particular Standard amends and supplements a set of IEC publications, hereinafter referred to as the General Standard’, consisting of
IEC 60601-1:1988. Medical electrical equipment— Part 1: General requirements for safety and its Amendments 1 (1991) and 2 (1995)
IEC 60601-1 -2:2001, Medical electrical equipment — Part 1-2: General requirements for safety — Collateral standard: Electromagnetic compatibility — Requirements and tests iI
IEC 60601-1-4:1996. Medical electrical equipment — Part 1-4: General requirements for
safety — 4. Collateral Standard: Programmable electrical medical systems and its Amendment 1
(1999)
The numbering of sections, clauses and subclauses of this Particular Standard corresponds to that of the General Standard. The changes to the text of the General Standard are specified by the use of the following words:
‘Replacemenr means that the clause or subclause of the General Standard is replaced completely by the text of this Particular Standard.
“Addition means that the text of this Particular Standard is additional to the requirements of the General Standard.
‘Amendment means that the clause or subclause of the General Standard is amended as indicated by the text of this Particular Standard.
Subclauses or figures which are additional to those of the General Standard are numbered starting from 101, additional annexes are lettered AA, BB. etc., and additional items aa), bb), etc.
Clauses and subclauses to which there is a rationale are marked with an asterisk () These rationales can be found In an informative annex BB. Annex BB should be used in determining the relevance of the requirements addressed, but should never be used to establish additional test requirements.
Where there Is no corresponding section, clause or subclause in this Particular Standard, the section, clause or subclause of the General Standard applies without modification.
Where it Is Intended that any part of the General Standard, although possibly relevant, Is not to be applied, a statement to that effect is given in this Particular Standard.
A requirement of this Particular Standard replacing or modifying requirements of the General Standard or of a Collateral Standard takes precedence over the corresponding general requirement(s).
1.3.101 Related international standards
IEC 60529:1989, Degrees of protection provided by enclosures (IP Code)
IEC 60788:1984, Medical radiology — Terminology
IEC 61102:1991, Measurement and characterisation of ultrasonic fields using hydrophones in the frequency range 0,5 MHz to 15 MHz
IEC 61157:1992. Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment
IEC 61161:1992, Ultrasonic power measurement in liquids in the frequency range 0,5 MHz to
25 MHz
Amendment 1 (1998)
is the distance from the source to the point of interest in centimetres:
Jawt is the ACOUSTIC WORKING FREQUENCY in megahertz;
Ita.a(:) is the ATTENUATED TEMPORAL-AVERAGE INTENSITY ifl milliwatts per centimetre squared;
Ita(:) Is the TEMPORAL-AVERAGE INTENSITY measured in water in milliwalts per centimetre squared.
Symbol: !ta,a()
Unit: milliwatts per centimetre squared, mW cm-2
2.1.109
BEAM AREA
area in a specified plane perpendicular to the BEAM-ALIGNMENT AXIS consisting of all points at which the PULSE-INTENSITY INTEGRAL is greater than a specified fraction of the maximum PULSE-INTENSITY INTEGRAL in that plane
(3.6 of IEC 61102, modified]
NOTE For measurement purposes the PULSE INTENSITY INTEGRAL can be taken as being proportional to the PULSE PRESSURE-SQUARED INTEGRAl..
2.1.110
BEAM ALIGNMENT AXIS
straight line joining the points of maximum PULSE INTENSITY INTEGRAL measured at several different distances in the far field. For the purposes of alignment, this line may be projected to the face of the ULTRASONIC TRANSDUCER
(3.5 of IEC 61102, modified]
2.1.111
BONE THERMAL INDEX
THERMAL INDEX for applications, such as foetal (second and third trimester) or neonatal cephalic (through the fontanelle), in which the ultrasound beam passes through soft tissue and a focal region is in the immediate vicinity of bone
Symbol: TIB
Unit: None
NOTE See annex DD4.2 and DD5.2 for methods of determining the BONE THERMAL INDEX.
2.1.112
BOUNDED OUTPUT POWER
OUTPUT POWER emitted in SCANNING MODE from a region of the active area of the transducer
whose width in the scan plane is limited to 1 cm
Symbol: P1
Unit: milliwatts, mW.BS EN 60601-2-37-2001 pdf download.