AS/NZS 4194:1994

1 - AS/NZS 4194:1994 REQUIREMENTS FOR THE DECLARATION OF THE ACOUSTIC OUTPUT OF MEDICAL DIAGNOSTIC ULTRASONIC EQUIPMENT
4 - PREFACE
5 - CONTENTS
6 - 1 Scope
6 - 2 Normative references
6 - 3 Definitions and symbols
7 - 3.1 accompanying literature
7 - 3.2 acoustic initialization fraction
7 - 3.3 acoustic output freeze
7 - 3.4 acoustic power-up fraction
7 - 3.5 bandwidth
7 - 3.6 combined-operating mode
7 - 3.7 discrete-operating mode
7 - 3.8 inclusive mode
8 - 3.9 initialization mode
8 - 3.10 manufacturer
8 - 3.11 medical diagnostic ultrasonicequipment (or system)
8 - 3.12 non-scanning mode
8 - 3.13 output beam area
8 - 3.14 output beam dimensions
8 - 3.15 output beam intensity
8 - 3.16 patient entry plane
8 - 3.17 power-up mode
8 - 3.18 pulse beam-width
9 - 3.19 reference direction
9 - 3.20 scan direction
9 - 3.21 scanning mode
9 - 3.22 transducer assembly
9 - 3.23 transducer output face
9 - 3.24 transducer stand-off distance
10 - 3.25 transducer to transducer-output-face distance
10 - 3.26 type testing values
10 - 3.27 ultrasonic scan line
10 - 3.28 ultrasound instrument console
10 - 3.29 acoustic pulse waveform
10 - 3.30 arithmetic-mean acoustic-working frequency
11 - 3.31 beam-alignment axis
11 - 3.32 central scan line
11 - 3.33 nominal frequency
11 - 3.34 peak-negative (or peak-rarefactional) acoustic pressure
11 - 3.35 pulse-pressure-squared integral
12 - 3.36 pulse repetition period
12 - 3.37 pulse repetition rate
12 - 3.38 scan plane
12 - 3.39 scan repetition period
12 - 3.40 scan repetition rate
12 - 3.41 spatial-peak temporal-average derived intensity
13 - 3.42 ultrasonic scan line separation
13 - 4 Requirements
13 - 4.1 General
15 - 4.2 Requi rements for the declaration of acousti c output i nformati on
15 - 4.2.1 Inf ormati on to be declared i n techni cal data sheets
15 - 4.2.2 Inf ormati on to be declared i n the accompanying literature/manual
18 - 4.2.3 Background information
18 - 4.2.3.1 All discrete-operating modes
19 - 4.2.3.2 All scanni ng modes
19 - 5 Sampling
20 - 6 Declaration exemption
21 - 7 Test methods
21 - 8 Labelling
21 - 8.1 Present ati on of resul ts
22 - Annex A - Presentation of acoustic output information
24 - Annex B - Declaration requirements for complex systems
26 - Annex C - Rationale

Establishes requirements for the declaration of the acoustic output of medical diagnostic equipment for the information of intending purchasers. This Standard is identical with and reproduced from IEC 1157:1993.

This International Standard is applicable to medical diagnostic ultrasonic equipment.It establishes requirements for the declaration of the acoustic output information:- to be presented in technical data sheets supplied to prospective purchasers of equipment by manufacturers;- to be declared in the accompanying literature/manual supplied by manufacturers;- as background information to be made available on request to interested parties by manufacturers.It also gives exemption conditions for equipment generating low acoustic output levels.

First published as Joint AS/NZS 4194:1994.