Table of Contents

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

Abstract

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.

Scope

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.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	Standards Australia
ProductNote	Pending Revision indicates that as a result of the Aged Standards review process, the document needs updating. If no project proposal, meeting the quality criteria, is received within the 12 month timeframe, the document shall be withdrawn.
Pages
ISBN
Committee	HE-003