AS/NZS 4374:1996

Table of Contents

1 -  AS/NZS 4374:1996 ULTRASONICS-HAND-HELD PROBE DOPPLER FOETAL HEARTBEAT DETECTORS-PERFORMANCE REQUIREMENTS AND METHODS OF...
4 -  PREFACE
5 -  CONTENTS
7 -  1 Scope
7 -  2 Normative references
8 -  3 Definitions
8 -  3.1 acoustic coupl ing medium:
8 -  3.2 acoustic working frequency:
8 -  3.3 continuous wave ultrasound:
8 -  3.4 Doppler frequency:
8 -  3.5 effective area of the ultrasonic transducer active element:
8 -  3.6 Doppler signal:
8 -  3.7 equipment:
8 -  3.8 nominal acoustic working frequency:
8 -  3.9 output power:
9 -  3.10 overall sensitivity:
9 -  3.11 probe:
9 -  3.12 recei ver unit:
9 -  3.13 signal output part:
9 -  3.14 spatial-peak temporal-peak acoustic pressure:
9 -  3.15 target plane-wave reflection loss:
10 -  3.16 transmitter unit:
10 -  4 List of symbols
10 -  5 Configuration
11 -  6 Performance
11 -  6.1 acoustic working frequency
11 -  7 Safety
11 -  8 Tests
11 -  8.1 Acoustic worki ng frequency
11 -  8.2 Output power
12 -  8.3 Spatial -peak temporal-peak acoustic pressure
12 -  8.4 Effective area of the ultrasoni c transducer active element
12 -  8.5 Overall sensitivity
12 -  8.5.1 Test equipment
14 -  8.5.2 Measuri ng procedure
15 -  9 Preferred method for reporting performance of existing equipment
16 -  10 Specifications for labelling
17 -  11 Sampling
20 -  Annex A - Choice of target and determination of target plane-wave reflection loss
20 -  A.1 Choice of target
21 -  A.2 Determination of target plane-wave reflection loss
27 -  Annex B - Typical test equipment and test procedures
27 -  B.1 Test instrument
28 -  B.2 Coupling to the equipment to be tested
28 -  B.3 Measuring procedure
30 -  Annex C - Determination of the two-way insertion loss of acoustic attenuators
32 -  Annex D - Rationale
33 -  Annex E - Bibliography

Abstract

Specifies a series of tests, and the terminology for reporting these tests, to be carried out by manufacturers, enabling them to declare the characteristics of Doppler foetal heartbeat detectors on a common basis, thus allowing the purchaser to compare the performance of various models and chose that one which is best suited to their requirements. This Standard is identical with and has been reproduced from IEC 1266:1994.

Scope

This International Standard IEC 1266 establishes:
- methods of measurement of performance of a complete ultrasonic hand-held Doppler foetal heartbeat detector (hereinafter referred to as "equipment");
- requirements for the performance of equipment;
- requirements for the reporting of the performance of existing equipment;
- requirements for the declaration by manufacturers in accompanying literature of aspects of the performance of equipment.
This International Standard is applicable to ultrasonic Doppler foetal heartbeat detectors which generate a single ultrasound beam and consist of a hand-held probe which is applied to the maternal abdomen to obtain information on foetal heart activity by means of the Doppler method using continuous wave (c.w.) or quasi-continuous wave ultrasound. This standard, however, currently does not cover the continuous monitoring devices which generate more than one ultrasound beam and are usually of the type utilising a similar principle of operation but using a flat probe strapped to the patient.
This International Standard is not an equipment design standard.

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
Supersedes	DR 95241