AS/NZS 3200.2.

202:1996

Australian/New Zealand Standard

This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.

Approval and test specification—

Medical electrical equipment

Part 2.202: Particular requirements

for safety—Infant apnoea monitors
for domestic use
 AS/NZS 3200.2.202:1996

This Joint Australian/New Zealand Standard was prepared by Joint Technical

Committee HT/19, Baby Incubators/Infant Care Units. It was approved on behalf of
the Council of Standards Australia on 30 August 1996 and on behalf of the Council
of Standards New Zealand on 12 August 1996. It was published on 5 October 1996.

The following interests are represented on Committee HT/19:

Australasian College of Physical Scientists and Engineers in Medicine
Australian Chamber of Commerce and Industry
Australian College of Paediatrics
Canterbury Health, New Zealand
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Department of Health, N.S.W.

Health Industry Suppliers Association of New Zealand
Medical Industry Association of Australia
Ministry of Commerce, New Zealand
Monash Medical Centre, Victoria
Newborn Emergency Transport Service, Victoria
Queensland Health
South Australian Health Commission
Wellington Area Health Board, New Zealand

Review of Standards. To keep abreast of progress in industry, Joint Australian/

New Zealand Standards are subject to periodic review and are kept up to date by the issue
of amendments or new editions as necessary. It is important therefore that Standards users
ensure that they are in possession of the latest edition, and any amendments thereto.
Full details of all Joint Standards and related publications will be found in the Standards
Australia and Standards New Zealand Catalogue of Publications; this information is
supplemented each month by the magazines ‘The Australian Standard’ and ‘Standards
New Zealand’, which subscribing members receive, and which give details of new
publications, new editions and amendments, and of withdrawn Standards.
Suggestions for improvements to Joint Standards, addressed to the head office of either
Standards Australia or Standards New Zealand, are welcomed. Notification of any
inaccuracy or ambiguity found in a Joint Australian/New Zealand Standard should be made
without delay in order that the matter may be investigated and appropriate action taken.

This Standard was issued in draft form for comment as DR 95394.

First published as AS/NZS 3200.2.202:1996.

 AS/NZS 3200.2.202:1996

Australian/New Zealand Standard

This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.

Approval and test specification—

Medical electrical equipment

Part 2.202: Particular requirements

for safety—Infant apnoea monitors
for domestic use

PUBLISHED JOINTLY BY:

STANDARDS AUSTRALIA
1 The Crescent,
Homebush NSW 2140 Australia
STANDARDS NEW ZEALAND
Level 10, Standards House,
155 The Terrace,
Wellington 6001 New Zealand
ISBN 0 7337 0725 4
 AS/NZS 3200.2.202:1996 2

PREFACE

This Joint Standard was prepared by the Standards Australia/Standards New Zealand
Committee, HT/19, on Baby Incubators/Infant Care Units.
It was originally intended to be a type-test Standard in the AS 3200.2 series but attempts to
accumulate sufficient comparative test data met with a series of problems which could not
be resolved within justifiable resource and cost parameters.
However, it was decided that sufficient worthwhile information had been accumulated during
the development period to justify the publication of a Standard which would also provide
enough information to intending purchasers for them to assess if devices being offered were
of acceptable quality.
This Particular Standard is one of a series of Approval and Test Specifications issued by
Standards Australia and Standards New Zealand for various categories of medical equipment.
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It is supplementary to AS 3200.1.0:1990 (NZS 6150:1990), Approval and test

specification — Medical electrical equipment, Part 1.0: General requirements for safety —
Parent Standard. All tables, diagrams and appendices of the Parent Standard, if relevant to
this Standard, apply to this Standard.
As this document is intended for use as a Particular Standard, it follows the format and
numbering practices used in the Parent Standard.
Australian and Australian/New Zealand Standards referenced in this document are detailed
in Appendix LL.
Additional requirements relating to the equipment and its accessories, which are not subject
to technical testing, are listed in Appendix MM.
Procedural advice for users of the equipment is provided in Appendix NN.
The use of a double identifier, e.g. LL, indicates that an appendix replaces the single
identifier, e.g. L, appendix in the Parent Standard.
Permission to use information from a pamphlet on the safe positioning of babies, produced
by the Menzies Centre for Population Health Research, Hobart, in Appendix NN is gratefully
acknowledged.
The terms ‘normative’ and ‘informative’ have been used in this Standard to define the
application of the Appendix to which they apply. A ‘normative’ Appendix is an integral part
of a Standard, whereas an ‘informative’ one is only for information and guidance.

 Copyright STANDARDS AUSTRALIA/ STANDARDS NEW ZEALAND

Users of Standards are reminded that copyright subsists in all Standards Australia and Standards New Zealand publications and software.
Except where the Copyright Act allows and except where provided for below no publications or software produced by Standards Australia
or Standards New Zealand may be reproduced, stored in a retrieval system in any form or transmitted by any means without prior permission
in writing from Standards Australia or Standards New Zealand. Permission may be conditional on an appropriate royalty payment. Australian
requests for permission and information on commercial software royalties should be directed to the head office of Standards Australia.
New Zealand requests should be directed to Standards New Zealand.
Up to 10 percent of the technical content pages of a Standard may be copied for use exclusively in-house by purchasers of the
Standard without payment of a royalty or advice to Standards Australia or Standards New Zealand.
Inclusion of copyright material in computer software programs is also permitted without royalty payment provided such programs are
used exclusively in-house by the creators of the programs.
Care should be taken to ensure that material used is from the current edition of the Standard and that it is updated whenever the Standard
is amended or revised. The number and date of the Standard should therefore be clearly identified.
The use of material in print form or in computer software programs to be used commercially, with or without payment, or in commercial
contracts is subject to the payment of a royalty. This policy may be varied by Standards Australia or Standards New Zealand at any time.
 3 AS/NZS 3200.2.202:1996

CONTENTS
Page

SECTION 1 GENERAL
1.1 SCOPE AND OBJECT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.2 OBJECT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.3 PARTICULAR STAND ARDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2 DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
3 GENERAL REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
4 GENERAL REQUIREMENTS FOR TESTS . . . . . . . . . . . . . . . . . . . . . . . 6
5 CLASSIFICATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
6 IDENTIFICATION, MARKING AND DOCUMENTS . . . . . . . . . . . . . . . . 6
7 POWER INPUT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
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SECTION 2 ENVIRONMENTAL CONDITIONS

8 Not used
9 Not used
10 ENVIRONMENTAL CONDITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
11 Not used
12 Not used

SECTION 3 PROTECTION AGAINST ELECTRIC SHOCK HAZARDS

13 GENERAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
14 REQUIREMENTS RELATED TO CLASSIFICATION . . . . . . . . . . . . . . . 7
15 LIMITATIONS OF VOLTAGE AND/OR ENERGY . . . . . . . . . . . . . . . . . 7
16 ENCLOSURES AND PROTECTIVE COVERS . . . . . . . . . . . . . . . . . . . . 7
17 SEPARATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
18 PROTECTIVE EARTHING, FUNCTIONAL EARTHING AND POTENTIAL
EQUALIZATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
19 CONTINUOUS LEAKAGE CURRENTS AND PATIENT AUXILIARY
CIRCUITS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
20 DIELECTRIC STRENGTH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

SECTION 4 PROTECTION AGAINST MECHANICAL HAZARDS

22 MECHANICAL STRENGTH . . . . . . . . . . . . . . . . . . . . . . .. .. . . .. .. . 7
21 MOVING PARTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. .. .. ... 7
23 SURFACES, CORNERS AND EDGES . . . . . . . . . . . . . . . .. .. .. .. ... 7
24 STABILITY IN NORMAL USE . . . . . . . . . . . . . . . . . . . . .. .. .. . . .. . 7
25 EXPELLED PARTS (not relevant)
26 VIBRATION AND NOISE (not used)
27 PNEUMATIC AND HYDRAULIC POWER (not used)
28 SUSPENDED MASSES (not relevant)

SECTION 5 PROTECTION AGAINST HAZARDS FROM UNWANTE D OR

EXCESSIVE RADIATION
29 X-RADIATION (not relevant)
30 ALPHA, BETA, GAMMA, NEUTRON RADIATION AND OTHER
PARTICLE RADIATION (not relevant)
31 MICROWAVE RADIATION (not relevant)
32 LIGHT RADIATION (INCLUDING LASERS) (not relevant)
 AS/NZS 3200.2.202:1996 4

Page
33 INFRA-RED RADIATION (not relevant)
34 ULTRAVIOLET RADIATION (not relevant)
35 ACOUSTICAL ENERGY (INCLUDING ULTRASONICS) (not relevant)
36 ELECTROMAGNETIC COMPATIBILITY . . . . . . . . . . . . . . . . . . . . . . . . 7

SECTION 6 PROTECTION AGAINST HAZARDS OF IGNITION OF

FLAMMABLE ANAESTHETIC MIXTURES
37 LOCATIONS AND BASIC REQUIREMENTS (not relevant)
38 MARKING AND ACCOMPANYING DOCUMENTS (not relevant)
39 COMMON REQUIREMENTS FOR CATEGORY AP AND CATEGORY
APG EQUIPMENT (not relevant)
40 REQUIREMENTS AND TESTS FOR CATEGORY AP EQUIPMENT,
PARTS AND COMPONENTS THEREOF (not relevant)
41 REQUIREMENTS AND TESTS FOR CATEGORY APG EQUIPMENT,
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PARTS AND COMPONENTS THEREOF (not relevant)

SECTION 7 PROTECTION AGAINST EXCESSIVE TEMPERATURES AND

OTHER SAFETY HAZARDS
42 EXCESSIVE TEMPERATURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
43 FIRE PREVENTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
44 OVERFLOW, SPILLAGE, LEAKAGE, HUMIDITY, INGRESS OF
LIQUIDS, CLEANING, STERILIZATION AND DISINFECTION . . . . . . . 8
45 PRESSURE VESSELS AND PARTS SUBJECT TO PRESSURE . . . . . . . . 8
46 HUMAN ERRORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
47 ELECTROSTATIC CHARGES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
48 MATERIAL IN APPLIED PARTS IN CONTACT WITH THE BODY OF
THE PATIENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
49 INTERRUPTION OF THE POWER SUPPLY . . . . . . . . . . . . . . . . . . . . . 8

SECTION 8 ACCURACY OF OPERATING DATA AND PROTECTION

AGAINST HAZARDOUS OUTPUT
50 ACCURACY OF OPERATING DATA . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
51 PROTECTION AGAINST HAZARDOUS OUTPUT . . . . . . . . . . . . . . . . . 8

SECTION 9 ABNORMAL OPERATION AND FAULT CONDITIONS;

ENVIRONMENTAL TESTS
52 ABNORMAL OPERATION AND FAULT CONDITIONS . . . . . . . . . . . . . 8
53 ENVIRONMENTAL TESTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

SECTION 10 CONSTRUCTIONAL REQUIREMENTS

54 GENERAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
55 ENCLOSURES AND COVERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
56 COMPONENTS AND GENERAL ASSEMBLY . . . . . . . . . . . . . . . . . . . . 9
57 MAINS PARTS, COMPONENTS AND LAYOU T . . . . . . . . . . . . . . . . . . 9
58 PROTECTIVE EARTHING— TERMINALS AND CONNECTIONS . . . . . . 9
59 CONSTRUCTION AND LAYOU T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

APPENDICES
LL REFERENCED DOCUMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
MM ADDITIONAL REQUIREMENTS NOT SUBJECT TO TECHNICAL
TESTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
NN FOR THE USER —ESSENTIAL SAFETY PRACTICES . . . . . . . . . . . . . . 16
PP RESOURCES— OTHER SOURCES OF ADVICE . . . . . . . . . . . . . . . . . . . 18
 5 AS/NZS 3200.2.202:1996

STANDARDS AUSTRALIA/ STANDARDS NEW ZEALAND

Australian/New Zealand Standard

Approval and test specification — Medical electrical equipment

Part 2.202: Particular requirements for safety — Infant apnoea monitors for
domestic use

S E C T I O N 1 G EN E R AL

1 Scope and object This Clause of the General Standard applies except as follows:
1.1 Scope
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Replacement:
This Standard specifies general safety requirements for infant apnoea monitors, either single
or dual modality, for domestic use. This Standard applies to both battery-powered equipment
and mains-powered equipment. This equipment should only be used under the supervision
of a health care practitioner. An intending purchaser of equipment should be able to gather
sufficient information from the Appendices of this Standard to evaluate the quality of
equipment being offered and gain helpful advice on the safe use of the equipment.
1.2 Object
Replacement:
The object of this Particular Standard is to—
(a) establish particular requirements for the design and manufacture of infant apnoea
monitors, either single or dual modality, for domestic use;
(b) ensure safe use of the equipment; and
(c) specify methods of demonstrating compliance with these requirements.
1.3 Particular Standards
Replacement:
The requirements of this Particular Standard take precedence over the requirements of its
Parent Standard (also referred to as the ‘General Standard’), AS 3200.1.0 (NZS 6150) and
its subsequent amendments.

2 Definitions For the purposes of this Standard the definitions listed below apply.
2.1 Apnoea — cessation of respiratory air flow.
2.2 Health care practitioner —a prescribing physician who orders the use of the equipment,
or his or her delegate. For the purpose of solving technical problems this term is extended
to cover a qualified biomedical engineer or biomedical technician. In remote areas the term
may refer to a suitably qualified technician.
2.3 Infant apnoea monitor — a monitor to detect apnoea and intended for use on humans less
than three years of age. The infant apnoea monitor is a complete monitoring system that
includes sensors, signal processing systems, alarm systems, power supplies, accessories
supplied or recommended by the manufacturer, labelling, accompanying documents and
training documents. It may be used as a stand-alone unit or as part of a system. Hereinafter
it is referred to as ‘equipment’.
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AS/NZS 3200.2.202:1996, Approval and test

specification - Medical electrical equipment
Particular requirements for safety - Infant apnoea
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monitors for domestic use

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