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AS 1928

Australian Standard™

Child-resistant packages
AS 1928—2001
 This Australian Standard was prepared by Committee HE-001, Medical, Diagnostic
and Surgical Products. It was approved on behalf of the Council of Standards
Australia on 15 December 2000 and published on 31 January 2001.

The following interests are represented on Committee HE-001:

Australian Chemical Specialties Manufacturers Association
Australian Institute of Packaging
Australian Self Medication Industry
Commonwealth Department of Health and Aged Care
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Consumers Federation of Australia

Consumers Health Forum of Australia
Department of Human Services, Vic.
Health Department, W.A.
National Injury Prevention Advisory Council Standards WorkingGroup
New Children’s Hospital, Westmead
New South Wales Health Department
Pharmaceutical Society of Australia
Royal Children’s Hospital, Melbourne

Keeping Standards up-to-date

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may have been published since the Standard was purchased.
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Executive, Standards Australia International Ltd, GPO Box 5420, Sydney,
NSW 2001.

This Standard was issued in draft form for comment as DR 99506.

 AS 1928—2001

Australian Standard™
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Child-resistant packages

Originated as AS 1928—1976.
Previous edition AS 1928—1982.
Third edition 2001.

COPYRIGHT
© Standards Australia International
All rights are reserved. No part of this work may be reproduced or copied in any form or by any
means, electronic or mechanical, including photocopying, without the written permission of the
publisher.
Published by Standards Australia International Ltd
GPO Box 5420, Sydney, NSW 2001, Australia
ISBN 0 7337 3739 0
 AS 1928—2001 2

PREFACE
This Standard was prepared by the Standards Australia Subcommittee HE-001-08,
Packaging Systems and Devices—Child-resistant—Chemicals, under the responsibility of
Committee HE-001, Medical, Diagnostic and Surgical Products, as a revision of AS 1928—
1982, Child-resistant packaging.
The objective of this Standard is to set particular requirements for packages, containing
chemicals, that will be resistant to opening by children.
This Standard differs from the 1982 edition in the following respects:
(a) The adult panel has been extended to include a broader age range.
(b) The range of closures of packaging systems in Appendix D has been varied.
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(c) The sequential test strategy has been modified for both children and adults testing
panels.
(d) Consideration has been given to other forms of non-reclosable packages (see
Section 3 and Appendix E).
In the preparation of this Standard, account was taken of the Code of Federal Regulations,
Subchapter E— Poison Prevention Packaging Act of 1970 Regulations, BS EN 862:1997,
Packaging— Child-resistant packaging— Requirements and testing procedures for non-
reclosable packages for non-pharmaceutical products, and ISO 8317:1989, Child-resistant
packaging— Requirements and testing procedures for reclosable packages. The Standard
differs from ISO 8317:1989 in the following aspects:
(a) A distinction in the categories of reclosable and non-access packages has been made.
(b) Requirements for non-reclosable packages are specified.
(c) Appendix D reflects the local experience with extrapolating results from type testing
to evaluation of similar reclosable packages.
In a future edition of the Standard, consideration may be given in Appendix B to an
instruction that children may use their teeth to open packages if new evidence is
forthcoming.
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’ appendix is only for information and guidance.
 3 AS 1928—2001

CONTENTS

Page

FOREWORD.............................................................................................................................. 4

SECTION 1 SCOPE AND GENERAL REQUIREMENTS

1.1 SCOPE......................................................................................................................... 5
1.2 REFERENCED DOCUMENT..................................................................................... 5
1.3 DEFINITIONS............................................................................................................. 5
1.4 MATERIALS............................................................................................................... 6
1.5 FREEDOM FROM DEFECTS .................................................................................... 6
1.6 MARKING .................................................................................................................. 6
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1.7 PACKAGING .............................................................................................................. 6

SECTION 2 REQUIREMENTS FOR RECLOSABLE PACKAGES

2.1 SCOPE OF SECTION ................................................................................................. 7
2.2 DESIGN IN RELATION TO WADS OR LINERS...................................................... 7
2.3 PERFORMANCE TESTS FOR RESISTANCE TO OPENING................................... 7
2.4 QUALITY MAINTENANCE ...................................................................................... 8

SECTION 3 REQUIREMENTS FOR NON-RECLOSABLE PACKAGES

3.1 SCOPE OF SECTION ............................................................................................... 13
3.2 MATERIALS............................................................................................................. 13
3.3 SEAL STRENGTH AND INTEGRITY..................................................................... 13

APPENDICES
A CONSTITUTION OF TEST PANELS ...................................................................... 14
B PROCEDURES FOR TESTING BY CHILDREN ..................................................... 16
C PROCEDURES FOR TESTING BY ADULTS ......................................................... 19
D EVALUATION OF A SERIES OF SIMILAR RECLOSABLE PACKAGES............ 21
E TEST FOR INTEGRITY OF SEAL........................................................................... 22
 AS 1928—2001 4

FOREWORD
The purpose of this Standard is to assess the resistance of packaging, designated as being
child-resistant, to opening by children. However, the Committee recognizes that adults,
particularly aged persons, represent a significant proportion of the consuming public. It
therefore recommends that bodies approving packaging as child-resistant for legal purposes
should take into account the possible inability of some old or disabled people to open
certain types of packaging which comply with this Standard.
For the testing of reclosable packages, it will be noted that the children in the child panel
are aged 42 to 51 months. This is at the high end of the age range at which child poisoning
is most common, so as to challenge the packaging with children most likely to have the
dexterity to succeed. Similarly the adult age range of 18 to 65 years is not intended to be
representative of the population as a whole, but of the adults who can read the instructions
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and would be expected to be able to implement them with a high probability of success.
Older or non-English-speaking people are more likely to need help.
It is recommended that discussion take place between designers, manufacturers, testing and
regulatory authorities during the design and development stage of proposed child-resistant
packaging.
The Committee had no data on the effect of transparency of the package and has not
specified this aspect in the present revision. It recommends that this matter, together with
the questions of physical standards for both reclosable and non-reclosable packages and the
ability of old or disabled people to open the package should be considered at a future
revision when more data may be available and valid tests may have been developed.
It should be noted that ‘child-resistant’ is not synonymous with ‘child-proof’. Child-
resistant packaging provides only one safeguard—delay in access—in the protection of
children against accidental poisoning. Other precautions should also be taken by parents,
legislators, educators and marketeers to ensure that hazardous substances are kept out of
reach of children.
For reclosable packages, the Standard requires that panels of children and adults be given
the packages to open and the criteria for complying with the Standard are expressed in
terms of the minimum number of children in the children’s panel who will successfully
open the packages and the maximum number of adults who may fail to open the packages.
For non-reclosable packages, the Standard requires an examination of the materials of
construction and the carrying out of tests for seal strength and seal integrity. Compliance is
expressed in terms of the material requirements and maximum permissible leakage.
 5 AS 1928—2001

STANDARDS AUSTRALIA

Australian Standard
Child-resistant packages

S EC TION 1 S C OP E AND G E NER A L

REQU IR EMEN TS

1.1 SCOPE
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This Standard specifies requirements for reclosable (containers with closures) and non-
reclosable packages, designated as being resistant to opening by children. It is intended to
be particularly applicable to the packaging of chemicals, e.g. poisons, including medicines
and toxic substances, where child-resistant packaging is required.
NOTE: Packaging systems for chemicals, not intended for access by humans, are dealt with in
another Standard.

1.2 REFERENCED DOCUMENT

The document below is referred to in this Standard.
ICH Guidelines for Good Clinical Practice.

1.3 DEFINITIONS
For the purpose of this Standard, the definitions below apply.
1.3.1 Blister
A package in which one or more dosage units are enclosed between a pre-formed tray with
individual pockets and a lidding material which may be flat or shaped. The dosage units can
only be extracted singly. The material of the tray is usually different from that of the lid.
1.3.2 Non-reclosable package
A package in which a unit of use is individually protected until the time of release, e.g.
from a strip, blister, pouch or sachet.
1.3.3 Placebo
An inert substitute for the product it is to simulate.
1.3.4 Reclosable package (system)
A form of container with closure which, once opened, can be reclosed to its original form.
1.3.5 Strip
A package in which one or more dosage units are enclosed individually in a continuous
strip made by bonding two layers of material together so that the dosage units are separated
and protected and can only be extracted singly. Each layer may be of the same or different
material.

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