AS/NZS 4179:1997

ISO 10282:1994

Australian/New Zealand Standard®

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Single-use sterile surgical rubber

gloves—Specification
 AS/NZS 4179:1997

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

Committee HT/14, Surgical Apparel. It was approved on behalf of the Council of
Standards Australia on 14 March 1997 and on behalf of the Council of Standards
New Zealand on 28 April 1997. It was published on 5 May 1997.

The following interests are represented on Committee HT/14:

Australian Chamber of Manufactures
Australian Chamber of Commerce and Industry
Australian Confederation of Operating Room Nurses
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Australian Dental Association

Australian Hospital Association
Australian Infection Control Association
Australian Private Hospitals Association
Commonwealth Department of Health and Family Services
Department of Human Services, Vic.
Department of Public Works and Services, N.S.W.
Medical Industry Association of Australia
Ministry of Health, New Zealand
National Association of Testing Authorities, Australia
N.S.W. Health Department
Royal Australasian College of Surgeons
Royal Australasian College of Physicians
Royal College of Pathologists of Australasia

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publications, new editions and amendments, and of withdrawn Standards.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 96541.

 AS/NZS 4179:1997

Australian/New Zealand Standard®

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

Single-use sterile surgical rubber

gloves—Specification

Originated in Australia as AS 4179 — 1994.

Jointly revised and designated AS/NZS 4179:1997.
Amdt 1—1998

PUBLISHED JOINTLY BY:

STANDARDS AUSTRALIA
1 The Crescent,
Homebush NSW 2140 Australia

STANDARDS NEW ZEALAND

Level 10, Radio New Zealand House,
155 The Terrace,
Wellington 6001 New Zealand
ISBN 0 7337 1163 4
 ii

PREFACE

This Standard was prepared by the Joint Standards Australia/Standards New Zealand Committee HT/14
on Surgical Apparel, to supersede AS 4179 — 1994, Single use (sterile) rubber surgical gloves. It is
technically equivalent to, and reproduced from ISO 10282, Single-use sterile surgical rubber
gloves — Specification.
The objective of this Standard is to achieve an acceptable level of safety to protect the patient and the
user from cross-contamination.
In some parts of this Standard, the Australian/New Zealand requirements differ from the ISO Standard.
To accommodate these differences, a marginal bar is placed alongside the ISO text, and Appendices XX
and YY detail the Australian/New Zealand specifications for the deviations.
At the request of the Therapeutic Goods Administration in Australia and the Ministry of Health in
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New Zealand, the sampling and conformance requirements from ISO 10282 have been retained for use
by the regulatory authorities when they conduct testing.
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.
As this Standard is reproduced from an International Standard, the following applies:
(a) The number appears on the cover and title page while the International Standard number appears
only on the cover.
(b) In the source text, ‘this International Standard’ should read ‘this Australian/New Zealand
Standard’.
(c) A full point substitutes for a comma when referring to a decimal marker.
(d) The reference to International Standards should be replaced by the equivalent Australian
Standards, as follows:
Reference to International Standard Australian Standard
ISO AS
37 Rubber, vulcanized or thermoplastic — 1683.11 Methods of test for elastomers
Determination of tensile stress-strain Method 11: Tension testing of
properties vulcanized rubber

188 Rubber, vulcanized — Accelerated 1683.26 Methods of test for elastomers

ageing or heat-resistance tests Method 26: Rubber, vulcanized —
Accelerated ageing or heat-resistance
tests
2859-1 Sampling procedures for inspection by 1199 Sampling procedures and tables for
attributes inspection by attributes
Part 1: Sampling plans indexed by
acceptable quality level (AQL) for
lot-by-lot inspection
4648 Rubber, vulcanized or thermoplastic — —
Determination of dimensions of test
pieces and products for test purposes
7000 Graphical symbols for use on —
equipment — Index and synopsis
 iii

CONTENTS
Page
1 SCOPE . . . . . . . . . . . . . . . . . . . . . . . . ....... . . . . . . . . . . . . . . . . . . . . . . 1
2 NORMATIVE REFERENCES . . . . . . . . ....... . . . . . . . . . . . . . . . . . . . . . . 1
3 CLASSIFICATION . . . . . . . . . . . . . . . . ....... . . . . . . . . . . . . . . . . . . . . . . 1
4 MATERIALS . . . . . . . . . . . . . . . . . . . . ....... . . . . . . . . . . . . . . . . . . . . . . 2
5 DESIGN . . . . . . . . . . . . . . . . . . . . . . . ....... . . . . . . . . . . . . . . . . . . . . . . 2
6 SAMPLING AND SELECTION OF TEST PIECES . . . . . . . . . . . . . . . . . . . . . . 2
7 REQUIREMENTS . . . . . . . . . . . . . . . . ....... . . . . . . . . . . . . . . . . . . . . . . 2
8 PACKAGING . . . . . . . . . . . . . . . . . . . . ....... . . . . . . . . . . . . . . . . . . . . . . 4
9 MARKING . . . . . . . . . . . . . . . . . . . . . ....... . . . . . . . . . . . . . . . . . . . . . . 4
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ANNEX A TEST FOR WATERTIGHTNESS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

APPENDICES
XX AMENDMENTS TO ISO 10282 FOR APPLICATION IN AUSTRALIA AND
IN NEW ZEALAND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

YY REQUIREMENT AND TEST METHOD FOR GLOVE CUFF RUPTURE

RESISTANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

© Copyright STANDARDS AUSTRALIA / STANDARDS NEW ZEALAND

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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
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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
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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.
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contracts is subject to the payment of a royalty. This policy may be varied by Standards Australia or Standards New Zealand at any time.
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iv

NOTES
 1

AUSTRALIAN/NEW ZEALAND STANDARD

Single-use sterile surgical rubber gloves —

Specification

1 Scope ISO 4648:1991, Rubber, vulcanized or thermoplastic —

Determination of dimensions of test pieces and
This International Standard specifies requirements for products for test purposes.
packaged sterile gloves intended for use in surgical
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procedures to protect the patient and the user from ISO 7000:1989, Graphical symbols for use on equip-
cross-contamination. It is applicable to single-use ment — Index and synopsis.
gloves that are worn once and then discarded. It does
not apply to examination or procedure gloves.

This standard is intended as a reference for the per- 3 Classification

formance and safety of rubber surgical gloves. The safe
and proper usage of surgical gloves and sterilization Gloves are classified by type, design and finish as
procedures with subsequent handling and storage follows:
procedures are outside the scope of this International
Standard.
3.1 Type

Two types are classified:

type 1: gloves made primarily from natural

2 Normative references rubber latex;

The following standards contain provisions which, type 2: gloves made primarily from synthetic
through reference in this text, constitute provisions of rubber latex or from a solution of rubber.
this International Standard. At the time of publication,
the editions indicated were valid. All standards are
subject to revision, and parties to agreements based on 3.2 Design
this International Standard are encouraged to investi-
gate the possibility of applying the most recent editions Two designs are classified:
of the standards indicated below. Members of IEC and
ISO maintain registers of currently valid International design R: gloves with straight fingers;
Standards.
design C: gloves with fingers curved in the
ISO 37:1994, Rubber; vulcanized or thermoplastic — palmar direction.
Determination of tensile stress-strain properties.

ISO 188:1982, Rubber; vulcanized — Accelerated 3.3 Finish

ageing or heat-resistance tests.
Two finishes are classified:
ISO 2859-1:1989, Sampling procedures for inspection
by attributes — Part 7: Sampling plans indexed by finish T: textured surface over part or all of the
acceptable quality level (AQL) for lot-by-lot inspection. glove;

finish P: smooth surface.

COPYRIGHT
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AS/NZS 4179:1997, Single-use sterile surgical

rubber gloves - Specification
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