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AS 1079.

3—1994

Australian Standard
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Packaging of items (sterile) for


patient care

Part 3: Paper bags—For single use


in health care facilities
This Australian Standard was prepared by Committee PK/18, Packaging of Sterile
Goods. It was approved on behalf of the Council of Standards Australia on
16 November 1993 and published on 17 January 1994.

The following interests are represented on Committee PK/18:


Appita
Australian Chamber of Commerce and Industry
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Australian Institute of Packaging


Commercial Services Group, N.S.W.
Department of Health, Housing, Local Government and Community Services
(Commonwealth)
Health Department, W.A.
Medical Industry Association of Australia
National Council of Chemical and Pharmaceutical Inndustries
Packaging Council of Australia
Queensland Health
South Australian Health Commission
Sterilizing Research and Advisory Council of Australia (N.S.W. Branch)
The Plastics Industry Association

Review of Australian Standards. To keep abreast of progress in industry, Australi an Standards are subject
to periodic review and are kept up to date by the issue of amendments or new editi ons as necessary. It is
important therefore that Standards users ensure that they are in possession of the latest editi on, and any
amendments thereto.
Full detail s of all Australi an Standards and related publications wil l be found in the Standards Australia
Catalogue of Publications; this information is supplemented each month by the magazine ‘The Australian
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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 93017.


AS 1079.3—1994

Australian Standard
This is a free 5 page sample. Access the full version at http://infostore.saiglobal.com.

Packaging of items (sterile) for


patient care

Part 3: Paper bags—For single use


in health care facilities

First publi shed as part of AS 1662 — 1974.


Revised and redesignated in part as AS 1079.3— 1983.
Second editi on 1994.

PUBLISHED BY STANDARDS AUSTRALIA


(STANDARDS ASSOCIATION OF AUSTRALIA)
1 THE CRESCENT, HOMEBUSH, NSW 2140
ISBN 0 7262 8786 5
AS 1079.3 — 1994 2

PREFACE
This Standard was prepared by the Standards Australia Committee on Packaging of Sterile
Goods, under the direction of the Multitechnics Standards Policy Board, to supersede
AS 1079.3 — 1983, Packaging of items (sterile) for patient care, Part 3: Paper bags for
goods undergoing sterilization.
This edition has been revised to incorporate all sizes of sterilization bags which are currently
being manufactured or stocked, and to delete those which are no longer in use.
Consideration was given to the sterilization of paper bags by ethylene oxide gas, although
indicators currently provided on the bags are not sensitive to this sterilization agent. Whilst
the Standard is confined to sterilization of paper bags by saturated steam under pressure, bags
will be suitable to ethylene oxide sterilization by affixing an additional ethylene oxide
sensitive indicator.
The term ‘normative’ has been used in this Standard to define the application of the
This is a free 5 page sample. Access the full version at http://infostore.saiglobal.com.

Appendix to which it applies. A ‘normative’ Appendix is an integral part of a Standard.


This Standard is one of a series which deals with packaging of items (sterile) for patient care.
The other Standards in the AS 1079 series are as follows:
Part 1: Selection of packaging materials for goods undergoing sterilization.
Part 2: Non-reusable papers —For the wrapping of goods undergoing sterilization in health
care facilities.
Part 4: Flexible packaging systems —For single use in hospitals.
A further Part (Part 5) dealing with non-reusable, non-woven wrapping materials, for goods
undergoing sterilization in health care facilities is being considered.

CONTENTS
Page
1 SCOPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2 REFERENCED DOCUMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
3 DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
4 PAPER REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
5 DESIGN AND MANUFACTURING CONSIDERATIONS . . . . . . . . . . . . . . . . . . 4
6 PERFORMANCE REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
7 PACKAGING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
8 MARKING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

APPENDICES
A DETERMINATION OF BAG CHARACTERISTICS AFTER
STERILIZATION BY SATURATED STEAM UNDER PRESSURE . . . . . . . . . 9
B DETERMINATION OF SEAM AND SEAL INTEGRITY . . . . . . . . . . . . . . . 11

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3 AS 1079.3—1994

STANDARDS AUSTRALIA

Australian Standard
Packaging of items (sterile) for patient care

Part 3: Paper bags— For single use in health care facilities

1 SCOPE This Standard specifies requirements for single-use paper bags sterilized by
saturated steam under pressure for packaging items intended for use in health care facilities.
NOTE: The paper used for the manufacture of the bags, as specified in AS 1079.2, provides only
limited microbiological barrier properties even when the sterilized package is stored for a short
period of time in a dry, dust-free and vermin-free environment.
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2 REFERENCED DOCUMENTS The following documents are referred to in this


Standard:

AS
1079 Packaging of items (sterile) for patient care
1079.1 Part 1: Selection of packaging materials for goods undergoing sterilization
1079.2 Part 2: Paper for the wrapping of goods undergoing sterilization
1301 Methods of test for pulp and paper
1301.P404s Method P404s: Tensile strength of paper and paperboard
1410 Sterilizers —Steam — Pre-vacuum
2400 Packaging
2400.1 Part 1: Glossary of packaging terms

3 DEFINITIONS For the purpose of this Standard, the definitions given in AS 2400.1,
AS 1079.1 and those below apply.
3.1 Health care facility — a site, either public or private, at which health care is
delivered; it may be an area health service, hospital, nursing home or any other facility which
provides health care on either a short-term or long-term basis.
3.2 Seal —the final closure of the bag effected by the user (see Figure 1).

FIGURE 1 EXAMPLE OF A TOP SEAL

COPYRIGHT
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AS 1079.3-1994, Packaging of items (sterile) for


patient care Paper bags - For single use in health
care facilities
This is a free 5 page sample. Access the full version at http://infostore.saiglobal.com.

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