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As 1079.3-1994 Packaging of Items (Sterile) For Patient Care Paper Bags - For Single Use in Health Care Facil
As 1079.3-1994 Packaging of Items (Sterile) For Patient Care Paper Bags - For Single Use in Health Care Facil
3—1994
Australian Standard
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Review of Australian Standards. To keep abreast of progress in industry, Australi an Standards are subject
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important therefore that Standards users ensure that they are in possession of the latest editi on, and any
amendments thereto.
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Australian Standard
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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
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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
STANDARDS AUSTRALIA
Australian Standard
Packaging of items (sterile) for patient care
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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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).
COPYRIGHT
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