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Australian Standard
AS 21821998

SterilizersSteamBenchtop

This Australian Standard was prepared by Committee ME/3, Sterilizing Equipment. It was approved on behalf of the Council of Standards Australia on 24 July 1998 and published on 5 October 1998.

The following interests are represented on Committee ME/3: Australian Chamber of Commerce and Industry Australian Chamber of Manufactures
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Australian Dental Association Australian Dental Industry Association Australian Stainless Steel Development Association Commonwealth Department of Health and Family Services Department of Human Services (Victoria) Department of Public Works and Services, N.S.W. Health Department of W.A. Institute of Hospital Engineering, Australia Medical Industry Association of Australia Metal Trades Industry Association of Australia Queensland Health Royal College of Pathologists of Australasia South Australian Health Commission Sterilizing Research and Advisory Council of Australia (N.S.W. Branch)

Review of Australian Standards. To keep abreast of progress in industry, Australian 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 Australian Standards and related publications will be found in the Standards Australia Catalogue of Publications; this information is supplemented each month by the magazine The Australian Standard, which subscribing members receive, and which gives details of new publications, new editions and amendments, and of withdrawn Standards. Suggestions for improvements to Australian Standards, addressed to the head office of Standards Australia, are welcomed. Notication of any inaccuracy or ambiguity found in an Australian 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 95250.

AS 21821998

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Australian Standard
SterilizersSteamBenchtop

Originated as AS T56 1971. Previous edition AS 2182 1994. Fourth edition 1998.

Published by Standards Australia (Standards Association of Australia) 1 The Crescent, Homebush, NSW 2140
ISBN 0 7337 2163 X

AS 2182 1998

PREFACE
This Standard was prepared by the Standards Australia Committee ME/3, Sterilizing Equipment, to supersede AS 21821994, Sterilizers Steam Portable. This Standard is intended to ensure the safety and performance of machines that comply. This edition includes the following technical changes to the previous edition: (a) (b) (c)
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Clause 1.1 does not restrict the Standard to just electrical heating and air displacement by downward displacement. Clause 1.1 permits sterilization of fluids, provided specific requirements are complied with. Clause 1.1 comments on the difficulty of sterilizing lubricated devices. Clause 1.4 includes some definitions. Clause 3.4 amends the requirements for surface finish. Clause 3.14.1 includes the new Item (e), which refers to external drain containers. Clause 3.21.2 on colours of stage indicators has been amended. Clause 3.23 permits the use of external heat accumulators/generators. Clause 3.24 now permits positive-pressure air drying. Clause 3.26 is a new Clause limiting the emission of electromagnetic radiation. Item (d) of Section 4 now permits the sterilizer to automatically restart in the event of an aborted cycle. Clause 5.2 includes additional requirements for marking. Clause 6.1(d) is a new Clause specifying a dryness test. Clause 6.5 refers to the new Appendix G. Paragraph A3 is new advice relating to the sterilization of fluids.

(d) (e) (f) (g) (h) (i) (j) (k) (l) (m) (n) (o)

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.

Copyright

STANDARDS AUSTRALIA

Users of Standards are reminded that copyright subsists in all Standards Australia publications and software. Except where the Copyright Act allows and except where provided for below no publications or software produced by Standards Australia may be reproduced, stored in a retrieval system in any form or transmitted by any means without prior permission in writing from Standards Australia. Permission may be conditional on an appropriate royalty payment. Requests for permission and information on commercial software royalties should be directed to the head office of Standards Australia. Standards Australia will permit up to 10 percent of the technical content pages of a Standard to be copied for use exclusively in-house by purchasers of the Standard without payment of a royalty or advice to Standards Australia. Standards Australia will also permit the inclusion of its copyright material in computer software programs for no 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 at any time.

AS 2182 1998

CONTENTS
Page SECTION 1 SCOPE AND GENERAL 1.1 SCOPE . . . . . . . . . . . . . . . . . . . . . . . . 1.2 INNOVATION . . . . . . . . . . . . . . . . . . 1.3 REFERENCED DOCUMENTS . . . . . . . 1.4 DEFINITIONS . . . . . . . . . . . . . . . . . . . 1.5 EXPRESSION OF PRESSURE VALVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 5 5 7 7

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SECTION 2 MATERIALS 2.1 PRESSURIZED COMPONENTS . . . . . . . . . . . . . . . . . . . . 2.2 DISSIMILAR METALS . . . . . . . . . . . . . . . . . . . . . . . . . . 2.3 WELDING AND BRAZING CONSUMABLES . . . . . . . . . . 2.4 GALVANIZING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.5 CHAMBER, CLOSURE HOLDING ELEMENT AND DOOR 2.6 WATER RESERVOIR . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.7 FRAMEWORK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.8 EXTERNAL PANELS . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.9 LOADING EQUIPMENT . . . . . . . . . . . . . . . . . . . . . . . . . SECTION 3 DESIGN AND CONSTRUCTION 3.1 WELDING . . . . . . . . . . . . . . . . . . . . . . . . . 3.2 NOISE . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.3 THERMAL PROTECTION . . . . . . . . . . . . . . 3.4 EXTERNAL PANELS . . . . . . . . . . . . . . . . . 3.5 SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . 3.6 PRESSURIZED COMPONENTS . . . . . . . . . . 3.7 CHAMBERS . . . . . . . . . . . . . . . . . . . . . . . . 3.8 DOORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.9 LOADING EQUIPMENT . . . . . . . . . . . . . . . 3.10 PIPEWORK AND PIPE FITTINGS . . . . . . . . 3.11 TEST CONNECTIONS . . . . . . . . . . . . . . . . . 3.12 VALVES . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.13 AIR REMOVAL . . . . . . . . . . . . . . . . . . . . . 3.14 WATER SYSTEMS . . . . . . . . . . . . . . . . . . . 3.15 EQUIPMENT ON THE FRONT PANEL . . . . 3.16 PRESSURE INDICATORS . . . . . . . . . . . . . . 3.17 TEMPERATURE INDICATORS . . . . . . . . . . 3.18 CHAMBER TEMPERATURE CONTROLLER 3.19 TIMERS . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.20 CYCLE AND POWER FAILURES . . . . . . . . 3.21 STAGE INDICATION . . . . . . . . . . . . . . . . . 3.22 PROCESS RECORDER . . . . . . . . . . . . . . . . 3.23 ELECTRICAL . . . . . . . . . . . . . . . . . . . . . . . 3.24 DRYING . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.25 AIR FILTERS . . . . . . . . . . . . . . . . . . . . . . . 3.26 ELECTROMAGNETIC DISTURBANCE . . . .

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AS 2182 1998

Page SECTION 4 OPERATING CYCLE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 SECTION 5 MARKING AND INFORMATION 5.1 LANGUAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 5.2 MARKING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 5.3 TECHNICAL INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 SECTION 6 TESTING 6.1 OPERATION TEST . . . . . . . . . . . . . . 6.2 PERFORMANCE TESTING . . . . . . . . 6.3 BIOLOGICAL TEST . . . . . . . . . . . . . 6.4 ADDITIONAL TESTS . . . . . . . . . . . . 6.5 WORKS TEST . . . . . . . . . . . . . . . . . . 6.6 COMMISSIONING TEST . . . . . . . . . . 6.7 VALIDATION . . . . . . . . . . . . . . . . . . 6.8 DEMONSTRATION OF COMPLIANCE

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18 18 19 19 19 19 19 20

APPENDICES A STERILIZATION OF BOTTLED FLUIDS . . . . . . . . . . . . . . . . . . . . B DESIGN CAPABILITIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C QUALITY OF FEED WATER FOR STEAM GENERATION . . . . . . . D INFORMATION THAT SHOULD BE SUPPLIED WITH ENQUIRIES AND ORDERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E STANDARDS FOR MACHINES THAT WASH, STERILIZE OR DRY MEDICAL EQUIPMENT IN HEALTH CARE FACILITIES . F STANDARD TEST PACKS AND STANDARD BIOLOGICAL INDICATING MATERIAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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AS 2182 1998

STANDARDS AUSTRALIA Australian Standard Sterilizers Steam Benchtop S E C T I O N 1 S C O P E A N D G E N E R A L

1.1 SCOPE This Standard specifies requirements for benchtop electrically heated sterilizers that generate saturated steam within the unit at selected temperatures up to and including 136C.
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These sterilizers are intended for use in health care facilities, generally for the sterilization of instruments and utensils (wrapped and unwrapped).
NOTES: 1 Sterilizers complying with this Standard (a) (b) (c) (d) (e) 2 3 4 5 6 are not suitable for the sterilization of fluids, unless the sterilizer also complies with the relevant requirements of AS 2192 for the sterilization of fluids (see Appendix A); if not provided with a drying stage, should not be used for the sterilization of wrapped instruments and porous loads (see Appendix B); if provided with a drying stage, are suitable for the sterilization of wrapped instruments and porous loads; should not be installed in any location where flammable anaesthetics or volatile liquids may be used (see AS 1169); and have a water supply reservoir that is manually filled and does not require connection to mains plumbing.

There are difficulties in sterilizing lubricated devices. In such cases, advice should be sought from AS 4187. General information on design capabilities is given in Appendix B. Guidance on quality of feed water for steam generation is given in Appendix C. Guidance on information that should be supplied with enquires and orders is given in Appendix D. Standards for machines that wash, sterilize or dry medical equipment in health care facilities are listed in Appendix E.

1.2 INNOVATION Any use of new or unusual materials or methods to achieve the intent of this Standard is encouraged. Manufacturers employing innovative materials or methods shall show documented third-party proof that the innovation is not inferior to that of the intent of this Standard. 1.3 REFERENCED DOCUMENTS Standard: AS 1079 1079.4 1167 1167.1 1167.2 The following documents are referred to in this

Packaging of items (sterile) for patient care Part 4: Flexible packaging systems For single use in hospitals Welding and brazingFiller metals Part 1: Filler metal for brazing and braze welding Part 2: Filler metal for welding

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AS 2182-1998, Sterilizers - Steam - Benchtop


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