CAN CSA-Z314 7-2003 Steam Sterilizers for Health Care Facilities (Fourth Edition Update No 1 December 2005).pdf

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33、ssociation (National Standards of Canada text inserted December 2005)National Standard of Canada (approved December 2005) CAN/CSA-Z314.7-03 Steam Sterilizers for Health Care Facilities Published in September 2003 by Canadian Standards Association A not-for-profit private sector organization 5060 Spe

34、ctrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N6 1-800-463-6727 416-747-4044 Visit our Online Store at www.ShopCSA.ca Approved by Standards Council of Canada Prepared by ISBN 1-55397-430-1 Technical Editor: Mike Dodd Canadian Standards Association 2003 All rights reserved. No part of this

35、publication may be reproduced in any form whatsoever without the prior permission of the publisher. (Copyright page replaced December 2005)Standards Update ServiceZ314.7-03September 2003Title: Steam sterilizers for health care facilitiesPagination: 29 pages (viii preliminary and 21 text), each dated

36、 September 2003To register for e-mail notification about any updates to this publicationgo to shop.csa.caclick on CSA Update ServiceThe List ID that you will need to register for updates to this publication is 2015476.If you require assistance, please e-mail techsupportcsagroup.org or call 416-747-2

37、233.Visit CSA Groups policy on privacy at csagroup.org/legal to find out how we protect your personal information.CSA Standard Z314.7-03 Steam Sterilizers for Health Care Facilities Published in September 2003 by Canadian Standards Association A not-for-profit private sector organization 5060 Spectr

38、um Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4044 Visit our Online Store at www.csa.ca ISBN 1-55397-430-1 Technical Editor: Mike Dodd Canadian Standards Association 2003 All rights reserved. No part of this publication may be reproduced in any form whatsoever without

39、 the prior permission of the publisher. Canadian Standards Association Steam Sterilizers for Health Care Facilities September 2003 iii Contents Technical Committee on Sterilization iv Subcommittee on Moist Heat (Steam) Sterilization vi Preface viii 1 Scope 1 2 Reference Publications 2 3 Definitions

40、2 4 Construction 3 4.1 General 3 4.2 Pressure Vessels 3 4.3 Chamber Construction 4 4.4 Piping 4 4.5 Steam Baffle Plate or Similar Device 4 4.6 Air Filter 4 4.7 Process-Monitoring Devices 4 4.7.1 General 4 4.7.2 Temperature-Indicating and -Recording Devices 4 4.7.3 Pressure-Indicating Devices 5 4.7.4

41、 Timers 5 4.7.5 Door Interlocks 5 5 Process Requirements 6 5.1 Chamber Temperature 6 5.2 Cycle Documentation 6 5.3 Sterilizer Performance 6 6 Information to Be Provided by the Manufacturer 7 6.1 General 7 6.2 Installation Instructions 7 6.3 Operating Instructions 7 6.4 Inspection and Routine Mainten

42、ance Instructions 7 7 Labelling 7 8 Tests 8 8.1 General 8 8.2 Leakage 8 8.3 Door Interlocks 8 8.4 Doors and Door-Release Mechanisms 8 8.5 Temperature-Indicating and -Recording Devices 8 8.6 Pressure-Indicating Devices 8 8.7 Process Temperature Limits 8 8.8 Biological Performance 9 Annex A (normative

43、) Biological and Air Removal Testing of Sterilizers 10 Z314.7-03 Canadian Standards Association iv September 2003 Technical Committee on Sterilization D. Trudeau Vancouver Hospital and Health Sciences Centre, Chair Vancouver, British Columbia Representing British Columbia Central Processing Associat

44、ion C.O. Hancock Charles O. Hancock Associates, Inc., Vice-Chair Fairport, New York, USA J.W. Barnard Acsion Industries Incorporated, Associate Pinawa, Manitoba C. Bastien Consoltex Inc., Saint-Laurent, Qubec C. Bensmihen Sir Mortimer B. Davis Jewish General Hospital, Montral, Qubec B. Bolding Consu

45、ltant, Associate Burnaby, British Columbia K. Bruce Lakeridge Health Bowmanville, Bowmanville, Ontario Representing Operating Room Nurses Association of Canada (ORNAC) R. Chu MDS Nordion Inc., Ottawa, Ontario J.A. Daley 3M Canada Company, London, Ontario J.C. Dowler Health Canada, Ottawa, Ontario P.

46、 Fabry CSA, Associate Toronto, Ontario P. Fallis Humber River Regional Hospital, Toronto, Ontario B. Geeson University of Alberta Hospital, Edmonton, Alberta S. Hadfield Health Sciences Centre, Winnipeg, Manitoba V. Hay Consultant, Associate Gloucester, Ontario Canadian Standards Association Steam S

47、terilizers for Health Care Facilities September 2003 v L. Jakeman Capital Health, Dartmouth General Hospital, Dartmouth, Nova Scotia Representing Central Service Association of Nova Scotia and the Nova Scotia Department of Health L. Kingsbury Health Canada, Associate Ottawa, Ontario S. Lafferty Roya

48、l Alexandra Hospital, Edmonton, Alberta Representing Community and Hospital Infection Control Association of Canada (CHICA) C. Landers Central Service Association of Ontario, Timmins, Ontario S. Lee STERIS Corporation, Mentor, Ohio, USA L. McConnell Aventis Pasteur Limited, Associate Toronto, Ontari

49、o P.J. McCormick Bausch (b) the reference publications have been updated; (c) new requirements have been specified for cycle documentation and sterilizer performance; (d) the sterilizer labelling provisions have been revised to reflect current requirements; (e) a new biological indicator test, based on the test procedure in ANSI/AAMI ST8, Hos