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

1、Z314.7-03(reaffirmed 2013)Steam sterilizers for health care facilitiesLegal Notice for StandardsCanadian Standards Association (operating as “CSA Group”) develops standards through a consensus standards development process approved by the Standards Council of Canada. This process brings together vol

2、unteers representing varied viewpoints and interests to achieve consensus and develop a standard. Although CSA Group administers the process and establishes rules to promote fairness in achieving consensus, it does not independently test, evaluate, or verify the content of standards.Disclaimer and e

3、xclusion of liabilityThis document is provided without any representations, warranties, or conditions of any kind, express or implied, including, without limitation, implied warranties or conditions concerning this documents fitness for a particular purpose or use, its merchantability, or its non-in

4、fringement of any third partys intellectual property rights. CSA Group does not warrant the accuracy, completeness, or currency of any of the information published in this document. CSA Group makes no representations or warranties regarding this documents compliance with any applicable statute, rule

5、, or regulation. IN NO EVENT SHALL CSA GROUP, ITS VOLUNTEERS, MEMBERS, SUBSIDIARIES, OR AFFILIATED COMPANIES, OR THEIR EMPLOYEES, DIRECTORS, OR OFFICERS, BE LIABLE FOR ANY DIRECT, INDIRECT, OR INCIDENTAL DAMAGES, INJURY, LOSS, COSTS, OR EXPENSES, HOWSOEVER CAUSED, INCLUDING BUT NOT LIMITED TO SPECIA

6、L OR CONSEQUENTIAL DAMAGES, LOST REVENUE, BUSINESS INTERRUPTION, LOST OR DAMAGED DATA, OR ANY OTHER COMMERCIAL OR ECONOMIC LOSS, WHETHER BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE), OR ANY OTHER THEORY OF LIABILITY, ARISING OUT OF OR RESULTING FROM ACCESS TO OR POSSESSION OR USE OF THIS DOCUMENT,

7、 EVEN IF CSA GROUP HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, INJURY, LOSS, COSTS, OR EXPENSES.In publishing and making this document available, CSA Group is not undertaking to render professional or other services for or on behalf of any person or entity or to perform any duty owed by any

8、 person or entity to another person or entity. The information in this document is directed to those who have the appropriate degree of experience to use and apply its contents, and CSA Group accepts no responsibility whatsoever arising in any way from any and all use of or reliance on the informati

9、on contained in this document. CSA Group is a private not-for-profit company that publishes voluntary standards and related documents. CSA Group has no power, nor does it undertake, to enforce compliance with the contents of the standards or other documents it publishes. Intellectual property rights

10、 and ownershipAs between CSA Group and the users of this document (whether it be in printed or electronic form), CSA Group is the owner, or the authorized licensee, of all works contained herein that are protected by copyright, all trade-marks (except as otherwise noted to the contrary), and all inv

11、entions and trade secrets that may be contained in this document, whether or not such inventions and trade secrets are protected by patents and applications for patents. Without limitation, the unauthorized use, modification, copying, or disclosure of this document may violate laws that protect CSA

12、Groups and/or others intellectual property and may give rise to a right in CSA Group and/or others to seek legal redress for such use, modification, copying, or disclosure. To the extent permitted by licence or by law, CSA Group reserves all intellectual property rights in this document.Patent right

13、sAttention is drawn to the possibility that some of the elements of this standard may be the subject of patent rights. CSA Group shall not be held responsible for identifying any or all such patent rights. Users of this standard are expressly advised that determination of the validity of any such pa

14、tent rights is entirely their own responsibility.Authorized use of this documentThis document is being provided by CSA Group for informational and non-commercial use only. The user of this document is authorized to do only the following:If this document is in electronic form:sLOADTHISDOCUMENTONTOACO

15、MPUTERFORTHESOLEPURPOSEOFREVIEWINGITsSEARCHANDBROWSETHISDOCUMENTANDsPRINTTHISDOCUMENTIFITISIN0$.search and browse this document; and.print this document. Limited copies of this document in print or paper form may be distributed only to persons who are authorized by CSA to have such copies, and only

16、if this Legal Notice appears on each such copy.In addition, users may not and may not permit others to.alter this document in any way or remove this Legal Notice from the attached standard;.sell this document without authorization from CSA; or.make an electronic copy of this document.If you do not a

17、gree with any of the terms and conditions contained in this Legal Notice, you may not load or use this document or make any copies of the contents hereof, and if you do make such copies, you are required to destroy them immediately. Use of this document constitutes your acceptance of the terms and c

18、onditions of this Legal Notice.The Canadian Standards Association (CSA), under whose auspices this National Standard has been produced, was chartered in 1919 and accredited by the Standards Council of Canada to the National Standards system in 1973. It is a not-for-profit, nonstatutory, voluntary me

19、mbership association engaged in standards development and certification activities. CSA standards reflect a national consensus of producers and users including manufacturers, consumers, retailers, unions and professional organizations, and governmental agencies. The standards are used widely by indu

20、stry and commerce and often adopted by municipal, provincial, and federal governments in their regulations, particularly in the fields of health, safety, building and construction, and the environment. Individuals, companies, and associations across Canada indicate their support for CSAs standards d

21、evelopment by volunteering their time and skills to CSA Committee work and supporting the Associations objectives through sustaining memberships. The more than 7000 committee volunteers and the 2000 sustaining memberships together form CSAs total membership from which its Directors are chosen. Susta

22、ining memberships represent a major source of income for CSAs standards development activities. The Association offers certification and testing services in support of and as an extension to its standards development activities. To ensure the integrity of its certification process, the Association r

23、egularly and continually audits and inspects products that bear the CSA Mark. In addition to its head office and laboratory complex in Toronto, CSA has regional branch offices in major centres across Canada and inspection and testing agencies in eight countries. Since 1919, the Association has devel

24、oped the necessary expertise to meet its corporate mission: CSA is an independent service organization whose mission is to provide an open and effective forum for activities facilitating the exchange of goods and services through the use of standards, certification and related services to meet natio

25、nal and international needs. For further information on CSA services, write to Canadian Standards Association 5060 Spectrum Way, Suite 100 Mississauga, Ontario, L4W 5N6 Canada The Standards Council of Canada is the coordinating body of the National Standards system, a federation of independent, auto

26、nomous organizations working towards the further development and improvement of voluntary standardization in the national interest. The principal objects of the Council are to foster and promote voluntary standardization as a means of advancing the national economy, benefiting the health, safety, an

27、d welfare of the public, assisting and protecting the consumer, facilitating domestic and international trade, and furthering international cooperation in the field of standards. A National Standard of Canada is a standard which has been approved by the Standards Council of Canada and one which refl

28、ects a reasonable agreement among the views of a number of capable individuals whose collective interests provide to the greatest practicable extent a balance of representation of producers, users, consumers, and others with relevant interests, as may be appropriate to the subject in hand. It normal

29、ly is a standard which is capable of making a significant and timely contribution to the national interest. Approval of a standard as a National Standard of Canada indicates that a standard conforms to the criteria and procedures established by the Standards Council of Canada. Approval does not refe

30、r to the technical content of the standard; this remains the continuing responsibility of the accredited standards-development organization. Those who have a need to apply standards are encouraged to use National Standards of Canada whenever practicable. These standards are subject to periodic revie

31、w; therefore, users are cautioned to obtain the latest edition from the organization preparing the standard. The responsibility for approving National Standards of Canada rests with the Standards Council of Canada 270 Albert Street, Suite 200 Ottawa, Ontario, K1P 6N7 Canada Cette Norme nationale du

32、Canada est offerte en anglais et en franais. Although the intended primary application of this Standard is stated in its Scope, it is important to note that it remains the responsibility of the users to judge its suitability for their particular purpose. Registered trade-mark of Canadian Standards A

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