CSA Z314 1-2009 Ethylene oxide sterilizers for health care facilities (Fifth Edition).pdf

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1、Z314.1-09(reaffirmed 2013)Ethylene oxide 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 tog

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16、ed in accordance with the CSA Directives and guidelines governing standardization and are published in CSAs periodical Info Update, which is available on the CSA Web site at www.csa.ca. Canadian Standards Association Ethylene oxide sterilizers for health care facilitiesMarch 2009 1Z314.1-09Ethylene

17、oxide sterilizers for health care facilities1Scope1.1This Standard applies to ethylene oxide sterilizers that have automatic controls and are intended for general-purpose use in health care facilities.Notes: (1) The term “health care facilities” includes, but is not limited to, hospitals, nursing ho

18、mes, extended-care facilities, clinics, medical and dental offices, and health units in industry.(2) This Standard is intended for manufacturers of ethylene oxide sterilizers. Tests involving modifications to the sterilizer controls or safety features can present hazards to those who do not possess

19、specialized testing equipment and the expertise to conduct the tests.1.2This Standard specifies minimum construction, performance, testing, and labelling requirements to ensure that(a)the environment in the sterilizing chamber is effective in sterilizing products; and(b) personnel using the equipmen

20、t are protected from hazards associated with ethylene oxide.1.3This Standard does not provide requirements for the following:(a)pre- or post-sterilization procedures;(b) machine operators;(c) venting of waste gases used in the sterilization process; and(d) tests to indicate the probability of produc

21、t sterility.1.4In CSA Standards, “shall” is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the standard; “should” is used to express a recommendation or that which is advised but not required; “may” is used to express an option or that wh

22、ich is permissible within the limits of the standard; and “can” is used to express possibility or capability. Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative materi

23、al. Notes to tables and figures are considered part of the table or figure and may be written as requirements. Annexes are designated normative (mandatory) or informative (non-mandatory) to define their application.2 Reference publicationsThis Standard refers to the following publications, and where

24、 such reference is made, it shall be to the edition listed below:CSA (Canadian Standards Association)B51-09Boiler, pressure vessel, and pressure piping codeZ314.1-09 Canadian Standards Association2 March 2009C22.1-09Canadian Electrical Code, Part IZ32-04Electrical safety and essential electrical sys

25、tems in health care facilitiesZ314.2-09Effective sterilization in health care facilities by the ethylene oxide processZ314.9-09Installation, ventilation, and safe use of ethylene oxide sterilizers in health care facilitiesCAN/CSA-Z15882-04Sterilization of health care products Chemical indicators Gui

26、dance for selection, use, and interpretation of resultsANSI/AAMI (American National Standards Institute/Association for the Advancement of Medical Instrumentation)ANSI/AAMI ST41:2008Ethylene oxide sterilization in health care facilities: Safety and effectivenessNFPA (National Fire Protection Associa

27、tion)560-2007Standard for the Storage, Handling, and Use of Ethylene Oxide for Sterilization and FumigationOSHA (Occupational Safety and Health Administration US Department of Labor)CFR 1910.1047Ethylene OxideOther PublicationsAmerican Conference of Governmental Industrial Hygienists. 2007. 7th ed.

28、Threshold Limit Values and Biological Exposure Indices.Environment Canada. 2005. Guidelines for the Reduction of Ethylene Oxide Releases from Sterilization Applications. http:/www.ec.gc.ca/CEPARegistry/guidelines/ethylene_oxide.cfmGovernment of Ontario. Ministry of Labour. Occupational Health and Sa

29、fety Act, RSO 1990, c. O.1.Health Canada. Food and Drugs Act, RSC 1985, c. F-27, Medical Devices Regulations, SOR/98-282.3 DefinitionsThe following definitions apply in this Standard:Aeration a part of the sterilization process during which residual ethylene oxide and its reaction products desorb fr

30、om the medical device until predetermined levels are reached.Note: Aeration is performed either within the sterilizer or in a separate aeration chamber.Biological indicator (BI) a test system containing viable micro-organisms providing a defined resistance to the specified sterilization process.Chem

31、ical indicator (CI) a system that reveals a change in one or more predefined process variables based on a chemical or physical change resulting from exposure to a process.Note: See CAN/CSA-Z15882 for guidance on the selection and use of chemical indicators. Canadian Standards Association Ethylene ox

32、ide sterilizers for health care facilitiesMarch 2009 3Conditioning treatment of product within the sterilization cycle, occurring prior to sterilant admission, to attain a predetermined temperature and relative humidity.Note: This part of the sterilization cycle can be carried out either at atmosphe

33、ric pressure or under vacuum.Conditioning period the time when products to be sterilized are subjected to humidification in the sterilizer chamber.Note: Conditioning period occurs prior to exposure time.Exposure time the time for which the sterilizer chamber is maintained within the specified range

34、for temperature, sterilant concentration, pressure, and relative humidity.Preconditioning the treatment of product prior to the sterilization cycle in a room or chamber to attain specified limits for temperature and relative humidity. See also Conditioning.Pressure vessel an unfired, closed vessel u

35、sed for containing, storing, distributing, transferring, distilling, processing, or otherwise handling gas, vapour, or liquid exceeding the service and size limits in Figure A.1 of CSA B51.Note: In this Standard, pressure, unless stated otherwise, is expressed in kPa above atmospheric pressure (i.e.

36、, gauge pressure).Process challenge device (PCD) an item designed to constitute a defined resistance to a sterilization process and used to assess performance of the process.Note: PCD is a global term that encompasses a range of test devices intended to provide a challenge to the sterilization proce

37、ss that is equal to or greater than the challenge posed by the most difficult item routinely processed. For the purposes of this Standard, a PCD will usually be one of the following:(a) a BI challenge PCD (which also contains a CI);(b) a BI challenge test tray (which also contains a CI); or(c) a CI

38、challenge PCD (which contains a Class 5 integrating indicator or an enzyme-only indicator).Sterilization cycle treatment in a sealed chamber, comprising of the following:(a) air removal;(b) conditioning (if used);(c) injection of sterilant;(d) exposure to ethylene oxide;(e) removal of ethylene oxide

39、; and(f) flushing (if used).Sterilization process all treatments that are required to accomplish sterilization, including(a)preconditioning (if used);(b) the sterilization cycle; and(c) aeration.Type A sterilizer a sterilizing device, using ethylene oxide as the sterilant, in which the sterilizing c

40、hamber or the supply piping, or both, are at or above atmospheric pressure.Note: These devices commonly use a non-flammable ethylene oxide blend as the sterilant.Type B sterilizer a sterilizing device, using ethylene oxide as the sterilant, in which the sterilizing chamber and the supply piping (if

41、used) are below atmospheric pressure (i.e., under partial vacuum).Note: These devices commonly use 100% ethylene oxide, supplied in cartridges, as the sterilant.4 ConstructionCaution: ETHYLENE OXIDE IN LIQUID AND VAPOUR FORM IS ACUTELY TOXIC AND HAS BEEN CLASSIFIED AS A HUMAN CARCINOGEN. FOR PROVISI

42、ON OF ADEQUATE PROTECTION AGAINST THESE EFFECTS, REFER TO ENVIRONMENT CANADA GUIDELINES AND REGULATIONS, PROVINCIAL REGULATIONS, AND CSA Z314.9.Z314.1-09 Canadian Standards Association4 March 20094.1 Electrical componentsElectrically operated sterilizers shall comply with the applicable requirements

43、 of the Canadian Electrical Code, Part I, and CSA Z32.4.2 Sterilization chambers4.2.1Regardless of size, sterilization chambers intended to be operated with an internal pressure of 103 kPa or greater shall comply with CSA B51.Note: The registration of pressure chambers and boilers is covered by prov

44、incial regulations.4.2.2Regardless of size, positive pressure sterilization chambers for use below 103 kPa with a multiple-charge source shall(a)have a pressure relief valve; and(b) be subjected to a hydrostatic pressure test performed at not less than 1.5 times the pressure relief setting (see Clau

45、se 8.3.)Note: This Clause excludes Type B sterilizers.4.3 Door interlock system4.3.1A gas sterilizer shall be equipped with a door interlock system. This system shall prevent the sterilizer from operating unless the sterilizer door(s) is closed and sealed.Note: This Clause does not preclude the open

46、ing of the door of an automatic sterilizer for the purpose of removing the devices in the event of a power failure.4.3.2A door interlock system shall be adequate under normal operating conditions to prevent the opening of the chamber door(s) after a fluid (e.g., air, steam, or ethylene oxide), under

47、 positive pressure of 27 kPa, has been admitted to the sterilizer chamber and before the completion of the total sterilization cycle. Compliance of the door interlock system to this Clause shall be determined using the test method described in Clause 8.4.4.4 FiltersA high-efficiency air-filter unit

48、intended for the removal of very fine particulate matter or microbial contamination (not less than 99.97% of 0.3 m diameter particles) should be used to protect the valves.4.5 Process-monitoring devices4.5.1As a minimum, ethylene oxide sterilizers shall be equipped with a device or devices to indica

49、te and record the following:(a)temperature within the sterilizer chamber;(b) pressure within the sterilizer chamber;(c) duration of the conditioning period; and(d) exposure time to the ethylene oxide gas or gas mixture.4.5.2The completion of each sterilization cycle shall be indicated by both audible and visual means. Canadian Standards Association Ethylene oxide sterilize