NFPA 560-2007 Standard for the Storage Handling and Use of Ethylene Oxide for Sterilization and Fumigation (Effective Date 12 20 2006).pdf

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1、NFPA 560 Standard for the Storage, Handling, and Use of Ethylene Oxide for Sterilization and Fumigation 2007 Edition NFPA, 1 Batterymarch Park, Quincy, MA 02169-7471 An International Codes and Standards Organization IMPORTANT NOTICES AND DISCLAIMERS CONCERNING NFPA DOCUMENTSNOTICE AND DISCLAIMER OF

2、LIABILITY CONCERNING THE USE OF NFPA DOCUMENTSNFPA codes, standards, recommended practices, and guides, of which the document contained herein is one, are de-veloped through a consensus standards development process approved by the American National Standards Institute.This process brings together v

3、olunteers representing varied viewpoints and interests to achieve consensus on fire andother safety issues. While the NFPA administers the process and establishes rules to promote fairness in the develop-ment of consensus, it does not independently test, evaluate, or verify the accuracy of any infor

4、mation or the soundnessof any judgments contained in its codes and standards.The NFPA disclaims liability for any personal injury, property or other damages of any nature whatsoever, whetherspecial, indirect, consequential or compensatory, directly or indirectly resulting from the publication, use o

5、f, or relianceon this document. The NFPA also makes no guaranty or warranty as to the accuracy or completeness of any informationpublished herein.In issuing and making this document available, the NFPA is not undertaking to render professional or other servicesfor or on behalf of any person or entit

6、y. Nor is the NFPA undertaking to perform any duty owed by any person or entityto someone else. Anyone using this document should rely on his or her own independent judgment or, as appropriate,seek the advice of a competent professional in determining the exercise of reasonable care in any given cir

7、cumstances.The NFPA has no power, nor does it undertake, to police or enforce compliance with the contents of this document.Nor does the NFPA list, certify, test or inspect products, designs, or installations for compliance with this document.Any certification or other statement of compliance with t

8、he requirements of this document shall not be attributable tothe NFPA and is solely the responsibility of the certifier or maker of the statement.ADDITIONAL NOTICES AND DISCLAIMERSUpdating of NFPA DocumentsUsers of NFPA codes, standards, recommended practices, and guides should be aware thatthese do

9、cuments may be superseded at any time by the issuance of new editions or may beamended from time to time through the issuance of Tentative Interim Amendments. An offi-cial NFPA document at any point in time consists of the current edition of the documenttogether with any Tentative Interim Amendments

10、 and any Errata then in effect. In order todetermine whether a given document is the current edition and whether it has been amendedthrough the issuance of Tentative Interim Amendments or corrected through the issuance ofErrata, consult appropriate NFPA publications such as the National Fire CodesSu

11、bscriptionService, visit the NFPA website at www.nfpa.org, or contact the NFPA at the address listedbelow.Interpretations of NFPA DocumentsA statement, written or oral, that is not processed in accordance with Section 6 of the Reg-ulations Governing Committee Projects shall not be considered the off

12、icial position of NFPAor any of its Committees and shall not be considered to be, nor be relied upon as, a FormalInterpretation.PatentsThe NFPA does not take any position with respect to the validity of any patent rightsasserted in connection with any items which are mentioned in or are the subject

13、of NFPAcodes, standards, recommended practices, and guides, and the NFPA disclaims liability forthe infringement of any patent resulting from the use of or reliance on these documents.Users of these documents are expressly advised that determination of the validity of any suchpatent rights, and the

14、risk of infringement of such rights, is entirely their own responsibility.NFPA adheres to applicable policies of the American National Standards Institute withrespect to patents. For further information contact the NFPA at the address listed below.Law and RegulationsUsers of these documents should c

15、onsult applicable federal, state, and local laws and reg-ulations. NFPA does not, by the publication of its codes, standards, recommended practices,and guides, intend to urge action that is not in compliance with applicable laws, and thesedocuments may not be construed as doing so.CopyrightsThis doc

16、ument is copyrighted by the NFPA. It is made available for a wide variety of bothpublic and private uses. These include both use, by reference, in laws and regulations, anduse in private self-regulation, standardization, and the promotion of safe practices andmethods. By making this document availab

17、le for use and adoption by public authorities andprivate users, the NFPA does not waive any rights in copyright to this document.Use of NFPA documents for regulatory purposes should be accomplished through adop-tion by reference. The term “adoption by reference” means the citing of title, edition, a

18、ndpublishing information only. Any deletions, additions, and changes desired by the adoptingauthority should be noted separately in the adopting instrument. In order to assist NFPA infollowing the uses made of its documents, adopting authorities are requested to notify theNFPA (Attention: Secretary,

19、 Standards Council) in writing of such use. For technical assis-tance and questions concerning adoption of NFPA documents, contact NFPA at the addressbelow.For Further InformationAll questions or other communications relating to NFPA codes, standards, recommendedpractices, and guides and all request

20、s for information on NFPA procedures governing itscodes and standards development process, including information on the procedures forrequesting Formal Interpretations, for proposing Tentative Interim Amendments, and forproposing revisions to NFPA documents during regular revision cycles, should be

21、sent toNFPA headquarters, addressed to the attention of the Secretary, Standards Council, NFPA,1 Batterymarch Park, P.O. Box 9101, Quincy, MA 02269-9101.For more information about NFPA, visit the NFPA website at www.nfpa.org.Copyright 2007 National Fire Protection Association. All Rights Reserved.NF

22、PA 560Standard for theStorage, Handling, and Use of Ethylene Oxidefor Sterilization and Fumigation2007 EditionThis edition of NFPA 560, Standard for the Storage, Handling, and Use of Ethylene Oxide forSterilization and Fumigation, was prepared by the Technical Committee on Industrial and Medi-cal Ga

23、ses. It was issued by the Standards Council on December 1, 2006, with an effective dateof December 20, 2006, and supersedes all previous editions.This edition of NFPA 560 was approved as an American National Standard on December 20,2006.Origin and Development of NFPA 560In June 1990, a request was m

24、ade by a manufacturer of ethylene oxide to develop a newstandard for the storage, handling, and use of ethylene oxide for sterilization and fumigation.This request addressed the replacement of the nonflammable mixture of ethylene oxide andfreon with pure ethylene oxide, which was occurring concurren

25、t with the reduced use offreon for environmental reasons. The request was reviewed by the NFPA Standards Council,which published a notice in the August 1990 edition of Fire News asking for public input on therecommendation.At its January 1991 meeting, the NFPA Standards Council approved the request

26、and the devel-opment of the standard was assigned to the NFPATechnical Committee on Industrial and MedicalGases (IMGAS). The IMGAS Committee established a task force on ethylene oxide, which devel-oped a draft standard that was made available for public review. Notice of its availability waspublishe

27、d in the December 1993/January 1994 edition of Fire News with a public proposal closingdate of January 21, 1994. The IMGAS Committee reviewed the proposals, and the Committeesreport was published in the 1995 Annual Meeting Report on Proposals. Further revisions werepublished in the 1995 Annual Meeti

28、ng Report on Comments.The 2002 edition contained requirements in Chapter 11 that addressed the use of oxidiz-ing emission control devices. These requirements were based on the recommendations of aNIOSH report generated after several incidents occurred that involved oxidizing emissioncontrol device o

29、perations.The 2002 edition was also revised to conform to the new Manual of Style for NFPATechnicalDocuments requirements.The 2007 edition includes the following changes: Elimination of the concept of special rooms to achieve consistency with NFPA 5000,Building Construction and Safety Code Addition

30、of the definition of Sterilization Building Correlation of gas storage requirements with NFPA 55, Standard for the Storage, Use, andHandling of Compressed Gases and Cryogenic Fluids in Portable and Stationary Containers, Cylinders,and Tanks Updated definitions5601Technical Committee on Industrial an

31、d Medical GasesMichael W. St. Clair, ChairOstrander, OH URep. NFPA Industrial Fire Protection SectionWilliam J. Satterfield, III, SecretaryHydrogen Safety, LLC/Rode the installation of associated storage, piping, and distribution equipment; and operating practices.The Committee also has a technical

32、responsibility for contributions in the same areas for medical gases andclean rooms.5602 STORAGE, HANDLING, AND USE OF ETHYLENE OXIDE FOR STERILIZATION AND FUMIGATION2007 EditionContentsChapter 1 Administration . 56041.1 Scope . 56041.2 Purpose 56041.3 Alternate Materials, Equipment, andProcedures 5

33、6041.4 Retroactivity 56041.5 Equivalency . 5604Chapter 2 Referenced Publications . 56042.1 General 56042.2 NFPA Publications . 56042.3 Other Publications 56042.4 References for Extracts in MandatorySections 5605Chapter 3 Definitions 56053.1 General 56053.2 NFPA Official Definitions 56053.3 General D

34、efinitions . 5605Chapter 4 Receiving and Unloading EthyleneOxide Containers . 56054.1 Scope . 56054.2 Procedures 5606Chapter 5 Storage of Ethylene Oxide 56065.1 General 56065.2 Indoor Storage . 56065.3 Storage Outside of Buildings . 5606Chapter 6 Piping Systems . 56066.1 Scope . 56066.2 Materials fo

35、r Piping, Valves, and Fittings . 56076.3 Preparation for Dismantling of Piping . 56076.4 Valves . 56076.5 Testing . 56076.6 Identification . 5607Chapter 7 Gas Dispensing Areas . 56077.1 General 56077.2 Ethylene Oxide Containers . 56077.3 Nitrogen System . 56077.4 Vaporizer 56077.5 Liquid Ethylene Ox

36、ide Piping . 5607Chapter 8 Operations 56088.1 Operating Procedures Manual . 56088.2 Sterilizer Operation 56088.3 Area Monitoring for Ethylene Oxide . 56088.4 Emergency Stop . 5608Chapter 9 Electrical Installation . 56089.1 Area Electrical Classification . 56089.2 Static Electricity Control . 56089.3

37、 Grounding Requirements . 5608Chapter 10 Sterilizer Construction 560810.1 Vessel . 560810.2 Rotating Equipment 560810.3 Pressure Relief Device 5608Chapter 11 Disposal and Emissions . 560811.1 Scope . 560811.2 Wet Scrubbers 560811.3 Flare Stacks . 560811.4 Catalytic Converter 560811.5 Oxidizing Emiss

38、ion Control Devices 5609Chapter 12 Maintenance 560912.1 General Requirements . 560912.2 Maintenance Manuals 5609Chapter 13 Construction 560913.1 Scope . 560913.2 Separate Structures or Buildings 5609Chapter 14 Fire Protection 560914.1 Sprinklers . 5609Annex A Explanatory Material . 5609Annex B Signi

39、ficant Properties of EthyleneOxide 56010Annex C Informational References . 56012Index . 560135603CONTENTS2007 EditionNFPA 560Standard for theStorage, Handling, and Use of EthyleneOxide for Sterilization and Fumigation2007 EditionIMPORTANT NOTE: This NFPA document is made available foruse subject to

40、important notices and legal disclaimers. These noticesand disclaimers appear in all publications containing this documentand may be found under the heading “Important Notices and Dis-claimers Concerning NFPA Documents.” They can also be obtainedon request from NFPA or viewed at www.nfpa.org/disclaim

41、ers.NOTICE: An asterisk (*) following the number or letter des-ignating a paragraph indicates that explanatory material on theparagraph can be found in Annex A.Changes other than editorial are indicated by a vertical rulebeside the paragraph, table, or figure in which the change oc-curred. These rul

42、es are included as an aid to the user in identify-ing changes from the previous edition. Where one or more com-plete paragraphs have been deleted, the deletion is indicated bya bullet ( ) between the paragraphs that remain.A reference in brackets following a section or paragraphindicates material th

43、at has been extracted from another NFPAdocument. As an aid to the user, the complete title and edition ofthe source documents for extracts in mandatory sections of thedocument are given in Chapter 2 and those for extracts in infor-mational sections are given in Annex C. Editorial changes to ex-tract

44、ed material consist of revising references to an appropriatedivision in this document or the inclusion of the document num-ber with the division number when the reference is to the origi-nal document. Requests for interpretations or revisions of ex-tracted text shall be sent to the technical committ

45、ee responsiblefor the source document.Information on referenced publications can be found inChapter 2 and Annex C.Chapter 1 Administration1.1 Scope. This standard shall apply to the storage and han-dling of ethylene oxide in portable containers for its use insterilization and fumigation. It also sha

46、ll apply to flammablemixtures of ethylene oxide with other chemicals.1.1.1 This standard shall not apply to the following:(1) Nonflammable mixtures of ethylene oxide with otherchemicals(2) Ethylene oxide manufacturing facilities, and container fill-ing, refilling, or transfilling facilities(3)*The o

47、ff-site transportation of portable containers of ethyl-ene oxide(4) Facilities using ethylene oxide as a chemical feedstock(5) Ethylene oxide in chambers 0.283 m3(10 ft3) or less involume, or for containers holding 200 g (7.05 oz) of eth-ylene oxide or less1.2 Purpose. The purpose of this document i

48、s to give require-ments to reduce the occurrence of fire explosions in the use ofethylene oxide sterilizing systems.1.3 Alternate Materials, Equipment, and Procedures. The provi-sions of this standard are not intended to prevent the use of anymaterial, method of construction, or installation procedu

49、re notspecifically prescribed by this standard, provided any such alter-nate is acceptable to the authority having jurisdiction (see 3.2.1).The authority having jurisdiction shall require that sufficient evi-dence be submitted to substantiate any claims made regardingthe safety of such alternates.1.4 Retroactivity. The provisions of this standard reflect a con-sensus of what is necessary to provide an acceptable degree ofprotection from the hazards addressed in this standard at thetime the standard was issued.

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