CSA Z7396 1-2012 Medical gas pipeline systems - Part 1 Pipelines for medical gases medical vacuum medical support gases and anaesthetic gas scavenging systems (Third Edition).pdf

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1、Z7396.1-12Medical gas pipeline systems Part1:Pipelines for medical gases, medical vacuum, medical support gases, and anaesthetic gas scavenging systemsLegal Notice for StandardsCanadian Standards Association (operating as “CSA Group”) develops standards through a consensus standards development proc

2、ess approved by the Standards Council of Canada. This process brings together volunteers 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

3、independently test, evaluate, or verify the content of standards.Disclaimer and exclusion 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 docu

4、ments fitness for a particular purpose or use, its merchantability, or its non-infringement 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

5、 warranties regarding this documents compliance with any applicable statute, rule, 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

6、, LOSS, COSTS, OR EXPENSES, HOWSOEVER CAUSED, INCLUDING BUT NOT LIMITED TO SPECIAL 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,

7、ARISING OUT OF OR RESULTING FROM ACCESS TO OR POSSESSION OR USE OF THIS DOCUMENT, 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 ser

8、vices for or on behalf of any person or entity or to perform any duty owed by any 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 w

9、hatsoever arising in any way from any and all use of or reliance on the information 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 conten

10、ts of the standards or other documents it publishes. Intellectual property rights 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 co

11、pyright, all trade-marks (except as otherwise noted to the contrary), and all inventions 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, modific

12、ation, copying, or disclosure of this document may violate laws that protect CSA 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,

13、CSA Group reserves all intellectual property rights in this document.Patent rightsAttention 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

14、 standard are expressly advised that determination of the validity of any such patent 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 o

15、nly the following:If this document is in electronic form:sLOADTHISDOCUMENTONTOACOMPUTERFORTHESOLEPURPOSEOFREVIEWINGITsSEARCHANDBROWSETHISDOCUMENTANDsPRINTTHISDOCUMENTIFITISIN0$(b) provide an explanation of circumstances surrounding the actual field condition; and(c) where possible, phrase the reques

16、t in such a way that a specific “yes” or “no” answer will address the issue.Committee interpretations are processed in accordance with the CSA Directives and guidelines governing standardization and are available on the Current Standards Activities page at standardsactivities.csa.ca.(5) This Standar

17、d is subject to periodic review, and suggestions for its improvement will be referred to the appropriate committee. To submit a proposal for change, please send the following information to inquiriescsagroup.org and include “Proposal for change” in the subject line:(a) Standard designation (number);

18、(b) relevant clause, table, and/or figure number;(c) wording of the proposed change; and(d) rationale for the change. 2012 CSA GroupMedical gas pipeline systems Part1:Pipelines formedical gases, medical vacuum, medical supportgases, and anaesthetic gas scavenging systemsDecember 2012 1Z7396.1-12Medi

19、cal gas pipeline systems Part1:Pipelines for medical gases, medical vacuum, medical support gases, and anaesthetic gas scavenging systems1Scope1.1This Standard specifies safety requirements for pipelines for medical gases, medical vacuum, medical support gases, and anaesthetic gas scavenging systems

20、 in health care facilities, both public and private. It applies to all facilities providing health care services, regardless of type, size, location, or range of services, including, but not limited to(a) acute care hospitals;(b) in-patient continuing care hospitals;(c) long-term care facilities;(d)

21、 community-based providers;(e) leased/rental suites in office buildings; and(f) ambulatory and outpatient care clinics (e.g., day surgery, endoscopy clinics, dentists offices, and doctors offices).1.2*This Standard is intended for use by anyone involved in the design, installation, commissioning and

22、 testing, documentation, operation, and maintenance of pipelines for medical gases, medical vacuum, medical support gases, and anaesthetic gas scavenging systems. The requirements cover(a)the design of systems to ensure the continuous supply of gas or vacuum in normal condition or in single fault co

23、ndition;(b) the selection of materials and components;(c) the non-interchangeability of equipment between different gas systems and services;(d) the cleanliness of materials and components and of the completed system;(e) installation procedures for supply systems and pipelines;(f) the configuration

24、of system components;(g) control, monitoring, and alarm systems;(h) the markings and information to be supplied by the manufacturer or installer;(i) contaminant testing of pipelines;(j) the final testing of each medical gas pipeline prior to its use in patient care to ensure that it contains only th

25、e specified gas; and(k) maintenance and ongoing verification.1.3This Standard applies to pipeline systems for(a) medical gases or medical gas mixtures, including(i) oxygen USP;Z7396.1-12 2012 CSA Group2 December 2012(ii) oxygen 93 USP;(iii) medical air USP;(iv) nitrous oxide USP;(v) carbon dioxide U

26、SP;(vi) helium USP;(vii) oxygen USP/nitrous oxide USP mixtures;(viii) helium USP/oxygen USP mixtures; and(ix)* other medical gases;(b)* medical support gases, including(i) instrument air; and(ii) nitrogen NF;(c) medical vacuum; and(d) anaesthetic gas scavenging systems (AGSSs).1.4This Standard does

27、not provide specific requirements for hyperbaric chambers connected to medical gas pipeline distribution systems. See Clause 7.6.4 for the hyperbaric demarcation point.Note: Requirements for hyperbaric chambers are provided in CSA Z275.1.1.5This Standard does not provide specific requirements for ox

28、ygen concentrator supply systems connected to medical gas pipeline distribution systems.Note: Requirements for oxygen concentrator supply systems for connection to the oxygen pipeline distribution systems described in this Standard are provided in CAN/CSA-Z10083.1.6This Standard does not apply to ve

29、terinary and animal research facilities.Note: The relevant requirements of this Standard, particularly those regarding safety, should be incorporated in the design, installation, and maintenance of piping systems in veterinary and animal research facilities. These systems should be inspected and tes

30、ted by inspection bodies.1.7In this Standard, “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; and “may” is used to express an

31、option or that which is permissible within the limits of the standard.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 material.Notes to tables and figures are consi

32、dered part of the table or figure and may be written as requirements.Annexes are designated normative (mandatory) or informative (nonmandatory) to define their application. 1.8The values given in SI (metric) units are the standard. The values given in parentheses are for information only. Unless oth

33、erwise specified, pressures and vacuum in this Standard are expressed as gauge pressure (i.e., atmospheric pressure is defined as 0). 2012 CSA GroupMedical gas pipeline systems Part1:Pipelines formedical gases, medical vacuum, medical supportgases, and anaesthetic gas scavenging systemsDecember 2012

34、 32 Reference publicationsThis Standard refers to the following publications, and where such reference is made, it shall be to the edition listed below, including all amendments published thereto.CSA GroupB51-09Boiler, pressure vessel, and pressure piping codeC22.1-12Canadian Electrical Code, Part I

35、Z32-09Electrical safety and essential electrical systems in health care facilitiesCAN/CSA-Z180.1-00 (R2010)Compressed breathing air and systemsZ275.1-05 (R2012)Hyperbaric facilitiesCAN/CSA-Z305.8-03 (R2008)Medical supply unitsZ305.12-06 (R2012)Safe storage, handling, and use of portable oxygen syste

36、ms in residential buildings and health care facilitiesCAN/CSA-Z317.2-10Special requirements for heating, ventilation, and air-conditioning (HVAC) systems in health care facilitiesZ462-12Workplace electrical safetyCAN/CSA-Z1000-06 (R2011)Occupational health and safety managementCAN/CSA-Z5359-10Low-pr

37、essure hose assemblies for use with medical gasesCAN/CSA-Z9170-1-11Terminal units for medical gas pipeline systems Part 1: Terminal units for use with compressed medical gases, vacuum, and anaesthetic gas scavenging systemsCAN/CSA-Z10083-08Oxygen concentrator supply systems for use with medical gas

38、pipeline systemsCAN/CSA-Z10524-2:12Pressure regulators for use with medical gases Part 2: Manifold and line pressure regulatorsCAN/CSA-Z15001:12Anaesthetic and respiratory equipment Compatibility with oxygenACGIH (American Conference of Governmental Industrial Hygienists)TLV 2008 (2012 edition)Z7396

39、.1-12 2012 CSA Group4 December 2012ASME (American Society of Mechanical Engineers)ASME BPVC (2010)Boiler and Pressure Vessel CodeB16.22-2012Wrought Copper and Copper Alloy Solder-Joint Pressure FittingsB16.50-2001Wrought Copper and Copper Alloy Braze-Joint Pressure FittingsASTM International (Americ

40、an Society for Testing and Materials)B819-00 (2011)Standard Specification for Seamless Copper Tube for Medical Gas SystemsAWS (American Welding Society)A5.8/A5.8M:2004Specification for Filler Metals for Brazing and Braze WeldingCGA (Compressed Gas Association)G-4.1-2009Cleaning Equipment for Oxygen

41、ServiceG-8.1-2007Standard for Nitrous Oxide Systems at Customer SitesV-1-2005Standard for Compressed Gas Cylinder Valve Outlet and Inlet ConnectionsV-5-2008 (R2013)Diameter Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications)Copper Development AssociationCop

42、per Tube Handbook, 2010Institute of Environmental Sciences and TestingIESTRP-CC001.5 (2009)HEPA and ULPA FiltersISO (International Organization for Standardization)7396-1:2007Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum7396-2:2007Medical gas pipeline

43、systems Part 2: Anaesthetic gas scavenging disposal systemsISO/IEC (International Organization for Standardization/International Electrotechnical Commission)17020:2012Conformity assessment Requirements for the operatio n of various types of bodies performing inspection17025:2005General requirements

44、for the competence of testing and calibration laboratories 2012 CSA GroupMedical gas pipeline systems Part1:Pipelines formedical gases, medical vacuum, medical supportgases, and anaesthetic gas scavenging systemsDecember 2012 5NFPA (National Fire Protection Association)55 (2010)Compressed Gases and

45、Cryogenic Fluids Code99 (2012)Health Care Facilities CodeUSP (United States Pharmacopeial Convention)United States Pharmacopeia 35/National Formulary 303 DefinitionsThe following definitions shall apply in this Standard:Addition an extension to an existing medical gas pipeline distribution system.Ai

46、r compressor system a supply system with a compressor(s) designed to provide medical air or air for driving surgical tools, or both.Anaesthetic gas scavenging system (AGSS) a complete system that is connected to the exhaust port(s) of a breathing system or other equipment for the purpose of conveyin

47、g expired or excess anaesthetic gases to an appropriate place of discharge.Anaesthetizing location any room in a health care facility in which the induction and maintenance of general anaesthesia are routinely carried out in the course of the examination or treatment of patients.Authority having jur

48、isdiction a federal, provincial, or municipal person or body responsible for the administration of the legislation prescribing this Standard.Auxiliary oxygen inlet an inlet to the oxygen supply system, connected on the bulk pad on the supply system side of the supply shut-off valve.Auxiliary supply

49、connection an inlet to the medical gas distribution system, connected on the patient-side of the supply shut-off valve.Branch a portion of the pipeline distribution system that supplies one or more zones on the same floor of the facility.Commissioning the proof of function to verify that the agreed system specification is met and is accepted by the user or the use

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