NAVY UFGS-11 70 00-2011 GENERAL REQUIREMENTS FOR MEDICAL AND DENTAL EQUIPMENT《医疗和牙科设备的一般要求》.pdf

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1、*USACE / NAVFAC / AFCESA / NASA UFGS-11 70 00 (May 2011)-Preparing Activity: NAVFAC SupersedingUFGS-11 70 00 (April 2006)UFGS-11700 (August 2004)UNIFIED FACILITIES GUIDE SPECIFICATIONSReferences are in agreement with UMRL dated April 2011*SECTION TABLE OF CONTENTSDIVISION 11 - EQUIPMENTSECTION 11 70

2、 00GENERAL REQUIREMENTS FOR MEDICAL AND DENTAL EQUIPMENT05/11PART 1 GENERAL1.1 REFERENCES1.2 LOGISTICAL CLASSIFICATION1.3 SUBMITTALS1.4 QUALITY ASSURANCE1.4.1 Materials and Equipment1.4.2 Alternative Service Record1.4.3 Service Support1.4.4 Manufacturers Nameplate1.4.5 Factory Inspection1.4.6 Produc

3、t Qualifications1.4.7 Design Parameters1.5 STANDARDS COMPLIANCE1.6 STANDARDS DEVIATIONS1.7 SUBSTITUTIONS1.8 CERTIFICATE OF FULL APPROVAL1.9 PACKAGING, STORAGE AND PROTECTION1.9.1 Packaging1.9.2 Storage and ProtectionPART 2 PRODUCTS2.1 MATERIALS2.2 EQUIPMENT2.2.1 Safety2.2.2 Anesthetizing Areas2.2.3

4、Electrical Motors2.2.4 Backflow Preventers2.3 COMPONENTS2.3.1 Mechanical2.3.2 ElectricalPART 3 EXECUTIONSECTION 11 70 00 Page 1Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-3.1 EXAMINATION3.2 PROTECTION3.3 INSTALLATION3.3.1 Mounting3.3.2 Operation3

5、.4 FIELD INSPECTION3.5 CLEANING AND ADJUSTING3.6 OPERATING AND MAINTENANCE DATA- End of Section Table of Contents -SECTION 11 70 00 Page 2Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-*USACE / NAVFAC / AFCESA / NASA UFGS-11 70 00 (May 2011)-Prepari

6、ng Activity: NAVFAC SupersedingUFGS-11 70 00 (April 2006)UFGS-11700 (August 2004)UNIFIED FACILITIES GUIDE SPECIFICATIONSReferences are in agreement with UMRL dated April 2011*SECTION 11 70 00GENERAL REQUIREMENTS FOR MEDICAL AND DENTAL EQUIPMENT05/11*NOTE: This guide specification covers the requirem

7、ents for general requirements for medical and dental equipment and similar related specialties.Adhere to UFC 1-300-02 Unified Facilities Guide Specifications (UFGS) Format Standard when editing this guide specification or preparing new project specification sections. Edit this guide specification fo

8、r project specific requirements by adding, deleting, or revising text. For bracketed items, choose applicable items(s) or insert appropriate information.Remove information and requirements not required in respective project, whether or not brackets are present.Comments, suggestions and recommended c

9、hanges for this guide specification are welcome and should be submitted as a Criteria Change Request (CCR).*NOTE: Specific product requirements are included in the technical sections that make reference to this section.*NOTE: On the drawings show:1. Location of equipment2. Installation layout, detai

10、ls, and space requirements.*SECTION 11 70 00 Page 3Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-PART 1 GENERAL1.1 REFERENCES*NOTE: This paragraph is used to list the publications cited in the text of the guide specification. The publications are r

11、eferred to in the text by basic designation only and listed in this paragraph by organization, designation, date, and title.Use the Reference Wizards Check Reference feature when you add a RID outside of the Sections Reference Article to automatically place the reference in the Reference Article. Al

12、so use the Reference Wizards Check Reference feature to update the issue dates.References not used in the text will automatically be deleted from this section of the project specification when you choose to reconcile references in the publish print process.*The publications listed below form a part

13、of this specification to the extent referenced. The publications are referred to within the text by the basic designation only.AMERICAN WATER WORKS ASSOCIATION (AWWA)AWWA C510 (2007) Standard for Double Check Valve Backflow Prevention AssemblyAWWA C511 (2007) Standard for Reduced-Pressure Principle

14、Backflow Prevention AssemblyFOUNDATION FOR CROSS-CONNECTION CONTROL AND HYDRAULIC RESEARCH (FCCCHR)FCCCHR List (continuously updated) List of Approved Backflow Prevention AssembliesNATIONAL ELECTRICAL MANUFACTURERS ASSOCIATION (NEMA)NEMA MG 1 (2009) Motors and GeneratorsNATIONAL FIRE PROTECTION ASSO

15、CIATION (NFPA)NFPA 101 (2009; TIA 09-1; TIA 09-2) Life Safety CodeNFPA 70 (2011) National Electrical CodeNFPA 99 (2005; TIA 05-1; TIA 05-2; TIA 05-3; Errata 05-1) Standard for Health Care FacilitiesSECTION 11 70 00 Page 4Provided by IHSNot for ResaleNo reproduction or networking permitted without li

16、cense from IHS-,-,-SHEET METAL AND AIR CONDITIONING CONTRACTORS NATIONAL ASSOCIATION (SMACNA)SMACNA 1650 (2008) Seismic Restraint Manual Guidelines for Mechanical Systems, 2nd EditionU.S. NATIONAL ARCHIVES AND RECORDS ADMINISTRATION (NARA)21 CFR 701 Cosmetic LabelingUNDERWRITERS LABORATORIES (UL)UL

17、1067 (2006) Electrically Conductive Equipment and Materials for Use in Flammable Anesthetizing LocationsUL 544 (1998; R 1999) Standard for Medical and Dental EquipmentUL 674 (2003; Reprint Aug 2008) Electric Motors and Generators for Use in Division 1 Hazardous (Classified) Locations1.2 LOGISTICAL C

18、LASSIFICATION*NOTE: The logistical classification listed in this guide specification follows MIL-STD-1691, “Military Standard Construction and Material for Military Medical and Dental Equipment.“*Methods of procurement are defined as follows:a. Category A: Contractor furnished and Contractor install

19、ed.b. Category B: Government furnished and Contractor installed.c. Category C: Government furnished and Government installed.d. Category D: Other (leased or rented equipment or that obtained under special conditions. Funds will be determined by the using service.)e. Category E: Government furnished

20、and contractor installed. (Procurement to be delayed until the latest date feasible that will not interfere with project completion. This will provide the latest model of equipment at the time it is needed.)f. Category F: Government furnished and Government installed. (Procurement to be delayed unti

21、l the latest date feasible that will not interfere with project completion. This will provide the latest model of equipment at the time it is needed.)Equipment designated Logistical Category “B“ “C“ “E“ “F“ will be Government provided. For equipment installed by the Government, the Contractor shall

22、make preparations for installation, as indicated.SECTION 11 70 00 Page 5Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-1.3 SUBMITTALS*NOTE: Review submittal description (SD) definitions in Section 01 33 00 SUBMITTAL PROCEDURES and edit the following

23、 list to reflect only the submittals required for the project. Submittals should be kept to the minimum required for adequate quality control.A “G” following a submittal item indicates that the submittal requires Government approval. Some submittals are already marked with a “G”. Only delete an exis

24、ting “G” if the submittal item is not complex and can be reviewed through the Contractors Quality Control system. Only add a “G” if the submittal is sufficiently important or complex in context of the project.For submittals requiring Government approval on Army projects, a code of up to three charac

25、ters within the submittal tags may be used following the “G“ designation to indicate the approving authority. Codes for Army projects using the Resident Management System (RMS) are: “AE“ for Architect-Engineer; “DO“ for District Office (Engineering Division or other organization in the District Offi

26、ce); “AO“ for Area Office; “RO“ for Resident Office; and “PO“ for Project Office. Codes following the “G“ typically are not used for Navy, Air Force, and NASA projects.Choose the first bracketed item for Navy, Air Force and NASA projects, or choose the second bracketed item for Army projects.*Govern

27、ment approval is required for submittals with a “G“ designation; submittals not having a “G“ designation are for Contractor Quality Control approval.for information only. When used, a designation following the “G“ designation identifies the office that will review the submittal for the Government. T

28、he following shall be submitted in accordance with Section 01 33 00 SUBMITTAL PROCEDURES:SD-02 Shop DrawingsINSTALLATION DrawingsSubmit for equipment items that interface with other pieces of equipment or construction. Indicate:Installation layoutCoordination of equipment servicesDetails of construc

29、tion and rough-in requirementsSchedule of Contractor-furnished equipmentSD-03 Product DataSECTION 11 70 00 Page 6Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-Contractor-furnished medical and dental materials and equipmentSubmit within 60 days afte

30、r award of contract, but before ordering equipment. Submit names and addresses of manufacturers, items catalog numbers, trade names, literature, data sheets, diagrams, drawings, and other pertinent data for each referenced item to evaluate performance, dimensions, and appearance of the equipment and

31、 materials. Submit in triplicate _ copies of manufacturers printed specifications and installation requirements.SD-04 SamplesManufacturers standard color charts for medical and dental equipment; G; G, _SD-06 Test ReportsFactory inspectionSubmit three _ copies of the test reports required or specifie

32、d and performed by an approved laboratory.SD-07 CertificatesMedical and dental equipment deviationsMedical and dental equipment substitutionsBackflow preventers Certificate of Full ApprovalSD-10 Operation and Maintenance DataMedical and dental equipment, Data Package 3; ; G; G, _Submit in accord wit

33、h Section 01 78 23 OPERATION AND MAINTENANCE DATA. Submit manual data for each unit of equipment furnished for the project.1.4 QUALITY ASSURANCE*NOTE: The qualifications clause in this guide specification has been approved by NAVFACENGCOM in accordance with the requirements of Naval Facilities Acqui

34、sition Supplement (NFAS). NFAS can be found at the following link:https:/portal.navfac.navy.mil/portal/page/portal/navfac/navfac_forbusinesses_The paragraph in this guide specification may be used without any other NAVFACENGCOM approval or request for waiver.*1.4.1 Materials and EquipmentMaterials a

35、nd equipment shall be standard products of a manufacturer regularly engaged in the manufacture of products which are of a similar material, design, and workmanship and are offered for sale on the SECTION 11 70 00 Page 7Provided by IHSNot for ResaleNo reproduction or networking permitted without lice

36、nse from IHS-,-,-commercial market through advertisements, manufacturers catalogs, or sales brochures. The products shall have been in commercial or industrial use under similar circumstances and of similar size for 2 years prior to the bid opening.1.4.2 Alternative Service RecordProducts having les

37、s than a 2-year field service record will be acceptable if a certified record of the manufacturers factory or laboratory tests demonstrating performance compliance is provided to the Contracting Officer.1.4.3 Service SupportEquipment items shall be supported by service organizations located near the

38、 equipment installation, and able to service the equipment on a regular basis and respond immediately on emergency calls throughout the warranty period.1.4.4 Manufacturers NameplateEach piece of equipment shall have the manufacturers name, address, model number, and serial number utility ranges or c

39、apacities, including voltage and amperage rating if electrically powered on the nameplate, securely affixed in a conspicuous place. The name of only the distributing agent on the plate is not acceptable.1.4.5 Factory InspectionArrange and perform all factory inspections required by the technical sec

40、tions of the specification, unless otherwise specified. Report these inspections in the daily report to the Government inspector.1.4.6 Product QualificationsThe products specified by the technical sections of the specification establish standards for each item.1.4.7 Design ParametersEquipment furnis

41、hed shall meet each of the following parameters specified in the technical sections.a. Size of equipmentb. Function of equipmentc. Standard and listed accessoriesd. Equipment controls and performance of equipmente. Construction of equipment.1.5 STANDARDS COMPLIANCESubmit one of the following as evid

42、ence of proof of conformance for materials or equipment specified to conform to the standards of organizations such as the American National Standards Institute (ANSI), American Society for Testing and Materials (ASTM), National Electrical Manufacturers Association (NEMA), ASME INTERNATIONAL (ASME),

43、 American Gas SECTION 11 70 00 Page 8Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-Association (AGA), Air Conditioning and Refrigeration Institute (ARI), and Underwriters Laboratories (UL).a. If an organization uses a label or listing to indicate c

44、ompliance with a particular standard, the label or listing will be acceptable evidence, unless otherwise specified in the individual sections.b. In lieu of the label or listing, submit a certificate from an independent testing organization which is competent to perform acceptable testing and is approved by the Contracting Officer. The certificate