DOD MIL-D-42048-1987 DEPLOYABLE MEDICAL SYSTEMS GENERAL REQUIREMENTS FOR《可配置医学系统总说明书》.pdf

1、. - LI 7 MIL-D-LI20Y 65 W 4979906 0264650 7 -1 c-53- ao MIL-D-42048 26 June 1987 MILITARY SPECIFICATION DEPLOYABLE MEDICAL SYSTEMS, GENERAL REQUIREMENTS FOR This specification is approved for use by all Departments and Agencies of the Department of Defense. 1. SCOPE 1.1 Scope. This document covers g

2、eneral requirements for medical equipment used in DoD Deployable Medical Systems (DNS) and is intended to be used in conjunction with the detailed specification, purchase description or procurement document covering such additional requirements as are applicable to each equipment item. 2. APPLICABLE

3、 DOCUMENTS 2.1 Government documents. 2.1.1 Specifications and standards, and handbooks. The following specifications, standards, and handbooks form a part of this specification to the extent specified herein. Unless otherwise specified, the issues of these documents shall be those listed in the issu

4、e of the Department of Defense Index of Specifications and Standards (DODISS) and supplement thereto, cited in the solicitation. (Beneficial comments (recommendations, additions, deletions) and any I I Ipertinent data which may be of use in improving this document I Ishould be addressed to: IDirecto

5、rate of Medical Materiel, DPSC-RST, 2800 South 20th Street, I IPhiladelphia, PA 19101, by using the self-addressed Standardization I IDocument Improvement Proposal (DD Form 1426) appearing at the end of1 Defense Personnel Support Center, Ithis I document or by letter. AMSC/NA FSCI -65GP DISTRIBUTION

6、 STATEMENT A. Approved for public release; distribution is unlimited. , -7 THIS DOCUMENT CONTAINS jy PAGES. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-SPECIFICATIONS FEDERAL L-P-3 90 PPP-c-1752 MELXTARY MIL-M-7 29 8 MIL-P-26514 MIL-V-27166 MIL-C

7、-4616 8 STANDARDS FEDERAL FED-STD-101 MILITARY MIL-STD-129 MIL-STD-130 MIL-STD-13 88 MIL-STD-1472 MIL-CTD-1561 HANDBOOK8 HILZTARY MIL-HDEK-3 04 Plastic, Molding and Extrucion Material, Polyethelene and Copolymers (Low, Medium, and High Densities). Cushioning Material, Packaging, Unicellular Poly- et

8、helene Foam, Flexible. L “ Manual, Technical, Commercial Equipment Polyurethane Foam, Rigid or Flexible, or Valve, Pressure Equalizing, Gaseous Products Coating, Aliphatic Polyurethane, Chemical Agent Packaging Resistant Test Procedures for Packaging material, Marking for Shipment and Storage Identi

9、fication Marking of U.S. Military Property DOD Requirements for a Logistical Support Analysis Record. Human Engineering Design Criteria or Military Systems, Equipment and Facilities Provisioning Procedures, Uniform DoD Package Cushioning Design 2 Provided by IHSNot for ResaleNo reproduction or netwo

10、rking permitted without license from IHS-,-,-MIL-D-420Ll 65 W 9999906 0269652 O MIL-D-4204 8 2.1.2 Other Government documents. The following other Government documents form a part of this specification to the extent specified herein. Unless otherwise specified, the issues shall be those in effect on

11、 the date of the solicitation. DFARS 52,227-7013 Rights in Technical Data and Computer Software NAT-STD 2905 Basic Voltage and Current Characteristics of Electromedical Equipment . 2.2 Other publications. The following document(s) form a part of this specification to the extent specified herein. Unl

12、ess otherwise specified, the issues of the documents which are DoD adopted shall be those listed in the issue of the DODISS specified in the solicitation. Unless otherwise specified, the issues of documents not listed in the DODISS shall be the issue of the nongovernment document which is current on

13、 the date of the solicitation. NATIONAL FIRE PROTECTION ASSOCIATION (NFPA) NFPA 70 National Electrical Code (specifically Article 517) NFPA 99 Standard for Health Care Facilities (Application for copies should be addressed to the National Fire Protection Association, Batterymarch Park, Quincy , MA 0

14、2269) . DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Public Law 90-602 Radiation Control for Health and Safety Act - Federal Food, Drug and Cosmetic Act, as amended. (Subchapter J of Title 21, The code of Federal Regulations). AMERICAN NATIONAL STANDARDS INSTITUTE (ANSI) ANSI/AAMI ES1 Safe Current

15、Limits for Electromedical Apparatus. (Application for copies should be addressed to the American National Standards Institute, 1430 Broadway, New York, NY 10018) . UNDERWRITERS LABORATORIES UL 544 Standard for Safety, Medical and Dental Equipment (Application for copies should be addressed to Underw

16、riters Laboratories, 333 Pfingsten Road, Northbrook, IL 60062). 3 . Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-MIL-D-42048 (IndUStKy association specifications and standards are generally They are also distributed In the event of a conflict betw

17、een the available for reference from libraries. among technical groups and using Federal agencies). text o this specification and the references cited herein, the text sf this specification shall take precedence. specification, however, shall supercede applicable laws and regulations unless a specif

18、ic exemption ha6 been obtained. 2-3 Order of precedence. Nothing in this 3. RJQUIREMENTC 3.1 -. All equipment offered shall conform to the requirements specified herein and the manufacturers commercial specifications, standards, and drawings. be cm specified herein and in accordance with the applica

19、ble specification sheets. requirements of this specification and the specification sheets, the latter shall govern. 3.2.1 Specification sheets, The individual item requirements shall In the event of any conflict between 3.2 Characteristics. 3.2,1 Shysical characteristics. The contractor shall provid

20、e the Electrical Characteristics of the Equipment Item Offered: following information: Required Nominal Voltage Range: V Required Frequency: Hz Wattage Used: watts Line Current, Max: amps NBITE: Horsepower ratings shall be converted to watts. Nominal Weight and Volume of Equipment Item with Reuseabl

21、e Container: Weight: lbs Cube: Et Dimensions: linches (LxWxH) N8TE: On large assemblies weight and volume shall be provided for each component. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-MIL-D-42048 Nominal Weight and Volume of Equipment Item wi

22、thout Reuseable Container: Weight: lbs Cube: ft Dimensions: inches (LxWxH) j; NOTE: On large assemblies weight and volume shall be provided fo; each component. Nominal Packed Shipping Weight and Volume of Each Shipping Container: lbs 3.2.2 Storage characteristics. Item may be subjected to storage in

23、 an uncontrolled environment (temperature and humidity) for extended periods of time (e.g., 5 to 10 years). If the item can only be storec in a controlled environment, the contractor shall submit information with the bid/proposal which clearly explains the environmental limits within which the item

24、shall be stored. The contractor shall provide list of parts subject to deterioration during storage, (e.g., rubber goods, tubing, batteries), and maintenance/inspection schedules to prevent problems in operation after extended periods of storage. 3.2.2.1 Periodic inspection/maintenance. For items re

25、quiring periodic inspection/maintenance while in storage, the contractor chal provide detailed instructions delineating appropriate methods and procedures. In addition, the contractor shall provide a means to access the equipment/components without permanently destroying the packaging container (e.g

26、., provide reusable shipping/storage containers). The cost of providing such packaging, if different from the usual method of shipping, will be separately identified in the bid/proposal. effectiveness of this requirement versus the Government performing it own packaging or storage. This will allow t

27、he Government to determine the cost 3.3 Desiqn and construction. Shall be in accordance with the essential salient characteristics of the applicable specification sheet (see 3.1.1). 3.3.1 Electrical characteristics. 3.3.1.1 Alternating Current (AC) powered equipment. 5 Provided by IHSNot for ResaleN

28、o reproduction or networking permitted without license from IHS-,-,-MIL-D-YZ044 bci 79999Ob tlSb7bci5 b MIL-D-42048 3.3.1.1.1 Input power. AC equipment, as identified in the specification sheets shall be capable o operating from the Eollowing line sources: 110 volts, plus and minus 10 percent, and 2

29、30 voltsr plus and minura 10 percent alternating current, multiple frequency, 50 and 68 Hz plus OK minus 2 Hz. Modifications to the oferors standard commercial item which will allow opration on all the above voltage levels and 50/60 Hz may be accept ab le. The design modilication may be integral to

30、the equipment or may consist f a separate external equipment item(s). The conversion kit shall include adequate instructions for the Government to perform the modificatlsns. Complex modifications requiring more than one manhour to accomplish are not acceptable. permit operation on multi-voltage 50/6

31、0 Hz (either 3.10 or 220 volt) shall, be Get Ear Air Force 110 voltr 50 Hz, and Navy/Marines/Army 110 All medical equipment shall be supplied with a UL-approved three-wire ground line cord and a 110 volt green dot hospital grade male plug. not available, a plug suitable or use in hospital environmen

32、ts shall 1 3.3.1.1.2 Line sensing. Equipment which does not automatically volt, 60 Hz. 3.3.1.1.3 Power line cord and plug. Where a hospital grade plug is be provided. 3,3.l.2 Direct Current (DC) powered equipment. 3.3.1.2.1 Input Power. DC equipment, as identified in the specification sheet, shall b

33、e capable of operating from the DC sources specifed within the specification sheet. Items sfeered which operate form both AC and DC power shall be capable o operating by AC power when the DC power source (battery(ies) is removed from the equipment. operating from the DC source(s) when the AC power s

34、ource is removed rom the equipment. 3,3.1.2.2 Power line cord and plug. The provisions o paragraph 3.3.1.1.3 are applicable when the equipment, as identified in the specfication sheet (see 3.1.1) contains a battery charger. The items shall also be capable of 3.3.2 Identification markinq. 3.3,2,1 Nam

35、eplates and product marking. Unless otherwise specified in the applicable specification sheet, each unit shall have as a minimum the hllowing information on one or more nameplates: 6 - _ Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-MIL-D-42048 65

36、M 9999906 0269656 8 i MIL-D-42048 a. Name or Registered Trademark of the Manufacturer. b. Type or Model Number. c. Serial Number. d. Electrical Characteristics. e. National Stock Number (NSN). f. Federal Supply Code For Manufacturers (FSCM). g. Quarter and Year of Manufacture (3681 - Designates thir

37、d quarter of 1981). Nameplates shall be permanently and securely attached to the equipment. Adhesives shall not be used. Equipment shall be permanently and legibly marked in accordance with the general marking requirements of MIL-STD-130. external equipment surface which is readily accessible. The n

38、ameplate shall. be located on an 3.3.3 Interchanqeability. Parts having the same manufacturers part number shall be fully and functionally interchangeable. All major components of the assembled system having the same model number shall be physically and functionally interchangeable. 3.3.3.1 Enqineer

39、inq desiqn changes. The contractor shall notify the provisioning activity of all changes whether of a production or modification type which are approved for incorporation into the end item furnished under the contract and which modify, add to, delete, or supersede parts in the end item or its suppor

40、ting equipment. Requirements for Design Change Notices are described in the attached DD 1423, Contract Data Requirements List (CDRL). and DD 1664, Data Item Description (DID). 3.3.4 Safety. All items shall conform to the applicable requirements of a nationally recognized standard for the safety of m

41、edical equipment of the issue in effect on the date of solicitation. All items shall be approved as conforming to such a standard by an independent nationally recognized testing laboratory, as applicable. Items which fit into one or more of the general descriptions given in table I shall conform/com

42、ply to the indicated Health/Safety document. 7 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-_ MIL-D-42048 bS 9994706 Ob9b57 T MIL-D-4204 8 Table I. General Health/Safety Requirements, General Description Applicable Documents 100 Devices used in He

43、alth Care Facilities NFPA 99 101 Devices requiring contractor NFPA 70 (Article 517) 102 Electronic devices generating radiation Public Law 90-602 a03 Devices subject to recall by FDA 104 Alb electrsmedical apparatus ANSI/AAMI ES1 installation (Subchapter J of Title 21) Federal Food, Dzug . and Cosme

44、tic Act section 518 (b) * 3.4 -. 3.4.1 Cteniny of lid to container base. Quantity 3.6.8 The container design shall include stainless steel quarter 3.6.9 Cushion and support system of the container shall provide adequate vibration, shock, and compression protection of the contents. Evidence of confor

45、mance shall be qualification of container through to be utillaed, they shall be constructed of unicellular, polyethylene foam (colar charcoal gray) conforming to PPP-C-1752 Type I, Class 2, or flexible polyurethane foam conforming to MIL-P-26514 Type I, Class 2, Grade C. Cushioning system shall be d

46、esigned in accordance with MIL-EIDBK-304 . 3.6.10 Container identifications and markings shall be in accordance with MIL-STD-129 and MIL-STD-130 for medical mateiiiel. 3.6A.1, Catchs and strikes shall be mechanically affixed to the container with stainless steel rivets and using molded-in steel inse

47、rts. Handles shall be installed using back-up plates and neoprene gae;ketr% OR both inside and outside surfaces. All hardware shall be recessed within the outer surface of the container. I the rough handling tests o Federal Standard 101. If foam inserts are I I 1 I 3.6.12 The container must be resil

48、ient so as not to sustain permanent dents, even under severe impacts. 3.6.13 There shall be no nutrient materials used in the construction o the case which shall support fungal life. 3.6.14 The container shall be abrasion resistant. Color pigmentation shall be compounded throughout the container she

49、ll material . 10 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-f MIL-D-42048 65 9999906 0269bb0 T II MIL-D-4204 8 3.6.15 Container material shall not require painting (other than chemical resistant coating, if required) , but shall readily accept a variety of paints used to apply tactical identification markings. 3.6.16 Instructions and illustrat