1、 MIL-0-36788 65 m 9999906 0262678 5 MIL-0-36788 23 August 1971 MILITARY SPECIFICATION OXYGEN, USP, WITH TUBE AND FACE MASK 24 GAL. (90 LITERS) This specification is mandatory for use by allDepartments and Agencies of the Department of Defense. 1. SCOPE 1.1 This specification covers a portable, dispo
2、sable , emergency oxygen apparatus, suitable for the administration of oxygen. 2. APPLICABLE DOCUMENTS 2.1 The following documents of the issue in effect on date of invitation for bids or request for proposals, form a part of the specification to the extent specified herein : SPECIFICATIONS Federal
3、PPPLB-5 85 PPP-B-601 PPP-B-621 PPP-B-6 36 Military MIL-L-10547 Boxes. Wood , Wirebound. Boxes, Wood, Cleated-Plywood. Boxes, Wood, Nailed and Lock-Corner. Box , Fiberboard. Liners , Case , and Sheet , Overwrap ; Water- Vaporproof or Waterproof, Flexible. FSC 6505 THIS DOCUMENT CW4TABW35 PAGES, Provi
4、ded by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-MIL-0-36788 65 7777706 0262677 7 H MIL-0-36 7 8 8 STANDARDS Military MIL-STD-105 MIL-STD-129 Marking for Shipment and Storage. Sampling Procedures and Tables for Inspection by Attributes. (Copies of specific
5、ations and standards required by suppliers in con- nection with specific procurement functions should be obtained from the procuring activity or as directed by the contracting of ricer. ) 2.2 Other pub.lications. The following document forms a part of this purchase description to the extent specifie
6、d herein. Unless otherwise indicated, the issue in effect on date of invitation for bids or request for proposals shall apply - U. S. PHARMACOPEIAL CONVENTION, INC. The Pharmacopeia of the United States of America (U.S.P.) (Application for copies should be addressed to the Mack Publishing Company, E
7、aston, Pa. 18042). U. S. DEPARTMENT OF HEALTH, EDUCATION , AND TJFLFAE Federal Food,Drug and Cosmetic Act and General Regulations for its Enforcement. (Applications should be addressed to the Food and Drug Administration, U. S. Department of Health , Education i and Welf are i Washington , D. C. 202
8、04 1 3. REQUIREMENTS 3.1 Material. Material shall be as herein specified. Material shall be of the highest quality and suitable for the purpose intended. 3.1.1 Oxygen. Oxygen shall comply with the requirements, tests, and standards of the current edition of the Pharmacopeia of the United States (U.S
9、 .P .) . 3.1.2 Cylinder. Cylinder shall be a seamless container fabricated from carbon steel. 3.1.3 Valve. Valve shall be fabricated of a material compatible with the . service intended and shall be brass, nickel or chrome plated, or anodized aluminum. 3.1.4 Gasket. Gasket shall be fabricated of mat
10、erials compatible with oxygen at pressures , temperatures and concentrations specified herein. 3.1.5 Tube, mask, and reservoir bag. The tube, mask, and reservoir bag shall be safe (nontoxic), polyethylene, or vinyl, plastic material suitable for the purpose intended. -2- Provided by IHSNot for Resal
11、eNo reproduction or networking permitted without license from IHS-,-,-MIL-0-36788 b5 7977706 02b2680 3 MIL-0-36788 3.2 Style, design, and dimensions. Disposable, emergency oxygen apparatus shall consist essentially of a filled oxygen cylinder, regulator, plastic face mask, plastic reservoir bag, and
12、 plastic tubing. Cylinders must be fabricated, charged, and shipped under terms of an Interstate Commerce Commision special permit. Each manufacturer and shipper must have his own permit. 3.2.1 Cylinder. The cylinder shall be not less than 12.00 inches nor more than 18 inches in overall length and n
13、ot less than.l-15/16 inches nor more than 4 inches in diameter, and shall have a minimum wall thickness of 0.045 inch and a minimum volume of 96 cubic inches (1570 cubic centimeters). The cylinder shall have a minimum burst strength in accordance with Table I below, be pressure- tested in accordance
14、 with Table I without evidence of leakage, distortion, or other defect. When required by the Interstate Commerce Commission, the cylinder shall be equipped with a fusible plug safety device utilizing fuse metal having a yield temperature of 212“ Fahrenheit (F.). be capable of preventing rupture of t
15、he normally charged cylinder when it is placed in a fire. The complete cylinder shall show no evidence of leakage when tested as specified in 4.4.3. The fusible plug safety device shall Table I Burst Strength Cylinder Pounds Minimum Cylinder press Ure type Per burst at 70“ F square strength (lbs per
16、 sq. inch) in ch I 1 1200 1 2500 lbs I 975 to 1025 II I 2250 3600 lbs 1775 to 1825 3.2.2 Regulator. The regulator shall be so constructed as to be an integral part of the unit and shall permit the flow of gas to be turned off without disconnecting the regulator from the irnit. The operation of the r
17、egulator control knob in a clockwise direction to the maximum extent will permit oxygen to flow at a fixed rate of 6 liters per minute across the entire range of tank pressure (see 3.5). 3.2.3 Oxygen. The cylinder shall contain 90 to 100 liters of oxygen at standard conditions (O“ Centigrade C. and
18、760 millimeters m. of mercury); The cylinder pressure shall be in accordance with Table I (see 3.2. i). A contents indicator may be provided which will visually provide indication of oxygen contents across the range of cylinder pressures. -3- Provided by IHSNot for ResaleNo reproduction or networkin
19、g permitted without license from IHS-,-,-MIL-0-36788 65 3399906 0262683 5 MIL-0-36788 3.2.4 Mask, reservoir bag, and tubing. Mask shall be anatomically designed to fit over the mouth and nose, and shall be supplied with a reservoir bag as well as an elastic band to fit around the head. minimum of 5
20、feet in length; outside diameter shall be a minimum of 5/32 inch. Tubing shall be a 3.3 Weight. The weight of the cylinder, complete with the regulator and oxygen, shall be 2-114 pounds minimum. 3.4 Performance characteristics. The unit shall deliver oxygen at a rate of 6 liters per minute minimum a
21、t 1000 pounds per square inch gage through 50 pounds per square inch gage at 70“ F, or at 1800 p.s .i.g. through 80 p.s .i.g. at 70“ F., for 15 (+ - 1.3) minutes, at 16 liters per minute. 3.5 Safety (nontoxicity). 3.5.1 Tubing. Tubes shall be safe (nontoxic), when tested or safety as specified in 4.
22、4.2.1. 3.5.2 Mask and reservoir bag. idhen tested as specified in 4.4.2.2, the sample shall comply with the requirements of the U.S.P. for Systemic Injection Test , Plastic Container. 3.6 Certificates of safety (nontoxicity) . A certificate of safety (non- toxicity), listing all lot or control numbe
23、rs, shall state that samples from each lot or control have been tested for safety (nontoxicity), as required in 3.6 and 4.4.2, and have been found to be safe (nontoxic). The certificate shall reference the method used in determining safetv (nontoxicity). Por destination inspection, certificates shal
24、l be submitted by the contractor directly to Defense Personnel Support Center, Directorate of Medical Materiel Technical Operations Division, 2800 South 20th Street, Philadelphia, Pa. 1910 ATTN: each shipment to the consignee. For source inspection, certificates shall be furnished to the procuring a
25、ctivity via the government inspector. Quality Control Branch, and one copy of each shall be forwarded with 3.7 Manufacturers record. The manufacturer shall place a code or lot number on the paper label, or cylinder and on the printed carton, which can be verified against the manufacturers records of
26、 all tests made on nontoxic masks, reservoir bags, and tubes. These records shall be made available for inspection by any duly authorized Government representative. No shipment shall be made until alL tests have been completed, verified, and recorded in the permanent records of the manufacturer . 3.
27、8 Finish. Cylinder shall be painted with green or white enamel, and in- structions thereon shall be printed with a suitable contrasting color. -4- Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-MIL-0-36788 65 4944306 0262682 7 W MIL-0-36788 3.9 Iden
28、tification and labeling. - Cylinder shall be legibly and permanently marked with the manufacturers name or registered trademark. Labeling shall comply with the regulations of the Federal Food, Drug, and Cosmetic Act. 3.10 Instructions. Each unit shall be supplied with an instruction sheet indicating
29、 proper use of equipment. In addition, instructions for proper use of equipment shall be printed on the cylinder. 3.11 Workmanship. Workmamship shall be first class throughout. The equipment shall be free from defects which detract from its appearance or may impair its serviceability. 4. QUALITY ASS
30、URANCE PROVISIONS 4.1 Responsibility for inspection. Unless otherwise specified in the contract or purchase order, the supplier is responsible for the performance of all inspection requirements as Specified herein. Except as otherwise specified in the contract or order, the supplier may use his own
31、or any other facilities suitable for the performance of the inspection requirements specified herein, unless disapproved by the Government. The Government reserves the right to perform any of the inspections set forth in the specification where such inspections are deemed necessary to assure supplie
32、s and services conform to prescribed requirements. 4.1.1 Records. Records of examinations and tests performed by or for the contractor shall be maintained by the contractor and made available to the Government, upon the Governments request, at any time, or from time to time, during the performance o
33、f the contract and for a period of three years after delivery of the supplies to which such records relate. 4.1.2 Inspection. Inspection, as used in this specification, is defined as both examination (such as visual of auditory investigation without the use of special laboratory appliances or proced
34、ures) and testing (determination by technical means of physical and chemical properties) of the item. 4.1.3 Certificates of quality. Certificates of quality, supplied by the manufacturer of the steel, plastic, brass or aluminum, may be furnished in lieu of actual performance of such testing by the c
35、ontractor, provided lot identity has been maintained and can be demonstrated to the Government. The certificate shall include the name of the contractor, the contract number, the name of the manufacturer or supplier, the FSN, the item identification, the name of the material, the lot number, the lot
36、 size, the sample size, the date of testing, the test method, individual test results, and the specification requirements. 4.2 Sampling. -5- Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-MIL-0-36788 65 = 7777706 0262683 7 MIL-0-36788 4.2.1 For exam
37、ination. Sampling for examination shall be conducted in accordance with MIL-STD-105 and as indicated in Table II. The unit of product for examination purposes shall be one emergency oxygen apparatus. Table II Sampling for Examination I t Defect category Inspection level AQL (percent defective) Major
38、 Minor II II 1.0 2.5 I I 4.2.2 For tests. 4.2.2.1 For oxygen. Sampling for the oxygen test shall be conducted as indicated in the U. S .P. 4.2.2.2 For other tests. Sampling for other tests shall be conducted in accordance with MIL-STD-105 and as indicated in Table III. Where feasible, the same sampl
39、e shall be used for the determination of two or more test characteristics. The unit of product shall be one emergency oxygen apparatus. Component Cylinder Cylinder Cylinder Tubes Mask and res e mo ir bag Table III Sampling ( Characteris tic Dimensions Burst strength Leakage Safety Systemic injection
40、 Require - ment 3.2.1 3.2.1 3.2.1 3.5.1 3.5.2 iteria for Test procedure - 4.4.1 4.4.2 4.4.3.1 4.4.3.2 ests Inspection level s-2 s-1 100% * *Y: AQL (percent defect ive) 1.0 * * * * * Acceptance number shall be zero. * Sampling or tests shall be on component lots. 4.3 Examination. The emergency oxygen
41、 apparatus shall be examined to determine compliance with all the requirements contained in this specification. Examination shall be conducted in accordance with MIL-STD-105 and the classi- Zlcatfon of defects specified in Table IV. he restricted to the classified possible defects listed in Table IV
42、. apparatus in the sample containing one or more defects shall be rejected. If the number of defective devices fn any sample exceeds the acceptance number for that sample, the lot represented by that sample shall be rejected. Inspection, however, shall not Any emergency -6- Provided by IHSNot for Re
43、saleNo reproduction or networking permitted without license from IHS-,-,-MIL-0-36788 65 7779706 0262684 MIL-0-36788 Table IV Classification of Defects Categories Defects Critical None defined. Major 101 One or more components missing. 102 Cylinder not of size specified. 103 Weight not as specified.
44、104 Instructions for proper use incomplete, or illegible. 105 Performance characteristics not as specified. 10 6 Finish not as specified. Minor 201 Packaging, packing and marking not as specified. 4.4 Tests. Tests shall be conducted to determine compliance with specification requirements. 4.4.1. Bur
45、st test. Burst test shall be performed by use of hydrostatic pressure apparatus with the cylinder enclosed in a heavy steel pipe or jacket. 4.4.2 Leakage. The filled cylinder shall be tested for leakage by pouring Winton solution, or equal, around valve and safety device, and allowing it to remain i
46、dle for a period of 30 minutes. There shall be no uniform continuous bubbles upon visual inspection. 4.4.3 Safety tests. 4.4.3.1 Tubes. Tubes shall be tested for safety in accordance with the U.S.P. for transfusion and infusion assemblies. 4.4.3.2 Mask and reservoir bag. Mask and reservoir bag shall
47、 be tested in accordance with the U.S.P. for Systemic Injection Test, Plastic Container. 4.4.4 Oxygen. Oxygen in the filled cylinder shall be tested in accordance with U.S.P. Monograph. Alternate assay method and procedures are not permitted. 5. PREPARATION FOR DELIVERY 5.1 Packaging. 5.1.1. Unit of
48、 issue. One package containing one oxygen cylinder with regulator, face mask, tubing and reservoir bag as specified, constitutes one unit of issue. -7- Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-flIL-0-3b788 b5 H 777770b 02b2685 2 MIL-0-36788 5.
49、1.2 Packaging quantities. The number of units of issue indicated in Table V shall be packaged in each unit, intermediate, and exterior container, as applicable, or the required level of protection specified in the procurement do cumen t. Table V Packaging Quantities Unit 1 Intermediate I Exterior Package I package I container I I required I l2 units 1 unit 5.1.2.1 Packing variation permitted. If the required number of units to b
