DLA MIL-T-37923-1978 HYPODERMIC AUTO-INJECTOR DEMONSTRATION《自动注射器皮下注射示范》.pdf

1、MILITARY SPECIFICATION HYPODERMIC AUTO-INJECTOR, DEMONSTRATION This specification is approved for use by the Defense Personnel Support Center, Defense Logistics Agency, and is available for use by all Departments and Agencies of the Department of Defense, 1. SCOPE 1.1 Scope, This specification cover

2、s a training device (demonstrator) for Antidote, Nerve Agents, Injector (see 6.2). 2. APPLICABLE DOCUMENTS 2.1 Issues of documents, The following documents, of the issue in effect on date of invitation for bids or request for proposals, form a part of this specification to the extent specified herei

3、n. STANDARDS FEDERAL FED-STD-595 MI L ITARY MIL-STD-105 MIL-STD- 129 (Copies of spec - .Colors I - ficat Sampling Procedures and Tables .for Inspection Marking for Shipment and Storage, by Attributes. ons and standards required by contractors in connection with specific procurement functions should

4、be obtained from the procuring activity or as directed by the contracting officer.) Beneficial comments (recommendations, additions, deletions) and any perti- nent data which may be of use in improving this document should be addressed to: Headquarters, Defense Personnel Support Center, ATTN: Direct

5、orate of Medical Materiel, DPSC-ATT, 2800 South 20th Street, Philadelphia, PA 19101, by using the self-addressed Standardization Document Improvement Proposal .I I I I (DD Form 1426) appearing - at the end of this document or by II- letter, A Provided by IHSNot for ResaleNo reproduction or networkin

6、g permitted without license from IHS-,-,-3, REQUIREMENTS 3.1 Material. Shall be a pressure-activated automatic injector device suitable for training individuals in the use of Antidote, Nerve Agents, Injector (see 6.3). 3.1.1 Physical characteristics. 3.1.1.1 Training device. The training device shal

7、l, have the same basic The appearance (configuration and engineering design) as the Antidote, Nerve Agents,Injector, except for color coding and description of contents. training device shall function in the same manner as the actual injector except that the training device shall not contain drug pr

8、oduct or needle. In addition, the training device shall have an overall length of 5.75 inches (14.6 cm) + 0.25 inch (0.63 cm) and a maximum diameter of 0.75 inch (1,9 cm). The devices maximum gross weight shall be 35 grams,rvhen tested as specified in 4.2.3.1. 3.1.1.2 - Prod. The training device sha

9、ll incorporate a dull plastic prod. When the training device is activated, the prod shall be propelled from the black end (front) of the injector 0.125 inch (0.32 cm) + 0.0125 inch ., (0.032 cm. The prods diameter shall be 0.1 inch (0.25 cm) - + 0.01 inch (0.025 cm)- 3.1.1.3 Safety cap, The training

10、 device shall also incorporate a removable gray safety cap having a maximum diameter of 0.8 inch2,0 cm), 3.2 Activation force. The training device shall activate when a force of 1.5 to 9 pounds (0.7 to 4 kg) is axially applied as specified in 4.2.3.2, The front end of the training device shall not b

11、ecome dislodged during activation. 3,3 Repeated use, The training device shall be capable of being recocked and reused. The average number of recockings shall be at least nine when tested as specified in 4.2.3.3. 3.4 Accessories. The accessories for the training device shall be the . f o 1 lowing :

12、3.4.1 Plastic bags. Shall be a clear polyethylene bag the same as the one in which each trainer device is packaged (see 5.1.2) except shall be open at one end. closure clip (see 3.4.2). The bag shall be capable of being heat sealed using the bag 2 Provided by IHSNot for ResaleNo reproduction or netw

13、orking permitted without license from IHS-,-,-MIL-T-37723 67 7777706 0387761f 5 W MI L-T- 3 7 9 2 3 (DLA- DM) 3,4,2 Bag closure clips. Shall be a closure tool which when placed over the open end of the plastic bag(see 3.4.l)in accordance with manufacturers directions enables easy repackaging and sea

14、ling of the training device in the plastic bag. bag closure clips shall accompany the clips. An instruction card illustrating the use of the 1 3.4,3 Recocking caps. Shall be a device which will enable the training device to be recocked when placed over the safety end of the trainer in accordance wit

15、h the manufacturers directions, 3.4.4 Instruction cards. The laminated instruction cards shall illustrate - the use and recocking of the training device. instruction cards shall be 5 inches (13 cm) X 8 inches (20 cm). The nominal size of the NOTE: See 5.1.1 for the quantity of the accessories per un

16、it of issue. 3;5 Labeling - individual training device, Each individual training device shall be durably and legibly marked or labeled as specified. tested as specified in 4.2.3.4, the marking shall remain entirely legible; any labels used shall be unaffected and shall remain entirely adhered to eac

17、h training device. When 3.5.1 Label information. Each training device label shall only bear the following information. color number 35550 of FED-STD-595 and shall have the following information imprinted: The label of the training device shall approximate (a) TRAINING DEVICE (c) (d) 1. PULL OUT GRAY

18、 SAFETY (e) (f) (b) ANTIDOTE, NERVE AGENTS AUTO-INJECTOR Contains no drug product or needle 2. HOLD FIRMLY IN PLACE FOR TEN SECONDS PLACE BLACK END on outer.thigh and PUSH HARD till injector functions 3.6 Delivery. Not more than 6 months shall have elapsed from the date . of manufacture of the train

19、ing device to the date of delivery to the Government, 3.7 Workmanship. The training devices shall be free from defects which detract from their appearance or impair their serviceability. . 4. QUALITY ASSURANCE PROVISIONS 4.1 Supplier responsibility for inspection, Unless otherwise specified Except a

20、s in the contract or purchase order, the contractor is responsible for the performance of all inspection requirements as specified herein. otherwise specified in the contract or order, the contractor may use his own or any other facilities suitable for the performance of the inspection require- ment

21、s specified herein; unless disapproved by the Government. The Governnient Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-_-_- MIL-T-37723 b9 m 7797706 0387765 7 = MIL-T-37923 (DLA-DM) reserves the right to perform any of the inspections set forth in

22、 the specification where such inspections are deemed necessary to assure supplies and services conform to prescribed requirements. 4.1.1 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 Governmen

23、ts request, at any time, or from time to time, during the performance of the contract and, (i) as to any expiration dated item, for the expiration dating period specified by the contractor for such item, or such longer period as may be required by regulation of any federal agency; or (ii) as to non-

24、dated items, for not less than 3 years after delivery of the item to the Government. 4.1.2 No company supplying any ingredient(s) to the contractor will be considered an acceptable facility for the performance of any inspection requirements specified herein. 4.2 Quality conformance inspection. 4.2.1

25、 Sampling. 4,2,1.1 For examination, Sampling for examination shall be conducted in accordance with MIL-STD-105, 4.2.1.2 For tests. Samples for each test shall be selected in accordance with MIL-STD-105, level S-4, using an AQL of 1,5 (percent defective). 42.2 Inspection procedure. 4.2,2.1 For examin

26、ation. Examination shall be conducted in accordance with the following classification of defects. TABLE I. Classification of defects (training device) I Cat e gories Defects - l/ I Critical : 1 2 3 Prod missing, Safety cap missing. Marking or labeling of the training device incorrect, missing or ill

27、egible. 4 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-c MIL-T-37723 67 m 7777706 0389766 7 m MI L-T- 37923 (DLA-DM) TABLE I. Classification of defects (training device). (Continued) - Categories Defects i/ Maj or: 101 102 103 104 1 o5 AQL 2.5 (pe

28、rcent defective) Length or diameter of training device not as Diameter O safety cap not as specified. Prod diameter not as specified, Distance prod propelled from front of the injector Label color not as specified. specified. not as specified, I - i/ Inspection is not restricted to the classified po

29、ssible defects listed above. 4.2.2.2 For tests. Samples selected in accordance with 4,2.1,2 shall be tested as Specified in 4.2.3, two or more tests, Where possible, the samples shall be used for 4.2.3 Tests, 4.2.3.1 Weight. 4.2,3.2 Activation force, Remove the safety mechanism from the training Pla

30、ce the training device in a suitable device capable of applying Shall be determined by using a suitable accurate balance. _.- device. and measuring required loads. with the least possible .impact and increase the load until the training device is activated. Examine the training device to determine i

31、f the front end has become dis- lodged during the activation. Apply a load axially to the training device Record the actual load at which the training device was activated. 4.2.3.3 Repeated use. The training device shall be fired and recocked as illustrated on the instruction card. 4.2,3.4 labeling

32、on the training device ten times with fingers using moderate pressure. Marking or labeling durably and legibly, Examine for legibility and permanency of marking or labeling, Rub the marking or 5. PACKAGING 5.1 Packaging. 5.1.1 Unit of issue, Packaging shall be level A or C, as specified (see 6.1). O

33、ne box containing the following items constitutes one unit of issue: (a) Twenty-four (24) training devices packaged as per 5.1.2. (b) Two hundred sixteen (216) plastic bags. 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-I MIL-T-37723 67 m 7797706

34、 0387767 O m I b I c MIL-T- 3792 3 (DLA-DM) (c) Four (4) bag closure clips (heat closure tools) (d) One (1) instruction card illustrating use of bag closure clips. (e) Twelve (12) recocking caps. (f) Twelve (12) laminated instruction cards illustrating use and recocking as shown on attached instruct

35、ion sheet, 5.1.2 Level A. Each training device shall be packaged in a clear tear-off polyethylene bag having an average thickness of no less than 0.003 inch (.O08 cm). All seams of the bag shall be completely sealed. The minimum inside dimensions of the bag shall be 7.5 inches by 1.5 inches (18,75 c

36、m x 3.75 cm), Each bag shall be designed to permit fast and easy opening and shall have a clearly identified tear-off end, bag shall be proximate to safety end of the device, Tear-off portion of the 5.1.2.1 Unit Package. A fiberboard box containing one unit of unit I constitutes the unit package. .

37、5.1.3 Level C, Units shall be Packaged in standard commercial containers of the size and kind commonly used. which will afford the degree of Protection - required for shipment and use of the product for its intended purpose, 5,2 Packing, Packing shall be level A, B or C, as specified (see 6.1). 5.2.

38、1 Level A. Twelve (12) units of issue shall be packed in a weather resistant fiberboard container, 5.2.2 Level B. Twelve (12) units of issue shall be packed in a fiberboard container, 5.2.3 Level C. The packaged commodity shall be packed in shipping containers that will afford adequate protection ag

39、ainst damage during direct shipment from the supply source to the first receiving activity. shall conform to the applicable carriers rules and regulations. These packs 5.3 Marking. 5.3.1 Training device, The poly bag in which the training device is enclosed shall have the words “PULL QUICKLY! imprin

40、ted on each side of the perforated line. device shall have information imprinted as specified in 3.5.1. Each device shall have a label affixed. Each label on 5,3.2 Unit of Issue. issue (box) shall include: The minimum labeling information of the unit of (a) National Stock Number. (b) (c) Contents (a

41、s such). (d) Training Device, Antidote, Nerve Agents Auto- Injector (contains no drug product or needle). Name and address of manufacturer. 6 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,- MIL-T-37723 69 = 7777906 0389768 2 -1 MIL-T-37923 (DLA-DM)

42、5.3,3 Exterior container, Exterior container shall be marked in accordance with MIL-STD-129 except that the date of manufacture shall be shown in lieu of the date packed. Lot (control) number shall be shown. 6, NOTES 6,l Orderiilg data, Procurement documents should specify the following: (a b) Natio

43、nal Stock Number. Title, number and date of this specification, (cl Selection of applicable levels of packaging and packing (see 5.2 and 5,3), 6,2 This specification covers the following item: National Stock Number 6910-01-061-6444 Item Identification HYPODERMIC AUTO-INJECTOR, DEMONSTRATION, Nerve A

44、gents, 24s 6.5 6505-00-134-2943, covered by MIL-A-37251 and Int. Amend-1, The National Stock Number for Antidote, Nerve Agents, Injector is Preparing activity: . DLA-DM Project No, 6910-0383 *u.S. G0VERNMEN.T PRLNTING OFFICE: 1978-603-022/166 7 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-