DOD MIL-F-42024-1987 FORCEPS HEMOSTATIC CLIP (SMALL)《止血夹镊子(小的)》.pdf

1、MIL-F-42024 (DM) 26 February 1987 ATTN: Directorate of Medical Materiel, DPSC-RST, 2800 S. 20th Street, Philadelphia, PA 19101, by using self-addressed Standardization Document Improvement Proposal (DD Form 1426) appearing at the end of this document or by letter. MILITARY SPECIFICATION FORCEPS, HEM

2、OSTATIC CLIP (Small) This specification is approved for use within the Defense- Personnel Support Center and is available for use by all Departments and Agencies of the Department of Defense. 1. SCOPE 1.1 Scope. This specification covers a small size hemostatic cli applying forceps for small hemosta

3、tic clips. -L 2 . APPLICABLE DOCUMENTS 2.1 Government documents. 2.1.1 Specifications and standards. The following specifications and standards 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 iss

4、ue of the Department of Defense Index of Specifications and Standards (DoDISS) and supplement thereto, cited in the solicitation. SPEC1 FI CATIONS FEDERAL THIS DOCUMENT CONTAINS / PAGES. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-MIL-F-42024 (DM

5、) MILTARY MIL-P- S. 16 - Preservation, Methods of. MIL-L-10547 - Liners, Case and Sheet, Overwrap; Water- Vaporproof or Waterproof, Flexible, STANDARDS MILITARY MfL-STD-LOS - Sampling Procedures and Tables for Inspection by Attributes. MIL-STD-129 - Marking for Shipment and Storage. MIL-STD-147 - Pa

6、lletized Unit Loads. MIL-STD-794 - Parts and Equipment, Procedures for Packaging of . 2.1.2 Drawing. The following drawing forms a part of this specification ta the extent specified herein. Unless otherwise specified, the issues shall be those in effect: on the date of the solicitation. DRAWING Defe

7、nse Personnel Support Center (DPSC) 23350 “ FORCEPS, HEMOSTATIC CLIP, Applying (Copies of specifications, standards, and drawing required by contractore in connection with specific acquisition functions should he obtained from the contracting activity or as directed by the contiacting activity.) 2,2

8、 Other publications. The following documents form a part of this specification to the extent specified herein. Unless otherwise specified, the issues of the documents which are DoD adopted shall be those listed in the issue of the DoBISS specified in the solicitation. Unless otherwise specified, the

9、 issues of documents not listed in the RoDXSS shall be the issue of the nongovernment documents which is current on the date of the solicitation. 2 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-MIL-F-Ll202q 65 39933Ob 02b7433 b d MIL-F-42024 (DM) A

10、MERICAN SOCIETY FOR TESTING AND MATERIALS (ASTM) STANDARDS E ia - Rockwell Hardness and Rockwell Superficial Hardness of Metallic Materials, Tests for. E 92 - Vickers Hardness of Metallic Materials, Tests for. E 140 - Hardness Conversion Tables for Metals (Relationship Between Brinell Hardness, Vick

11、ers Hardness, Rockwell Hardness, Rockwell Superficial Hardness and Knoop Hardness). F 899 - Stainless Steel Billet, Bar and Wire for Surgical Instruments. F 921 - Standard Definition of Terms Relating to Hemostatic Forceps. (Application for copies should be addressed to the American Societ for Testi

12、ng and Materials, 1916 Race St., Philadelphia, PA 19103.) (Nongovernment standards and other publications are normally available from the organizations which prepare or which distribute th documents. These documents also may be available in or through libraries or other informational services. 2.3 O

13、rder of precedence. In the event of a conflict between the text of this specification and the references cited herein, the text of this specification shall take precedence. Nothing in this specification, however, shall supersede applicable laws and regulations unless a specific exemption has been ob

14、tained. 3 . REQUIREMENTS 3.1 General requirements. The forceps shall be in accordance wit the applicable requirements of GG-1-526 and as specified herein. It shall-be compatibe with small hemostatic clips.- Where referenced ir; this document, the term clip shall mean small hemostatic clip. 3 Provide

15、d by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-3.2 Style, desiqn and dimensions. The orceps shall be a ringed clip applying forceps suitable for holding and the application o small size hemostatic clips. The forceps shall be approximately 7-1/2 inches in l

16、ength with the distal clip holding jaw at a 15 degree angle to the handles. The handles shall be color coded to match the color coding of the hemostatic clips. The forceps shall be in strict accordance with DelEense Personnel Support Center (DPSC) Drawing 23350. The forceps shall have a spring betwe

17、en the handles so that the forceps are held in the Eully open position. The forceps shall contain a mechanism that limits the opening of the distal tip jaws to the maximum opening as shown on DPSC Drawing 23350. The tip of the jaws shall close first and the clip holding section shall be the only par

18、t o the jaws to close completely. 3.3 Material. The forceps shall be fabricate from Class 4, martensitic etainless steel in accordance with ASTM F899. 3.4 Hardness. Forceps shall have a Rockwell hardness o C40 to C47 when tested as specified in 4.4.1. The requirements of GG-1-526 tmii apply. 3.5 Pas

19、sivation. The forceps shall be properly passivated. 3.6 Clip retention. When tested as specified in 4.4.2, the clips shall not fall out of the jaws of the forceps when the forceps are held with jaws vertically downwmd. 3.7 Performance. When tested in accordance with 4.4.3, the orceps shall close the

20、 clips as specified. 3,8 Lucks. Shall be of box lock type. The box lock construction shall be accuEately fitted, and shall be without crevices, burrs, or sharp edges at any place in the lock construction. permanently secured. The joint performance shall be smooth, of equal resistance, and non-bindin

21、g in all positions when opening or closing the orceps (the lock may be lubricated). Further, under no circumstances shall looseness or free play of either shank permit any misalignment of the jaws in closing. NOTE: This paragraph shall replace the requirements specieied in GG-1-526 for locks. Pin or

22、 rivet shall 3.9 Finish. Finish shall be entirely mirror, satin or matte. Should the forceps be of mirror finish, the locks and ratchets shall be polished smooth, but need not possess a mirror finish. The matte einfeh shall exhibit a uniform non-directional surface texture equivalent to that produce

23、d by lightly blasting the prepared surface with Eine abrasives under pressure. 3,J.O Identification markinq. In addition to the requirements specified in GG-1-526, forceps o foreign manufacture shall be marked “etaSnless, 4 O E 4 a e Provided by IHSNot for ResaleNo reproduction or networking permitt

24、ed without license from IHS-,-,-MIL-F-42024 (DM) 3.11 Workmanship. The forceps shall be free from burrs, cracks, pits, sharp edges, scale, corrosion, or other defects which detract from its appearance or impair its serviceability. O 4. QUALITY ASSURANCE PROVISIONS 4.1 Responsibility for inspection.

25、Unless otherwise specified in the contract or purchase order, the contractor is responsible for the performance of all inspection requirements as specified herein. Except as otherwise specified in the contract or order, the contractor may use his own or any other facilities suitable for the performa

26、nce 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 supplies and services conform to prescribed requirements

27、. 4.1.1 Responsibility for compliance. All items must meet all requirements of sections 3 and 5. specification shall become part of the contractors overall inspectior system or quality program. The absence of any inspection requirementg in the specification shall not relieve the contractor of the re

28、sponsibility of assuring that all products or supplies submitted to the Government for acceptance comply with all requirements of the contract. submission of known defective material, either indicated or actual, nor does it commit the Government to acceptance of defective material, 4.1.2 Inspection.

29、 Inspection, as used in this specifcation, is defined as both examination (such as visual, auditory, etc. investigation without the use of special laboratory appliances or procedures) and testing (determination by technical means of physical and chemical properties), of the item. 4.1.3 Records. Reco

30、rds 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 of the contract an( for a period of 3 years after delivery of the suppl

31、ies to which such records relate. The inspection set forth in this Sampling in quality conformance does not authorize 4.1.4 Certificates of quality. Certificates of quality supplied by the manufacturer of the corrosion-resistant steel may be furnished in lieu of actual performance of such testing by

32、 the contractor, 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 National Stock Number, the item identification, the lot number, the lot

33、 size, the sample size, the date of testing, the test method, individual test results, and the specification requirements. 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-MIL-F-42024 (DM) f a 4.2 Inspection level AQL (percent defective) Sampling. I

34、 i Majar II Minor II 4.2.1 For examination. Sampling for examination shall be conducted in accordance with MIL-STD-105, and as indicated in table I. Unit of product: or examination purpose shall be one forceps. 1.0 2.5 TABLE I. Sampling criteria for inspection f Test Enspection AQL (percent Characte

35、ristic Requirement level defective) Procedure i t 4.2.2 For tests. Sampling for tests shall be conducted in accsrance with MIL-STB-105 and as indicated in table II. The unit of pgoduct or test purpose shall be one forceps, Where feasible, the sane sample unit shall be used Eor the determination of t

36、wo or more test characteristics. TABLE II. Sampling criteria for tests ;Hardness test I 3.3 st a .Dimensions lCopger sulfate tes iBoil. test Performance test ;Clip retention GG- I = 5 2 6 3.4 GG-1-526 GG-1-526 3.7 i 3.6 i GG-1-526 5-2 GG-1-5 2 6 s- 2 s-2 4.0 4.0 4.4.3 , s-2 I 4.4b2 4.2.3 Raw materia

37、ls. A sufficient quantity of each lot of metal used in the manufacture of the forceps shall be selected for chemical analysis. 4.3 Examination . 4.3,l Examination of forceps. The forceps shall be examined to determine compliance with all the requirements contained in this specification. Examination

38、shall be conducted as specified in tables f and II%. Examination, however, shall not be restricted to defects listed in table III. Any forceps in the sample containing one or more defects shall be rejected and if the number of defective forceps in any sample exc-eeds the acceptance number for the sa

39、mple, the lot represented by that sample shall be rejected. 6 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-MIL-F-42024 b5 9999706 0269497 3 6 TABLE III. Classification of defects Categories Defects I Major 101 102 103 104 105 106 107 108 Minor 201

40、 202 None defined Forceps not of the specified design for appropriate Both jaws not serrated as specified. Jaw serrations not of uniform depth and not well Forceps not free from cracks, pits, burs, sharp edges, Finish of forceps not uniform and not as specified. Box lock performance not as specified

41、. Jaws possess sharp tips. Pin for box lock not flush with surface and not free type, stock number and item identification. defined. scale, rough areas or corrosion. from crevices. Forceps not free from dirt, polishing material or Identification markings not present, not correct, not foreign matter.

42、 complete, or not legible. l. 4.4 Tests. Tests shall be conducted to determine compliance with specification requirements. 4.4.1 Hardness test. Hardness shall be determined in accordance with ASTM Standards E 18 or E 92. Conversion of Vickers hardness values to Rockwell values shall be in accordance

43、 with ASTM Standard E 140. 4.4.2 Clip retention. With the hemostatic clips in their retaine. on a horizontal surface and the forceps in their fully open position, load the forceps by pressing them over the clip and deforming the clips to the forceps shape. Remove the clips from their retainer and ho

44、ld the forceps with the jaws in the vertically downward position. With no pressure being applied to the finger rings, the clip shall remain firmly grasped inside the jaws of the forceps for a.period of one minute. Remove the clip and repeat the test five times for each forceps. rejected. Forceps whi

45、ch do not retain the clips firmly shall be 7 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-MIL-F-42024 (DM) 5.1.2 Level Ca 5m1.2a1 Unit package. Preservation for forceps shall conform to the requirements of MIL-STD-794 for level C. packed in accord

46、ance with the requirements of MIL-STD-794 for level C. , I 5a1.2.2 Intermediate package. Twelve unit package$ shall be 1 4.4.3 Performance test. Load the forceps with the hemostatic clip as deacribed in section 4.4.2. closing the forceps. Take the compressed clip and measure gap and scisgor a9 shown

47、 in DPSC Drawing 23350, If either the gap or the scietssr exceed the dimensions given in DPSC Drawing 23350 for the subject NSN, then the Eorceps shall be rejected. Repeat this test ive timest foi: each forceps tested. Compress the hemostatic clip by I 1 5.2 Packing. Packing shall be level A, B or C

48、 as specified (see I 6.2). , 4.5 Xnspection of packaging. The sampling and inspection of the preservation and interior package marking shall be in accordance with groups A and B quality conformance inspection requirements of MIL-P- 116. shipment and storage shall be in accordance with the quality as

49、surance provisions of the applicable container specification and the marking requirements o MIL-STD-129. The sampling and inspection of the packing and marking fol: 5. PACKAGING 5*l Pcesrvation. Preservation shall be level A or C as specified (see 6.2). 5.1.1 Level A. 5.1.1.1 Cleaning and drying. Forceps shall be cleaned and dried lin accordance with MIL-P-116. 5.1.1.2 Preservative applications. Preservatives shall not be Used s