DOD MIL-B-42014-1986 BURS BONE SURGERY ( J NOTCHED)《骨外科粘附物》.pdf

1、MIL-B-42014 (DM) 18 August 1986 MILITARY SPECIFICATION BURS, BONE SURGERY (“J“ Notched) This specification is approved for use within DLA, Defense Personnel Support Center (DM), and is available for use by all Departments and Agencies of the Department of Defense. 1. SCOPE 1.1 Scope. This document c

2、overs requirements for “Jn-notched steel and carbide bone surgery burs used in DoD Deployable Medical Systems (DMS) . 1.2 Classification. 1.2.1 Types. Bone surgery burs shall be of the following types: Type I - Corrosion Resistant Steel Type II - Tungsten Carbide 1.2.2 Shapes. Bone surgery burs shal

3、l have a head of the following shapes as indicated (see 6.1.1). Shape A - Round. Shape B - Side cutting, straight, cross-cut. Shape C - Side cutting, tapered, cross-cut. Shape D - Lindeman. Shape E - Tapered, end and side cutting. AMSC N/A PSC 6515 IBeneficial comments (reconmendations, additions, d

4、eletions) and lany pertinent data which may be of use in improving this Idocunent should be addressed to: Defense Personnel Support (Center, Directorate of Medical Materiel, DPSC-RSTS, 2800 South 120th Street, Philadelphia, PA 19101, by using the self- laddressed Standardization Document Improvewent

5、 Proposal (DD 1Form 1426) appearinq at the end of this document or by letter. DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited. THIS DOCUMENT CONTAINS /z PAGES. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-MIL-B-420

6、14 (DM) 2. APPLICABLE DOCUMENTS 2.1 Governirent ocunwnts. 2,L.l. Becificutions and standards. The following seclffcatisns and standarda fom a Ilart of this specification to the extent specified herein. fsueat sf them oeuirents shall be those listed in the issue o tho Department: of Defense Index of

7、Specifications and Standards tDsDXaSS) and supplenient thereto, cited in the solicitation. Unless- otherwise specified, the SPECIFICATIONS Federal GG-1-5 26 PPB-B-5 66 PPB-B-636 PPB-B-676 Military MIL-P-116 - Instruments, Dental and Surgical; General - Boxes, Folding, Paperboard. - Boxe Test Methods

8、. Military MIL-STB-105 - Sanpling Procedures and Table for MIL-CTD-129 - Marking for Shipment and Storage. MIL-STD-147 - Palletized Unit Loads. HXL-STB-794 - Parts and Equipment, Procedures for Packaging of. Inspection by Attributes. (Copalec of sgecifieations and standards, require8 by contractors

9、in emneetion with specific acquisition functions should be obtained KOF the contracting activity or as directed by the contracthg activity. ) thio speciffcation ts the extent specified herein. uthrwioe cjpeeified, the issues of the docunents which are DoD adopted ohal% be those listed in the issue o

10、f the DoDTSS specified in the solicitation. ismw of the Qscusnts not listed .in the BoBISS shall be the isme sf the nsngovernwnt dscunents which is current on the date of the solicitation, 2.2 Other aicatisns. The following docurents fern a part of Unless UnlesrJ otherwise specified, the 2 Provided

11、by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-(Nongovernment standards and other publications are normally available from the organizations which prepare or which distribute the documents. These documents also may be available in or through libraries or oth

12、er informational services.) 2.3 Order 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. this specification, however, shall supersede applicable laws and regulations unless a specific

13、 exemption has been obtainipeciffed herein. Except as otherwise specified in the contract OE purchase order, the contractor ray use his own or any aeilitfecj suitable for the perforrrance of the inspection requiren-ents cpecified herein, unless disapproved by the Govewnnent. The Governvent reserves

14、the right to perform any of the inspections set forth in the specification where such inspections are deewed necessary to assure supplies and services confsrn to prescribed requirewents. 4,l,l Xnspectfsn. Inspection, as used in this specification, fsr define6 i18 both exandmation (such as visual and

15、 auditory fnveetfgatdon without the use of special laboratory appliances or prscedures) and testing (dtemination by technical neans o phpieal arid ehenical properties) of the iteni. by ar for the contractor shall be rraintained by the contractor an8 rrade available to the Governrent, upon the Govern

16、pents request, at any tirre, or ron tine to tine, during the perforancs OE the contract and for a period of three years after dellivery sf th supplies to which such records relate. 4,1,3 Certificates of quality. Certificates G quality, supplied by the vanufacturer of the materials, rray be furnished

17、 in fieu sf actual perfornanc of such testing by the contractor, pirovfded 1st fclentfty has been rraintained and can be denonstrated ta the Governvent, The certificate shall include the name of the cQntractmr, the contract nuwber, the nave of the nvmuEacturer or supplier, the NSN, the Item Identifi

18、cation, the name of the eonpsnnt/rPaterial, the lot number, the lot size, the sample size, the date o testing, the test nethod, individual test reults, an the specification requirements. 4.31.4 Inspection lot, An inspection lot, for purposes of safiplhg and testing in accordance with MIL-STD-105, sh

19、all consist of burs of the sare type and shape, ranufactured under essentiaXly the Bave conditions. Each unit package of burs shall be pemanently parked with a serial number, or a corrbination of letters and numbers, which shall refer to the manufacturers records fut- that particular lot or batch, 4

20、.1,2 Rcords. Records o exarinations and tests performed 6 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-MIL-B-42014 (DM) 4.2 Quality conformance inspection. The examinations and tests required to assure conformance of those burs or lots of burs to

21、be offered for acceptance are classified as specified in tables I, II, and III (see 4.2.1, 402.2, and 4.3). 4.2.1 Samplinq for examination. Sampling for examination shall be conducted in accordance with MIL-STD-105. The inspection levels and acceptable quality levels (AQLs) shall be as indicated in

22、table I. The unit of product for examination purposes shall be the individual bur. 4.2.2 Samplinq for tests. Sampling for tests shall be conducted in accordance with MIL-STD-105 and as specified in table II. The acceptance number shall be zero for all sample sizes. The unit of product for test purpo

23、ses shall be the individual bur, unless otherwise stated in the table. TABLE II. Test criteria . Test Inspection Characteristic Requirement procedu re level Chemical 3.1.1 and 4.4.1 see 4.2.3 Hardness 3.2 4.4.2 s-2 Surface roughness 3.6 4.4.3 s-2 Autoclaving 3.5 4.4.4 s-1 . composition 3.1.2 . 4.2.3

24、 Raw material. A sufficient quantity of each lot of rab material used in the manufacture of the burs shall be selected for chemical analysis. shall be used for the determination of two or more test characteristics. 4.2.4 Samplinq unit usaqe. Where feasible, the same burs 7 Provided by IHSNot for Res

25、aleNo reproduction or networking permitted without license from IHS-,-,-MIL-3-42014 (DM) 4,s ExaFination, The burs shall be exarrined for the possible defects listed in table III. The exaaination shall not be lirited to those defects shown in the table. Unless otherwise indicated in the table, the d

26、efect listed shall apply to all burs covered by thist specification, TABLE III. Classification of defects Majoc A: 301 102 103 Total indicated runout exceeds 0,001 inch. 104 Major BE 151 Dirwnsions (other than 204 below) not as specified. Minor 201 202 203 204 2Q5 Bur type and shape not as specified

27、. Bur not of one piece construction. Nunber of flutes not as specified for the applicable bur, Cutoff end on ishank not as shown in applicable Burs not free frop deects such as chipped blades, Finish on bur not as specified. Overall length of bur not within specification Instructions for use inaccur

28、ate, inadequate or figure. crackst OE pits, liFits, nissing. 4.3.1 Dirrnsions. Exaaination of the diirensions shall be rade with a toolrakers rrieroscope, or other instruvent of equal accuracy. calibrated checking standards are used in conjunction with the gages Manufacturers gages nay be used if pr

29、operly 4A2 RunQut. hloek of: precision chuck, and rotated slowly. A dial indicator sensitive to 0.0062 inch and equipped with a knife-edge foot, or a shadow-graph or other suitable equipnent of equal accuracy, shall be ongloyed. If a dial indicator is used, the indicator shall be nounted with the sh

30、aft perpendicular to the axis of the bur, and SQ positioned that the foot contacts the bur neck at: the point of srallest diareter. The rraxirrurr and Finireurn readings obtained during one corrplete 360-degree rotation of the bur shall be neasured and recorded to the nearest 0.0005 inch. The differ

31、ence between these two readings shall be taken as the total indicated runout. The bur shall be placed and held in a “V” 8 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-MIL-B-42014 (DM) 4.3.3 Visual examination. Examination for possible bur defects

32、not perceptible to the unaided eye shall be made using a 1OX magnification. 4.4 Tests. Tests shall be conducted to determine compliance with the requirements of this specification (see 4.2.2). 4.4.1 Chemical composition. In the absence of certificates of quality for the raw material, chemical analys

33、is shall be conducted in accordance with method 111 or 112 of FED-STD-151. In case of dispute, method 111 shall govern. 4.4.2 Hardness. Hardness shall be determined in accordance with ASTM Designation E18 (Rockwell) or E92 (Vickers or Diamond Pyramid) . 4.4.3 Surface roughness. The surface roughness

34、 of the burs shall be deterpined by using a Brush Surfindicator or other equipment of equal accuracy. The RMS average shall be determined by squaring the height peasurements of the peaks and valleys of the surface of the shank, obtaining the averages of the squared values, and then extracting the sq

35、uare root of this square root. 4.4.4 Autoclaving. The test bur shall be cleaned in accordance with the instructions supplied by the manufacturer. The bur shall then be autoclaved at 2700 + 5OF and 27 ,+ f pounds per square inch pressure for a mininum of-20 minutes. After the bur is removed from the

36、autoclave, the entire surface area of the bur shall be exanined for evidence of corrosion. 4.5 Inspection of packaqinq. The sappling and inspection of the preservation and interior package marking shall be in accordance with groups A and B quality confornance inspection requirements of MIL-P-116. Th

37、e sampling and inspection of the packing and marking for shipment and storage shall be in accordance with the quality assurance provisions of the applicable container specification and the parking requirements of MIL-STD-129. 5. PACKAGING 5.1 Preservation. Preservation shall be level A or C, as spec

38、ified (see 6.1) . 5.1.1 Level A. 5.1.1.1 Cleaninq and dryinq. Burs sha1.l be cleaned and dried in accordance with MIL-P-116. 9 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-MIL-B-42014 (DM) 5.1.1.2 Preservative applications. Preservatives shall not

39、 be used. 5.1013 Unit: acka e. Each bur shall be packaged in accordance with MIL-P-1 6, method IC+. As an alternate, each bur shall be packaged in a xigid plastic container having a friction or plug-type closure. protected with suitable cushioning naterial and the bur shall be imobi3iized within the

40、 container, The operative end shall be smloi.4 Intermediate package. Twelve unit packages containing burs of one type and shape only shall be packaged in a box conforming to PPP-B-566 or PPP-B-676. specified in the applicable box specification. Closure shall be as 5oIm2 Level C. 5.1.2.3. Unit packag

41、e. Preservation for burs shall conforni to 5.1.2.2 Intermediate packaqe. Twelve unit packages the requirenents of MIL-STD-794 for level C. containing burs o one type and shape only shall be packaged in accordance with the requirements of MIL-STD-794 for level C. 5.2 Packing. Packing shall be level A

42、, B or C, as specified (see 6.3.17 5.2.5. Level A. Twelve intermediate packages containing burs of one type and shape only (144 units) shall be packe8 in an exterior container designed for a type 2 load and conforming to BPP-B-636, class weather-resistant. Closure, strapping, and waterproofing shall

43、 be as specified in the applicable box specPicaton . 5.2,2 Level 3. Twelve interrediate packages containing burs of one type and shape only (144 units) shall be packed in an exterior container designed for a type 2 load and conforring to PPP-EI-636, class dmestic. Closure shall be as specified in th

44、e box specification, 5.2.3 Level C. Twelve interrediate packages containing burs of one type and shape only (144 units) shall be packed in accordance with the requixements of MIL-CTD-794 for level C. 10 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,

45、-MIL-B-42014 (DM) 5.2.4 Packinq variation permitted. If the required number of units to be shipped is less than the number of units specified to be overpacked in an exterior container, such units shall be packed in an exterior container of suitable size and design, acceptable to a common carrier, wh

46、ich will insure safe delivery to destination. 5.2.5 Unitized loads. Unitized loads, commensurate with the level of packing specified in the contract or order, shall be used whenever total quantities for shipment to one destination equal 40 cubic feet or more. Loads shall be unitized on pallets confo

47、rming to MIL-STD-147. Quantities less than 40 cubic feet need not be unitized. Pallet loads including-the pallet shall- not exceed 43 inches in height, 48 inches in width, and 40 inches in length. Pallet shall conform to Type IV or Type V. 5.2.5.1 Levels A and B. Burs packed as specified in 5.2.1 an

48、d 5.2.2 shall be unitized on pallets as specified in 5.2.5. 5.2.5.2 Level C. Burs packed as specified in 5.2.3 shall be unitized as specified in MIL-STD-794. 5.3 Markinq. 5.3.1 Levels A, B and C. Each unit pack, internediate package, exterior container and unitized load shall be marked as Specified

49、in MIL-STD-129 . 5.4 General. 5.4.1 Exterior container. Exterior container (see 5.2.1r 5.2.2, and 5.2.3) shall be of minimum tare and cube consistent with the protection required and shall contain equal quantities of identical stock numbered items to the greatest extent practicable. 5.4.2 Packaqinq inspection. The inspection of these packaging requirements shall be in accordance with 4.5. 6. NOTES 6.1 - Intended