ASTM F565-2004 Standard Practice for Care and Handling of Orthopedic Implants and Instruments《矫形植入物和器具的维护与管理的标准实施规程》.pdf

1、Designation: F 565 04Standard Practice forCare and Handling of Orthopedic Implants and Instruments1This standard is issued under the fixed designation F 565; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision

2、. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This practice covers recommended procedures for thehandling of orthopedic implants and instruments.1.2 Hospital receiving personne

3、l, central supply personnel,operating room personnel, surgeons, and occasionally otherindividuals will handle orthopedic implants and instruments.All personnel should be informed of recommended care andhandling procedures to prevent damage of orthopedic implantsand instruments.1.3 This practice does

4、 not cover producer level handlingand packaging procedures.1.4 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bi

5、lity of regulatory limitations prior to use.2. Terminology2.1 Definitions of Terms Specific to This Standard:2.1.1 orthopedic implanta device introduced by surgicallypenetrating the skin or mucosa of the body with the intentionthat it remain within or attached to the skeleton within the bodyfollowin

6、g the surgery. This device is referred to in this practiceas an “implant.”2.1.2 orthopedic instrumentany cooperative device usedduring surgical procedures involving the implantation of or-thopedic implants. This device is referred to in this practice asan “instrument.”3. Receiving Implants and Instr

7、uments3.1 Receipt:3.1.1 Many implants are wrapped in special sterilizable orpre-sterilized packages, envelopes, or other containers. Thesewrappings should not be removed by the receiving personnel.3.1.2 Carefully unwrap and handle non-sterilized implantsand instruments upon receipt to avoid scratchi

8、ng, marking, orabrasion by other implants, instruments, unpacking tools, or bydropping or otherwise endangering the surface finish or con-figuration.3.2 TransportPerform transport in a manner to precludeany damage or alteration to the received condition of theimplant or instrument.3.3 Storage:3.3.1

9、Store implants or instruments prior to use in such amanner as to maintain the devices surface finish or configu-ration, or both.3.3.2 Many implants are identified by a serial or lot number,or both, on the package label, package insert, or surface of thedevice. Record these control numbers and retain

10、 for transfer topatient records, to facilitate inventory, stock rotation, medicaldevice reporting, and possible traceability to the manufacturer.3.3.3 Stock RotationThe principle of first in, first out, isrecommended.3.3.4 Store implants in the operating room in such a manneras to isolate and protec

11、t the implants surface, sterility, andconfiguration. Keep implants made of different metals sepa-rated.3.3.5 Store the implants and instruments in the operatingroom in such a manner as to isolate the instruments from theimplants.4. Handling4.1 Mixing MetalsMaintain orthopedic implants and in-strumen

12、ts of different metals separately to avoid the possibilityof mixing during surgery.4.2 Cleaning and Sterilization:4.2.1 Prior to initial sterilization and promptly followingeach surgical procedure, thoroughly and carefully clean allinstruments and implants. Ultrasonic cleaners, mechanizedwashers, or

13、 hand scrubbing are suitable methods, if carefullydone. The method employed should be utilized to preventimpact, scratching, bending, or surface contact with anymaterials that might affect the implant or instrument surface orconfiguration.4.2.2 Closely follow the manufacturers recommendationson clea

14、ning. In hand scrubbing, use soft brushes and avoidharsh chemicals or harsh cleaning solutions.4.2.3 After cleaning, rinse the orthopedic implants andinstruments completely free of all residuals, soap, detergent, or1This practice is under the jurisdiction of ASTM Committee F04 on Medical andSurgical

15、 Materials and Devices and is the direct responsibility of SubcommitteeF04.21 on Osteosynthesis.Current edition approved Oct. 1, 2004. Published October 2004. Originallyapproved in 1978. Last previous edition approved in 2003 as F 565 00 (2003).1Copyright ASTM International, 100 Barr Harbor Drive, P

16、O Box C700, West Conshohocken, PA 19428-2959, United States.cleaning solutions. Following rinsing, dry them thoroughly.Devote special attention to hinges, pivots, box locks, and otherrecesses since these are points that entrap both chemicals andrinse water.4.2.4 Lubricate instruments that require lu

17、brication imme-diately after drying. Follow the recommendations of themanufacturers of such instruments explicitly as to method,type, and amount of lubricant. Insufficient or excessive lubri-cation can be nearly as disastrous as no lubrication.4.2.5 Carry out sterilization by steam autoclaving or ot

18、hermethods in a manner that protects the integrity of the implantsand instruments.4.2.6 Sterilize implants and instruments of polymericmaterials in accordance with methods recommended by themanufacturer.4.2.7 Do not sterilize implants in contact with instrumentsor implants of other materials. Metall

19、ic oxide could transfer tothe implant, initiating an unacceptable conditioning.4.2.8 Do not expose instrumental cutting edges and teeth tothe hazard of dulling.4.3 AppearanceDispose of orthopedic implants that ex-hibit surface or configuration damage.4.4 Contouring and Modifying Implants and Instrum

20、ents:4.4.1 Contouring or clamping of orthopedic implants, whennecessary, shall be performed by the surgeon in a manner thatwill least damage the implant.4.4.2 It is recommended that metallic orthopedic implantsshould not be sharply bent, re-bent, angulated at a screw hole,notched, or scratched.4.4.3

21、 Reshaping or contouring may cause complete loss ofperformance for instruments. It is recommended that orthope-dic instruments be handled with care to prevent costly rework-ing or destruction. If modifications are necessary, the instru-ment should not be sharply bent, re-bent, or angulated.4.4.4 Ort

22、hopedic instruments in general have a long servicelife, but mishandling or inadequate protection can quicklydiminish the instruments life expectancy.4.4.5 Dispose of instruments whose performance capabili-ties have been jeopardized by mishandling or improper care.5. Reuse5.1 Avoid the reimplantation

23、 of previously implanted ortho-pedic implants.5.2 Trial fitting of an orthopedic implant in a patient,followed by proper cleaning and sterilization if not immedi-ately implanted in the same patient, may not in all instances beconsidered as reimplantation. The user is cautioned that anymechanical alt

24、eration of the components (for example, platebending), coating damage, or surface damage (for example,nicks,ch scratches) should prevent the device from beingreimplanted. In addition, certain coatings (porous coating, HA)may not be able to be recleaned or resterilized, or both, whileproperly maintai

25、ning the integrity of the implant. The usershould refer to the manufacturers instructions for guidance; or,in their absence, the device should not be reimplanted.6. Keywords6.1 handling of implants; instruments; material handlingASTM International takes no position respecting the validity of any pat

26、ent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision

27、 at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comm

28、ents will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighte

29、d by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).F565042