ASTM F565-2004(2009)e1 Standard Practice for Care and Handling of Orthopedic Implants and Instruments《矫形移植物与器具的维护与管理的标准实施规程》.pdf

1、Designation: F 565 04 (Reapproved 2009)1Standard 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 ye

2、ar of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1NOTEUnits information was editorially corrected in August 2009.1. Scope1.1 This practice covers recommended procedures for

3、thehandling of orthopedic implants and instruments.1.2 Hospital receiving personnel, 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 procedu

4、res to prevent damage to orthopedic implantsand instruments.1.3 This practice does not cover producer level handlingand packaging procedures.1.4 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.1.5 This standard does not purport

5、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-bility of regulatory limitations prior to use.2. Terminology2.1 Definitions of Terms Specific to

6、 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 bodyfollowing the surgery. This device is referred to in this practiceas an “implant.”2.1.2 orthopedic ins

7、trumentany 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 Instruments3.1 Receipt:3.1.1 Many implants are wrapped in special sterilizable orpre-sterilized pac

8、kages, 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 scratching, marking, orabrasion by other implants, instruments, unpacking tools, or bydropping or othe

9、rwise 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 Store implants or instruments prior to use in such amanner as to maintain the devices surface

10、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 for transfer topatient records, to facilitate inventory, stock rotation, medicaldevice report

11、ing, 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 protect the implants surface, sterility, andconfiguration. Keep implants made of different metals se

12、pa-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-struments of different metals separately to avoid the possibilityof mixing during surgery.4.2 Cleanin

13、g 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 hand scrubbing are suitable methods, if carefullydone. The method employed should be utilized

14、 to prevent1This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.21 on Osteosynthesis.Current edition approved April 1, 2009. Published April 2009. Originallyapproved in 1978. Last previous editi

15、on approved in 2004 as F 565 04.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.impact, scratching, bending, or surface contact with anymaterials that might affect the implant or instrument surface orconfiguration.4.2.2 Closely follo

16、w the manufacturers recommendationson cleaning. When 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, orcleaning solutions. Following rinsing, dr

17、y 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 lubrication imme-diately after drying. Follow the recommendations of themanufacturers of such instrumen

18、ts explicitly as to the 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 othermethods in a manner that protects the integrity of the implantsand instruments.4.2.6 Sterilize

19、 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. Metallic oxide could transfer tothe implant, initiating an unacceptable conditioning.4.2.8 Do not expos

20、e 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 Instruments:4.4.1 Contouring or clamping of orthopedic implants, whennecessary, shall be performed by th

21、e 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 Reshaping or contouring may cause complete loss ofperformance for instruments. It is recommended

22、 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 Orthopedic instruments in general have a long servicelife, but mishandling or inadequate protection

23、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 of previously implanted ortho-pedic implants.5.2 Trial fitting of an orthopedic implant in a pat

24、ient,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 alteration of the components (for example, platebending), coating damage, or surface damage (for exa

25、mple,nicks, dents, and scratches) should prevent the device frombeing reimplanted. In addition, certain coatings (porous coat-ing, hydroxyapatite (HA) may not be able to be recleaned orresterilized, or both, while properly maintaining the integrity ofthe implant. The user should refer to the manufac

26、turersinstructions for guidance; or, in their absence, the deviceshould not be reimplanted.6. Keywords6.1 handling of implants; instruments; material handlingASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standa

27、rd. 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 at any time by the responsible technical committee and must be reviewe

28、d 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 comments will receive careful consideration at a meeting of theresponsible

29、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 copyrighted 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).F 565 04 (2009)12