1、Designation: F565 04 (Reapproved 2018)Standard Practice forCare and Handling of Orthopedic Implants and Instruments1This standard is issued under the fixed designation F565; the number immediately following the designation indicates the year of originaladoption or, in the case of revision, the year
2、of last revision. A number in parentheses indicates the year of last reapproval. A superscriptepsilon () 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 rec
3、eiving 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 procedures to prevent damage to orthopedic implantsand instruments.1.3 Thi
4、s 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 to address all of thesafety concerns, if any, associated with its u
5、se. It is theresponsibility of the user of this standard to establish appro-priate safety, health, and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.6 This international standard was developed in accor-dance with internationally recognized principl
6、es on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Terminology2.1 Definitions of Terms Specific to This Standard:2.1.1 orthope
7、dic 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 instrumentany cooperative devic
8、e 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 packages, envelopes, or other c
9、ontainers. 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 otherwise endangering the surfac
10、e 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 finish orconfiguration, or b
11、oth.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 reporting, and possible traceability
12、 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 sepa-rated.3.3.5 Store the impla
13、nts 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 Cleaning and Sterilization:4.2.1 Prio
14、r 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 to prevent1This practice is u
15、nder the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.21 on Osteosynthesis.Current edition approved Feb. 1, 2018. Published April 2018. Originallyapproved in 1978. Last previous edition approved in 2013 as F565 04
16、(2013).DOI: 10.1520/F0565-04R18.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Princi
17、ples for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.1impact, scratching, bending, or surface contact with anymaterials that might affect the implant or instrument surface orconfiguration.4.2
18、.2 Closely follow 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. Follo
19、wing 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 lubrication imme-diately after drying. Follow the recommendations of themanufacturers o
20、f such instruments 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
21、.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. Metallic oxide could transfer tothe implant, initiating an unacceptable conditioning.4.
22、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 Instruments:4.4.1 Contouring or clamping of orthopedic implants, whennecessary, shall be
23、 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 Reshaping or contouring may cause complete loss ofperformance for instruments. I
24、t 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 Orthopedic instruments in general have a long servicelife, but mishandling or inadeq
25、uate 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 of previously implanted ortho-pedic implants.5.2 Trial fitting of an orthopedic
26、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 alteration of the components (for example, platebending), coating damage, or surface
27、 damage (for example,nicks, dents, and scratches) should prevent the device frombeing reimplanted. In addition, certain coatings (porouscoating, hydroxyapatite (HA) may not be able to be recleanedor resterilized, or both, while properly maintaining the integrityof the implant. The user should refer
28、to the manufacturersinstructions 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 mentioned
29、in 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 at any time by the responsible technical committee and m
30、ust 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 comments will receive careful consideration at a meeting of t
31、heresponsible 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 C7
32、00, 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). Permission rights to photocopy the standard may also be secured from the Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 04 (2018)2
