ASTM F701 - 81(2008) Standard Practice for Care and Handling of Neurosurgical Implants and Instruments (Withdrawn 2017).pdf

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1、Designation: F701 81 (Reapproved 2008)Standard Practice forCare and Handling of Neurosurgical Implants andInstruments1This standard is issued under the fixed designation F701; the number immediately following the designation indicates the year of originaladoption or, in the case of revision, the yea

2、r 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 han-dling neurosurgical implants and instruments.1.2 This practic

3、e is intended to inform hospital receivingpersonnel, central supply personnel, operating room personnel,and other individuals who will handle neurosurgical implantsand instruments of recommended care and handling proceduresto prevent damage of neurosurgical implants and instruments.2. Terminology2.1

4、 Definitions:2.1.1 neurosurgical implantfor the purpose of thispractice, a device introduced by surgically penetrating the skinor mucosa of the body with the intention that it remainindefinitely within the body following surgery. This device isreferred to in this practice as an “implant.”2.1.2 neuro

5、surgical instrumentany cooperative deviceused during surgical procedures involving the implantation ofneurosurgical implants. This device is referred to in thispractice as an “instrument.”3. Receiving Implants and Instruments3.1 Receipt:3.1.1 Many implants are wrapped in special sterilizable orprest

6、erilized packages, envelopes, or other containers. Thesewrappings should not be removed by the personnel whoreceive the packages.3.1.2 Carefully unwrap and handle nonsterilized implantsand instruments upon receipt in such a manner to avoidscratching, marking, or abrasion by other implants,instrument

7、s, unpackaging tools, or by such mishaps as drop-ping or otherwise endangering the surface finish or configura-tion.3.2 TransportTransport in a manner to preclude anydamage or alteration to the received condition of the implant orinstrument when received.3.3 Storage:3.3.1 Store implants or instrumen

8、ts prior to use in such amanner as to maintain the devices surface finish orconfiguration, 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 recor

9、ds to facilitate inventory, stock rotation, andpossible 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

10、 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.3.3.6 Mixing MetalsMaintain neurosurgical implants andinstruments of different metals separately to avoid the possi-bility of mi

11、xing during surgery.4. Cleaning and Sterilization4.1 Prior to initial sterilization and promptly following eachsurgical procedure, thoroughly and carefully clean all instru-ments and implants. Ultrasonic cleaners, mechanized washers,or hand scrubbing are suitable methods if carefully done. Themethod

12、 employed should be utilized to prevent impact,scratching, bending, or surface contact with any materials thatmight affect the implant or instrument surface or configuration.4.2 Closely follow the manufacturers recommendations oncleaning. In hand scrubbing, use soft brushes and avoid harshchemicals

13、or harsh cleaning solutions.4.3 After cleaning, rinse the neurosurgical implants andinstruments completely free of all residuals, soap, detergent, orcleaning solutions. Dry thoroughly after rinsing. Devote spe-cial attention to hinges, pivots, chemicals, and water.4.4 Lubricate instruments that requ

14、ire lubrication immedi-ately after drying. Follow the recommendations of the manu-facturers of such instruments explicitly as to method, type, andamount of lubricant. Insufficient or excessive lubrication canbe nearly as disastrous as no lubrication.1This practice is under the jurisdiction of ASTM C

15、ommittee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.31 on Neurosurgical Standards.Current edition approved Feb. 1, 2008. Published March 2008. Originallyapproved in 1981. Last previous edition approved in 2002 as F701 81 (2002).DOI: 10.1520/F

16、0701-81R08.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesNOTICE: This standard has either been superseded and replaced by a new version or withdrawn.Contact ASTM International (www.astm.org) for the latest information14.5 Carry out s

17、terilization by steam autoclaving or othermethods in a manner that protects the integrity of the implantsand instruments.4.6 Sterilize implants and instruments of polymeric materi-als in accordance with methods recommended by the manu-facturer.4.7 Do not sterilize implants in contact with instrument

18、s orimplants of other materials. Metallic oxide could transfer to theimplant initiating an unacceptable condition.4.8 Do not expose instrument cutting edges and teeth to thehazard of dulling.5. Contouring and Modifying Implants and Instruments5.1 Attempts to contour an implant may alter its perfor-m

19、ance characteristics.5.2 Neurosurgical instruments, in general, have a longservice life, but mishandling or inadequate protection canquickly diminish the instruments life expectancy.5.3 Dispose of instruments whose performance capabilitieshave been jeopardized by mishandling or improper care.Dispose

20、 of neurosurgical implants that exhibit surface orconfiguration damage.6. Reuse6.1 Do not use neurosurgical implants that previously havebeen implanted and subsequently removed at surgery orautopsy.7. Keywords7.1 handling of implants; instruments; material handling;neurosurgical medical devices/appl

21、icationsASTM International takes no position respecting the validity of any patent 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 rig

22、hts, are entirely their own responsibility.This standard is subject to revision 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

23、 standardsand should be addressed to ASTM International Headquarters. Your comments 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

24、 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). Permission rights to photocopy the standard may also be secured from the ASTM website (www.astm.org/COPYRIGHT/).F701 81 (2008)2