1、Designation:F70181(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 year of l
2、ast revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon()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 practice is intended
3、 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 Definitions:2.1
4、.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 neurosurgical instrument
5、any 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 orpresterilized packages,enve
6、lopes,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,orabrasionbyotherimplants,instruments,unpackaging tools,or by such
7、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 instruments prior to use in such amanner a
8、s 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 records to facilitate inventory,stock rotat
9、ion,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 implants made of different metals sepa-rate
10、d.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 mixing during surgery.4.Cleaning and Steriliza
11、tion4.1 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 employed should be utilized to prevent impact,sc
12、ratching,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 or harsh cleaning solutions.4.3 After cleaning,rinse
13、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 require lubrication immedi-ately after drying.Follow the recommend
14、ations 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 ofASTM Committee F04 on Medical andSurgical Materials and Devices and is th
15、e 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/F0701-81R08.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,
16、West Conshohocken,PA 19428-2959.United States1 4.5 Carry out sterilization 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 instruments orimplants of other materials.Metallic oxide could transfer to theimplant initiating an unacceptable condition.4.8 Do not expose instrum