ASTM F701-1981(2002) Standard Practice for Care and Handling of Neurosurgical Implants and Instruments《神经外科用植入物及仪器的保养及管理》.pdf

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1、Designation: F 701 81 (Reapproved 2002)Standard Practice forCare and Handling of Neurosurgical Implants andInstruments1This standard is issued under the fixed designation F 701; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the y

2、ear of last revision. 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 han-dling neurosurgical implants and instruments.1.2 This prac

3、tice 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. Terminology

4、2.1 Definitions:2.1.1 neurosurgical implantfor the purpose of this prac-tice, a device introduced by surgically penetrating the skin ormucosa of the body with the intention that it remain indefi-nitely within the body following surgery. This device isreferred to in this practice as an “implant.”2.1.

5、2 neurosurgical 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

6、orpresterilized 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, in

7、stru-ments, unpackaging tools, or by such mishaps as dropping orotherwise endangering the surface finish or configuration.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 ins

8、truments 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 for transfer topatie

9、nt records 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, andconfigurati

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

11、ty of mixing 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. T

12、hemethod 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 harshch

13、emicals 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 t

14、hat require 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.4.5 Carry out sterilization by steam autoc

15、laving or other1This practice is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.31 on Neurosurgical Standards.Current edition approved Jan. 30, 1981. Published March 1981.1Copyright ASTM International, 100

16、 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.methods 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 steril

17、ize implants in contact with instruments 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 co

18、ntour an implant may alter its perfor-mance 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

19、by mishandling or improper care.Dispose 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 hand

20、ling;neurosurgical medical devices/applicationsASTM 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,

21、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 reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revi

22、sion 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 technical committee, which you may attend. If you feel that your comments have not received a fair hearing you

23、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 701 81 (2002)2