ASTM F700-1993(2008) Standard Practice for Care and Handling of Intracranial Aneurysm Clips and Instruments《颅内动脉卡箍及仪器的保养及管理的标准实施规程》.pdf

1、Designation: F 700 93 (Reapproved 2008)Standard Practice forCare and Handling of Intracranial Aneurysm Clips andInstruments1This standard is issued under the fixed designation F 700; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision,

2、the year 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 of neurosurgical intracranial aneurysm clips an

3、d the clipappliers (instruments).1.2 This practice is intended to inform hospital receivingpersonnel, central supply personnel, operating room personnel,and other individuals who will handle intracranial aneurysmclips and the instruments related thereto of recommended careand handling procedures to

4、prevent damage of intracranialaneurysm clips and instruments.1.3 Handling and packaging procedures for the product arenot a part of this practice and are covered in other practices.2. Terminology2.1 Definitions:2.1.1 clip applierany clip holder designed specifically fora particular type clip used du

5、ring surgical procedures involvingthe implantation of intracranial aneurysm clips. This device isreferred to in this practice as a clip applier.2.1.2 intracranial aneurysm clipa device introduced sur-gically to occlude the blood inlet into an intracranial aneurysmwith the intention that it remain wi

6、thin the body following thesurgery. This device is referred to in this practice as an“implant,” specifically as an intracranial aneurysm clip.3. Receiving Implants and Instruments3.1 Receipt:3.1.1 Many implants are wrapped in special packages,envelopes, or other containers. These wrappings should no

7、t beremoved by the receiving personnel.3.1.2 Carefully handle nonsterilized implants and instru-ments upon receipt to avoid scratching, marking, or abrasionby other implants, instruments, unpacking tools, or by drop-ping or otherwise endangering the surface finish or configura-tion.3.2 TransportTran

8、sport in a manner to preclude anydamage or alteration to the received condition of the implant orinstrument (clip applier).3.3 Storage:3.3.1 Store the aneurysm clips and appliers prior to use insuch a manner to maintain the devices surface finish orconfiguration, or both.3.3.2 Implants will be ident

9、ified by a unique code on thesurface of the device. When implanted, it is necessary that thetype of aneurysm clip and its code be noted in the operativereport.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 isol

10、ate and protect the implants surface, sterility, andconfiguration. Keep implants made of different metals sepa-rated.4. Cleaning and Sterilization4.1 Prior to resterilization and promptly following eachsurgical procedure, thoroughly and carefully clean all instru-ments and implants with approved cle

11、aning techniques. Ultra-sonic cleaners or hand scrubbing are suitable methods ifcarefully done. The method employed should be utilized toprevent impact, scratching, bending, or surface contact withany materials that might affect the implant or instrumentconfiguration. Aneurysm clips must not be open

12、ed except bytheir specific applier.4.2 Any clip that has been implanted or in direct contactwith blood or body fluids and is not used in the procedureshould not be reused in any subsequent procedure. The clipsshould be discarded; in accordance with tracing requirements,the manufacturer must be infor

13、med of each clip that isdiscarded.4.3 After cleaning, rinse the neurosurgical intracranial an-eurysm clips and instruments completely free of all residuals1This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of Su

14、bcommitteeF04.31 on Neurosurgical Standards.Current edition approved Feb. 1, 2008. Published March 2008. Originallyapproved in 1981. Last previous edition approved in 2002 as F 700 93 (2002).1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United S

15、tates.including soap, detergent, or cleaning solutions; and drythoroughly. Devote special attention to hinges on the instru-ments and recesses on the clips since these are points thatentrap both chemicals and rinse water. In so doing, the clipmust not be opened except by its designated applier.4.4 L

16、ubricate clip appliers that require lubrication immedi-ately after drying. Follow the recommendations of the manu-facturers of such instruments explicitly as to the method, type,and amount of lubricant. Do not lubricate the clips.4.5 Carry out sterilization by steam autoclaving or othermethods in a

17、manner that protects the integrity of the aneurysmclips and appliers.4.6 Do not sterilize implants in contact with instruments orimplants of other materials. Metallic oxide could transfer to theimplant, initiating an unacceptable condition.5. Use of Neurosurgical Intracranial Aneurysm Clips andAppli

18、ers5.1 Open and close an aneurysm clip with the clip applierspecifically manufactured to handle that particular aneurysmclip. At no time should an aneurysm clip be opened with thefingertips.5.1.1 Any aneurysm clip that has been opened with thefingertips should be discarded and never used in a patien

19、t.5.2 No attempt should be made to alter the configuration ofpreformed aneurysm clip legs or springs.5.2.1 Dispose of intracranial aneurysm clips that exhibitsurface or configuration damage.5.2.2 Dispose of intracranial aneurysm clips whose perfor-mance capabilities have been jeopardized by mishandl

20、ing orimproper care.6. Keywords6.1 handling of implants; instruments; material handling;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 a

21、re 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 reviewed every five years andif not

22、 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 technical committee, which y

23、ou 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 700 93 (2008)2