ASTM_F_882_-_84_2002.pdf

Designation:F 882 84(Reapproved 2002)Standard Performance and Safety Specification forCryosurgical Medical Instruments1This standard is issued under the fixed designation F 882;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,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.This standard has been approved for use by agencies of the Department of Defense.INTRODUCTIONThis performance and safety specification was developed by Task Force F04.08 on CryosurgicalMedical Instruments.This specification is intended to provide the user of Cryosurgical Medical Instruments with theassurance that the equipment will meet or exceed all safety and performance levels established by thisdocument as claimed by the manufacturer.This is predicated on the requirements that the equipmentis operated according to the manufacturers recommendations.Since,in the pursuit of improved health care and reduced medical costs,the medical industry isrequired to be innovative and dynamic,this standard must be capable of being upgraded in a swift andefficient manner.All inquiries regarding this standard should be addressed to:Committee F04 StaffManager,ASTM,100 Barr Harbor Drive,West Conshohocken,PA 19428.1.Scope1.1 This specification covers standards a manufacturer shallmeet in the designing,manufacturing,testing,labeling,anddocumenting of cryosurgical medical instruments,but it is notto be construed as production methods,quality control tech-niques,or manufacturers lot release criteria,or clinical rec-ommendations.1.2 This specification represents the best currently availabletest procedures at this time and is a minimum safety andperformance standard.1.3 This specification covers only those cryosurgical de-vices intended for use on humans or animals for therapeuticpurposes.This specification assumes the user is well-trained inthe procedures of cryosurgery and has the ability to determineif an abnormality is treatable by cryosurgery,particularly bythe type of equipment to be used.1.4 Cryosurgical medical instruments produce low tempera-tures either inside a cryoprobe or directly on the target tissue bythe principle of Latent Heat of Vaporization or the Joule-Thompson Effect,or both.The cryogen may be transportedfrom the source as a liquid or a gas.These systems may beclosed or open depending on the application and cryogen.Inthe open cryotip system,the cryogen is applied directly to thetarget tissue,while in the closed cryotip system,the cryogen isapplied indirectly and is exhausted away from the target area.1.5 Cryosurgical medical instruments are used to producecryonecrosis,inflammatory response,or cryoadhesion.1.6 Monitoring the progress of treatment during applicationis sometimes very important.Such monitoring is done byaccessories that indicate the temperature of the cryotip or thetarget area being frozen.The temperature of the tissue may bemeasured directly(for example,by a thermocouple).Theseaccessories are also covered by this specification.1.7 The following precautionary caveat pertains only to theTest Method portion,Sections 8 through 13,of this specifica-tion:This standard may involve hazardous materials,opera-tions,and equipment.This standard does not purport toaddress all of the safety concerns,if any,associated with itsuse.It is the responsibility of the user of this standard toestablish appropriate safety and health practices and deter-mine the applicability of regulatory limitations prior to use.2.Referenced Documents2.1ANSI Standard:ANSI B40.1-1974 Use and Installation of Pressure Gauges22.2ANSI/AAMI Document:ANSI/AAMI SCL 12/7832.3Canadian Standards Association(C.S.A.)Standard:C22.2-125Electromedical Equipment 197341This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.33 on Medical/Surgical Instruments.Current edition approved Sept.11,1984.Published February 1985.2Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036.3Available from the Association for the Advancement of Medical Instrumenta-tion(AAMI).1901 North Fort Myer Drive,Suite 602,Arlington,VA 22209.4Available from the Canadian Standards Association(C.S.A),173 RexdaleBlvd.,Rexdale,Ontario M9W 1R3,Canada.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.2.4International ElectroTechnical Commission(IEC)Document:IEC 601-1197752.5Compressed Gas Association Document:CGA V-1197762.6FDA Document:21CFR801:Labeling Specifications72.7NBS Document:Table IPTS-68 NBS Monograph 12583.Terminology3.1 Definitions:3.1.1 closed cryotipa hollow,closed end usually shapedto fit a particular anatomical site where the cryogen cools theexternal surface which is applied to the target tissue