ASTM_F_2401_-_16.pdf

Designation:F240116Standard Practice forSecurity Checkpoint Metal Detector Screening of Personswith Medical Devices1This standard is issued under the fixed designation F2401;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()indicates an editorial change since the last revision or reapproval.1.Scope1.1 The following practice is intended to address the needsand concerns of persons with implanted,active,medicaldevices or active ambulatory medical devices,as well aspassive implanted medical devices,while maintaining theintegrity of the security checkpoint.1.2 Active and passive implanted medical devices are beingused at an increasing rate as a means to prolong and improvequality of life.Although these medical devices are typicallydesigned to operate in the electromagnetic environment expe-rienced in daily life,there is a potential for the disruption ofactive medical device function when exposed to certain elec-tromagnetic fields emitted by commonly encountered electri-cally powered products,including handheld and walk-throughmetal detectors used in security checkpoint screening.Inaddition,some active or passive implanted devices may triggerthe unintended alarm of the metal detector.1.3 The values stated in SI units are to be regarded as thestandard.The values shown in parentheses are for informationonly.1.4 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ISO Standards:2ISO 14117 Active implantable medical devices Electro-magnetic compatibility EMC test protocols for implant-able cardiac pacemakers,implantable cardioverterdefibrillators,and cardiac resynchronization devicesISO 14708-1 Implants for surgery Active implantablemedical devices Part 1:General requirements for safety,marking and for information to be provided by themanufacturerISO 14708-2 Implants for surgery Active implantablemedical devices Part 2:Cardiac pacemakersISO 14708-3 Implants for surgery Active implantablemedical devices Part 3:Implantable neurostimulatorsISO 14708-4 Implants for surgery Active implantablemedical devices Part 4:Implantable infusion pumpsISO 14708-5 Implants for surgery Active implantablemedical devices Part 5:Circulatory support devicesISO 14708-6 Implants for surgery Active implantablemedical devices Part 6:Particular requirements foractive implantable medical devices intended to treat tach-yarrhythmia(including implantable defibrillators)ISO 14708-7 Implants for surgery Active implantablemedical devices Part 7:Particular requirements forcochlear implant systems3.Terminology3.1 Definitions:3.1.1 active medical devices,nelectrically powered medi-cal devices,usually employing electronic circuitry,for humanphysiological monitoring or to deliver medical treatment ortherapy such as drugs or electrical stimulation.These devicescan be implanted,patient worn,or both.3.1.2 ambulatory medical devices,nany medical device(active or nonactive)that can be body mounted,worn,implanted,or otherwise mobile with the patient and thussubject to screening at the security checkpoint.3.1.3 archway,nphysical structure of a walk-throughmetal detector.3.1.4 electromagnetic field,nwhen referenced in thispractice,it describes the energy field created by the metaldetector as a means to produce a response to materials withelectrical conductivity or magnetic susceptibility,or both.Theelectromagnetic fields used in metal detectors for securityscreening applications are typically low frequency and varywith time and locations.1This practice is under the jurisdiction of ASTM Committee F12 on SecuritySystems and Equipment and is the direct responsibility of Subcommittee F12.60 onControlled Access Security,Search,and Screening Equipment.Current edition approved Oct.1,2016.Published October 2016.Originallyapproved in 2004.Last previous edition approved in 2010 as F2401 04(2010).DOI:10.1520/F2401-16.2Available from International Organization for Standardization(ISO),ISOCentral Secretariat,BIBC II,Chemin de Blandonnet 8,CP 401,1214 Vernier,Geneva,Switzerland,http:/www.iso.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.1.5 handheld metal detector,nportable metal detectorproduct used by a security screener to provide localizedsearches of a person.3.1.6 passive(nonactive)medicaldevices,nnonelectrically powered medical devices.These types ofmedical devices may have sufficient metallic content to causea response from a metal detector.These devices can beimplanted,patient worn,or both.3.1.7 security checkpoint,naccess point equipped withpersonnel and screening devices used as a