ASTM F2401-2016 Standard Practice for Security Checkpoint Metal Detector Screening of Persons with Medical Devices《带医疗设备的人员安全检测点金属探测器屏蔽的标准实施规程》.pdf
《ASTM F2401-2016 Standard Practice for Security Checkpoint Metal Detector Screening of Persons with Medical Devices《带医疗设备的人员安全检测点金属探测器屏蔽的标准实施规程》.pdf》由会员分享,可在线阅读,更多相关《ASTM F2401-2016 Standard Practice for Security Checkpoint Metal Detector Screening of Persons with Medical Devices《带医疗设备的人员安全检测点金属探测器屏蔽的标准实施规程》.pdf(7页珍藏版)》请在麦多课文档分享上搜索。
1、Designation: F2401 04 (Reapproved 2010)F2401 16Standard 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 th
2、e 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 needs and concerns of persons with i
3、mplanted, active, medical devices oractive ambulatory medical devices, as well as passive implanted medical devices, while maintaining the integrity of the securitycheckpoint.1.2 Active and passive implanted medical devices are being used at an increasing rate as a means to prolong and improve quali
4、tyof life. Although these medical devices are typically designed to operate in the electromagnetic environment experienced in dailylife, there is a potential for the disruption of active medical device function when exposed to certain electromagnetic fields emittedby commonly encountered electricall
5、y powered products, including handheld and walk-through metal detectors used in securitycheckpoint screening. In addition, some active or passive implanted devices may trigger the unintended alarm of the metal detector.1.3 The values stated in SI units are to be regarded as the standard. The values
6、shown in parentheses are for information only.1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety and health practices and determine the applicability of regula
7、torylimitations prior to use.2. Referenced Documents2.1 ISO Standards:2ISO 14117 Active implantable medical devices Electromagnetic compatibility EMC test protocols for implantable cardiacpacemakers, implantable cardioverter defibrillators, and cardiac resynchronization devicesISO 14708-1 Implants f
8、or surgery Active implantable medical devices Part 1: General requirements for safety, marking andfor information to be provided by the manufacturerISO 14708-2 Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakersISO 14708-3 Implants for surgery Active implantable medica
9、l devices Part 3: Implantable neurostimulatorsISO 14708-4 Implants for surgery Active implantable medical devices Part 4: Implantable infusion pumpsISO 14708-5 Implants for surgery Active implantable medical devices Part 5: Circulatory support devicesISO 14708-6 Implants for surgery Active implantab
10、le medical devices Part 6: Particular requirements for active implantablemedical devices intended to treat tachyarrhythmia (including implantable defibrillators)ISO 14708-7 Implants for surgery Active implantable medical devices Part 7: Particular requirements for cochlear implantsystems3. Terminolo
11、gy3.1 Definitions:3.1.1 active medical devices, nelectrically powered medical devices, usually employing electronic circuitry, for humanphysiological monitoring or to deliver medical treatment or therapy such as drugs or electrical stimulation. These devices can beimplanted, patient worn, or both.3.
12、1.2 ambulatory medical devices, nany medical device (active or nonactive) that can be body mounted, worn, implanted, orotherwise mobile with the patient and thus subject to screening at the security checkpoint.1 This practice is under the jurisdiction of ASTM Committee F12 on Security Systems and Eq
13、uipment and is the direct responsibility of Subcommittee F12.60 onControlled Access Security, Search, and Screening Equipment.Current edition approved May 1, 2010Oct. 1, 2016. Published May 2010October 2016. Originally approved in 2004. Last previous edition approved in 20042010 asF2401F2401 04. 04
14、(2010). DOI: 10.1520/F2401-04R10.10.1520/F2401-16.2 Available from International Organization for Standardization (ISO), ISO Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva,Switzerland, http:/www.iso.org.This document is not an ASTM standard and is intended only to
15、 provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof
16、 the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States13.1.3 archway, nphysical structure of a walk-through metal detector.3.1.4 electromagnetic field, nwhen refere
17、nced in this practice, it describes the energy field created by the metal detector asa means to produce a response to materials with electrical conductivity or magnetic susceptibility, or both. The electromagneticfields used in metal detectors for security screening applications are typically low fr
18、equency and vary with time and locations.3.1.5 handheld metal detector, nportable metal detector product used by a security screener to provide localized searches ofa person.3.1.6 passive (nonactive) medical devices, nnonelectrically powered medical devices. These types of medical devices mayhave su
19、fficient metallic content to cause a response from a metal detector. These devices can be implanted, patient worn, or both.3.1.7 security checkpoint, naccess point equipped with personnel and screening devices used as a means to control the flowof weapons or contraband material, or both.3.1.8 securi
20、ty screener, ntrained person performing the necessary functions at a security checkpoint.3.1.9 walk-through metal detector, npermanently placeda stationary metal detector product typically in an archway form thatis typically permanently fixed in a particular location but may be temporarily fixed, is
21、 typically constructed in an archway form,and that provides a search of the entire body as a person passes through the portal of the detector.4. Summary of Practice4.1 This practice provides the means to identify, evaluate, and screen persons with ambulatory medical devices and reportincidences invo
22、lving medical device users.4.2 These means shall include security checkpoint layout, signage, screening procedures, screener training, and information forthe medical community (physicians, nurses, device manufacturers, patients, and so forth) about checkpoint security procedures toencourage the stan
23、dardization of information and media provided to persons with medical devices.5. Significance and Use5.1 This practice is intended to be used as a guide for the design, configuration, and operation of security checkpoints tominimize exposure of ambulatory medical devices to the electromagnetic field
24、s emitted by metal detector security systems.Guidance is presented for signage and information to help identify persons with ambulatory medical devices and process themthrough the security checkpoint.5.2 This practice is intended to help in the training of checkpoint screeners to address the concern
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