1、Designation: F2428 04 (Reapproved 2011)Standard Guide forSelection and Use for Pelvic Ring CircumferentialCompression Stabilization Devices (PRCCSD)1This standard is issued under the fixed designation F2428; the number immediately following the designation indicates the year oforiginal adoption or,
2、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 This guide establishes minimum standards for devicesdesignated here as pelvic rin
3、g circumferential compressionstabilization devices(s) (PRCCSD), commonly known as pel-vic slings, belts, or binders. The PRCCSD is used as the initialpelvic ring stabilization device on patients suspected of havingsustained traumatic disruptions of the pelvic ring. It is usedduring patient transport
4、 by emergency personnel and beforedefinitive treatment.1.2 This guide addresses the recognized need to reduce andstabilize pelvic ring disruptions through the use of circumfer-ential compression devices.1.3 Peer-reviewed medical literature does describe specifictesting methods used to determine the
5、range of effectivecompression force, efficacy in reduction, stability, and safetyfor a particular (PRCCSD). This guide, however, does notidentify specific testing methods as it is recognized suchmethods could vary according to device configuration andstudy design.1.4 This guide does not address indi
6、vidual quantitativeperformance standards for any particular device, but doesaddress general performance standards and good practicecharacteristics for all devices using circumferential compres-sion to reduce and stabilize disruptions of the pelvic ring.1.5 This standard does not purport to address a
7、ll 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 to determine theapplicability of regulatory limitations prior to use.2. Terminology2.1 Definitions:2.1.1 circumferential compressi
8、on force, ninfluence thatdeforms an object by shortening its circumference.2.1.2 compression force, ninfluence that deforms an ob-ject by making it smaller or shorter.2.1.3 controlled level of force, nforce confined withincertain defined limits.2.1.4 disruption of the pelvic ring, nany traumatic alt
9、era-tion of the normal anatomic relationships of the bony structuresforming the pelvic ring. Included in these disruptions arefractures, dislocations, subluxation, and diastasis.2.1.5 effective level of force, nthat range of quantifiedforce required by the particular pelvic ring circumferentialcompr
10、ession stabilization device (PRCCSD) to reduce andstabilize disruptions of the pelvic ring in the 95thpercentile ofadult American males.22.1.6 immobilization, nlimitation of motion.2.1.7 pelvic ring, nnormal anatomic ring-shaped structureformed by three bones: two innominate bones (each made up ofth
11、e ilium, ischium, and pubis) and the sacrum.2.1.8 reduction, nreturning anatomic structures to theirnormal anatomic position.2.1.9 retention system, nan adjunct to or an integral partof the primary platform that allows the patient to be securelyattached to that platform, used in whatever configurati
12、on andsize necessary to accomplish the goal, while still allowingreasonable and necessary access to the patient.2.1.10 safe level of circumferential compression force,nthat range of quantified force producing a resultant effect inwhich no undue alteration of the normal anatomic relationshipof the pe
13、lvic ring occurs.2.1.11 stabilize, vmaintaining in a firm, constant, or fixedstate.2.1.12 spinal immobilization system, ndevice(s) that im-mobilize the spine and contiguous structures, the pelvis, andthe skull.1This guide is under the jurisdiction of ASTM Committee F30 on EmergencyMedical Services a
14、nd is the direct responsibility of Subcommittee F30.01 on EMSEquipment.Current edition approved July 1, 2011. Published September 2011. Originalapproved in 2004. Last previous edition approved in 2004 as F242804. DOI:10.1520/F2428-04.2The Handbook of Adult Anthropometric and Strength Measurements Da
15、ta forDesign Safety, University of Nottingham, University Park, Nottingham NG7 2RDUnited Kingdom.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3. Significance and Use3.1 The intent of this guide is to identify the generalperformanc
16、e and good practice standards that a pelvic ringcircumferential compression stabilization device (PRCCSD)should possess.3.2 Currently, a number of base platforms such as full-bodyspinal immobilization devices (long boards) are used to immo-bilize patients during transport and before definitive treat
17、ment.These platforms limit gross movements of the spine and pelvisbut do not specifically reduce and stabilize disruptions of thepelvic ring. The PRCCSD applied circumferentially about thepatient exerts a compressive force to reduce and stabilizedisruptions of the pelvic ring.3.3 The PRCCSD may be u
18、sed alone but, according toclinical situations, will commonly be used in conjunction withdifferent supporting base platforms during transport and beforedefinitive treatment.3.4 The PRCCSD, when circumferentially applied, shouldbe centered at the level of the greater trochanters and symphsispubis.33.
19、5 A device intended for use with adult patients shallaccommodate the 95thpercentile adult American male.23.6 The device should be able to be applied by a singlepractitioner.4. Characteristics4.1 When applied, the PRCCSD shall accommodate the95th percentile adult American male patient.24.2 The PRCCSD
20、 should be configured to allow ease ofapplication by a single practitioner.4.3 The PRCCSD should be sufficiently radiolucent to allowgood quality X-rays.4.4 The PRCCSD, when affixed about a patient, shall becapable of applying a controlled level of circumferentialcompression force.4.5 The PRCCSD, wh
21、en affixed about a patient, shall becapable of applying an effective level of circumferentialcompression force.4.6 The controlled level of circumferential compressionforce applied by the PRCCSD to the pelvic ring should notexceed a safe level of circumferential compression force.4.7 The design of th
22、e PRCCSD should allow access forurinary catheterization.4.8 The design of the PRCCSD should allow access to thefemoral vessels.4.9 The design of the PRCCSD should allow access to thepelvic ring for purposes of external fixation.4.10 The design of the PRCCSD should facilitate and notimpede movement o
23、f the patient across the surface of supportplatforms such as spine boards or stretchers.4.11 The design of the PRCCSD should not impede the useof other spinal immobilization systems.4.12 The PRCCSD, when applied, shall not alter the posi-tion of the patients spine.4.13 The PRCCSD should be packaged
24、with instructionsdescribing application and removal protocols.4.14 When the PRCCSD is applied on a patient, the pressureexerted by the PRCCSD on the patients skin shall not exceed32 mm Hg.44.15 When a PRCCSD is applied for an extended period, aregular skin inspection protocol should be used.4.16 The
25、 PRCCSD should support reasonable air and mois-ture transmission.5. Durability5.1 The PRCCSD should be functional over the extremerange of normal ambient temperatures.5.2 The function of the PRCCSD should not be affected bychanges in altitude.6. Maintenance6.1 The PRCCSD shall be disposable or easil
26、y cleaned,consistent with Center for Disease Control (CDC) and Occu-pational Safety open book fracture; pelvicfracture3Bottlang, M., Krieg, J. C., Mohr, M., Simpson, T. S., and Madey, S. M.,“Emergent Management of Pelvic Ring Fractures with Use of CircumferentialCompression,” Journal of Bone and Joi
27、nt Surgery, Vol 84-A(Supplement 2), 2002,pp. 43-47.4Landis, E.M., “Micro-Injection Studies of Capillary Blood Pressure in HumanSkin,” Heart, Vol 18, 1929, pp. 209-228.F2428 04 (2011)2ASTM International takes no position respecting the validity of any patent rights asserted in connection with any ite
28、m mentionedin this standard. Users of this standard are 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 comm
29、ittee and must be reviewed every five years andif not 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 m
30、eeting of theresponsible technical committee, which you 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
31、, 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). Permission rights to photocopy the standard may also be secured from the ASTM website (www.astm.org/COPYRIGHT/).F2428 04 (2011)3
