ASTM_F_920_-_93_1999.pdf

Designation:F 920 93(Reapproved 1999)Standard Specification forMinimum Performance and Safety Requirements forResuscitators Intended for Use With Humans1This standard is issued under the fixed designation F 920;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.INTRODUCTIONIn January of 1989,ASTM Subcommittee F29.03.03 met in Boston with representatives of theAmerican Heart Association and the U.S.Department of Defense to discuss the revision of thisspecification.It was unanimously determined that until a revised version of this specification thatwould be consistent with the American Heart Associations revised Standards and Guidelines forCardiopulmonary Resuscitation and Emergency Cardiac Care was available,ISO 8382-1988,shouldbe used as the specific reference for manually-triggered gas-powered resuscitators.Shortly thereafter,the Subcommittee Chairman published a letter to this effect in the Journal of the American MedicalAssociation.2The Subcommittee reaffirmed this stance at a subsequent meeting in March of 1990.Thisspecification is therefore similar in content to ISO 8382.1.Scope1.1 This specification covers ventilatory resuscitators,thatis,small portable ventilators intended to be used in emergen-cies both outside and inside hospitals.These devices areintended for use by medical personnel and for emergency useby personnel with varying degrees of training.They areintended to be used at the site of an emergency and duringpatient transport.Resuscitators intended for use on all agegroups are included within the scope of this specification.1.1.1 This specification does not intend to discourage orimpede future innovation or development of resuscitators.1.2 The effective and safe use of a resuscitator is determinednot only by the performance of the resuscitator,but also by theskill of the operator.This specification does not describe thecontent of the training programs to develop such skill and doesnot state who should or should not use a resuscitator.This willbe determined by the organizations involved in teachingresuscitation.1.2.1 In certain countries,resuscitators are intended for useby nontrained personnel and lower pressure limits are set.Some countries also reserve the use of automatic gas-poweredresuscitators to trained individuals under medical supervision.This specification is not intended to conflict with these estab-lished practices.1.3 Annex A1 details test methods,while Annex A2 pro-vides tables of resistances and compliances required to set upthe test lung.Annex A3 gives a rationale for various clauses inthis specification and is included to provide additional insightinto the reasoning that led to the requirements and recommen-dations that have been given.AnnexA4 andAnnexA5 provideadvice concerning materials to be used in resuscitators and facemasks.1.4 The values stated in SI units are to be regarded as thestandard.1.5 This standard does not purport to address all of thesafety problems,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 The following standards contain provisions that,through reference in this text,constitute provisions of thisspecification.At the time of publication,the editions indicatedwere valid.All standards are subject to revision,and parties toagreements based on this specification are encouraged toinvestigate the possibility of applying the most recent editionsof the standards listed below.1This specification is under the jurisdiction of ASTM Committee F29 onAnesthetic and Respiratory Equipment and is the direct responsibility of Subcom-mittee F29.14 on Ventilators.Current edition approved March 15,1993.Published May 1993.Originallypublished as F 920 85.Last previous edition F 920 85.2American Heart Association,“Standards and Guidelines for CardiopulmonaryResuscitation(CPR)and Emergency Cardia Care(ECC),”Journal of the AmericanMedical Association,Vol 255,No.21,June 6,1986,pp.2905-2984.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.2.2 ASTM Standards:F 1054 Specification for Conical Fittings of 15 mm and 22mm Sizes3F 1243 Specification for Tracheal Tube Connectors32.3ANSI Standard:ANSI/CAAV-1 Compressed Gas Cylinder Valve Outlet andInlet Connections42.4ISO Standards:ISO 407 Small Medical Gas CylindersYoke-Type ValveConnections4ISO 4135 AnaesthesiologyVocabulary4ISO 5356-1 Anaesthetic and Respiratory EquipmentConical ConnectorsPart 1:Cones and Sockets4ISO 5359 Low-Pressure Flexible Connecting Assemblies(Hose Ass