ASTM_F_1464_-_93_2005.pdf

Designation:F 1464 93(Reapproved 2005)Standard Specification forOxygen Concentrators for Domiciliary Use1This standard is issued under the fixed designation F 1464;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.INTRODUCTIONOxygen concentrators provide a safe source of oxygen-enriched air for patients in need.They aredevices that raise the level of inspired oxygen by separating nitrogen or oxygen from ambient air.Oxygen concentrators fall into two main classes according to the means whereby gas separation iseffected,namely:oxygen concentrators in which oxygen selectively permeates or transports througha membrane or lattice,and pressure swing adsorbers(PSA)in which air is exposed at a certainpressure to molecular sieve material that selectively retains nitrogen and other components until theyare subsequently released when the pressure is reduced.The scope of this specification is not restricted to these two classes as alternative methods ofconcentrating oxygen may become available and it is not intended that this specification should restrictfuture developments.This particular specification is one of a series of standards based on IEC 601-1 second edition andit amends and supplements IEC 601-1 second edition,hereinafter called the“general standard.”Asstated in 1.3 of the general standard,the requirements of this particular specification take precedenceover those of the general standard.As in the general standard the requirements are followed by compliance tests.The numbers of thesections and clauses in this specification refer to the related sections and clauses in the generalstandard.Clauses,sub-clauses or figures that are additional to those of the general standard arenumbered starting after the last numbered clause in the general standard;additional annexes arelettered AA,BB,etc.and additional items(aa),(bb),etc.The changes from the text of the generalstandard are specified by the use of the following words:“Replacement”means that the clause,sub-clause or specified paragraph of the general standard isreplaced by the text of this specification.“Amendment”means that the clause,sub-clause or specified paragraph of the general standard isamended as indicated by the text of this specification.“Addition”means that the text of this specification is additional to the requirements of the generalstandard.Details of the arrangement of test apparatus for carrying out a number of the tests to checkcompliance with certain requirements are given in Annex A1.A rationale for the most important requirements is given in Annex A2.It is considered that aknowledge of the reasons for the requirements will not only facilitate the proper application of thestandard,but will expedite any subsequent revision.This annex does not form part of the specification.Test methods and apparatus other than those specified in this specification,but of equal or greateraccuracy may be used to verify compliance with particular requirements.However,in the event of adispute the methods and apparatus as specified in this specification shall be used to resolve the matter.The format of this specification is similar to that of IEC“particular standards”;but differs in thefollowing respects:Sections 1,2,and 3 will appear in the format as recommended in Form and Stylefor ASTM Standards Manual.Section 4 includes a chart listing all of the clauses of IEC 601-1 andindicates whether that clause applies(A),does not apply(NA),or applies with an amendment orreplacement(AM/R).For the text of clauses that either apply or do not apply,consult IEC 601-1Second Edition,1988.Section 5 includes,in numerical order,the text of all amendments,additions orreplacements to the general standard,and includes tests for compliance.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.1.Scope1.1 This clause of the general standard applies except asfollows(replacement):This particular specification specifiessafety requirements for oxygen concentrators as defined in 3.1.This specification does not apply to oxygen concentratorsintended to supply gas to several patients via a piped medicalgas installation or to those intended for use in the presence offlammable anaesthetic or cleaning agents,or both.1.2 The values stated in SI units are to be regarded as thestandard.2.Referenced Documents2.1ISO Standards:ISO 3744 AcousticsDetermination of Sound Power Lev-els of Noise SourcesEngineering Method for Free-FieldConditions Over a Reflecting Plane2ISO 8359 Oxygen Concentrators for Medical UseSafetyRequirements2ISO 9703 Anaesthesia and Respiratory Care AlarmSignalsPart 1:Visual Alarm Signals22.2 IEC Standards:IEC Publication 601-1 Medical Electrical Equipment Part I,General Requirements for Safety