ASTM_F_1690_-_96_2004.pdf

Designation:F 1690 96(Reapproved 2004)Standard Specification forHumidifiers for Medical UsePart 1:General Requirementsfor Active Humidification Systems1This standard is issued under the fixed designation F 1690;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.INTRODUCTIONHumidifiers are used to raise the water content of gases delivered to patients.Gases available formedical use do not contain sufficient moisture and may damage or irritate the respiratory tract ofpatients.Heat may be employed to increase the water output of the humidifier.In addition,many humidifiers utilize heated breathing tubes in order to increase operating efficiencyand reduce excessive water and heat loss.Ventilator and anesthesia breathing tubes in common usemay not withstand the heat generated by humidifiers and heated breathing tube mechanisms.Many humidifier manufacturers use off-the-shelf electrical connectors for their electrically heatedbreathing tubes.However,since different manufacturers have used the same electrical connector fordifferent power outputs,electrically heated breathing tubes may be physically,but not electrically,interchangeable.Improper electrically heated breathing tube use has caused overheating,circuitmelting,patient and care-giver burns,and fires.It was not found practical to specify the interfacerequirements for electrical connectors to ensure compatibility between humidifiers and breathing tubesproduced by different manufactures.Since the safe use of a humidifier is dependent on the interaction of the humidifier with its manyaccessories,this specification sets total system performance requirements,including accessories suchas breathing tubes(both heated and non heated),temperature sensor,and devices intended to controlthe environment within these breathing tubes.A rationale for the most important requirements is given in Appendix X1.It is considered that aknowledge of the reasons for the requirements will not only facilitate the proper application of thisspecification,but will expedite any subsequent revision.This specification along with IEC(International Electrotechnical Committee)601-1,henceforthknown as the“General Standard,”specify the minimum safety and performance requirements forhumidification systems.This specification indicates which clauses of the General Standard apply andamends certain clauses with additions or modifications.SECTION ONEGENERAL1.Scope1.1 The requirements given in Clause 1 of the GeneralStandard apply with the following additions and modifications:1.1.1 Replace 1.1 with the following:1.1.1.1 This specification includes requirements for thesafety and performance of active vaporizing and nebulizinghumidification systems,as defined in 3.63.1.6,suitable forinclusion in breathing systems(both intubated and non-intubated patients).1.1.1.2 This specification also includes requirements forbreathing tubes,including heated breathing tubes(heated-wirebreathing circuits),and devices intended to control theseheated breathing tubes,heated breathing tube controllers.1.1.1.3 Heat and moisture exchangers(HMEs)are outsidethe scope of this specification.However,it is recognized thattheir safety and performance may affect that of humidificationsystems.Numerous studies have been published citing thebenefits and risks of HMEs used in conjunction with humidi-fication systems.It is advisable to review the instructions for1This specification is under the jurisdiction of ASTM Committee F29 onAnesthetic and Respiratory Equipment and is under the direct responsibility ofSubcommittee F29.14 on Ventilators.Current edition approved June 1,2004.Published June 2004.Originallyapproved in 1996.Last previous edition approved in 1996 as F 1690 96.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.use provided with the humidification systems and HMEs andthe available literature for more details.1.1.1.4 Devices commonly referred to as“room humidifi-ers,”humidifiers used in heating,ventilation,and air-conditioning systems and humidifiers used to condition theenvironment within infant incubators are outside the scope ofthis specification.1.1.1.5 It has not been found possible to include guidanceon the matter of droplet size in the case of nebulizinghumidifiers.1.1.1.6 Gas-powered nebulizers used for the delivery ofdrugs to patients through their respiratory system are outsidethe scope of this specification.1.1.1.7 Appendices in this specification are not mandatoryunless made so by an explicit statement in the main text.1.2 The values stated in SI units are to be regarded as thestandard.2.Referenced Documents2.1 The following standards contain provisions that,through reference in this text,constitute provisions of thissp