ASTM_F_1101_-_90_2003e1.pdf

Designation:F 1101 90(Reapproved 2003)e1Standard Specification forVentilators Intended for Use During Anesthesia1This standard is issued under the fixed designation F 1101;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.e1NOTEThe precaution note in paragraph 7.1.7was moved into the text editorially in December 2003.1.Scope1.1 This specification applies to all ventilators specificallyintroduced for sale following acceptance of this specificationand intended for use during the administration of anesthesia.Definitions,performance requirements,test methods,and arationale for all mandatory requirements are included.1.2 The anesthesia ventilator cannot protect against mal-functions within the anesthesia machine,nor can it protectagainst inappropriate or inadvertent use of the oxygen flushvalve,and therefore,no attempt has been made to addressproblems that may arise from malfunctions with these devicesin this specification.(See also X3.1.)1.3 Several definitions have been included in Section 2 andAppendix X1 that are not used in the text of this specification.This material has been included for the sake of completeness,and for any possible educational benefit that may be served.Appendix X1 also outlines various characteristics of ventilatorsintended for use during anesthesia and defines the main classesof breathing machines that may be used in medical practice andindicates how these may be subdivided according to their modeof action.1.4 The following precautionary caveat pertains to the testmethods portion,Section 6 of this specification.This standardmay involve hazardous materials,operations,and equipment.This standard does not purport to address all of the safetyconcerns associated with its use.It is the responsibility of theuser of this standard to establish appropriate safety and healthpractices and determine the applicability of regulatory limita-tions prior to use.For an additional safety precaution,see7.1.7.2.Referenced Documents2.1 ASTM Standards:2F 1054 Specification for Conical FittingsF 1161 Specification for Minimum Performance and SafetyRequirements for Components and Systems of AnesthesiaGas Machines32.2ANSI Standards:Z-79.10 Standard for Oxygen Analyzers4Z-79.11 Standard for Scavenging Systems for Excess forAnesthetic Gases42.3ISO Standard:ISO 4135 Anesthesiology Vocabulary52.4Other Standards:IEC 601-1 Safety of Medical Electrical Equipment6CGA V-5,1978 Specifications for DISS Connections73.Terminology3.1 DefinitionsFor the purposes of this specification,thedefinitions in 3.1.1-3.1.51 shall apply.3.1.1 airway pressure(Paw)pressure at a specified point inthe patients airway.The site and conditions under whichmeasurements are made should be given.3.1.2 alarma means of alerting the operator that a par-ticular condition exists.3.1.3 alveolar pressure(PA)pressure in the alveoli.In thecase of the lung model,this is represented by the pressure inthe compliance chamber.3.1.4 apparatus internal compliancevolume/pressure re-lationship,expressed in millilitres per kilopascal(or millilitresper centimetre H2O)of those portions of the patient system thatare pressurized during the inspiratory phase time(see also 5.8and 3.1.36).3.1.5 continuous positive airway pressure(CPAP)Pawmaintained by the ventilator above ambient.3.1.5.1 DiscussionCommon usage of the term referencesspontaneous ventilation.1This specification is under the jurisdiction of ASTM Committee F29 onAnesthetic and Respiratory Equipment and is the direct responsibility of Subcom-mittee F29.10 on Anesthesia Workstations.Current edition approved Dec.1,2003.Published December 2003.Originallyapproved in 1990.Last previous edition approved in 1996 as F 1101 90(1996).2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Withdrawn.4Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036.5Available from International Standards Organization,1,Rue de Varembe,Casepostale 56,CH-1211,Geneva 20,Switzerland.6Available from International Electrotechnical Commission,3 rue de Varemb,Case Postale 131,CH-1211,Geneva 20,Switzerland.7Available from Compressed Gas Association,1235 Jefferson Davis Highway,Arlington,VA 22202.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.3.1.6 controla means available to the operator of directlyadjusting a ventilator function.3.1.7 cycling pressurethat pressure which,when reachedin the patient system,causes the ventilator to cycle frominspiratory to expiratory phase or from expiratory to inspira-tory phase.3.1.8 differ