ASTM_F_1452_-_01.pdf

Designation:F 1452 01Standard Specification forMinimum Performance and Safety Requirements forAnesthetic Gas Monitors1This standard is issued under the fixed designation F 1452;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.INTRODUCTIONThe measurement of the concentration of inhaled anesthetic gases is becoming common practice.This specification establishes minimum safety and performance requirements for anesthetic gasmonitors that are achievable within the limits of existing technology.The appendix contains rationale for some of the important requirements.It is included to provideadditional insight for the reasoning that led to the requirements and recommendations that have beenincorporated in this specification.This specification uses IEC 60601-1:1988 including Amendment 1 and 2(hereafter called theGeneral Standard)for many of the general requirements for safety.Additional requirements specificto anesthetic gas monitors begin at Clause 60.SECTION ONEGENERALThe clauses and subclauses of this section of the GeneralStandard apply except as follows:1.Scope1.1 This clause of the General Standard applies except asfollows:1.1.1 This specification applies to anesthetic gas monitorsused with adults,children,and neonates.1.1.2 It does not apply to devices intended for use inlaboratory research applications,nonhuman applications,or forcalibration of anesthetic agent vaporizers.1.1.3 This specification does not apply to anesthetic gasmonitors intended for use with flammable anesthetic mixtures.2.Referenced Documents2.1 The following standards contain provisions,whichthrough reference in this specification constitute provisions ofthis specification.At the time of publication of this specifica-tion,the editions indicated were current.All standards aresubject to revision,and parties using this specification areencouraged to investigate the possibility of applying the mostrecent editions of the standards listed as follows.2.2 ASTM Standards:F 1054 Specification for Conical Fittings of 15-mm and22-mm Sizes2F 1463 Specification for Alarm Signals in Medical Equip-ment Used in Anesthesia and Respiratory Care22.3IEC Standards:3IEC 60079-4:1975 Electrical Apparatus for Explosive GasAtmospheresPart 4:Method of Test for Ignition Tem-peratureIEC 60601-1:1988 Medical Electrical EquipmentPart 1:General Requirements for Safety.IncludingAmendment 1and Amendment 2IEC 60601-1-2:1992 Medical Electrical Equipment:Collat-eral Requirements Electromagnetic Compatibility2.4ISO Standards:3ISO 4135:1995 AnaesthesiologyVocabularyISO 7000-1989 GraphicalSymbolsforUseonEquipmentIndex and SynopsisISO 7504:1984 Gas AnalysisVocabulary2.5Other Documents:NFPA 53M FireHazardsinOxygen-EnrichedAtmospheres1990 Edition41This specification is under the jurisdiction of ASTM Committee F29 onAnesthetic and Respiratory Equipment and is the direct responsibility of Subcom-mittee F29.11 on Gas Monitors.Current edition approved April 10,2001.Published December 2001.Originallypublished as F 1452 92.Last previous edition F 1452 92.2Annual Book of ASTM Standards,Vol 13.01.3Available from American National Standards Institute,25 W.43rd St.,4thFloor,New York,NY 10036.4Available from National Fire ProtectionAssociation(NFPA),470AtlanticAve.,Boston,MA 02210.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.AAMI HE-48:1993 Human Factors Engineering Guidelinesand Preferred Practices for the Design of Medical De-vices5AAMI ES-1:1993 Safe Current Limits for ElectromedicalApparatus5CGA C-9-1982 Standard Color Markings of CompressedGas Cylinders Intended for Medical Use63.Terminology3.1 Clause 2 of the General Standard applies together withISO 4135 and the following additions:3.1.1 accuracythe quality that characterizes the ability ofa device to give indications approximating to the true value ofthe quantity measured.3.1.2 alarm conditiona condition that occurs when avariable that is being monitored by an alarm system equals orfalls outside the set alarm limits.3.1.2.1 DiscussionThe monitored variable may be dis-played or internal.3.1.3 alarm limit(s)value(s)that are set by the manufac-turer,the device,the user,or operator which define thethreshold range of the alarm condition.3.1.3.1 DiscussionTerms such as“alarm set points”or“alarm threshold”are frequently used to describe the samefunction.3.1.4 alarm signala signal,the purpose of which is toalert the operator of an abnormal condition in the patient or theequipment that may develop into a safety hazard whichrequires operator awareness or action.3.1.5 alarm systema system that is intended to make theoperator(s)aware of an alarm condition in the patient orequipment,by means of its alarm signal or signals.3.1.6 anesthetic gas l