ASTM_F_1456_-_01.pdf

Designation:F 1456 01Standard Specification forMinimum Performance and Safety Requirements forCapnometers1This standard is issued under the fixed designation F 1456;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 carbon dioxide in a gaseous mixture has become a common practice in manyareas of clinical medicine,such as anesthesia,pediatrics,respiratory care,and intensive care.Thisspecification establishes minimum safety and performance requirements for capnometers based onparameters that are achievable within the limits of existing technology.Appendix X1 contains a rationale for the most important requirements.It is included to provideadditional insight for the reasoning that led to the requirements and recommendations that have beenincorporated into this specification.This specification uses IEC 601-1:1988 includingAmendment 1 and 2(hereafter called the GeneralStandard)for many of the general requirements for safety.Additional requirements specific tocapnometers 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 capnometers for use withadults,children,and neonates.1.1.2 It does not apply to qualitative devices or devicessolely intended for use as cutaneous monitors.1.1.3 It does not apply to devices intended for use inlaboratory research applications or nonhuman applications.1.1.4 This specification does not apply to capnometersintended for use with flammable anesthetic mixtures.1.1.5 This specification does not apply to devices that areintended for use in single-breath,spot-check,or noncontinuousmonitoring applications.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 Anethesia and Respiratory Care22.3IEC Standards:IEC 60079-4:1975 Electrical Apparatus for Explosive GasAtmospheresPart 4:Method of Test for Ignition Tem-perature3IEC 60601-1:1988 SafetyofMedicalElectricalEquipmentPart I:General Safety Requirements Includ-ing Amendment 1 and Amendment 23IEC 60601-1-2:1992 Medical Electrical Equipment:Collat-eral Requirements Electromagnetic Compatibility32.4ISO Standards:ISO 4135:1995 AnaesthesiologyVocabulary3ISO 7000-1989 Graphical Symbols for Use on Equipment-Index and Synopsis3ISO 7504:1984 Gas AnalysisVocabulary32.5Other Standards:1This 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 1456 92.Last previous edition F 1456 92.2Annual Book of ASTM Standards,Vol 13.01.3Available from American National Standards Institute,25 W.43rd St.,4thFloor,New York,NY 10036.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.AAMI ES-1:1993 Safe Current Limits for ElectromedicalApparatus4AAMI HE-48:1993 Human Factors Engineering Guidelinesand Preferred Practices for the Design of Medical De-vices4CGA C-9-1982 Standard Color Markings of CompressedGas Cylinders Intended for Medical Use5NFPA 53M FireHazardsinOxygen-EnrichedAtmospheres1990 Edition63.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)which are set by the manu-facturer,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 a