ASTM_F_1415_-_92_2000.pdf

Designation:F 1415 92(Reapproved 2000)Standard Specification forPulse Oximeters1This standard is issued under the fixed designation F 1415;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 approximation of hemoglobin saturation through the use of pulse oximetry has become anincreasingly common practice in many areas of clinical medicine.These areas include,but are notlimited to anesthesia,respiratory therapy,pediatrics,and intensive care.A variety of devices arecurrently available that are intended for these applications.This specification covers minimum safetyand performance requirements based on parameters that are believed to be achievable within the limitsof existing technology.Appendix X1 contains a rationale for the most important requirements.It is included to provideadditional insight into the reasoning that led to the requirements and recommendations that have beenincorporated in this specification.This specification references IEC 601-1 for many of the general requirements for safety.Requirements specific to pulse oximeters not included in IEC 601-1.1.Scope1.1 The scope given in Clause 1 of IEC 601-1 applies exceptthat 1.1 shall be replaced by the following:1.1.1 This specification includes requirements for the safetyand performance of pulse oximeters,as defined in 3.2.9intended for use in approximating the saturation of arterialhemoglobin,non-invasively,from a light signal transmittedthrough the tissue,taking into account the pulsatile nature ofvolume changes with blood flow.1.2 The field of application includes,but is not limited to:intraoperative and perioperative use;adult critical care appli-cation;pediatric and neonatal application;and general deter-mination of saturation on hospitalized and non-hospitalizedpatients.1.3 Pulse oximeters intended for use in laboratory researchapplications and“bench”type oximeters that require a bloodsample from the patient are outside the scope of this specifi-cation.2.Referenced Documents2.1 The following standards contain provisions that,through reference in this text,constitute provisions of thisspecification.At the time of publication,the editions indicatedwere valid.All standards are subject to revision,and parties toagreements based on this specification are encouraged toinvestigate the possibility of applying the most recent editionsof the standards listed below.2.2 ASTM Standards:F 1463 Specification for Alarm Signals in Medical Equip-ment Used in Anesthesia and Respiratory Care22.3ISO Standards:ISO 7249 ControlsTerms,Suitability,Design Require-ments3ISO 7250 Basic List of Anthropomorphic Measurements32.4IEC Standards:IEC 79-3:1972 Electrical Apparatus for Explosive Atmo-spheres Part III:Spark Test Apparatus for IntrinsicallySafe Units3IEC 79-4:1975Electrical Apparatus for Explosive Atmo-sphere Part IV:Method of Test for Ignition Temperature3IEC 601-1:1988 Safety of Medical Electrical EquipmentPart I:General Safety Requirements3IEC 801-2 Electromagnetic Compatibility for IndustrialProcess Measurement and Control Equipment Part 2:Electrostatic Discharge Requirements(August,1990TC65(Secreteriat)13633.Terminology3.1 Definitions:3.1.1 For the purposes of this specification,the definitionsgiven in Clause 2 of IEC 601-1 apply together with thefollowing additional terms.1This specification is under the jurisdiction of ASTM F29 on Anesthetic andRespiratory Equipment and is the direct responsibility of Subcommittee F29.11 onGas Monitors.Current edition approved July 31,1992.Published December 1992.2Annual Book of ASTM Standards,Vol 13.01.3Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.3.2 Definitions of Terms Specific to This Standard:3.2.1 alarma warning signal.3.2.2 alarm set pointthe setting of the adjustment control,or display value that indicates the SpO2,at or beyond which thealarm is intended to be activated.3.2.2.1 DiscussionTerms such as alarm limits or alarmthreshold are frequently used to describe the same function.3.2.3 alarm systemthose parts of the pulse oximeter thatestablish the alarm set point(s);and activate an alarm when theSpO2is less than or equal to the low alarm set point,ifprovided,or is equal to or greater than the high alarm set point,if provided.3.2.4 calibration rangethe range of SpO2values overwhich the pulse oximeter has been tested and calibrated.3.2.5 display rangethe range of the SpO2values that maybe displayed by the pulse oximeter.3.2.6 display update frequencythe number of seconds orevents,that is,pulses,between possible changes in the dis-played value.3.2.7 probethe portion of the applied part of the pulseoxi