ASTM_F_1850_-_00.pdf

Designation:F 1850 00Standard Specification forParticular Requirements for Anesthesia Workstations andTheir Components1This standard is issued under the fixed designation F 1850;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.INTRODUCTIONThis specification covers minimum safety requirements for an ANESTHESIA WORKSTATION.Itapplies in addition to IEC Publication 601-1(ed.2 1988),2hereafter called the GENERALSTANDARD,and to IEC 601-1-1:19922as amended,hereafter called the SYSTEMS STANDARD.It is recognized that from time to time innovations and designs will appear that offer advantages andyet are not covered by specific safety related design or performance aspects of this specification;suchinnovations are not to be discouraged.If the techniques and technologies in these innovations advancebeyond those described in this specification,then they must meet the safety objectives of thisspecification.This specification also describes referee test methods necessary to ensure compliance with theperformance and safety requirements described herein.While qualification test procedures todetermine compliance are described and specified,equivalent or superior qualification test proceduresto determine compliance with the requirements may be used.SECTION ONEGENERAL1.ScopeThis clause of the GENERAL STANDARD applies with thefollowing amendment:1.5 This specification presents particular requirements for anANESTHESIAWORKSTATION when supplied as a completeunit,as well as particular requirements for individual deviceswhich together make up a complete ANESTHESIA WORK-STATION.It is the intent of this specification that both completeANESTHESIA WORKSTATIONS and the individual devicesbe commercially available to allow USERS to configure anANESTHESIA WORKSTATION to meet the needs of theirclinical practice in conformance with their national regulationsor guidelines,or both.To this end the standard has beenstructured in such a way as to clearly identify particularrequirements pertinent to specific devices currently available.NOTE1Although this specification does not mandate the use of asingle communication protocol,the purpose of digital data communicationin this standard is to facilitate transfer of data between devices.Possibleuses of data from multiple sources include integrated data display andalarm annunciation,and aiding DECISION SUPPORT SYSTEMS.Cen-tralized display integration and functional integration are the hallmarksdifferentiating this standard from previous anesthesia gas machine stan-dards.Digital communication makes possible integration among worksta-tion devices that may be modular,or interact only through communicationinterfaces.Documentation and disclosure requirements vary because ofexpected variations in implementation permitted by the specified stan-dards.Additional documentation requirements are imposed when interfacemethods not included in the specified DIGITAL INTERFACE standardsare encountered.Equipment that can be used with flammable anesthetic agents,intermit-tent flow machines,that only deliver gas to the patient at varying rates inresponse to the patients inspiratory efforts,and dental nitrous oxide-oxygen machines are not covered by this specification.1.5.1 This guide is arranged as follows:INTRODUCTION1SECTION ONEGENERALClausePage1.Scope1Table of Contents12.Terminology33.General Requirements44.General Requirements for Tests45.Classification56.Identification,Marking and Documents57.Power Input7SECTION TWOENVIRONMENTAL CONDITIONS1This 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 February 10,2000.Published March 2000.Originallypublished as F 1850 98.Last previous edition F 1850 98.2Available 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.8.Basic Safety Categories79.Removable Protective Means710.Environmental Conditions711.(Previous Title):Special Measures with Respect toSafety712.(Previous Title):Single Fault Condition7SECTION THREEPROTECTION AGAINST ELECTRIC SHOCKHAZARDS13.General714.Requirements Related to Classification715.Limitation of Voltage and/or Energy716.Enclosures and Protective Covers717.Separation(Previous Title:Insulation and Protective Im-pedances)718.Protective Earthing,Functional Earthing and PotentialEqualization719.Continuous Leakage Current and Patient Auxiliary Cur-rent820.Dielectric Strength8SECTION FOURPROTECTION AGAINST MECHANICALHAZARDS21.Mechanical Strength822.Moving Parts823.Surfaces,Corners,and Edges824.Stability in Normal Use825.