ASTM_F_1573_-_95_2000.pdf

Designation:F 1573 95(Reapproved 2000)Standard Specification forAnesthetic EquipmentOropharyngeal and NasopharyngealAirways1This standard is issued under the fixed designation F 1573;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.1.Scope1.1 This specification covers minimum performance andsafety requirements for oropharyngeal and nasopharyngealairways for human use.1.2 Size designations,dimensions,and tolerances;materialcompatibility;product marking and labeling;and packagingare considered.1.3 Because of the wide variation in size and configurationof the human airway,various conditions of use,user prefer-ences,and cost,this specification cannot cover all types oforopharyngeal and nasopharyngeal airways.1.4 Standards for the types of airways not specificallyaddressed by this specification may be developed in the future.1.5 This specification is not intended to limit the develop-ment of the other devices so long as the minimum safety andperformance requirements stated herein are met.2.Referenced Documents2.1 ASTM Standards:ANSI Z79.3-1983Anesthetic EquipmentOropharyngealand Nasopharyngeal Airways23.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 buccal end(flanged end)the end of the airway thatis flanged and is expected to fit between the teeth or gums oragainst the external nares.3.1.2 nasopharyngeal airwaya device intended to main-tain the patency of respiratory passages through the nasalcavity into the pharynx.3.1.3 oropharyngeal airwaya device intended to maintainthe patency of respiratory passages through the oral cavity intothe pharynx.3.1.4 pharyngeal endthe end of the airway that is in-tended to be inserted into the patients pharynx.3.1.5 shallthe word“shall,”as used in this specification,is to be understood as denoting a mandatory requirement.3.1.6 shouldthe word“should,”as used in this specifica-tion,is to be understood as denoting a recommendation that isa sound safety practice:it does not denote a mandatoryrequirement.4.Size Designation4.1 Measurement SystemThe metric system shall be thestandard of measurement used.Other units of measure may beprovided as supplemental information.4.2 Size:4.2.1 Oropharyngeal AirwaysThe size of oropharyngealairways shall be designated by a number giving the nominallength in centimetres in accordance with Table 13,4and Fig.1(a)and(b).4.2.2 Nasopharyngeal AirwaysThe size of nasopharyn-geal airways shall be designated by a number expressing theinside diameter in millimetres as the primary dimension,inaccordance with tolerances given in Table 23,4,5and Fig.1(c).5.Materials and Manufacture5.1 Airways shall be fabricated from plastics,or elastomericmaterials,or from combinations of these materials.5.1.1 Airways shall be nontoxic and compatible with thehuman tissue with which they are intended to be used,asdetermined by the implantation test in the U.S.Pharmacopeia.6NOTE1The designs shown in Fig.1 and Fig.2 are intended toillustrate typical common types of airways for the purpose of sizedesignation and marking,but are not otherwise intended to form a part ofthis specification.5.1.2 All material should be resistant to changes or deterio-ration from normal concentrations of substances encounteredduring routine use.5.2 Reusable airways shall be made of material capable ofbeing sterilized.The manufacturer shall supply recommendedmethods of sterilization.1This specification is under the jurisdiction of ASTM Committee F29 onAnesthetic and Respiratory Equipment and is the direct responsibility of Subcom-mittee F29.12 on Airways.Current edition approved Jan.15,1995.Published April 1995.2Available from American National Standards Institute,25 W.43rd St.,4thFloor,New York,NY 10036.3Table 1 and Table 2 are intended to relate nominal size to the length(ordiameter)of the airway.Clinical practice neither suggests nor requires theavailability of all nominal sizes given in the tables.4Sizes not shown may be added by interpolation.5For nasopharyngeal airways,the actual outside diameter shall be designated onthe product or the package label within 60.5 mm(see X1.1.2).6See U.S.Pharmacopeia,12601 Twinbrook Pkwy.,Rockville,MD 20852.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.5.3 Airways intended for single use or packages containingsuch airways shall be marked“Single Use Only”or“Do NotReuse”(see 8.4 and 9.4).6.Design6.1 Oropharyngeal Airways:6.1.1 Oropharyngeal airways should have sufficient rigidityto keep the base of the tongue in a forward position while theairway is in use.6.1.2 Oropharyngeal airways shall have sufficient rigidity atthe buccal(flanged)end(by use of an insert,if necessary)toprevent collapse when bitten by the patient.Collapse shall haveoccurred w