ASTM_D_8419_-_21.pdf

Designation:D841921Standard Specification forAnesthesia Reservoir Bags1This standard is issued under the fixed designation D8419;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()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This specification covers anesthesia reservoir bags foruse with anesthesia breathing systems.For purposes of thisspecification,the reservoir bag includes the neck,body,andneck bushing,if provided.Special-purpose bags,for example,bellows,evacuation,and self-expanding bags are excludedfrom the scope of this specification.1.2 Thefollowingsubjectsarecovered:material,construction,neck,size,compliance(pressure-volumerelationship),electrical conductivity,marking and labeling,andtest methods to substantiate compliance with the requirements.Alternative test methods may be employed provided they canbe shown to be equivalent or better.(A rationale is given inAppendix X1.)1.3 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety,health,and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.4 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.2.Referenced Documents2.1 ANSI Standard:ANSI/NFPA 99 Healthcare Facilities3.Terminology3.1 DefinitionsofTermsForthepurposeofthisspecification,the following descriptions of terms shall apply:3.2 Definitions:3.2.1 ambient temperature and pressureroom temperatureand pressure.3.2.2 anesthesia reservoir bagcollapsible container fromwhich the patient may draw his tidal volume.3.2.3 compliance(pressure-volume relationship)a changeof volume per change in pressure.3.2.3.1 DiscussionUnits of compliance are expressed asmilliliters per kilopascals or centimeters of water(milliliters/per centimeter H2O),or both.3.2.4 conductivea property of an anesthesia reservoir bagand any integrally attached components with electrical conduc-tivity acceptable in accordance with the applicable test(see9.1.1).3.2.5 disposablean item intended to be used once anddiscarded.3.2.6 hanging loopa loop for hanging which may beprovided near the tail of the bag(used to facilitate drying).3.2.7 labelinginformation and literature accompanyingthe device,such as brochures,package inserts,and manuals.3.2.8 markinginformation directly on the device.3.2.9 neckthe end of the anesthesia reservoir bag thatconnects with the anesthesia breathing system.3.2.10 nonconductivea property of an anesthesia reservoirbag and any integrally attached components with insufficientelectrical conductivity to meet the requirements of the appli-cable test(see 9.1.1).3.2.11 reusablean item intended for repeated use on oneor more patients.3.2.12 sizethe size of the anesthesia reservoir bag isdefined as the nominal or labeled capacity expressed in liters(L).3.2.13 tailthe end of the bag opposite of the neck.4.Material4.1 Requirements:4.1.1 The bag should be made of elastomeric materialsuitable for the intended use and should function satisfactorilyin the presence of anesthetic agents and gases commonly usedand not elute toxic substances.4.1.2 Unless designated as disposable(for single use),thebag should be resistant to deterioration by methods of cleaning,1This specification is under the jurisdiction ofASTM Committee D11 on Rubberand Rubber-like Materials and is the direct responsibility of Subcommittee D11.40on Consumer Rubber Products.Current edition approved Nov.1,2021.Published December 2021.DOI:10.1520/D8419-21.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.1?disinfection,and sterilization as recommended by the manu-facturer or the supplier.It is desirable that such products shouldwithstand accepted methods of steam sterilization.4.1.3 The material forming the body of the bag should bepliable to the extent that it remain elastic when the bag isinflated to its nominal size and shall inflate uniformly and beuniform in wall thickness with a nominal taper from the tipbeing the thickest and the neck being the thinnest.5.Construction5.1 Requirements:5.1.1 The bag shall maintain pressure and not leak morethan specified in acco