1、Designation:F280910Standard Terminology Relating toMedical and Surgical Materials and Devices1This standard is issued under the fixed designation F2809;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A numbe
2、r in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This terminology standard is a repository for the terms,and their standardized definitions,as relates to the technicalstandards generated by AST
3、M Committee F04 on Medical andSurgical Materials and Devices.The meanings and explana-tions of the technical terms have been written for both thenon-expert and the expert user.1.2 The terms are listed in alphabetical sequence;in Appen-dix X1 they are listed by the subcommittee of origin.1.3 At a min
4、imum,this standard is updated annually(at atime corresponding to the publication of the Annual Book ofASTM Standards containing this terminology standard)toeditorially include any terms approved in the Committeestechnical standards.1.4 The originating standard of each term is included forinformation
5、al purposes,following each listing of a term and itsassociated definition.2.Referenced Documents2.1 Historical ASTM Standards:2F921 Terminology Relating to Hemostatic ForcepsF1078 Terminology for Surgical ScissorsInserted andNon-Inserted BladesF1251 Terminology Relating to Polymeric Biomaterials inM
6、edical and Surgical Devices(Withdrawn 2012)3F1582 Terminology Relating to Spinal ImplantsF1638 Terminology for Surgical Tissue/Dressing/Pick-UpForceps(Thumb-Type)F1840 Terminology for Surgical Suture NeedlesF2005 Terminology for Nickel-Titanium Shape MemoryAlloysF2312 Terminology Relating to Tissue
7、Engineered MedicalProductsNOTE1The definition for each term is accompanied by a reference tothe standard from which it originated.All active standards of theCommittee may therefore be considered references,and are not repro-duced here.3.Significance and Use3.1 All approved F04 standards have their t
8、erms reproducedin this terminology document,per section 1.3.The terms arelisted both alphabetically,and by subcommittee of origin,persection 1.2.3.1.1 This standard maintains a single source for terminol-ogy reference for ASTM Committee F04.3.1.2 This standard assists in the authoring of new ASTMsta
9、ndards,and standard revisions,where authors can find andutilize existing terms to avoid generation of extraneous,duplicative,or contradicting terms.3.2 Some terms may appear more than once.3.2.1 In some cases,multiple definitions of a term areneeded,based on the variety of applications and sectors t
10、owhich it applies.3.2.2 Because this terminology standard is a repository forall approved terms of Committee F04,it may become evidentthat multiple definitions for a term have been developed,butneed coordination.3.2.2.1 An objective of this document is to make duplicationevident,and to facilitate ha
11、rmonization of terms by CommitteeF04 as appropriate.3.3 Appendix X2 provides background on the history andobjectives of this terminology standard.4.Terminologyaccelerator,nadditive used to increase the rate of cure.Anaccelerator may also be a catalyst,or it may actually changecomposition and,therefo
12、re,not qualify as a catalyst.F602acetal plastic,nplastic based on polymers having a predomi-nance of acetal linkages in the main chain.(See alsopolyoxymethylene.)F1251acousto-electric transfer function,HSE,nelectrical input tothe IMEHD output transducer E produced by a sound field,1This terminology
13、is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.97 on Editorial and Terminology.Current edition approved Aug.15,2010.Published December 2010.DOI:10.1520/F280910.2For referenced ASTM standards,visit the AS
14、TM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM Internatio
15、nal,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 divided by the input sound field pressure pS:HSE=E/pS.F2504DISCUSSIONHSEwill depend on the particular gain settings used,forexample,full-on gain or minimal gain.The gain should be reportedwhenever that transfer func
16、tion is used.acousto-vibrational transfer function(IMEHD aided),HSVA,nstapes velocity(IMEHD aided)divided by theinput sound field pressure:HSVA=vA/pS.F2504DISCUSSIONThis quantity can be measured directly or computedfrom the product of the electro-vibrational transfer function,HEV,andthe acousto-electric transfer function,HSE,measured in the IMEHD-aided condition:HSVA=vA/pS.acousto-vibrational transfer function(unimplanted),HSVU,nstapes velocity(unimplanted)when driven by the inputsound field,div