ASTM F748-2016 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices《选择材料和设备的通用生物试验方法的标准实施规程》.pdf

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1、Designation: F748 16Standard Practice forSelecting Generic Biological Test Methods for Materials andDevices1This standard is issued under the fixed designation F748; the number immediately following the designation indicates the year of originaladoption or, in the case of revision, the year of last

2、revision. A number in parentheses indicates the year of last reapproval. A superscriptepsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This practice recommends generic biological test meth-ods for materials and devices according to end-use applica-tions. Whi

3、le chemical testing for extractable additives andresidual monomers or residues from processing aids is neces-sary for most implant materials, such testing is not included aspart of this practice. The reader is cautioned that the area ofmaterials biocompatibility testing is a rapidly evolving field,a

4、nd improved methods are evolving rapidly, so this practice isby necessity only a guideline.Athorough knowledge of currenttechniques and research is critical to a complete evaluation ofnew materials.1.2 These test protocols are intended to apply to materialsand medical devices for human application.

5、Biological evalu-ation of materials and devices, and related subjects such aspyrogen testing, batch testing of production lots, and so on, arealso discussed. Tests include those performed on materials, endproducts, and extracts. Rationale and comments on currentstate of the art are included for all

6、test procedures described.1.3 The biocompatibility of materials used in single ormulticomponent medical devices for human use depends to alarge degree on the particular nature of the end-use application.Biological reactions that are detrimental to the success of amaterial in one device application m

7、ay have little or no bearingon the successful use of the material for a different application.It is, therefore, not possible to specify a set of biocompatibilitytest methods which will be necessary and sufficient to establishbiocompatibility for all materials and applications.1.4 The evaluation of t

8、issue engineered medical products(TEMPs) may, in some cases, involve different or additionaltesting beyond those suggested for non-tissue-based materialsand devices. Where appropriate, these differences are discussedin this practice and additional tests described.1.5 The ethical use of research anim

9、als places the obligationon the individual investigator to determine the most efficientmethods for performing the necessary testing without undueuse of animals. Where adequate prior data exists to substantiatecertain types of safety information, these guidelines should notbe interpreted to mean that

10、 testing should be unnecessarilyrepeated.1.6 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 and health practices and determine the applica-bility of regulatory

11、 limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2E1262 Guide for Performance of Chinese Hamster OvaryCell/Hypoxanthine Guanine Phosphoribosyl TransferaseGene Mutation AssayF619 Practice for Extraction of Medical PlasticsF719 Practice for Testing Biomaterials in Rabbits for Pri-ma

12、ry Skin IrritationF720 Practice for Testing Guinea Pigs for ContactAllergens:Guinea Pig Maximization TestF749 Practice for Evaluating Material Extracts by Intracuta-neous Injection in the RabbitF750 Practice for Evaluating Material Extracts by SystemicInjection in the MouseF756 Practice for Assessme

13、nt of Hemolytic Properties ofMaterialsF763 Practice for Short-Term Screening of Implant Materi-alsF813 Practice for Direct Contact Cell Culture Evaluation ofMaterials for Medical DevicesF895 Test Method forAgar Diffusion Cell Culture Screeningfor CytotoxicityF981 Practice for Assessment of Compatibi

14、lity of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneF1027 Practice for Assessment of Tissue and Cell Compat-ibility of Orofacial Prosthetic Materials and Devices1This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials

15、 and Devicesand is direct responsibility of Subcommittee F04.16on Biocompatibility Test Methods.Current edition approved April 1, 2016. Published May 2016. Originallyapproved in 1982. Last previous edition approved in 2010 as F748 06 (2010).DOI: 10.1520/F0748-16.2For referenced ASTM standards, visit

16、 the ASTM 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.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959

17、. United States1F1408 Practice for Subcutaneous Screening Test for ImplantMaterialsF1439 Guide for Performance of Lifetime Bioassay for theTumorigenic Potential of Implant MaterialsF1877 Practice for Characterization of ParticlesF1903 Practice for Testing For Biological Responses toParticles In Vitr

18、oF1904 Practice for Testing the Biological Responses toParticles in vivoF1983 Practice for Assessment of Selected Tissue Effects ofAbsorbable Biomaterials for Implant ApplicationsF1984 Practice for Testing for Whole Complement Activa-tion in Serum by Solid MaterialsF2065 Practice for Testing for Alt

19、ernative Pathway Comple-ment Activation in Serum by Solid Materials (Withdrawn2016)3F2147 Practice for Guinea Pig: Split Adjuvant and ClosedPatch Testing for Contact AllergensF2148 Practice for Evaluation of Delayed Contact Hyper-sensitivity Using the Murine Local Lymph Node Assay(LLNA)F2382 Test Me

20、thod for Assessment of Intravascular MedicalDevice Materials on Partial Thromboplastin Time (PTT)2.2 Other Referenced Documents:ISO/AAMI/ANSI 10993-1 Biological Testing of Medicaland Dental Materials and DevicesPart 1: Evaluation andTesting within a Risk Management Process4EN 10993-1 Biological Test

21、ing of Medical and Dental Ma-terials and DevicesPart 1: Evaluation and Testing withina Risk Management Process4General Program Memorandum #G95-1 FDA5Immunotoxicity Testing Guidance-FDA53. Summary of Practice3.1 A matrix listing biological endpoints relevant to abiocompatibility evaluation versus mat

22、erials (devices) andtheir applications is included in Table 1. The expected durationof use of the device is also considered. Intraoperative is lessthan 24 h, short-term is up to and including 30 days, andchronic is greater than 30 days. The position of row andcolumn intersection is marked to indicat

23、e whether assessmentof a biological endpoint is recommended for a material ordevice for the specific application indicated. The terms relatingto device or material type and application are addressed inSection 5. Discussion of applicability, current state of the art,and rationale for individual biolo

24、gical endpoint assessmentsalso appears in that section.4. Significance and Use4.1 The objective of this practice is to recommend appro-priate biological endpoint assessments (which may or may notrequire testing) to establish a reasonable level of confidenceconcerning the biological response to a mat

25、erial or device,while at the same time avoiding unnecessary testing.4.2 This practice is intended to provide guidance to thematerials investigator in selecting the proper procedures to becarried out for the screening of new or modified materials.Because each material and each implant situation invol

26、ves itsown unique circumstances, these recommendations should bemodified as necessary and do not constitute the only assess-ment that will be required for a material. Nor should theseguidelines be interpreted as minimum requirements for anyparticular situation. While an attempt has been made to prov

27、iderecommendation for different implant circumstances, some ofthe recommended assessment may not be necessary or reason-able for a specific material or application.5. Classification of Materials and Devices by End-UseApplications5.1 General:5.1.1 When new materials are sought for a medical appli-cat

28、ion for use on humans, the material(s) may comprise thewhole final device product, or may be one of many componentmaterials in the device. The first step is a thorough literaturesearch for previous use of the material or biocompatibilitytesting studies to ensure that it has not been known to produce

29、an adverse biological response that exceeds the expectedbenefit in the use of the device. Note that the final fabricatedproduct may differ chemically, physically, or biologically fromthe raw materials used to fabricate the product due to process-ing and this has to be considered when conducting a bi

30、ocom-patibility evaluation and/or designing test protocols. For somedevices, if testing is needed, it may be necessary or desirable totake material test samples directly from the final deviceproduct. Samples should be fully representative of the finishedproduct in terms of processing, cleaning, pack

31、aging,sterilization, and any other procedures that are performed onthe materials before the device is used.5.1.2 At this point, preliminary material screening may beemployed, depending on the expertise of the organization(s)evaluating the materials. Since preliminary screening is nor-mally an option

32、 to minimize the economic impact of acandidate material failing final biological tests after extensivetime and effort, it is not a required procedure. The investigatorshould be aware that, should an adverse tissue response beobserved with a final product, it may be impossible todetermine which compo

33、nent or process is responsible withoutthese initial screening tests.5.1.3 This practice addresses two aspects of tissue-materialinteractions: duration and tissue type. A third aspect, whichshould be considered, is the relative size difference between thehost and the material, that is, to how much ma

34、terial surfacearea is the host exposed. The material surface area-to-bodyweight ratio may become a significant factor for porousmaterials, and devices of repeated short-term applications (forexample, dialysis products). While this practice does notaddress the issue of “intensity factor” of increased

35、 surface area,the biocompatibility testing facility personnel should considerit in their material screening and testing protocol design.3The last approved version of this historical standard is referenced onwww.astm.org.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th

36、 Floor, New York, NY 10036, http:/www.ansi.org.5Available from CDRH, 5600 Fishers Ln., Rockville, MD 20857.F748 162TABLE1ApplicableBiologicalEndpointsforBiocompatibilityEvaluationClassificationofMaterialorDeviceandApplicationCell Culture CytotoxicitySensi- tizationSkin Irritation orIntra-cutaneousMu

37、cous Membrane IrritationSystemic Toxicity,AcuteorSubchronicBlood CompatibilityHemolysisPyrogenicityShort-term ImplantationLong-term ImplantationImmune ResponseGenotoxicityCarcinogenicityExternaldevicesIntactsurfaces(alltimeperiods)xxxBreachedsurfacesIntraoperativexxxShort-TermxxxxChronicxxxxxExterna

38、lDevicesCommunicatingwith:IntactNaturalChannelsIntraoperativexxxxShort-termxxxxxxChronicxxxxxxxxxBodyTissuesandFluidsIntraoperativexxxxiAShort-termxxxxiAxxChronicxxxxiAxxxxBloodPath,indirectIntraoperativexxxxxxxShort-termxxxxxxxChronicxxxxxxxxxBloodPath,directIntraoperativexxxxxxxShort-termxxxxxxxxx

39、ChronicxxxxxxxxxxxImplantedDevicesprincipallycontactingBone/Tissue/tissuefluidIntraoperativexxxxShort-termxxxxxxChronicxxxxxxxxxxBloodIntraoperativexxxxxxxShort-termxxxxxxxxxxChronicxxxxxxxxxxxxA(i)Pyrogenicitytestingmaybeconsideredforalldevicescontactingthecentralnervoussystem.F748 1635.1.4 For the

40、 purposes of this practice, devices and thematerials that comprise them are classified as to end-use humanapplication as outlined in 5.2 5.4.5.1.5 In general, the assessment for tissue engineered medi-cal products (TEMPs) should address the same issues specificto the type, location, and duration of

41、use as other medicaldevices and products. The selection of additional assessmentfor compatibility criteria unique to these type of productsshould be conducted with these recommendations in mind.5.1.6 When assessing materials that are intended to degradeand/or be metabolized while implanted in the bo

42、dy (bothsynthetic and TEMPs), consideration should be given to thedegradation or metabolic products and appropriate modifica-tions made in test and sample selection so that the compatibil-ity of degradation products as well as ungraded product aretested.5.2 External Devices:5.2.1 Devices That Contac

43、t Intact Body Surfaces Onlyexamples include electrodes, splints, external prostheses, cer-tain dressings, monitors of various types, or ostomy appliances.5.2.2 Devices That Contact Breached Body Surfacesexamples include ulcer, burn, and granulation tissue dressings,or healing devices.5.3 Externally

44、Communicating Devices:5.3.1 Devices Communicating with Intact Natural Chan-nels:5.3.1.1 Intraoperative (30 days)examples include urinarycatheters for chronic use and intrauterine devices.5.3.2 Devices Communicating with Body Tissues and Flu-ids:5.3.2.1 Intraoperative (30 days)examples include percut

45、ane-ous electrodes, active penetrating electrodes, stapedectomyprostheses, partial and total ossicular replacement prostheses,and tympanoplasty ventilation tubes.5.3.3 Blood Path, IndirectProducts contacting blood pathat one point (usually less than 24 hours), and that serve as aconduit for fluid en

46、try into the vascular system. Examplesinclude solution administration sets, extension sets, transfersets, and blood administration sets.5.3.3.1 Products that are used for 24 hours or that are usedrepeatedly in the same patient will be considered as chronicusage and should undergo extended testing.5.

47、3.4 Blood, Path, DirectSingle recirculating blood expo-sure or product that is in the blood path, generally for less than24 hours. Examples include intravenous catheters,oxygenators, extracorporeal oxygenator tubing and accesso-ries.5.3.5 Blood Path, Direct, Short Term, or Chronic, or re-peated expo

48、sureExamples include dialyzers or dialysis tub-ing and accessories, shunts.5.4 Implanted Long-Term Devices:5.4.1 Devices Principally Contacting Bonesexamples in-clude orthopedic pins, screws, replacement joints, boneprostheses, cements, and dental implants.5.4.2 Devices Principally Residing in the S

49、ubcutaneousSpaceexamples include pacemakers, neuromuscularstimulators, facial augmentation devices, tissue expanderdevices, and breast prostheses.5.4.3 Devices Principally Contacting Soft Tissue and TissueFluidsexamples include drug supply devices, neuromuscularsensors, replacement tendons, penile, and other implants,cerebrospinal fluid drains, artificial larynx, vas deferens valves,and ligation clips.5.4.4 Devices Principally Contacting Bloodexamples in-clude pacemaker leads, artificial arteriovenous fistulae, heartvalves, vascular grafts, stents, blood monitors,