ASTM F748-2006 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices《选择材料和装置用一般生物试验方法标准实施规程》.pdf

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1、Designation: F 748 06Standard Practice forSelecting Generic Biological Test Methods for Materials andDevices1This standard is issued under the fixed designation F 748; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of las

2、t 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 practice recommends generic biological test meth-ods for materials and devices according to end-use applica-tions.

3、While 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 fiel

4、d,and 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 applicatio

5、n. 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 a

6、ll 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 applicatio

7、n may 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 o

8、f tissue 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 a

9、nimals 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 t

10、hat 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 regulat

11、ory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2E 1202 Guide for Development of Micronucleus AssayStandardsE 1262 Guide for Performance of Chinese Hamster OvaryCell/Hypoxanthine Guanine Phosphoribosyl TransferaseGene Mutation AssayE 1263 Guide for Conduct of Micronucleus Assa

12、ys inMammalian Bone Marrow ErythrocytesE 1280 Guide for Performing the Mouse Lymphoma Assayfor Mammalian Cell MutagenicityE 1397 Practice for In Vitro Rat Hepatocyte DNA RepairAssayE 1398 Practice for In Vivo Rat Hepatocyte DNA RepairAssayF 619 Practice for Extraction of Medical PlasticsF 719 Practi

13、ce for Testing Biomaterials in Rabbits forPrimary Skin IrritationF 720 Practice for Testing Guinea Pigs for Contact Aller-gens: Guinea Pig Maximization TestF 749 Practice for Evaluating Material Extracts by Intracu-taneous Injection in the RabbitF 750 Practice for Evaluating Material Extracts by Sys

14、temicInjection in the MouseF 756 Practice for Assessment of Hemolytic Properties ofMaterialsF 763 Practice for Short-Term Screening of Implant Mate-rialsF 813 Practice for Direct Contact Cell Culture Evaluation of1This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Ma

15、terials and Devices and is direct responsibility of Subcommittee F04.16on Biocompatibility Test Methods.Current edition approved Dec. 1, 2006. Published January 2007. Originallyapproved in 1982. Last previous edition approved in 2004 as F 748 04.2For referenced ASTM standards, visit the ASTM website

16、, 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.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.

17、Materials for Medical DevicesF 895 Test Method for Agar Diffusion Cell Culture Screen-ing for CytotoxicityF 981 Practice for Assessment of Compatibility of Bioma-terials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneF 1027 Practice for Assessment of Tissue and Cell Compa

18、t-ibility of Orofacial Prosthetic Materials and DevicesF 1408 Practice for Subcutaneous Screening Test for Im-plant MaterialsF 1439 Guide for Performance of Lifetime Bioassay for theTumorigenic Potential of Implant MaterialsF 1877 Practice for Characterization of ParticlesF 1903 Practice for Testing

19、 For Biological Responses toParticles in vitroF 1904 Practice for Testing the Biological Responses toParticles in vivoF 1905 Practice For Selecting Tests for Determining thePropensity of Materials to Cause ImmunotoxicityF 1906 Practice for Evaluation of Immune Responses InBiocompatibility Testing Us

20、ing ELISA Tests, LymphocyteProliferation, and Cell MigrationF 1983 Practice for Assessment of Compatibility ofAbsorbable/Resorbable Biomaterials for Implant Applica-tionsF 1984 Practice for Testing for Whole Complement Activa-tion in Serum by Solid MaterialsF 2065 Practice for Testing for Alternativ

21、e PathwayComplement Activation in Serum by Solid MaterialsF 2147 Practice for Guinea Pig: Split Adjuvant and ClosedPatch Testing for Contact AllergensF 2148 Practice for Evaluation of Delayed Contact Hyper-sensitivity Using the Murine Local Lymph Node Assay(LLNA)F 2151 Practice for Assessment of Whi

22、te Blood Cell Mor-phology After Contact with MaterialsF 2382 Test Method for Assessment of Intravascular Medi-cal Device Materials on Partial Thromboplastin Time(PTT)2.2 Other Referenced Documents:ISO/AAMI/ANSI 10993-1 Biological Testing of Medicaland Dental Materials and Devices - Part 1: Guidance

23、onSelection of Tests3EN 309931 Biological Testing of Medical and DentalMaterials and Devices - Part 1: Guidance on Selection ofTests3General Program Memorandum #G95-1 FDA4Immunotoxicity Testing Guidance-FDA43. Summary of Practice3.1 A matrix listing biological test methods versus materials(devices)

24、and their applications is included in Table 1. Theexpected duration of use of the device is also considered.Intraoperative is less than 24 h, short-term is up to andincluding 30 days, chronic is greater than 30 days. The positionof row and column intersection is marked to indicate whetherthe test is

25、 recommended for a material or device for the specificapplication indicated. The terms relating to device or materialtype and application are addressed in Section 5. Discussion ofapplicability, current state of the art, and rationale for indi-vidual test methods also appears in that section.4. Signi

26、ficance and Use4.1 The objective of this practice is to recommend sufficientbiological testing to establish a reasonable level of confidenceconcerning the biological response to a material or device,while at the same time avoiding unnecessary testing.4.2 This practice is intended to provide guidance

27、 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 involves itsown unique circumstances, these recommendations should bemodified as necessary and do not constitute the only

28、testingthat will be required for a material nor should these guidelinesbe interpreted as minimum requirements for any particularsituation. While an attempt has been made to provide recom-mendation for different implant circumstances, some of therecommended testing may not be necessary or reasonable

29、for aspecific 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-cation for use on humans, the material(s) may comprise thewhole final device product, or may be one of many componentmaterials in

30、 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 producean adverse biological response that exceeds the expectedbenefit in the use of the device. Note that the final fabricatedproduc

31、t 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 designing test protocols.For some devices, it may be necessary or desirable to takematerial test samples directly from the final device produ

32、ct.Samples should be fully representative of the finished productin terms of processing, cleaning, packaging, sterilization, andany other procedures that are performed on the materials beforethe device is used.5.1.2 At this point, preliminary material screening may beemployed, depending on the exper

33、tise of the organizationsevaluating the materials. Since preliminary screening is nor-mally an option 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

34、adverse tissue response beobserved with a final product, it may be impossible todetermine which component or process is responsible withoutthese initial screening tests.5.1.3 This practice addresses two dimensions of tissue-material interactions: duration and tissue type. A third dimen-sion, which s

35、hould be considered, is the relative size difference3Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036.4Available from CDRH, 5600 Fishers Ln., Rockville, MD 20857.F748062TABLE1ApplicableTestsClassificationofMaterialorDeviceandApplicationCell Cu

36、lture CytotoxicitySensi- tizationSkin Irritation orIntra-cutaneousMucous Membrane IrritationSystemic Toxicity,AcuteorSubchronicBlood CompatibilityHemolysisPyrogen TestShort-term ImplantationLong-term ImplantationImmune ResponseGenotoxicityCarcinogenicityExternaldevicesIntactsurfaces(alltimeperiods)x

37、xxBreachedsurfacesIntraoperativexxxShort-TermxxxxChronicxxxxxExternalDevicesCommunicatingwith:IntactNaturalChannelsIntraoperativexxxxShort-termxxxxxxChronicxxxxxxxxxBodyTissuesandFluidsIntraoperativexxxxiAShort-termxxxxiAxxChronicxxxxiAxxxxBloodPath,indirectIntraoperativexxxxxxxShort-termxxxxxxxChro

38、nicxxxxxxxxxBloodPath,directIntraoperativexxxxxxxShort-termxxxxxxxxxChronicxxxxxxxxxxxImplantedDevicesprincipallycontactingBone/Tissue/tissuefluidIntraoperativexxxxShort-termxxxxxxChronicxxxxxxxxxxBloodIntraoperativexxxxxxxShort-termxxxxxxxxxxChronicxxxxxxxxxxxxA(i)Pyrogenicitytestingmaybeconsidered

39、foralldevicescontactingthecentralnervoussystem.F748063between the host and the material, that is, to how muchmaterial surface area is the host exposed. The material surfacearea to body weight ratio may become a significant factor forporous materials, and devices of repeated short-term applica-tions

40、(for example, dialysis products). While this practice doesnot address the issue of “intensity factor” of increased surfacearea, the biocompatibility testing facility personnel shouldconsider it in their material screening and testing protocoldesign.5.1.4 For the purposes of this practice, devices an

41、d thematerials that comprise them are classified as to end-use humanapplication as outlined in 5.2-5.4.5.1.5 In general, the testing for tissue engineered medicalproducts (TEMPs) should address the same issues specific tothe type, location, and duration of use as other medical devicesand products. T

42、he selection of additional testing for compat-ibility criteria unique to these type of products should beconducted with these recommendations in mind.5.1.6 When testing materials that are intended to degradeand/or be metabolized while implanted in the body (bothsynthetic and TEMPs), consideration sh

43、ould 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 is tested as well as the undegradedproduct.5.2 External Devices:5.2.1 Devices That Contact Intact Body Surfaces Onlyexamples inclu

44、de 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 Communicating Devices:5.3.1 Devices Commu

45、nicating 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 percutane-ous electrodes, active penetrating el

46、ectrodes, stapedectomyprostheses, partial and total ossicular replacement prostheses,or tympanoplasty ventilation tubes.5.3.3 Blood Path, IndirectProducts contacting blood pathat one point for usually less than 24 hours, and serves as aconduit for fluid entry into the vascular system. Examplesinclud

47、e solution administration sets, extension sets, transfersets, or 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.5.3.4 Blood, Path, DirectSingle recirculating b

48、lood expo-sure or product is in blood path generally less than 24 hours.Examples include intravenous catheters, oxygenators, extracor-poreal oxygenator tubing and accessories.5.3.5 Blood Path, Direct, Short Term, or Chronic, or re-peated exposureExamples include dialyzers or dialysis tub-ing and acc

49、essories, shunts.5.4 Implanted Long-Term Devices:5.4.1 Devices Principally Contacting Bonesexamples in-cludd orthopedic pins, screws, replacement joints, bone pros-theses, cements, or dental implants.5.4.2 Devices Principally Residing in the SubcutaneousSpaceexamples include pacemakers, neuromuscular stimu-lators, facial augmentation devices, tissue expander devices,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 f