ASTM F2475-2005 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials《医疗器件包装材料的生物可兼容性评价的标准指南》.pdf

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1、Designation: F 2475 05Standard Guide forBiocompatibility Evaluation of Medical Device PackagingMaterials1This standard is issued under the fixed designation F 2475; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last r

2、evision. 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 guide provides information to determine the appro-priate testing for biocompatibility of packaging materials usedto co

3、ntain a medical device.1.2 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 to determine theapplicability of regulatory limitations prio

4、r to use.2. Referenced Documents2.1 ASTM Standards:2F 1327 Terminology Relating to Barrier Materials for Medi-cal Packaging2.2 Other Standards:ANSI/AAMI/ISO 11607 Packaging for Terminally Steril-ized Medical DevicesISO 10993-1:2003 Biological Evaluation of Medical De-vices Part 1: Evaluation and Tes

5、tingUSP The Biocompatibility of Materials Used inDrug Containers, Medical Devices, and ImplantsFDA Center for Devices and Radiological Health: Re-quired Biocompatability Training and Toxicology Profilesfor Evaluation of Medical Devices (#G95-1)3. Terminology3.1 DefinitionsFor terminology related to

6、barrier materialsfor medical packaging see Terminology F 1327.3.2 Definitions of Terms Specific to This Standard:3.2.1 biocompatibilitythe inherent ability of a material toremain biologically inert with the host in its intended applica-tion.3.2.2 biocompatibility testingthe series of chemical andbio

7、logical tests that a material is subjected to in order todetermine the ability of the material to remain biologicallyinert with the host in its intended application.3.2.3 extent of contactthe degree to which the packageddevice will contact the patient (refer to ISO 10993-1 for levelsof contact of th

8、e device with the human body). When referringto the packaging, extent of contact refers to the degree to whichthe packaging will interact with the device. Degree of packag-ing contact (interaction) is related to the physical-chemicalnature of the packaging materials and the device, the intendeduse o

9、f the device (levels of contact with the body), and theextent to which the packaging may negatively impact thecontained device.4. Summary of Practice4.1 Materials used in packaging are to be evaluated perdefined guidelines, such as AAMI/ANSI/ISO 11607. Addi-tional biocompatibility testing for packag

10、ing materials may berequired based on the extent of material contact with thecontained medical device, the subsequent degree to which thepackaged device (product) will contact the patient, and theintended use of the device. When selecting the appropriate testsfor biological evaluation of medical dev

11、ices, the chemicalcharacteristics of the device materials, as well as the nature,degree, frequency and duration of the devices exposure to thebody must be considered. Similar testing may be consideredfor medical packaging, when there is not a history of safe useof packaging materials for their inten

12、ded sue or there may bea question as to whether the packaging may negatively impactthe contained device. Guidelines for biocompatibility verifica-tion of medical device packaging are based on FDA guidance(Memorandum #G-95), ANSI/AAMI/ISO 10993-1 and USPThe Biocompatibility of Materials Used in DrugC

13、ontainers, Medical Devices, and Implants. While the scope ofthese standards does not directly apply to medical devicepackaging, use of them will address the intent of ISO 11607.The reader is advised to consult these standards in determin-ing which tests apply for a given packaging application. Allme

14、dical device packages are considered to have indirect patientcontact, at a minimum. Therefore, the tests selected will not1This guide is under the jurisdiction of ASTM Committee F02 on FlexibleBarrier Materials and is the direct responsibility of Subcommittee F02.15 onChemical/Safety Properties.Curr

15、ent edition approved April 1, 2005. Published May 2005.2For referenced ASTM standards, visit 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.1Copyr

16、ight ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.typically require more extensive testing than that required formedical devices intended for indirect patient contact.However, test selection should also be based on the extent ofcontact betwe

17、en the package and the device, and the probabil-ity that the package may negatively impact the properties of thecontained medical device. For example, a device that is a solidstructure is less likely to interact with its packaging than adevice composed of a semi-solid or liquid material.5. Significa

18、nce and Use5.1 The compatibility of packaging materials with a medicaldevice is a requirement of many regulatory bodies. Since mostmedical devices are used or implanted in, around or on thehuman body, these devices must do no harm. Therefore, thepackaging materials that come in contact with the medi

19、caldevice must also be evaluated and determined to be safe for usewith the human body in that they have no negative impact onthe physical, chemical or biological properties of the device. .This evaluation may include both a study of relevant experi-ence with and actual testing of packaging materials

20、. Such anevaluation may result in the conclusion that no testing isneeded if the material has a demonstrable history of safe use inthe specific role that is the same as that of the package underdesign.The medical device manufacturer determines the need forappropriate testing, with consideration of t

21、he device/packageinteractions, if any. The responsibility of the packaging sup-plier is typically limited to the performance of cytotoxicitytesting.6. Procedure6.1 Select the contact level of packaging material based onits known intended usage. Consult the referenced ISO, FDAand USP guidances for se

22、lection of appropriate biocompatibil-ity tests. Because medical device packages are considered tohave indirect patient contact, it is unlikely that the testsselected will exceed the requirements for those medical devicesintended for indirect patient contact. However, due to thediversity of medical d

23、evices and the packaging materials usedfor them, it is recognized that all tests identified for a certaincontact category may not be necessary for any given packagingmaterial while other materials may require additional testing tobecome approved.Variations from standard testing plans may be justifie

24、d toeither reduce or expand tests to be done based on 1) knownpotential contact levels of the device with the patient, 2) theextent of contact between the package and the device, and 3)the relative risk that the package may interact with the product,resulting in a change to the devices physical, che

25、mical, orbiological properties.NOTE 1For semi-solid and liquid device packaging, specific attentionshould be paid to the potential for indirect contact components such asinks, varnish and adhesive to volatilize and migrate through the primarybarrier into the product.The history of use of packages an

26、d package materials forvarious medical device applications can also serve as avaluable resource in verifying the biocompatibility of a pack-age system.6.2 Prepare samples for testing based on testing facilitiesrequirements. Processing steps and labeling of packages canimpact the biocompatibility of

27、a package system. Therefore, itis important to test materials that have been manufactured andprocessed under “nominal conditions” as well as worst casemanufacturing conditions, including anticipated sterilizationprocess extremes. If a material is to be printed, insure that testmaterials are printed

28、and that documentation includes refer-ences for inks and label adhesives used. Record the followingdocumentation regarding test materials:6.2.1 Suppliers name,6.2.2 Generic material name,6.2.3 Complete description of material,6.2.4 Trade name , or number of material, or both,6.2.5 Lot number of test

29、 samples or other traceabilitynumber,6.2.6 Color of material,6.2.7 Known additives, secondary ingredients list, and soforth,6.2.8 Secondary processes conducted on materials, such ascleaning, treating, and so forth,6.2.9 Intended use of material and intended contact level,and6.2.10 Intended steriliza

30、tion method and worst case limits.6.3 Coordinate testing by testing facility and receivecompletion report. Verify the report has been approved/certified by a company representative that all studies complywith Good Laboratory Practices.7. Keywords7.1 biocompatibility; cytotoxicity; medical device; me

31、dicaldevice packaging; toxicityF2475052APPENDIX(Nonmandatory Information)X1. GUIDANCE FOR BIOCOMPATIBILITY TESTINGNOTEA common regulatory position for solid medical devices is that the packaging material contacts the device only and is generally consideredindirect contact to the patient and thus req

32、uires limited biocompatibility testing. If blood, blood products, fluid products, biologicals and drugs havepackaging materials that directly contact the patient product (for example, tissue, fluid, or blood), or if the packaging materials are considered an integralpart of a device that directly con

33、tacts the patient, then this would require additional biocompatibility testing of the packaging materials. Reference ContactCategories 3 through 6 in the table below for additional information regarding testing in these instances.Material ContactCategoriesBiological EffectMostpackagingmaterialsSome

34、packaging materials based on intended use.ContactLevels(1)Physico-chemical(2)Cytotoxicity AcuteSystemicToxicityIrritation Senstitiza-tionMutagenic-ityPyrogenicity Implanta-tion(muscle)Hemocom-patibilitySub-chronicToxicityNo Patient TissueContactLevel 1 XDevice Contact Only Level 2 X XPossible Patien

35、tTissue/Fluid ContactLevel 3 X X X XDirect Patient Tissue/Fluid ContactExternalLevel 4 X X X X XDirect Patient Tissue/Fluid ContactInternalLevel 5 X X X X X X X XDirect Blood Path /Short TermImplants/ (less than30 days)Level 5V X X X X X X XXXXImplant Level 6 X X X X X X X X XDefinitions/Examples:Le

36、vel 1 Components with no tissue contact; hermetic seal in normal use.Ex: Inks used to print outside of primary package materials.Level 2 Device contact materials. (Assumes no evidence of transfer to devices) Ex: Primary pkg. materials; Blisters, pouches, foam, paperboardLevel 3 Components with no ti

37、ssue/fluid contact with intended use: fluid contact possible through tortuous path; no hermetic sealEx: Primary packaging materials; Blisters, pouches, foam, paperboard that show some evidence of transfer of materials to device.Level 4 Components external to body which come in contact with either in

38、tact skin or breached surface for less than 12 hoursEx: Primary packaging materials; Blisters, pouches, foam, paperboard that show some evidence of transfer of materials to devices used in skin surfaceapplications.Level 5 Components internal to the body which come in contact with either intact natur

39、al channels or indirect blood pathEx: Primary packaging materials; Blisters, pouches, foam, paperboard that show some evidence of transfer of materials to devices used in indirect bloodpaths.Level 5V Direct blood path/Short term ImplantsEx: Primary packaging materials; Blisters, pouches, foam, paper

40、board that show some evidence of transfer of materials to devices used in direct bloodpaths.Level 6 Components to be implanted for greater than 12 hoursEx: Primary packaging materials; Blisters, pouches, foam, paperboard that show some evidence of transfer of materials to devices used in implantedap

41、plications for 12 hours.1) Guidelines are based on ISO guidelines.2) Some standard USP Physio-Chemical extract type tests may be determined inappropriate for primary packaging.F2475053ASTM International takes no position respecting the validity of any patent rights asserted in connection with any it

42、em mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical com

43、mittee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a

44、meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Driv

45、e, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).F2475054