ASTM F2475-2011 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials《医用装置包装材料生物兼容性评定指南》.pdf

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1、Designation:F247505 Designation: F2475 11Standard Guide forBiocompatibility Evaluation of Medical Device PackagingMaterials1This standard is issued under the fixed designation F2475; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision,

2、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 guide provides information to determine the appropriate testing for biocompatibility of materials (or

3、 packagingmaterials) in sterile barrier systems used to contain a medical device.1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety and health practices and to

4、 determine the applicability of regulatorylimitations prior to use.2. Referenced Documents2.1 ASTM Standards:2F1327Terminology Relating to Barrier Materials for Medical Packaging 17 Terminology Relating to Flexible Barrier Packaging2.2 Other Standards:ANSI/AAMI/ISO 11607 Packaging for Terminally Ste

5、rilized Medical DevicesISO 10993-1:20039 Biological Evaluation of Medical Devices Part 1: Evaluation and TestingUSP The Biocompatibility of Materials Used in Drug Containers, Medical Devices, and ImplantsFDA Center for Devices and Radiological Health: Required Biocompatability Training and Toxicolog

6、y Profiles forEvaluation of Medical Devices (#G95-1)3. Terminology3.1 DefinitionsFor terminology related to barrier materials for medical packaging see Terminology F1327F17.3.2 Definitions of Terms Specific to This Standard:3.2.1 biocompatibilitythe inherent ability of a material to remain biologica

7、lly inert with the host in its intended application.3.2.2 biocompatibility testingthe series of chemical and biological tests that a material is subjected to in order to determinethe ability of the material to remain biologically inert with the host in its intended application.3.2.3 extent of contac

8、tthe degree to which the packaged device will contact the patient (refer to ISO 10993-1 for levels ofcontact of the device with the human body). When referring to the packaging, extent of contact refers to the degree to which thepackaging will interact with the device. Degree of packaging contact (i

9、nteraction) is related to the physical-chemical nature of thepackaging materials and the device, the intended use of the device (levels of contact with the body), and the extent to which thepackaging may negatively impact the contained device.3.2.4 sterile barrier systemminimum package that prevents

10、 ingress of microorganisms and allows aseptic presentation of theproduct at the point of use.4. Summary of Practice4.1 Materials used in packaging are to be evaluated per defined guidelines, such as AAMI/ANSI/ISO 11607. Additionalbiocompatibility testing for packaging materials may be required based

11、 on the extent of material contact with the contained medicaldevice, the subsequent degree to which the packaged device (product) will contact the patient, and the intended use of the device.When selecting the appropriate tests for biological evaluation of medical devices, the chemical characteristi

12、cs of the devicematerials, as well as the nature, degree, frequency and duration of the devices exposure to the body must be considered. Similartesting may be considered for medical packaging, when there is not a history of safe use of packaging materials for their intended1This guide is under the j

13、urisdiction of ASTM Committee F02 on Flexible Barrier MaterialsPackaging and is the direct responsibility of Subcommittee F02.15 onChemical/Safety Properties.Current edition approved April 1, 2005. Published May 2005. DOI: 10.1520/F2475-05.Current edition approvedApril 1, 2011. PublishedApril 2011.

14、Originally approved in 2005. Last previous edition approved in 2005 as F2475 05. DOI: 10.1520/F2475-11.2For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standard

15、s Document Summary page on the ASTM website.1This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately,

16、 ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.sue

17、 or there may be a question as to whether the packaging may negatively impact the contained device. Guidelines forbiocompatibility verification of medical device packaging are based on FDA guidance (Memorandum #G-95), ANSI/AAMI/ISO10993-1 and USP The Biocompatibility of Materials Used in Drug Contai

18、ners, Medical Devices, and Implants. While thescope of these standards does not directly apply to medical device packaging, use of them will address the intent of ISO 11607.The reader is advised to consult these standards in determining which tests apply for a given packaging application. All medica

19、ldevice packages are considered to have indirect patient contact, at a minimum. Therefore, the tests selected will not typicallyrequire more extensive testing than that required for medical devices intended for indirect patient contact.However, test selection should also be based on the extent of co

20、ntact between the package and the device, and the probabilitythat the package may negatively impact the properties of the contained medical device. For example, a device that is a solidstructure is less likely to interact with its packaging than a device composed of a semi-solid or liquid material.5

21、. Significance and Use5.1 The compatibility of packaging materials with a medical device is a requirement of many regulatory bodies. Since mostmedical devices are used or implanted in, around or on the human body, these devices must do no harm. Therefore, the packagingmaterials that come in contact

22、with the medical device must also be evaluated and determined to be safe for use with the humanbody in that they have no negative impact on the physical, chemical or biological properties of the device. . This evaluation mayinclude both a study of relevant experience with and actual testing of packa

23、ging materials. Such an evaluation may result in theconclusion that no testing is needed if the material has a demonstrable history of safe use in the specific role that is the same asthat of the package under design.The medical device manufacturer determines the need for appropriate testing, with c

24、onsideration of the device/packageinteractions, if any. The responsibility of the packaging supplier is typically limited to the performance of cytotoxicity testing.6. Procedure6.1 Select the contact level of packaging material based on its known intended usage. Consult the referenced ISO, FDAand US

25、Pguidances for selection of appropriate biocompatibility tests. Because medical device packages are considered to have indirectpatient contact, it is unlikely that the tests selected will exceed the requirements for those medical devices intended for indirectpatient contact. However, due to the dive

26、rsity of medical devices and the packaging materials used for them, it is recognized thatall tests identified for a certain contact category may not be necessary for any given packaging material while other materials mayrequire additional testing to become approved.Variations from standard testing p

27、lans may be justified to either reduce or expand tests to be done based on 1) known potentialcontact levels of the device with the patient, 2) the extent of contact between the package and the device, and 3) the relative riskthat the package may interact with the product, resulting in a change to th

28、e devices physical, chemical, or biological properties.NOTE 1For semi-solid and liquid device packaging, specific attention should be paid to the potential for indirect contact components such as inks,varnish and adhesive to volatilize and migrate through the primary barrier into the product.The his

29、tory of use of packages and package materials for various medical device applications can also serve as a valuableresource in verifying the biocompatibility of a package system.6.2 Prepare samples for testing based on testing facilities requirements. Processing steps and labeling of packages can imp

30、actthe biocompatibility of a package system. Therefore, it is important to test materials that have been manufactured and processedunder “nominal conditions” as well as worst case manufacturing conditions, including anticipated sterilization process extremes.If a material is to be printed, insure th

31、at test materials are printed and that documentation includes references for inks and labeladhesives used. Record the following documentation 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

32、both,6.2.5 Lot number of test samples or other traceability number,6.2.6 Color of material,6.2.7 Known additives, secondary ingredients list, and so forth,6.2.8 Secondary processes conducted on materials, such as cleaning, treating, and so forth,6.2.9 Intended use of material and intended contact le

33、vel, and6.2.10 Intended sterilization method and worst case limits.6.3 Coordinate testing by testing facility and receive completion report. Verify the report has been approved/certified by acompany representative that all studies comply with Good Laboratory Practices.7. Keywords7.1 biocompatibility

34、; cytotoxicity; medical device; medical device packaging; toxicityF2475 112APPENDIX(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

35、 contact to the patient and thus requires 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 integr

36、alpart of a device that directly contacts 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 ContactCategoriesBiologic

37、al EffectMostpackagingmaterialsSome 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 Con

38、tact Only Level 2 X XPossible PatientTissue/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

39、X X X X X X XDefinitions/Examples:Level 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, pap

40、erboardLevel 3 Components with no tissue/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

41、which come in contact with either intact 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

42、 in contact with either intact natural 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 mater

43、ials; Blisters, pouches, foam, paperboard 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 mate

44、rials to devices used in implantedapplications 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.ASTM International takes no position respecting the validity of any patent rights assert

45、ed in connection with any item 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 t

46、he responsible technical committee 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

47、 careful consideration at a 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.F2475 113This standard is copyrighted by AST

48、M International, 100 Barr Harbor Drive, 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). Permission rights to photocopy the standard may also be secured from the ASTM website (www.astm.org/COPYRIGHT/).F2475 114