ASTM_F_2475_-_11.pdf

Designation:F247511Standard 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,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 appro-priate testing for biocompatibility of materials(or packagingmaterials)in sterile barrier systems used to contain a medicaldevice.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 prior to use.2.Referenced Documents2.1 ASTM Standards:2F17 Terminology Relating to Flexible Barrier Packaging2.2 Other Standards:ANSI/AAMI/ISO 11607 Packaging for Terminally Steril-ized Medical DevicesISO 10993-1:2009 Biological Evaluation of Medical De-vices Part 1:Evaluation and TestingUSP 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 barrier materialsfor medical packaging see Terminology F17.3.2 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 andbiological 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.3.2.3extent of contactthe degree to which the packageddevice will contact the patient(refer to ISO 10993-1 for levelsof contact of the 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 of the device(levels of contact with the body),and theextent to which the packaging may negatively impact thecontained device.3.2.4 sterile barrier systemminimum package that pre-vents ingress of microorganisms and allows aseptic presenta-tion of the product at the point of use.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 packaging 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 devices,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 intended 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 USP The Biocompatibility of Materials Used in DrugContainers,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.All1This guide is under the jurisdiction of ASTM Committee F02 on FlexibleBarrier Packaging and is the direct responsibility of Subcommittee F02.15 onChemical/Safety Properties.Current edition approved April 1,2011.Published April 2011.Originallyapproved 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,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.United States1 medical device packages are considered to have indirect patientcontact,at a minimum.Therefore,the tests selected will nottypically 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 b