ASTM_F_2808_-_10.pdf

Designation:F280810Standard Test Method forPerforming Behind-the-Knee(BTK)Test for Evaluating SkinIrritation Response to Products and Materials That ComeInto Repeated or Extended Contact with Skin1This standard is issued under the fixed designation F2808;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 The Behind-the-Knee(BTK)method,using thepopliteal fossa of human volunteers as a test site,simultane-ously evaluates the inherent chemical irritation,and the poten-tial for mechanical irritation of substrates and products that aredesigned to come into repeated or extended close contact withthe skin(see validation references 1-7).2This is a bilateral testcomparing a test material to a reference material with a knownsafety profile.1.2 This test method shall be used by qualified health careprofessionals experienced in good clinical practice(GCP)procedures.1.3 This test method can be performed using human sub-jects on either intact or compromised skin.Testing should beperformed on intact skin for test substrates or products ex-pected to have contact with normal,intact skin,or for directcomparison to products with a known skin irritation profile.Testing can be performed on compromised skin for testsubstrates or products that may commonly come into contactwith damaged skin(for example,skin with diaper rash,orchapped skin)or skin that is expected to be hydrated.1.4 Visual scoring of erythema and dryness is performed bya trained skin grader on a pre-defined scale.1.5 Prior to use in this test,materials shall undergo overallfavorable biocompatibility testing consistent with the approachoutlined in protocol Practice F748 or ISO 10993-1:2009.As apart of this series of testing,irritation per Practice F719 or ISO10993-10 shall be conducted.1.6 The values stated in inch-pound units are to be regardedas standard.No other units of measurement are included in thisstandard.1.7 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 limitations prior to use.2.Referenced Documents2.1 ASTM Standards:3D6355 Test Method for Human Repeat Insult Patch Testingof Medical GlovesF719 Practice for Testing Biomaterials in Rabbits for Pri-mary Skin IrritationF748 Practice for Selecting Generic Biological Test Methodsfor Materials and Devices2.2 ISO Standards:4ISO 10993-1:2009 Biological Evaluation of MedicalDevicesPart 1:Evaluation and Testing Within a RiskManagement ProcessISO 10993-10 Biological Evaluation of Medical DevicesPart 10:Tests for Irritation and Delayed-type Hypersensi-tivity3.Terminology3.1 Definitions:3.1.1 chemical irritation,nirritation caused by a physi-ological response to the chemical nature of a material.Suchphysiological responses may include:oxidation or reductionreactions,dehydration,disruption of the keratin ultra-structureor direct injury to cellular macromolecules or organelles.3.1.2 compromised skin,nskin that is treated with re-peated application of surgical tape prior to the first sampleapplication.3.1.3 edema,nobservable swelling from abnormal accu-mulation of fluid in connective tissue.1This test method is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.16 on Biocompatibility Test Methods.Current edition approved Oct.15,2010.Published November 2010.DOI:10.1520/F280810.2The boldface numbers in parentheses refer to the list of references at the end ofthis standard.3For 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.4Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.1.4 erythema,nredness of the skin.3.1.5 mechanical irritation,nirritation caused by move-ment and friction of products intended to remain in contactwith the skin for extended periods of time.3.1.6 popliteal fossa,nthe area at the back of the knee.3.1.7 reference material,na material similar in form andcomposition to the test material.The reference material shouldhave a known safety and irritation profile.3.1.8 skin grades,nvisual assessments of erythema anddryness according to a defined scale(see 10.3).3.1.9 test material,nany material or product expected tocome into contact with skin.3.1.10 trained skin grader,npersonnel who have beentrained to reliably reco