ASTM-F2808 2010

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F2808-10 Standard Test Method for Performing Behind-the-Knee (BTK) Test for Evaluating Skin Irritation Response to Products and Materials That Come Into Repeated or Extended Contact with Skin

Published By	Publication Date	Number of Pages
ASTM	2010	23

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Categories: 11.100.99 - Other standards related to laboratory medicine, ASTM

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Description

1.1 The Behind-the-Knee (BTK) method, using the popliteal fossa of human volunteers as a test site, simultaneously evaluates the inherent chemical irritation, and the potential for mechanical irritation of substrates and products that are designed to come into repeated or extended close contact with the skin (see validation references 1-7 ). This is a bilateral test comparing a test material to a reference material with a known safety profile.

1.2 This test method shall be used by qualified health care professionals experienced in good clinical practice (GCP) procedures.

1.3 This test method can be performed using human subjects on either intact or compromised skin. Testing should be performed on intact skin for test substrates or products expected to have contact with normal, intact skin, or for direct comparison to products with a known skin irritation profile. Testing can be performed on compromised skin for test substrates or products that may commonly come into contact with damaged skin (for example, skin with diaper rash, or chapped skin) or skin that is expected to be hydrated.

1.4 Visual scoring of erythema and dryness is performed by a trained skin grader on a pre-defined scale.

1.5 Prior to use in this test, materials shall undergo overall favorable biocompatibility testing consistent with the approach outlined in protocol Practice F748 or ISO 10993-1:2009. As a part of this series of testing, irritation per Practice F719 or ISO 10993-10 shall be conducted.

1.6 The values stated in inch-pound units are to be regarded as standard. No other units of measurement are included in this standard.

1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

PDF Catalog

PDF Pages	PDF Title
1	Scope Referenced Documents Terminology
2	Summary of Test Method Significance and Use Interferences and Precautions Apparatus Reagents and Materials Hazards Calibration and Standardization Institutional Review and Informed Consent
3	Procedure
5	Interpretation of Results TABLE 1
6	Report Precision and Bias Keywords TABLE 2
7	X1. SAMPLE: INCLUSION / EXCLUSION QUESTIONNAIRE X1.1 FIG. X1.1
8	X2. FITZPATRICK’S SKIN TYPE SCALE X2.1 TABLE X2.1
9	X3. SAMPLE: BTK WORKSHEET X3.1 FIG. X3.1
10	X4. SAMPLE: SUBJECT INSTRUCTIONS X4.1 TABLE X4.1
11	X5. SKIN IRRITATION GRADING SHEET X5.1 FIG. X5.1
12	X6. EXAMPLE OF PLACEMENT OF TEST MATERIALS X6.1 X7. SKIN IRRITATION GRADING SCALES X7.1 Skin Irritation Grading Scale–Erythema X7.2 Skin Irritation Grading Scale–Dryness FIG. X6.1 TABLE X7.1
13	X7.3 Erythema grading scale described in the below refer-ences X7.4 Skin Dryness grading scale described in X7.5 Examples: Skin Irritation Grading Scale Photographs—Erythema X7.6 Examples: Skin Irritation Grading Scale Photographs—Dryness TABLE X7.2
14	FIG. X7.1
15	FIG. X7.1
16	FIG. X7.3
17	X8. SAMPLE: SUBJECT SAMPLE APPLICATION TIME SHEET X8.1 FIG. X8.1
18	X9. SAMPLE: SUBJECT ACCOUNTABILITY REPORT X9.1 FIG. X9.1
19	X10. SAMPLE: SUMMARY ADVERSE EVENT REPORT FORM X10.1 FIG. X10.1
20	X11. STATISTICAL MODEL FOR ERYTHEMA AND DRYNESS SCORES X11.1 X11.2 FIG. X11.1
21	X12. SAMPLE REPORT SUMMARY TABLES (Data for example purposes only) X12.1 Example 1 X12.2 Example 2 X12.3 Example 3 TABLE X12.1 FIG. X12.1 TABLE X12.2
22	FIG. X12.2 TABLE X12.3 FIG. X12.3
23	REFERENCES

Additional information

Standard Title	F2808-10 Standard Test Method for Performing Behind-the-Knee (BTK) Test for Evaluating Skin Irritation Response to Products and Materials That Come Into Repeated or Extended Contact with Skin
Published Code	ASTM
Publication Date	2010
Pages Count	23
ICS Codes	11.100.99 - Other standards related to laboratory medicine

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ASTM-F2808 2010

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