ASTM D6355 -07 Test for Human Repeat Insult Patch Testing of Medical Gloves

ASTM D6355 -07 Test for Human Repeat Insult Patch Testing of Medical Gloves

ASTM D6355-07 test method evaluates the potential of glove materials to induce Type IV skin sensitization reactions (that is, allergic contact dermatitis) in humans. This test method is performed by individuals experienced in or under the supervision of those experienced in the use of good clinical practice procedures.

    Scope:

    ASTM D6355-07 test method is used to determine the probability of allergic reaction when medical devices such as gloves come in contact with human tissue. All medical devices must be safe and effective for their intended use. Since medical devices such as gloves come in contact with human tissue, they should be tested for biocompatibility in animals first. The human repeat insult patch test (RIPT) is one test that can be used to test rubber gloves for skin sensitization to chemicals used in the manufacture of gloves. Although this test is a clinical method, it is used as part of risk analysis to determine the potential for Type IV allergic contact dermatitis. 

    Test Procedure:

    A general medical history of the study subjects is considered which includes information on dermatologic conditions and sensitivities to specific compounds. Studies conducted following this human RIPT protocol employ a minimum of 200 study subjects. Before assessing the material in a human RIPT, acceptable toxicology data is studied. The sensitization potential of the study material is evaluated in a test panel of a minimum group size of 200 subjects. The study panel should include men and women. The induction phase of the human RIPT includes 10 multiple 48 hours (72 hours on weekends) patches at the same site typically on the upper back with no rest between repatching except for scoring. The patch site is graded for skin responses before each subsequent patch application. In the event of any significant erythema, the site of the patch application is moved to another location to confirm the reaction. Following the completion of the induction phase, there is approximately a 21 day rest period to allow the development of latent sensitization. This is followed by two consecutive 48-h challenge patches applied to naive sites. Responses are evaluated after the removal of each consecutive 48-h patch application. A minimum of two delayed skin site gradings is required to differentiate irritation from sensitization reactions. If the results are equivocal, a second challenge, after the original challenge dermatitis has cleared, is conducted to ensure that sensitization was not overlooked.

    Data:

    The following information is reported: 

    A general summary. A description of the clinical method. Identification of study materials. A description of the scoring system for grading reactions. The alphanumeric scores indicate induction and challenge exposures and times. The number of study subjects was found to be presensitized and withdrawn from the study. The number, age, gender, and ethnicity of the study subjects, and the interpretation of the outcome as either due to contact allergy or irritation. 

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