Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves

Importancia y uso:

4.1 This RIPT method assesses the potential of skin sensitization with a particular medical product by repeated topical applications to the skin of selected subjects. This is a procedure that has the potential to detect many, but not all, sensitzers. This requires multiple applications to induce a cell-mediated Type IV immune response sufficient to cause an allergic reaction.

4.2 In general, the sensitization procedure requires 10 multiple 48-h (72-h on weekends) applications of patches containing the study material over a three-week induction phase. Induction is followed by approximately a 21 day rest phase to allow the development of any latent sensitization. Study subjects are then challenged by the application of two consecutive 48-h patches of the study material to naive sites. Responses are evaluated and graded after the removal of each consecutive 48-h patch application.

4.3 Although this test method is a clinical method, it may be used as part of a risk analysis to determine the potential for Type IV allergic contact dermatitis.

4.4 This test method assumes that good clinical practices will be utilized, including adequate training of practitioners.

Subcomité:

D11.40

Referida por:

D6977-19R23, F2808-23, D7558-09R24, D7103-19R23

Volúmen:

09.02

Número ICS:

11.140 (Hospital equipment)

Palabras clave:

ACD; allergic contact dermatitis; allergy; dermatitis; Draize; glove; latex; natural rubber latex; repeat insult patch test; RIPT; rubber; sensitization; synthetic rubber;