Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)

Importancia y uso:

5.1 The propensity of a material to stimulate delayed contact hypersensitivity must be assessed before clinical application of devices containing this material. Delayed hypersensitivity may occur anywhere in the body. Systemic delayed hypersensitivity may have a complex set of reactions and consequences depending on the actual tissue/organ site of reaction. Although the reactions are seldom life-threatening, severe tissue and organ damage may result over time. Skin is the usual test site to determine the propensity of a material to cause delayed hypersensitivity.

5.2 The standard historical test methods have involved the use of guinea pigs with a cutaneous application and observation of the reaction site. The use of the murine local lymph node assay results in a numerical quantitation of stimulation, rather than subjective evaluation and could be used to determine dose responses.

5.3 This practice may not be predictive of events occurring during all types of medical device applications. The user is cautioned to consider the appropriateness of the method in view of the materials being tested, their potential applications, and the recommendations contained in Practice F748.

Subcomité:

F04.16

Referida por:

F0748-25, F2212-25

Volúmen:

13.01

Número ICS:

07.100.10 (Medical microbiology)

Palabras clave:

biocompatibility; contact hypersensitivity; local lymph node assay; LLNA; mouse; sensitization;