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ASTM F720-13
Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
3 стр.
Заменен
Печатное изданиеЭлектронный (pdf)
84.24 $ (включая НДС 20%)
Разработчик:
Зарубежные/ASTM
ICS:
11.220 Veterinary. Including equipment specific to veterinary medicine / Ветеринария. Включая специальное ветеринарное оборудование
Сборник (ASTM):
13.01 Medical and Surgical Materials and Devices (I): E667 – F2477 / Медицинские и хирургические материалы и приборы (I): E667 - F2477
Тематика:
Medical Devices & Implants
Описание
Значение и использование

4.1 In selecting a new material for human contact in medical applications, it is important to ensure that the material will not stimulate the immune system to produce an allergic reaction. The reaction would be due to substances which could leach out of a material. Therefore, this practice provides for using material extracts. The rationale for this practice is based on the fact that the guinea pig has been shown to be the best animal model for human allergic contact dermatitis. The use of Freund’s complete adjuvant and sodium lauryl sulfate tends to enhance the potential of a material to cause an allergy. Therefore, this test, while not guaranteeing that a material is nonallergenic, is the most severe animal test in common use today.

Область применения

1.1 This practice is intended to determine the potential for a substance, or material extract, to elicit contact dermal allergenicity.

1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.3 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.

Ключевые слова:
acute toxicity tests; allergenicity; biocompatibility; guinea pigs; sensitization; test animals