1.1 本规程旨在确定物质或材料提取物引起接触性皮肤过敏性的可能性。 1.2 以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.3 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.4 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 ====意义和用途====== 4.1 在选择医疗应用中与人体接触的新材料时，重要的是确保该材料不会刺激免疫系统产生过敏反应。反应可能是由于物质可能从材料中渗出。因此，本规程规定使用材料提取物。这种做法的理由是，豚鼠已被证明是人类过敏性接触性皮炎的最佳动物模型。使用弗氏完全佐剂和十二烷基硫酸钠往往会提高材料引起过敏的可能性。因此，这项试验虽然不能保证材料是非变性的，但却是当今常用的最严厉的动物试验。

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, health and environmental practices and determine the applicability of regulatory limitations prior to use. 1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 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.