1.1 本试验方法旨在评估受试手套材料诱发和诱发人类IV型皮肤致敏反应（即过敏性接触性皮炎）的可能性。 1.2 本试验方法应由在良好临床实践程序使用方面有经验的人员或在其监督下使用。 1.3 在进行人类重复侮辱斑贴试验（RIPT）以确定致敏性的过程中，研究人员面临着代表皮肤刺激（非免疫反应）或过敏性接触性皮炎（ACD）的皮肤反应。用于对两者强度进行分级的数字评分系统相似，测试设施在描述过敏和刺激性皮肤反应强度的分数上可能有所不同。 轻度过敏性接触性皮炎的特征是持续可触及的红斑反应。斑贴试验产生的延迟型过敏性接触反应具有强度特征，在较长时间内倾向于较高值的分数，并且在短时间（少于48小时）内通常不会产生最低分数（分数为1，只是可察觉的红斑）。研究者有责任根据刺激性反应评估分数，使反应本质上是过敏性的，而不是刺激性的。研究者应将最终分数表示为接触过敏或刺激所致。段落 9.5 – 9.5.5 描述一个常用的评分系统，并详细讨论过敏和刺激反应。 1.4 Draize IPT于1944年发布，旨在降低ACD的频率。 2. 当时的测试技术刚刚得到验证，这种实验设计在很大程度上是经验性的。 3. 试验原理如下: 1.4.1 在相对无刺激性或低刺激性水平下对研究材料进行多次诱导， 1.4.2 大约两周的休息时间，以及 1.4.3 贴片应用后约48小时的标准诊断挑战和约96小时的延迟读数。 1.5 在这几年中，随着对这种经验性方法的进一步实验，我们学到了三个额外的原则: 1.5.1 增加研究材料的浓度， 1.5.2 定义一个无影响水平（仅使用单个成分而非最终研究材料即可），以及 1.5.3 增强的灵敏度和遮挡的使用（通常不会出现遮挡）。 1.6 1945年，亨德森和莱利 4. 证明必须采用30000名受试者的测试小组样本量，以确保统计结果不超过0.1 % 敏感化如果由200名受试者组成的测试小组中没有过敏反应，暴露量与人群相当，那么每100名使用者中可能有多达1.5个过敏反应。 1.7 所有医疗设备必须安全有效地用于其预期用途。由于手套等医疗器械与人体组织接触，因此应首先测试其在动物体内的生物相容性。人体重复损伤斑贴试验（RIPT）是一种可用于测试橡胶手套对手套制造中使用的化学品的皮肤致敏性的试验。 1.7.1 由于存在各种形式的皮肤过敏性皮炎，应制定一种单一的标准化测试方法，概述测试方案、评分系统和皮肤致敏标准。 1.8 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。 1.9 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 该方法通过对选定受试者的皮肤反复局部应用，评估特定医疗产品的皮肤致敏潜力。 这是一种有可能检测到许多（但不是所有）感测器的程序。这需要多次应用来诱导足以引起过敏反应的细胞介导的IV型免疫反应。 4.2 一般来说，致敏程序需要在三周的诱导期内多次48小时（周末72小时）施用含有研究材料的贴片。诱导后大约有21天的休息期，以允许任何潜在致敏的发展。然后，通过将两个连续48小时的研究材料补丁应用于原始站点来挑战研究对象。在每次连续施用48小时贴片后，对反应进行评估和分级。 4.3 虽然该试验方法是一种临床方法，但它可以作为风险分析的一部分，以确定IV型过敏性接触性皮炎的可能性。 4.4 该测试方法假设将采用良好的临床实践，包括对从业人员进行充分培训。

1.1 This test method is designed to evaluate the potential of glove materials under test to induce and elicit Type IV skin sensitization reactions (that is, allergic contact dermatitis) in humans. 1.2 This test method should be used by individuals experienced in or under the supervision of those experienced in the use of good clinical practice procedures. 1.3 During the performance of the Human Repeat Insult Patch Test (RIPT) for determining sensitization, investigators are confronted with skin responses that represent skin irritation (non-immunologic responses) or allergic contact dermatitis (ACD). The numerical scoring system for grading the intensity of both are similar and test facilities may vary in their scores that describe intensities of allergic and irritant skin responses. The hallmark of a mild allergic contact dermatitis is a sustained palpable erythematous reaction. Delayed-type allergic contact reactions from patch tests have intensity characteristics that favor scores of higher values for longer periods of time and typically do not produce a minimal score (score of 1, a just-perceptible erythema) for short durations (less than 48 h). It is the responsibility of the investigator to evaluate the scores in light of irritant reactions so that the responses are allergic in nature and not irritant. The investigator should denote a final score as either due to contact allergy or irritation. Paragraphs 9.5 – 9.5.5 describe a commonly used scoring system and discuss allergic and irritant responses in detail. 1.4 The Draize RIPT was published in 1944 as an attempt to decrease the frequency ACD. 2 The test techniques at that time were just being validated and this experimental design was largely empiric. 3 The principle of the test is as follows: 1.4.1 Multiple inductions of the study material at relatively non or low irritancy levels, 1.4.2 Approximately a two-week rest period, and 1.4.3 A standard diagnostic challenge of approximately 48 h and a delayed reading at approximately 96 h after patch application. 1.5 In the intervening years, with further experimentation added to this empiric approach, three additional principles have been learned: 1.5.1 Increasing the concentration of the study material, 1.5.2 Defining a no effect level (this is possible with only individual ingredients and not the final study material), and 1.5.3 The enhanced sensitivity and the use of occlusion (where occlusion would not ordinarily be present). 1.6 In 1945, Henderson and Riley 4 demonstrated that a test panel sample size of 30 000 subjects would have to be employed to ensure statistically that there would be no more than 0.1 % sensitization. If there are no allergic responses in a test panel of 200 subjects with exposures comparable to those of the population, then there could be as many as 1.5 allergic reactions per 100 users. 1.7 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. 1.7.1 Since various forms of the RIPT exist, a single standardized test method that outlines the testing protocol, scoring system, and the criteria for skin sensitization should be developed. 1.8 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. 1.9 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 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.