1.1 本文中的方法规定了两种分析测试，用于定量评估具有杀菌特性的体检手套的表面杀菌效果。它们可用于测定手套外表面或内表面的杀菌活性。这些方法以两种不同的形式结合细菌挑战:方法（A）盐水或缓冲盐水溶液，和方法（B）含有有机负载的盐水或缓冲盐水溶液。每种方法都代表了医疗环境中可能出现的不同微生物污染方式。 1.2 本文所述方法不适用于杀病毒、杀真菌、杀结核或杀孢子评估，因为每种类别都需要独特的培养技术和测试条件。本文件所述试验方法的结果仅限于对植物性细菌的杀菌效果。 1.3 更广泛的手套描述，如广谱抗菌功效，将需要测试比植物细菌更广泛的微生物种类。建议感兴趣的制造商在开始测试之前与适当的监管机构讨论物种和菌株选择。 1.4 测试应由受过微生物技术培训的人员在适当的受控条件下进行，以确保结果的完整性和人员安全。 1.5 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。 1.6 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。 大多数监管机构要求遵守ISO 10993下的生物相容性指南。 1.7 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 在患者护理过程中，医疗保健提供者的手套经常受到微生物污染。 当他们直接或间接接触受污染的皮肤、渗出的伤口、呼吸道飞沫、血液、羊水、唾液或其他潜在感染性物质（OPIM）时，可能会发生这种情况。已经证明，几种已知为医院内病原体的细菌可以在戴手套的手触摸的表面上存活数天、数周甚至数月。手套上或手套中的有效抗菌处理可以快速减少其表面的活菌数量，也可能减少从污染源（水库）转移到易受感染患者或幼稚部位的细菌数量。 这些测试方法能够针对广泛的细菌和条件评估杀菌效果，为制造商、购买者和用户提供了一种有效性比较的方法。 4.2 列出了四种特定细菌，以实现实验室间和实验室内的测试校准，并提供比较产品抗菌效果的共同目标。 4.3 制造商还可以制定自己的细菌清单，对其产品进行评估，以反映其产品的使用环境、受监管的各机构提出的要求以及他们正在寻求的索赔。 必须验证并记录测试参数的更改。

1.1 The methods herein specify two analytical tests for quantitatively evaluating surface bactericidal efficacy of medical examination gloves incorporated with bactericidal properties. They may be used for the determination of bactericidal activity on either the outer or inner glove surface. The methods incorporate bacterial challenges in two different formats: Method (A) a saline or buffered saline solution, and Method (B) a saline or buffered saline solution containing an organic load. Each method represents a different means of microbial contamination that can be expected in the healthcare environment. 1.2 Methods described herein are not appropriate for virucidal, fungicidal, tuberculocidal or sporicidal evaluations as each of these categories require unique culture techniques and testing conditions. Results of the test methods described in this document are limited to bactericidal efficacy against vegetative bacteria. 1.3 A more expansive glove description, such as broad spectrum antimicrobial efficacy, would require testing of a broader list of microbial species than vegetative bacteria alone. It is recommended that interested manufacturers discuss species and strain selections with appropriate regulatory agencies before testing is commenced. 1.4 Testing is to be performed by individuals trained in microbiological techniques under appropriate controlled conditions to ensure integrity of results and personnel safety. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 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. Most regulatory agencies require compliance with Biocompatibility guidelines under ISO 10993. 1.7 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 the course of patient care, gloves of healthcare providers are often contaminated with microorganisms. This may occur when they come in direct or indirect contact with contaminated skin, oozing wounds, respiratory droplets, blood, amniotic fluid, saliva, or other potentially infectious materials (OPIM). It has been demonstrated that several bacteria known to be nosocomial pathogens, can survive for days, weeks and even months on surfaces that are touched by gloved hands. The presence of an effective antibacterial treatment on or in the glove that can rapidly reduce the number of viable bacteria on its surface, may also decrease the number of bacteria transferred from a contaminated source (reservoir) to a vulnerable patient or naïve site. These test methods enable assessment of bactericidal efficacy against a broad spectrum of bacteria and conditions, providing a means of efficacy comparisons for manufacturers, purchasers and users. 4.2 Four specific bacteria are listed to enable inter- and intra- laboratory test calibration and to provide common targets against which to compare antibacterial efficacy among products. 4.3 Manufacturers may additionally develop their own list of bacteria against which they will evaluate their products reflecting the circumstances in which their product will be used, the requirements set forth by the various agencies with which they are regulated, and the claims they are seeking. Alterations in test parameters must be validated and documented.