1.1 本指南涵盖了消费者和医院人员休假产品的测试方法和采样程序选项。休假产品，如酒精洗手液和含有抗菌成分的乳液，越来越多地在市场上销售，并被消费者和医疗保健人员使用。这些产品不同于传统的洗涤和擦洗制剂，因为它们不依赖于漂洗、物理去除和抗菌作用来确定其有效性。尽管搅动和摩擦可能有助于从皮肤、褶皱和裂缝中释放生物体，但生物体随后会在现场杀死，并且在采样之前不会从皮肤表面冲洗。 已经公布了适用于手的测试方法，同时需要其他采样方法来测试手以外的身体部位。 1.1.1 研究人员描述了识别皮肤上可能存在的扩展菌群的技术。在每次测试中试图恢复和鉴定这些种类的生物体是不切实际的，如果不是禁止的话。在测试设计的某个时候，需要做出决定来定义目标生物体。采样设计是否应尽可能多地恢复微生物区系或其特定部分？在确定测试产品的目标时，必须考虑瞬时菌群和驻留菌群、浅层菌群和深层菌群，或需氧菌群和厌氧菌群。 为任何测试选择的回收方法必须基于被测试产品类型的预期用途。 1.2 将污染生物体涂抹到身体某个部位后的恢复方法，而不是用手在玻璃皮氏培养板上搅拌/摩擦，也需要进行检查。应考虑接触电镀、用模板控制擦拭和杯子擦洗（使用清洁剂/搅拌），因为用于回收的目标生物体可能位于皮肤表层。 1.3 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。 1.4 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。 1.5 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 美国对手术擦洗的关注和测试力度远远超过了病人对病人日常护理中的手边护理。英国是感染控制护理的发起者，一直关注感染传播。在美国，已发表的文章记录了医护人员在患者之间洗手的短接触时间。平均时间不到10秒。减少暂时性菌群的理想产品是快速杀死或去除或同时去除在保健活动中获得的微生物负载。 强调快速性至关重要，因为医护人员在使用传统洗手产品时不会花费必要的时间。不与水一起使用的产品的使用量急剧增加，在欧洲国家使用这些产品很普遍，主要是因为它们方便有效。第二个特征是抗菌作用的水平。使用快速有效的活性产品来减少工作获得的微生物菌群是理想的。 4.2 自从严格的皮肤局部抗菌剂体外测试改为洗手、准备、现场访问测试和采样的模拟使用测试以来，重点一直是洗手、搅拌、摩擦和在皮肤部位用液体刷洗，以估计测试后去除的细菌。 4.3 没有刷子或只有轻微搅拌和摩擦的手术擦洗减少了硬搅拌的使用。 4.4 有微生物扩散的历史 ( 9 ) 淋浴导致深层表面细菌增多 ( 10- 12 ) ，清洗、擦洗和搅拌。在正常情况下，皮肤上存在浅表菌群和深层或隐藏菌群 ( 5. ) . Selwyn已经解决了一个对另一个的比例问题 ( 4. ) 他的判断是从20岁到50岁 % 《植物志》的主题是“深”皮肤采样的目的几乎总是擦洗、搅动和使用表面活性剂尽可能多地去除生物体。 在这样做时，我们完全忽略了这两种植物群。 4.5 此外，当用清洁剂或抗菌剂处理皮肤并随后冲洗掉时，“深层”或“隐藏”菌群被推到表面，因为皮脂从清洗时去除的皮脂腺中补充皮脂。许多早期的研究人员已经研究了更简单的采样方法，我们现在认识到这些方法主要是对浅表瞬态菌群进行采样。

1.1 This guide covers test methods and sampling procedure options for leave-on products for consumer and hospital personnel. Leave-on products, such as alcohol hand rubs and lotions containing antimicrobial ingredients, are increasingly marketed and used by consumers and health care personnel. These products are distinguished from conventional washing and scrubbing preparations in that they do not rely on the rinsing, physical removal, and antimicrobial action in determining their effectiveness. Although agitation and friction may serve to release organisms from the skin and folds and crevices, organisms are then killed in situ and are not rinsed from the skin surface before sampling. Appropriate test methods for the hands have been published, while other sampling methods will be needed for testing body areas other than the hands. 1.1.1 Researchers have described techniques to identify the expanded flora we now know can be present on the skin. It is impractical, if not prohibitive to attempt to recover and identify these varieties of organisms with each test. At some point in the design of a test, a decision is necessary for defining the target organisms. Should the sampling be designed to recover as much of the microflora as possible or a particular portion of it? Consideration of transient and resident, superficial and deep, or aerobic and anaerobic flora must be included in defining the objective in testing products. The recovery methods selected for any testing must be based on the projected use of the product type being tested. 1.2 Methods of recovery after application of the contaminating organisms to a part of the body other than by the agitation/rubbing of the hands against a glass petri plate also need examination. Consideration should be given to contact plating, controlled swabbing with a template, and cup scrubbing (detergent/agitation used) since the target organisms for recovery are likely to be on the superficial layers of skin. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 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. 1.5 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 The United States has concentrated attention and testing efforts on surgical scrubbing far more than on hand care in patient-to-patient routines. Great Britain, the originators of infection control nursing, have always had their focus on infection transmission. In the United States, published articles have documented the short exposure time for health care personnel who do wash their hands between patients. The average is less than 10 s. The ideal product for the reduction of transient flora is one that rapidly kills or removes or both the microbial load acquired during health care activities. The emphasis on rapidity is essential simply because health care personnel will not take the necessary time when using conventional hand-washing products. The use of products not intended for use with water has increased dramatically and their use is common in European countries largely because of convenience and effectiveness. A second characteristic is the level of antimicrobial action. The use of a rapid and potent active product to reduce work-acquired microbial flora is ideal. 4.2 Since the change from strictly in-vitro testing of topical antimicrobials for use on skin to simulated use testing in hand washing, prepping, site access testing, and sampling, emphasis has always been on washing hands, agitating, rubbing, and brushing with liquid on the skin site to estimate bacteria removed after testing. 4.3 The use of hard agitation has diminished with surgical scrubs without brushes or with only mild agitation and friction. 4.4 There is a history of microbial dispersal ( 9 ) and increase in surface bacteria from deeper layers resulting from showering ( 10- 12 ) , washing, scrubbing, and agitation. In the normal situation on the skin, there is a superficial, surface flora and a deeper or hidden flora ( 5 ) . The proportion of one to the other has been addressed by Selwyn ( 4 ) and his judgment is that from 20 to 50 % of the flora is “deep.” The intent in skin sampling has almost always been to scrub, agitate, and use surfactant to remove as many organisms as we can. In doing this, we have completely ignored the two types of flora. 4.5 Further, when the skin is treated with a cleansing agent or an antimicrobial that is subsequently rinsed away, the “deep” or “hidden” flora is pushed to the surface as the sebum replenishes the sebum from the sebaceous glands removed in washing. Many early investigators have looked at simpler sampling methods that we now recognize were sampling primarily the superficial transient flora.