1.1 本指南涵盖了手套上细菌内毒素测定方法的选择。 1.2 由于细菌可能继续在非无菌手套上生长，可报告的内毒素水平仅适用于标记为无菌的手套。由于大多数环境含有内毒素，一旦打开手套箱并操作手套，内毒素水平将增加，因此不适合报告盒装手套（例如检查手套）上的内毒素水平。即使包装盒在分发前经过灭菌，也是如此。 1.3 本指南也可能适用于不同生产阶段或工艺变更评估期间的内部质量控制或警示目的。 1.4 本指导原则不适用于细菌内毒素以外的热原测定。1.5 无论选择何种检测方法，都必须使用描述的样品制备方法。本方法未描述实验室检测方法验证、分析员资格或试剂确认。解决了产品特定验证问题。 1.6 医用手套的安全和正确使用超出了本指南的范围。 1.7 本标准并不旨在解决与其使用相关的所有安全性问题（如果有）。本标准的使用者有责任在使用前建立适当的安全、健康和环境实践并确定法规限制的适用性。 1.8 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》中确立的国际公认的标准化原则制定的。======意义和用途====== 5.1 本指南建立了标准样品制备方法，并提供了用于测定医用手套上内毒素的三种已建立和公认的测试方法的描述。如果样品中的干扰产生可疑结果，则应使用第二种方法。 5.2 本指南适用于检测经过可能影响最终内毒素水平的所有工艺（微生物污染或加工剂/原材料被内毒素污染）的最终产品。由于原料和工艺条件在这些参数方面因批次而异，如果要进行产品内毒素声明（例如，无热原），则应在常规基础上检测内毒素。用户可能会发现，将内毒素测试纳入其生产过程的易损区域作为警报机制是有益的。

1.1 This guide covers a selection of methodologies for the determination of bacterial endotoxin on gloves when such a determination is appropriate. 1.2 As bacteria may continue to grow on non-sterile gloves, reportable endotoxin levels are only appropriate for gloves labeled as sterile. Because most environments contain endotoxin, once a box of gloves is opened and the gloves are manipulated, endotoxin levels will increase making it inappropriate to report endotoxin levels on boxed gloves (ex. examination gloves). This is true even if the box had undergone sterilization prior to distribution. 1.3 This guide may also be appropriate for internal quality control or alert purposes at different stages of manufacturing or during process change evaluations. 1.4 This guide is not applicable to the determination of pyrogens other than bacterial endotoxins. 1.5 The sample preparation method described must be used regardless of the test method selected. This method does not describe laboratory test method validation, analyst qualification, or reagent confirmation. Product-specific validation is addressed. 1.6 The safe and proper use of medical gloves is beyond the scope of this guide. 1.7 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. 1.8 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 ====== 5.1 This guide establishes a standard sample preparation method and provides a description of three established and recognized test methods for the determination of endotoxin on medical gloves. If interferences in a sample yield suspect results, a second method should be used. 5.2 This guide is appropriate for testing final product that has been subjected to all processes that could influence the final endotoxin level (either microbial contamination or processing agents/raw materials contaminated with endotoxin). As raw materials and processing conditions vary from lot to lot with regard to these parameters, it is appropriate to test for endotoxin on a routine basis if a product endotoxin claim is to be made (for example, non-pyrogenic). The user may find it beneficial to incorporate endotoxin testing for vulnerable areas of their manufacturing process as an alert mechanism.