5.1 This test method, for the determination of protein levels in latex, is primarily intended to test NR, latex, and elastomeric materials for residual protein content. It is assumed that all who use this test method will be trained analysts capable of performing common laboratory procedures skillfully and safely. It is expected that work will be performed in a properly equipped laboratory.

1. Scope

1.1 This test method covers an analytical test for determining the amount of total aqueous extractable protein associated with NR, latex, and elastomeric products. Water soluble proteins are extracted in a buffer solution and then precipitated to concentrate them and also to separate them from water soluble substances that may interfere with the determination. The extracted protein is redissolved and quantified colorimetrically by the modified Lowry method using a protein standard.

1.2 For the purpose of this test method, the range of protein measurement will be based on the limit of detection and quantitation and recorded in micrograms per dm2 test specimen.

1.3 The test method is designed to be accurate and compatible with the industrial environment.

1.4 Steps are included in this test method to minimize the effects of interfering substances.

1.5 It is recognized that other methods for the analysis of leachable proteins exist and these may be used for routine quality control purposes provided they have been validated and a correlation established against the reference method specified by this test method.

1.6 This test method has not been validated for use with lubricated products such as condoms. Condoms with different lubricants as typically marketed, have not been tested in an ASTM ILS to determine if, and if so to what degree, the lubricant interferes with the assay.

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.

Test Requirement 测试要求：

天然橡胶及其产品中蛋白质分析

Sample Size 样品数量 / 送样规格: 300g
Lead Time / TAT (Turn Around Time) 测试周期: 常规服务 Regular service 15 working days

Report Summary 报告摘要:

Standard News 标准新闻：

天然乳胶(Natural Rubber Latex NRL)是由橡胶树割胶时流出来的乳白色液体，广泛用于制备消费品及医疗器材产品，如乳胶手套，安全套，创可贴，静脉导管和及其 它橡胶、软性塑料、胶黏剂制品。

天然橡胶天然乳胶中含有水溶性蛋白质，通过相关研究证明，如果乳胶中水溶性蛋白质超过一定的含量，部分使用者皮肤就会产生红斑、瘙痒，以及打喷嚏、咳嗽、呼吸困难、血压降低等过敏反应，严重的可能造成休克或死亡。

FDA明确规定，对含有天然乳胶的医疗器材及其包装，必须贴有警示标识的标签。WHO对于天然橡胶医用手套要求生产企业提供遵从“ISO 10993”及“蛋白质过敏实验” 的证明文件。对于天然乳胶可能产生的过敏性反应，很多产品尤其 是与皮肤直接接触产品都被要求提供产品中不含有天然乳胶的证明。