1.1
本指南涵盖了使用分层方法检测和表征消费纺织品中的银纳米材料,其中可能包括由天然纤维或人造纤维的任何组合制成的一些医疗设备(例如,伤口敷料或面罩)。
1.2
本指南涵盖但不限于纺织品制造过程中使用的织物和部件(例如,线、棉絮)以及可能含有银基纳米材料的消费纺织品产品的生产。它不适用于非消费性纺织品基质中银纳米材料的分析,也不适用于纳米尺度上只有一个维度的薄膜银涂层。
1.3
本指南旨在为制造商、生产商、分析师、决策者、监管机构和其他对纺织品感兴趣的人士提供参考。
1.4
本指南是在银纳米材料测量的特定背景下提出的;然而,本文所述的结构化方法适用于消费纺织品中的其他纳米材料,包括一些医疗器械。
1.5
单位-
以国际单位制表示的值应视为标准值。本标准不包括其他测量单位。
1.6
本标准并不旨在解决与其使用相关的所有安全问题(如有)。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,并确定监管限制的适用性。
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《国际标准、指南和建议制定原则决定》中确立的国际公认标准化原则制定的。
=====意义和用途======
4.1
天然和人造纺织品纤维可以用化学物质处理,以增强抗微生物(真菌、细菌、病毒)性能。在某些情况下,银纳米材料可用于处理纺织纤维
(
1.
)
.
6.
银纳米材料用于处理各种消费纺织品,包括但不限于各种服装;初级服装(衬衫、裤子)、外装(手套、夹克)、内装(袜子和内衣)、童装(睡衣);儿童毛绒玩具;浴巾和床上用品(床单、枕头);和医疗器械(例如,伤口敷料和面罩)
(
2.
)
.
4.2
用于处理纺织品的银有许多不同的化学和物理形式,本主题概述见
附录X1
.
4.3
银的检测和表征的几种适用技术在
附录X2
以便本指南的用户了解特定技术对其特定纺织品和银测量需求的适用性。
4.4
在产品生命周期的任何时候,都有许多不同的原因来测定纺织品中的纳米银。例如生产商可能希望验证纺织品是否符合其内部质量控制规范,或者监管机构可能希望了解用于在其管辖范围内制造消费纺织品的银纳米材料的性质。
无论具体原因如何,检测和表征纺织品中存在的银纳米材料的结构化方法将有助于测量和数据比较。纺织品中银的检测和表征是总体风险评估的一个组成部分。
4.5
本指南中介绍的方法(参见
图1
)由三个顺序层组成:获得纺织品样品(第节
7.
),银纳米材料的检测(第节
8.
)和银纳米材料的表征(第节
9
). 如果使用适当的(适合用途的)分析技术在纺织品样品中未检测到任何形式的银,则可以终止测试。如果检测到银,但银以非纳米级形式存在,则纺织品是化学银或大块银-
包含材料。银离子可以从含银材料中释放出来,在还原条件下,银离子可以转变成纳米级的含银颗粒。如果检测到纳米级的银,就可以得出结论,纺织品中含有银纳米材料。随后的测量可以表征银纳米材料的化学和物理性质。
图1
确定纺织品是否含有银纳米材料的分层方法(*可能无法知道纳米材料是如何在纺织品中形成的。它可能是经过工程设计或有意应用或从其他银源转化而来的。)
4.6
许多技术可用于检测和表征纺织品中的银纳米材料。
选择的广度可能会给那些有兴趣制定分析策略和选择适当技术的人带来困惑。一些技术仅适用于某些化学形式的银,并且对于被测物而言,所有技术的适用范围都有限。没有一种单一的技术适用于检测和充分表征纺织品中的银纳米材料。本指南描述并定义了使用商用测量技术的分层方法,以便制造商、生产商、分析师、决策者、监管机构和其他人在标准化框架内对纺织品中的银纳米材料进行分析时做出知情和适当的选择。提醒用户,本指南并非旨在解决所有可能的纺织品分析场景,也可能不适用于所有情况。
在任何情况下,专业判断都是必要的。
4.7
本指南提供了一种分层方法,以确定检测和表征纺织品中银的有效和高效程序,并确定是否存在任何银纳米材料。这种分层方法也可用于确定是否以适当和有意义的方式获得了纺织品中银纳米材料的报告测量值。
4.8
材料性能测量取决于方法。当比较来自不同物理或化学原理或不同测量范围的技术的相同被测数据时,需要谨慎。
4.9
纺织品中的银量可能会随着时间的推移而减少。
银金属和银化合物可以与环境中存在的氧和其他氧化还原(氧化还原)活性剂反应,形成可溶性银物种。这些可溶性银物种可通过与湿气接触(例如,来自环境湿度、洗涤、身体汗液、雨水或其他来源)而释放。如中所述
附录X1
可溶性银物种的释放可能以不同的速率发生。释放速率取决于许多特性,包括化学性质、表面积、结晶度和形状,银被施加到织物上的位置(在纤维表面上,以纤维的体积等),以及银以何种形式被施加到纺织品上(离散颗粒,带载体等)。
当从结果中得出时间推断时,必须考虑纺织品测试样品的条件和年龄,因为结果中只会捕捉到纺织品生命周期的一个瞬间。
4.10
纺织品的获取、储存、处理和制备也会影响银含量。
1.1
This guide covers the use of a tiered approach for detection and characterization of silver nanomaterials in consumer textile products, which can include some medical devices (for example, wound dressings or face masks), made of any combination of natural or manufactured fibers.
1.2
This guide covers, but is not limited to, fabrics and parts (for example, thread, batting) used during the manufacture of textiles and production of consumer textile products that may contain silver-based nanomaterials. It does not apply to analysis of silver nanomaterials in non-consumer textile product matrices nor does it cover thin film silver coatings with only one dimension in the nanoscale.
1.3
This guide is intended to serve as a resource for manufacturers, producers, analysts, policymakers, regulators, and others with an interest in textiles.
1.4
This guide is presented in the specific context of measurement of silver nanomaterials; however, the structured approach described herein is applicable to other nanomaterials in consumer textile products, including some medical devices.
1.5
Units—
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.
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
Natural and manufactured textiles fibers can be treated with chemicals to provide enhanced antimicrobial (fungi, bacteria, viruses) properties. In some cases, silver nanomaterials may be used to treat textile fibers
(
1
)
.
6
Silver nanomaterials are used to treat a wide array of consumer textile products, including, but not limited to, various clothing; primary garments (shirts, pants), outer wear (gloves, jackets), inner wear (socks and underwear), children’s clothing (sleepwear); children’s plush toys; bath towels and bedding (sheets, pillows); and medical devices (for example, wound dressings and face masks)
(
2
)
.
4.2
There are many different chemical and physical forms of silver that are used to treat textiles and an overview of this topic is provided in
Appendix X1
.
4.3
Several applicable techniques for detection and characterization of silver are listed and described in
Appendix X2
so that users of this guide may understand the suitability of a particular technique for their specific textile and silver measurement need.
4.4
There are many different reasons to assay for silver nanomaterials in a textile at any point in a product’s life cycle. For example, a producer may want to verify that a textile meets their internal quality control specifications or a regulator may want to understand the properties of silver nanomaterials used to make a consumer textile product under their jurisdiction or what quantity of silver nanomaterial is potentially available for release from the treated textile during the washing process or during product use. Regardless of the specific reason, a structured approach to detect and characterize silver nanomaterials present in a textile will facilitate measurements and data comparison. Detection and characterterization of silver in textiles is one component of an overall risk assessment.
4.5
The approach presented in this guide (see
Fig. 1
) consists of three sequential tiers: obtain a textile sample (Section
7
), detection of a silver nanomaterial (Section
8
), and characterization of a silver nanomaterial (Section
9
). If no forms of silver are detected in a textile sample using appropriate (fit for purpose) analytical techniques then testing can be terminated. If silver is detected, but present in a non-nanoscale form, the textile is a chemical or bulk silver-containing material. Silver ions may be released from silver-containing materials, and under reducing conditions these can transform into nanoscale silver-containing particles. If nanoscale silver is detected, one concludes that the textile contains a silver nanomaterial. Subsequent measurements can characterize the chemical and physical properties of the silver nanomaterial.
FIG. 1
Tiered Approach for Determining if a Textile Contains a Silver Nanomaterial (*It might not be possible to know how the nanomaterial formed in the textile. It may have been engineered or intentionally applied or transformed from another silver source.)
4.6
Numerous techniques are available to detect and characterize silver nanomaterials in textiles. The breadth of options can cause confusion for those interested in developing an analytical strategy and selecting appropriate techniques. Some techniques apply only to certain chemical forms of silver and all have limited ranges of applicability with respect to a measurand. No single technique is suitable to both detect and fully characterize silver nanomaterials in textiles. This guide describes and defines a tiered approach using commercially available measurement techniques so that manufacturers, producers, analysts, policymakers, regulators, and others may make informed and appropriate choices in assaying silver nanomaterials in textiles within a standardized framework. The user is cautioned that this guide does not purport to address all conceivable textile analysis scenarios and may not be appropriate for all situations. In all instances, professional judgment is necessary.
4.7
This guide provides a tiered approach to determine an efficacious and efficient procedure for detecting and characterizing silver in textiles and determine whether any silver nanomaterial is present. This tiered approach may also be used to determine whether a reported measurand for silver nanomaterials in a textile was obtained in an appropriate and meaningful way.
4.8
Material property measurement depends on the method. Caution is required when comparing data for the same measurand from techniques that operate on different physical or chemical principles or with different measurement ranges.
4.9
The amount of silver in a textile might decrease over time. Silver metal and silver compounds can react with oxygen and other oxidation-reduction (redox) active agents present in the environment to form soluble silver species. These soluble silver species can be released by contact with moisture (for example, from ambient humidity, washing, body sweat, rain, or other sources). As described in
Appendix X1
, release of soluble silver species may occur at varying rates. Release rates depend on many characteristics, including chemical nature, surface area, crystallinity, and shape, where the silver is applied to the textile (on the fiber surface, in the volume of the fiber, and so forth), and in what form the silver is applied to the textile (discrete particles, with carriers, and so forth). The condition and age of textile test samples must be considered when drawing temporal inferences from the results, as only a moment in time of the textile life cycle will be captured in the results.
4.10
Textile acquisition, storage, handling, and preparation can also affect silver content.