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Standard Guide for Assessment of Materials and Products for Declarable Substances 可申报物质材料和产品评估标准指南
发布日期: 2014-03-01
1.1本指南使用案例研究来说明在评估是否符合相关要求时评估可申报物质的材料和产品的决策过程。这可以通过应用现有知识来确定进一步行动的需要(例如,测试)来实现。 1.2本指南仅限于引用的欧盟指令。其他地区、国家、州或地方市政当局可采用这些或类似法规。 1.3 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和健康实践,并确定监管限制的适用性。 ====意义和用途====== 4.1由于对材料内(或上)物质浓度的要求,评估产品的符合性已成为一项复杂、耗时和昂贵的任务。本指南旨在帮助用户制定产品评估协议。 4.2 先验的 知识基于逻辑推理和科学原理,因此可能不需要对材料进行实际测试以评估其是否符合要求。 例如,可以推断有机物质无法在生产锻钢所需的温度下存活,因此不需要测试锻钢中的有机物质,也不可能开发用于测定锻钢中有机物质的测试方法和参考材料。 4.3 后部 我的知识是基于观察、经验和已知事实。如果 先验的 知识不能排除物质存在于材料内(或材料上)的可能性,可能需要一种试验方法来验证或生成有关该物质在材料内(或材料上)浓度的信息。 4.4试验方法可作为验证和提供材料内物质相关信息的手段。同时,当测试方法被误用时,可能会产生错误信息或得出不适当的结论。本指南旨在提供试验方法应用的建议。 4.5试验方法可由材料的生产商或临时或最终用户使用。然而,在生产的每个阶段测试材料是不必要的,也不具有成本效益。应用测试方法和测试频率的决定应基于用户感知的风险,也可以是一个协议问题。 4.6评估塑料中是否存在可申报物质比评估金属和合金更复杂,因为塑料制造中可能的成分相对较多。 4.7本指南包括一般流程和案例研究,以提供指导并区分 先验的 和 后验 应该应用知识。中提供了作为材料和产品评估指南的流程图 附录X1 .
1.1 This guide uses case studies to illustrate the decision process to assess materials and products for declarable substances when evaluating conformance to relevant requirements. This may be accomplished by applying existing knowledge to determine the need for further action (for example, testing). 1.2 This guide is limited to the referenced European Union directives. Other regions, countries, states or local municipalities may adopt these or similar regulations. 1.3 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 and health practices and determine the applicability of regulatory limitations prior to use. ====== Significance And Use ====== 4.1 Due to requirements being placed on concentrations of substances within (or on) materials, assessing conformance of products has become a complex, time-consuming and expensive task. This guide is intended to assist the user in developing a protocol for product assessment. 4.2 A priori knowledge is based on logical deduction and scientific principles, so actual testing of a material may not be required in order to assess conformance to requirements. For example, it is possible to deduce that organic substances will not survive the temperatures required to produce wrought steel, so there is no need to test for organic substances in wrought steel nor is it possible to develop test methods and reference materials for determination of organic substances within wrought steel. 4.3 A posterior i knowledge is based on observation, experience and known facts. If a priori knowledge cannot rule out the possibility that a substance is present within (or on) a material, a test method may be required to verify or generate information on the concentration of that substance within (or on) the material. 4.4 Test methods can be used as a means to verify and provide information related to substances within materials. At the same time, misinformation can be generated or inappropriate conclusions drawn when test methods are misapplied. This guide is intended to provide recommendations on the application of test methods. 4.5 Test methods may be applied by producers or by interim or end users of materials. However, it is not necessary or cost effective to test materials at each stage of production. The decision to apply test methods and the frequency of testing should be based on risk perceived by the user or can be a matter of agreement. 4.6 Assessment of plastics for presence of declarable substances is more complex than assessment of metals and alloys, since the possible ingredients are comparatively much more numerous in plastic manufacture. 4.7 This guide includes a general process and case studies in order to provide guidance and to distinguish where a priori and a posteriori knowledge should be applied. Flow charts as a guide for assessment of materials and products are provided in Appendix X1 .
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归口单位: F40.02
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