1.1 本规范涵盖ISO 25137-1中定义的聚砜树脂（聚（氧-1,4-苯磺酰基-1,4-苯（二甲基亚甲基）-1,4-苯））由供应商以原始形式（颗粒、粉末、预制形式等）提供，用于医疗应用。本规范规定了该热塑性塑料用于制造医疗器械或医疗器械组件时的要求和相关测试方法。 1.2 与任何材料一样，某些特性可能会因生产特定零件或装置所需的加工技术（如成型、挤压、机加工、灭菌等）而改变。因此，应使用适当的测试方法来评估这种树脂制成形式的性能，以确保供应商、买方和监管机构商定的安全性和有效性。 1.3 本标准允许指定用于所有医疗应用的聚砜树脂。供应商、买方和监管机构必须评估特定应用的实际性能范围和适用性。 1.4 本规范中包含的特性适用于添加着色剂和加工助剂的未填充聚砜（PSU）聚合物。所示属性适用于注塑成型。本规范不包括含有填料或其他添加剂的形式，以及含有PSU或再生材料的聚合物混合物。 1.5 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。 1.6 根据本规范评估材料时，可能涉及危险材料、操作和设备。 本标准并非旨在解决与其使用相关的所有问题（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。 1.7 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《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。

1.1 This specification covers polysulfone resin (poly(oxy-1,4-phenylenesulfonyl-1,4–phenylene (dimethylmethylene)-1,4–phenylene)) as defined in ISO 25137–1, supplied by a vendor in virgin form (pellets, powder, fabricated forms and so forth) for medical applications. This specification provides requirements and associated test methods for this thermoplastic when it is intended for use in manufacturing medical devices or components of medical devices. 1.2 As with any material, some characteristics may be altered by the processing techniques (such as molding, extrusion, machining, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated using test methods which are appropriate to ensure safety and efficacy as agreed upon by the vendor, purchaser, and regulating bodies. 1.3 The standard allows for designation of polysulfone resin for all medical applications. The actual extent of performance and suitability for a specific application must be evaluated by the vendor, purchaser, and regulating bodies. 1.4 The properties included in this specification are those applicable for unfilled polysulfone (PSU) polymers with the addition of colorants and processing aids. Indicated properties are for injection molded forms. Forms containing fillers or other additives, as well as polymer blends which contain PSU, or reclaimed materials, are not covered by this specification. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 When evaluating material in accordance with this specification, hazardous materials, operations, and equipment may be involved. This standard does not purport to address all of the 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.