1.1 本规范涵盖医用聚甲醛（缩醛）树脂。本规范提供了用于制造医疗器械、仪器或其组件的热塑性塑料的要求和相关测试方法。 1.2 与任何材料一样，某些特性可能会因特定应用所需的加工技术（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评估这种树脂的制造形式的性能，以确保安全性和有效性。 1.3 尽管该树脂在美国已用于特定的植入应用，但在成功完成适合预期应用的生物相容性评估之前，该树脂在医疗器械中的使用应限于非植入应用。 1.4 由含有着色剂、填料、加工助剂或其他添加剂的聚甲醛（缩醛）树脂以及含有聚缩醛的聚合物混合物组成的塑料化合物的生物相容性不应仅基于树脂的生物相容性。其生物相容性必须通过测试最终（结束- 使用）使用适合预期应用的评估方法的成分。应注意的是，对于某些最终用途，可能还必须评估化合物或混合物中所含添加剂产生的提取物的类型、测试水平和生物效应。 1.5 以英寸-磅为单位的数值应视为标准值。本标准不包括其他计量单位。 1.6 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、健康和环境实践，并确定监管限制的适用性。 1.7 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。 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》中确立的国际公认标准化原则制定的。

1.1 This specification covers polyoxymethylene (acetal) resin for medical applications. This specification provides requirements and associated test methods for a form of this thermoplastic which is intended for use in manufacturing medical devices, instrumentation or components thereof. 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 a specific application. Therefore properties of fabricated forms of this resin should be evaluated using appropriate test methods to assure safety and efficacy. 1.3 Although this resin has been used for specific implant applications in the United States, the use of this resin in medical devices should be restricted to non-implant applications until biocompatibility evaluations appropriate for the intended applications are successfully completed. 1.4 The biocompatibility of plastic compounds made up of polyoxymethylene (acetal) resin containing colorants, fillers, processing aids, or other additives as well as polymer blends which contain polyacetal should not be assumed on the basis of resin biocompatibility alone. Their biocompatibility must be established by testing the final (end-use) compositions using evaluation methods appropriate for the intended applications. It should be noted that the types, test levels, and biological effects of extractives yielded by the additives contained in a compound or blend may also have to be evaluated for some end-use applications. 1.5 The values stated in inch-pound 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 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. 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.