1.1 这些标准包括基于双酚A二缩水甘油醚（DGEBPA）的热固性塑料和适当的固化剂或催化剂，而不是基于环氧结构的热固性塑料。 1.2 这些标准是通用的，旨在提供植入式设备中使用的环氧塑料的定义和标准描述。它还旨在作为编制更具体文件的标准指南，其价值和限制涵盖特定的最终用途。 1.3 符合这些标准不得解释为对植入性的认可。 环氧塑料作为一类的生物相容性尚未确定。环氧塑料是一个通用术语，涉及由环氧树脂、某些固化剂或催化剂以及各种添加剂形成的聚合物类别。由于许多组合物和配方属于这一类，因此配方设计师或制造商必须确保特定组合物或配方在其预期最终用途中的生物相容性。由于这些标准为编写涵盖特定最终用途的更具体文件提供了指导，因此这些文件将为适用于特定最终用途的生物相容性标准化评估提供基础。 1.4 在选择用于特定最终用途的材料时，应考虑所列的每种特性。对于单独的产品规格，建议列出指定了极限值的选定特性列表。 1.5 列出的所有特性和测试方法可能与任何特定情况无关，也可能不需要列出的所有测试。 1.6 这些标准仅限于功能性或完全固化的环氧塑料。未固化或未完全固化的配方被明确排除在外。 1.7 本标准涵盖的环氧塑料是用于植入式生物医学设备的评估材料。 本文认为可植入一词包括体内使用时间超过30天的装置。 1.8 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。

1.1 These criteria cover thermoset plastics based on diglycidyl ethers of bisphenol A (DGEBPA) and appropriate curing agents or catalysts as opposed to thermoplastics based on epoxy structures. 1.2 These criteria are generic and are intended to provide definitions and a standard description of epoxy plastics used in implantable devices. It is also intended to serve as a standard guide for the preparation of more specific documents with values and limits covering specific end uses. 1.3 Compliance with these criteria shall not be construed as an endorsement of implantability. The biocompatibility of epoxy plastics as a class has not been established. Epoxy plastic is a generic term relating to the class of polymers formed from epoxy resins, certain curing agents or catalysts, and various additives. Since many compositions and formulations fall under this class, it is essential that the formulator or fabricator ensure biocompatibility of the specific composition or formulation in its intended end use. Since these criteria provide guidance for the preparation of more specific documents covering specific end uses, these documents will provide bases for standardized evaluation of biocompatibility appropriate for a specific end use. 1.4 Each of the properties listed shall be considered in selecting materials for specific end uses. A list of selected properties with limiting values assigned is suggested for separate product specifications. 1.5 All of the properties and test methods listed may not be pertinent in any specific situation, nor may all of the tests outlined be required. 1.6 These criteria are limited to functionally or fully cured epoxy plastics. Uncured or incompletely cured formulations are specifically excluded. 1.7 The epoxy plastics covered by this standard are those to be evaluated for use in implantable biomedical devices. The term implantable is herein considered to include devices used in vivo for time periods in excess of 30 days. 1.8 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.