1.1 本规范涵盖用于外科植入物的超高分子量聚乙烯粉末（UHMWPE）和制造形式。 1.2 本规范的要求以两种形式适用于超高分子量聚乙烯。一种是未经处理的聚合物粉末（第 4. ). 第二种是由该粉末制成的任何形式，随后可从中生产成品（第 5. ). 本规范涉及材料特性，不适用于包装和灭菌的成品植入物。 1.3 本规范的要求不适用于UHMWPE原始粉末或故意交联或与其他添加剂（例如抗氧化剂）混合的预制形式。 1.4 软组织和骨骼对聚乙烯的生物反应具有良好的临床应用历史 ( 1- 3. ) 2. 通过实验室研究 ( 4- 6. ) . 1.5 以国际单位制表示的数值应视为标准值。 1.6 以下预防性警告仅适用于试验方法部分第节 7. ，本规范: 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 ultra-high molecular weight polyethylene powder (UHMWPE) and fabricated forms intended for use in surgical implants. 1.2 The requirements of this specification apply to UHMWPE in two forms. One is virgin polymer powder (Section 4 ). The second is any form fabricated from this powder from which a finished product is subsequently produced (Section 5 ). This specification addresses material characteristics and does not apply to the packaged and sterilized finished implant. 1.3 The requirements of this specification do not apply to UHMWPE virgin powder or fabricated forms intentionally crosslinked or blended with other additives, for example, antioxidants. 1.4 The biological response to polyethylene in soft tissue and bone has been well characterized by a history of clinical use ( 1- 3 ) 2 and by laboratory studies ( 4- 6 ) . 1.5 The values stated in SI units are to be regarded as standard. 1.6 The following precautionary caveat pertains only to the test method portion, Section 7 , of this specification: 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.