FDA Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices
标准简介
Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices[附网盘链接]是于之前发布的FDA标准，适用于US。标准截图
![Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices[附网盘链接]](/img/20210914103608r9pcd.jpg)
标准文档说明
标准文档类型为Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices Guidance for Industry and Food and Drug Administration Staff This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page. I. Introduction
FDA has developed this guidance document for members of industry who submit and FDA staff who review testing of orthopedic devices using ultrahigh molecular weight polyethylene (UHMWPE) material. In this document, the terms “you” and “your” refer to members of industry, also known as sponsors, submitters, or applicants; and the terms “we,” “us,” and “our” refer to FDA. This guidance is intended to assist you in determining the appropriate information and testing to submit in Premarket Notifications (510(k)s), De Novo requests, Premarket Approval (PMA) applications, Humanitarian Device Exemptions (HDEs), and Investigational Device Exemptions (IDEs) for orthopedic devices that contain UHMWPE. This guidance addresses the characterization and testing of UHMWPE materials used in orthopedic devices. These materials include conventional UHMWPE, highly crosslinked UHMWPE, highly crosslinked UHMWPE containing antioxidants (e.g., α-tocopherol (an isomer of vitamin E)), and non-conventional UHMWPE. This document outlines the information we recommend you include in a submission to FDA to characterize the UHMWPE material (e.g., material description, sterility, biocompatibility, mechanical properties, and chemical properties). Many standards are referenced in this document. For the current edition of the FDA-
recognized standard(s) referenced in this document, see the FDA Recognized Consensus
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