本文件规定了可吸收心血管植入物的设计评估要求和建议，用于治疗循环系统内的血管和/或血管空间，包括心脏和所有脉管系统。本文件旨在通过提供可吸收植入物或组件或两者的特定指南来补充设备特定标准。购买本文件时可获得的所有当前修订均包含在购买本文件中。

This document establishes design evaluation requirements and recommendations for absorbable cardiovascular implants used to treat vessels and/or the vascular space within the circulatory system, including the heart and all vasculature. This document is intended to supplement device-specific standards by providing guidelines specific for either absorbable implants or components, or both.All current amendments available at time of purchase are included with the purchase of this document.