标准摘要
[中文适用范围]： 本文件规定了钉书机的通用要求，包括钉书机分类、预期性能、设计属性、设计评估、制造、灭菌、包装、制造商提供的信息以及用于证明符合这些要求的测试。本文件适用于一次性钉书机和可重复使用钉书机。本文件仅适用于使用钉书的器械。 [外文原描述]： This document specifies general requirements for staplers, including requirements for stapler classification, intended performance, design attributes, design evaluation, manufacturing, sterilization, packaging, information supplied by the manufacturer, and tests to demonstrate conformance with these requirements. This document is applicable to single-use staplers and reusable staplers. This document only applies to instruments that use staples.
英文名称Surgical instruments — Staplers — Part 2: General requirements