ISO 11608-5:2012 医用针式注射系统 要求和试验方法 第5部分：自动化功能

标准编号：ISO 11608-5:2012

中文名称：医用针式注射系统 要求和试验方法 第5部分：自动化功能

英文名称：Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions

发布日期：2012-10

标准范围

This part of ISO 11608 specifies requirements and test methods for the automated functions of needle-based injection systems with automated functions (NIS-AUTO), for the administration of medicinal products in humans, including but not limited to:a) drug product preparation (e.g. reconstitution);b) needle preparation;c) air removal;d) priming;e) dose setting;f) actuation;g) needle insertion;h) injection of the medicinal product;i) disabling the NIS-AUTO;j) needle retraction;k) needle shielding;l) needle hiding;m) sharps injury protection;n) needle removal.

标准预览图