标准编号:ISO/TR 16142:2006
中文名称:医疗器械-医疗器械的安全和性能基本原则的标准选择指南.
英文名称:Medical devices — Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
发布日期:2006-01
标准范围
This Technical Report considers and identifies certain significant standards and guides that can be useful inthe assessment of conformity of medical devices with recognized essential principles of safety andperformance.This Technical Report is intended for use by manufacturers, standardization bodies, regulatory bodies, and forconformity assessment purposes.