ISO/TR 16142:2006 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.

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

ISO/TR 16142:2006考虑并确定了某些重要标准和指南，这些标准和指南可用于评估医疗器械是否符合公认的基本安全和性能原则。ISO/TR 16142:2006适用于制造商、标准化机构、监管机构以及符合性评估目的。

ISO/TR 16142:2006 considers and identifies certain significant standards and guides that can be useful in the assessment of conformity of medical devices with recognized essential principles of safety and performance.ISO/TR 16142:2006 is intended for use by manufacturers, standardization bodies, regulatory bodies, and for conformity assessment purposes.

标准预览图