Donawa M E
Donawa and Associates Ltd, Rome, Italy.
Med Device Technol. 1997 May;8(4):12-4, 16-7.
The packaging of medical devices bearing the CE mark must comply with the European Directives for medical devices. Packaging of medical devices marketed in the United States (US) must meet US requirements. Although these requirements are more stringent for sterile products, they apply to sterile and non-sterile products. This article will discuss the requirements, US guidance for complying with them, and some of the international and European standards for packaging that are available or being prepared.
带有CE标志的医疗器械包装必须符合欧洲医疗器械指令。在美国销售的医疗器械包装必须符合美国要求。尽管这些要求对无菌产品更为严格，但它们适用于无菌和非无菌产品。本文将讨论这些要求、美国的合规指南以及一些现有的或正在制定的国际和欧洲包装标准。
