新质量管理体系标准对CE认证流程的影响。
The impact of the new quality management system standards on the CE-marking process.
作者信息
Donawa M
机构信息
Donawa and Associates Ltd, Via Fonte di Fauno 22, I-00153 Rome, Italy.
出版信息
Med Device Technol. 2001 Jan-Feb;12(1):34-9.
PMID:11317864
Abstract
In December 2000, the new ISO 9000 quality management system series of standards was published. This represents a significant development for manufacturers marketing medical devices in Europe, who use these standards to demonstrate conformity to the European medical device Directives. This article discusses some issues related to the introduction of these standards in Europe and their use in the CE-marking process.
摘要
2000年12月，新的ISO 9000质量管理体系系列标准发布。这对于在欧洲销售医疗设备的制造商而言是一项重大进展，他们利用这些标准来证明符合欧洲医疗器械指令。本文讨论了与这些标准在欧洲的引入及其在CE认证过程中的使用相关的一些问题。
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