Haindl H
B. Braun Melsungen AG, Federal Republic of Germany.
Med Device Technol. 1990 May-Jun;1(3):52-5.
Because of the heterogeneous nature of medical disposables, it is hard to define a uniform safety standard that is applicable to all products. Although good manufacturing practice (GMP) standards outline the framework for manufacturing conditions, a coherent safety philosophy for medical disposables does not exist. This article defines safety as it applies to these products and describes the various factors that can affect product safety, including economy, design, and inadequate instructions for use.
由于医用一次性产品性质各异,很难定义适用于所有产品的统一安全标准。尽管良好生产规范(GMP)标准概述了生产条件的框架,但针对医用一次性产品的连贯安全理念并不存在。本文定义了适用于这些产品的安全性,并描述了可能影响产品安全的各种因素,包括经济性、设计和使用说明不足。