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A methodology for evaluating, comparing, and selecting software safety and reliability standards

机译：评估，比较和选择软件安全性和可靠性标准的方法

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摘要

The regulated industries, which in the FDA's (US Food and Drug Administration) case include the manufacturers of food, cosmetics, pharmaceuticals, and medical devices, are responsible for selecting and justifying the selection and use of appropriate national and/or international consensus standards. This paper documents the results of a scientific inquiry which was undertaken to develop a methodology to evaluate and select individual standards as well as compatible sets of standards. Initially the scope was limited to software safety and reliability standards. Since then it has been expanded to other areas. It was found that six categories of criteria are important when evaluating the potential use of software safety standards: General Factors, Product Characterization, Process Characterization, Personnel Characterization, Risk Management, and Overall Standards Framework. The criteria in each of the six categories must be addressed, How they are addressed is both a technical and a policy decision. The goal should not be to try to find the "ultimate" standard because there isn't any. Rather the goal should be to select a balanced "diet" of standards based on these six categories. The methodology provides a systematic framework from which to make an objective determination about the appropriateness of using a particular standard.
机译：在FDA（美国食品和药物管理局）案例中，受监管的行业包括食品，化妆品，药​​品和医疗设备的制造商，这些行业负责选择和证明选择和使用适当的国家和/或国际共识标准的合理性。本文记录了科学查询的结果，该调查旨在开发一种评估和选择单个标准以及兼容标准集的方法。最初，范围仅限于软件安全性和可靠性标准。从那时起，它已扩展到其他领域。发现在评估软件安全标准的潜在使用时，六类标准很重要：通用因素，产品特征，过程特征，人员特征，风险管理和总体标准框架。必须解决六个类别中每个类别的标准。如何解决这些标准既是技术决策，也是政策决策。目标不应该是试图找到“最终”标准，因为没有任何标准。相反，目标应该是基于这六个类别选择平衡的“饮食”标准。该方法学提供了一个系统的框架，可以根据该框架来客观地确定使用特定标准的适当性。

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