Designing and testing products to meet the requirements of regulatory agencies

30th Annual Frontiers in Education Conference. Building on A Century of Progress in Engineering Education. Conference Proceedings (IEEE Cat. No.00CH37135) Pub Date : 2000-10-18 DOI:10.1109/FIE.2000.897647

M. Marcus

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Abstract

Conventional engineering and engineering technology courses may teach students how to design functional products, but almost never address the very practical problem of meeting regulatory requirements. The paper discusses actual instrumentation and some of the design specifications and modifications that were implemented to meet the requirements of various regulatory agencies. Both hardware and software considerations are discussed. Requirements to gain approval from the following agencies are considered: 1. Underwriter Lab Listing (UL). 2. Third party testing agencies. 3. FDA for Laser Safety. 4. Compliance engineering (C.E. Marking). 5. R.F. and EMI testing. 6. FDA Premarket Notification, 510 k. An understanding of the requirements from regulatory agencies leads to better product design and reduces product development time. Case histories of actual products that were submitted by the author and approved by various regulatory agencies are presented.

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设计和测试产品以满足监管机构的要求

传统的工程和工程技术课程可能会教学生如何设计功能性产品，但几乎从不解决满足法规要求的实际问题。本文讨论了实际的仪器和一些设计规范和修改，以满足各种监管机构的要求。讨论了硬件和软件方面的考虑。考虑获得以下机构批准的要求:保险商实验室名单(UL)。2. 第三方检测机构。3.FDA激光安全。法规遵从工程(ce标记)。5. 射频和电磁干扰测试。6. FDA上市前通知，510 k.了解监管机构的要求可以更好地设计产品并缩短产品开发时间。实际产品的历史案例，由作者提交，并由各种监管机构批准提出。

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30th Annual Frontiers in Education Conference. Building on A Century of Progress in Engineering Education. Conference Proceedings (IEEE Cat. No.00CH37135)

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