IEC Electromedical Safety Standard Third Edition Expected In August 2005
This article was originally published in The Gray Sheet
Executive Summary
Manufacturers planning declarations of conformity to the third edition of the International Engineering Consortium's electromedical equipment standard should come into compliance with international risk management standard ISO 14971, panelists at a recent AAMI/FDA meeting suggested
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Quality systems technical report: Final version of Technical Report 14969, which provides guidance on device use quality systems standard ISO 13485:2003, is expected by late spring or early summer, BSI Assistant VP-Product Services Paul Brooks tells participants at Regulatory Affairs Professionals Society Principles & Practices of EU Regulatory Affairs meeting Feb. 23-24 in Arlington,Va. TR 14969 previously was a guidance standard, but was changed to a technical report with the update of ISO 13485 (1"The Gray Sheet" July 2, 2001, p. 14). The ISO quality standard will replace its 1996 predecessor in July 2006...
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