IEC 62304-2006 Medical device software Software life cycle processes

This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this standard the following print types are used: • requirements and definitions: in roman type; • informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type; • terms used throughout this standard that have been defined in Clause 3 and also given in the index: in small capitals. An asterisk (*) as the first character of a title or at the beginni ng of a paragraph indicates that there is guidance related to that item in Annex B. The committee has decided that the contents of this publication will remain unchanged until the maintenance result date indicated on the IEC web site under “http://webstore.iec.ch” in the data related to the specific publication. At this date, the publication will be • reconfirmed; • withdrawn; • replaced by a revised edition, or • amended. Copyright International Electrotechnical Commission Provided by IHS under license with IEC No reproduction or networking permitted without license from IHS Not for Resale --`,,```,,,,````-`-`,,`,,`,`,,`---