ANSI/AAMI/IEC 62304:2006/A1:2016 – Medical device software – Software life cycle processes – Amendment has been released. This document is an amendment to the existing ANSI/AAMI/IEC 62304:2006 – Medical device software – Software life cycle processes standard.
ANSI/AAMI/IEC 62304:2006 is an international standard developed by the International Electrotechnical Commission (IEC), and it was based on American National Standard ANSI/AAMI SW68:2001 developed by the Association for the Advancement of Medical Instrumentation (AAMI). ANSI/AAMI/IEC 62304:2006 defines the life cycle of medical device software, establishing the life cycle processes by describing a set of processes, tasks, and activities.
The medical devices covered by the standard can be any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, software, material, or related equipment intended by the manufacturer to be used for one or more purposes by a medical professional. These devices, which enhance and secure the effectiveness and safety of the procedures and operations carried out by the medical professional, benefit from the inclusion of any software that can guarantee algorithmic precision. In establishing the life cycle processes, the standard addresses an assortment of tasks and activities.
For those who currently do not possess the original standard, it can be obtained from the ANSI Webstore: ANSI/AAMI/IEC 62304:2006 – Medical device software – Software life cycle processes
An amendment is the primary means by which standards can be changed outside of their official revision period. Amendments, which, like the standards themselves, must be agreed upon through the consensus process, include alterations or additions to the technical provisions previously agreed upon within an international standard.
ANSI/AAMI/IEC 62304:2006/A1:2016 does just this to the international standard it amends by improving upon its content. This amendment adds guidelines to ANSI/AAMI/IEC 62304:2006 for it to deal with legacy software, software whose design is prior to the existence of the current version. This is primarily to assist manufactures who must show compliance to the standard to meet European Directives. In addition to clarification of guidelines, this amendment updates the software safety classification to include a risk-based approach.
The changes brought forth by ANSI/AAMI/IEC 62304:2006/A1:2016 are numerous and reach through a multitude of sections in the original standard. To aid in compliance, the amendment walks the user through the structure of the document, clearly noting the location of each alteration.
ANSI/AAMI/IEC 62304:2006/A1:2016 – Medical device software – Software life cycle processes – Amendment is available on the ANSI Webstore