Time to Reboot: New Software Standard to Replace SW68

摘要

Software's unbridled growth as an integral part of medical device technology shows no signs of slowing down, and a new AAMI standard will play an important role in helping the next generation of software-dependent medical devices reach new heights in patient treatment and safety.nnThe new American National Standard ANSI/AAMI/IEC 62304:2006, Medical device software—Software life cycle processes updates the 2001 AAMI/American National Standard of the same name (previously designated SW68). The new standard is an identical adoption of a new International Electrotechnical Commission (IEC) standard that was largely based on the AAMI SW68 standard. The path may seem a bit circular, but the end result—international harmonization that provides manufacturers with a single set of guidelines for stand-alone medical device software as well as software that is an embedded or integral part of a medical device—is an important achievement.nn“While the development of 62304 began using the AAMI SW68 standard as its starting point, several significant changes and additions are important to note,” said Alan Kusinitz of SoftwareCPR in Winchester, MA. “The first significant difference to be aware of is that, while SW68 established minimum life cycle requirements for software of minor and moderate concern, 62304 also addresses minimum requirements for software of major levels of concern.”nnThe second important difference, according to Kusinitz, who is a member of the AAMI Medical Device Software Committee and a faculty member for AAMI programs including Software Validation Requirements and Industry Practice, is that “62304 requires identification of the risk of each software component into one of three levels defined in the standard, and defines different minimum life cycle requirements for each component based on risk level.”nnThe three software safety classes identified in 62304 are based on the possible effects on the patient, operator, or other people resulting from a hazard to which the software system can contribute. Manufacturers are required to assign a software safety class to each software system.nnClass A: No injury or damage to health is possiblennClass B: Non-serious injury is possiblennClass C: Death or serious injury is possible