A new standard, IEC 82304-1 was recently released. Titled “Health Software–Part 1: General requirements for product safety”, this standard will help to guide developers through the process of health software design providing particular emphasis on safety and security. It’s available now as a hard copy or for pdf download from Document Center, Inc.
Health software development is a complex and many-faceted process. This standard will help you through the many steps of design. The earliest stage covered includes guidance on defining your product’s general requirements and performing initial risk assessment. Other topics in this section include software use requirements and system requirements. It also provides guidance on the verification and update of said requirements.
The following sections detail life cycle processes for health software development. Following this is an in-depth look at how to have your software product validated. Next, guidance on how to identify your product and provide appropriate documentation that will accompany your software. Finally, there is a section on after-market considerations for your software product. These include maintenance, re-validation, communication, decommisioning, and disposal.
The last portion of this document is dedicated solely to supplementary material. This includes an appendix explaining the rationale for health software as well as a number of figures and tables explaining the scope of this document and related documents, health software product processes, and examples of products not within the scope of IEC 82304-1. Lastly, the document finishes with a 2-page bibliography.
Interested in health software development? You can buy IEC 82304-1 from Document Center. We’ve been selling IEC standards since the 1980’s and can provide a wide variety of products and expertise on them. Browse our webpage at www.document-center.com or, if you’d like to go directly to the order page for IEC 82304-1, here’s a link.
Need more information? Have questions? Get in touch with our friendly and knowledgeable staff at Document Center by phone (650-591-7600) or by email (info@document-center.com) and make us your Standards Experts!