This article outlines the standardization work on artificial intelligence (AI) being carried out in the joint International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC) committee, ISO/IEC JTC 1/SC 42. 1 The SC 42 committee develops international standards that cover both technology capability and nontechnical requirements, such as business, regulatory and policy requirements, and application domain needs, as well as ethical an...

This article outlines the work of SC 42, the technical subcommittee for artificial intelligence (AI) of the ISO/IEC’s joint technical committee 1, which aims to accelerate adoption of the standards while simultaneously addressing emerging issues to enable successful digitalization of sectors.   Introduction and overview The digital transformation of industry promises to revolutionize how we live, work, and play, unlocking the vast potential of new use cases and ap...

The Center for Devices and Radiological Health (CDRH), the US Food and Drug Administration's (FDA) device regulatory body, has released another update-its 35th-to its list of recognized third-party standards. Background Standards for the proper manufacture and testing of products are often highly technical, time-consuming to produce and, above all else, expensive to create. Rather than create its own standards or duplicate the efforts of other groups, FDA often chooses ...

The US Food and Drug Administration (FDA) has released a new Federal Register notice indicating the modification of 116 medical device standards recognized by the agency, as well as 38 new device standards now recognized. The oft-updated List of Recognized Standards is generally updated anywhere between one and three times per year, and was last updated in August 2012 and before that in March 2012. It was created under the FDA Modernization Act of 1997, which gav...

The US Food and Drug Administration (FDA) has announced the adoption of a number of new international standards to guide the development and regulatory review of some medical devices. The standards, collected within FDA's List of Recognized Standards , are used by FDA during the premarket review of some products and allow a company or product to claim conformity to the standards to satisfy certain components of the review process. The FDA Amendments Act of 2007...

One of the greatest challenges in discussing standards is trying to put things into context so all those affected can understand why they matter. To illustrate this, I want to start with a simple picture- a snapshot of a remarkable moment in time. It shows how small medical device companies can make major contributions to healthcare, and but also how one standard is threatening to undo these gains. [media:1248:embed:{800}:{500}] This photograph was taken in Brazil ...

A new guide put forth by the International Standards Organization (ISO) and the International Electrotechnical Commission (IEC) aims to address medical device safety by guiding the development of new safety standards. ISO/IEC Guide 63:2012,  Guide to the development and inclusion of safety aspects in international standards for medical devices , seeks to improve upon earlier ISO guides by promoting the "optimal use of resources" through limiting the development of...