For many years, the adoption and use of industry-wide technical standards have characterized industries such as telecommunications, computing and electronics. Until recently, there have been relatively few such standards in the biotechnology, bioengineering and biomedical research areas. Today, however, an increasing number of standards-setting activities are emerging in the biosciences, and participants that are involved in these activities, or are considering becoming involved, should be aware of the numerous legal, technical and operational issues that can plague standardization activities that are not planned and executed properly.

• Discuss current standardization activities in the biosciences arena
• Provide an overview of the legal issues that can affect technical standardization activities
• Provide tangible recommendations regarding best practices in standards-setting for bioscience standards-development activities