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Development of standards for laboratory automation.

In clinical laboratories, the installation of total laboratory automation systems and/or modular systems has grown dramatically in the 1990s, particularly in the US, Japan, and Europe. As the number of installations and level of interest grew, several individuals and corporations active in the automation field recognized that the development of prospective standards might enable customers of such systems or equipment to purchase analyzers, automation systems or devices, and software from different vendors and retain interconnectivity of such equipment. These individuals also believed that the total market for automation systems and equipment would be significantly greater with standards than without standards, especially if customers were not forced to purchase everything from one vendor, and that there might be competitive pricing and new technology fostered via the standards. This early interest in standards development led to the initiation of a program by NCCLS in 1996 to develop prospective standards for laboratory automation. Part of the NCCLS effort has involved interaction and cooperation with other standards organizations in the US and other countries. This report describes the current status of the development of prospective standards for laboratory automation by NCCLS and the relationship of those standards to those of other standards organizations.