As part of the FDA’s Standards Recognition Program its Office of In Vitro Diagnostics has recognized many standards. Some of these are NCCLS standards related to laboratory automation and computer interfaces including:
– NCCLS Auto3-A Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard
– NCCLS Auto4-A Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard
– NCCLS GP19-A2 Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline – Second Edition
– NCCLS AUTO7-A Laboratory Automation: Data Content for Specimen Identification; Approved Standard
– CLSI LIS01-A Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems
– CLSI LIS02-A2 Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard-Second Edition
– CLSI LIS03-A Standard Guide for Selection of a Clinical Laboratory Information Management System
– CLSI LIS05-A Standand Specification for Transferring Clinical Observations Between Independent Computer Systems
– CLSI LIS08-A Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems.