1.1 This specification describes the electronic transmission of digital information between clinical laboratory instruments and computer systems. The clinical laboratory instruments under consideration are those that measure one or more parameters from one or more patient samples. Often they will be automated instruments that measure many parameters from many patient samples. The computer systems considered here are those that are configured to accept instrument results for further processing, storage, reporting, or manipulation. This instrument output may include patient results, quality control results, and other related information. Typically, the computer system will be a Clinical Laboratory Information Management System (CLIMS).
1.2 The terminology of the Organization for International Standards (ISO) Reference Model for Open Systems Interconnection (OSI) is generally followed in describing the communications protocol and services. The electrical and mechanical connection between instrument and computer is described in the Physical Layer section. The methods for establishing communication, error detection, error recovery, and sending and receiving of messages are described in the Data Link Layer section. The data link layer interacts with higher layers in terms of sends and receives "messages," handles data link connection and release requests, and reports the data link status.
1.3 This specification addresses the low level protocol used for both serial binary data exchange and TCP/IP data exchange. For message content in the interface between clinical instruments and computer systems, reference Specification E 1394. Topics are found in the following sections:
| For Serial Binary Data Exchange | Section |
| Physical Layer | 5 |
| Overview | 5.1 |
| Electrical Characteristics | 5.2 |
| Signal Levels | 5.2.1 |
| Character Structure | 5.2.2 |
| Speed | 5.2.3 |
| Interface Connections | 5.2.4 |
| Mechanical Characteristics | 5.3 |
| Connector | 5.3.1 |
| Cable | 5.3.2 |
| Data Link Layer | 5 |
| Overview | 6.1 |
| Establishment Phase (Link Connection) | 6.2 |
| Contention | 6.2.1 |
| Transfer Phase | 6.3 |
| Frames | 6.3.1 |
| Frame Number | 6.3.2 |
| Checksum | 6.3.3 |
| Acknowledgments | 6.3.4 |
| Receiver Interrupts | 6.3.5 |
| Termination Phase (Link Release) | 6.4 |
| Error Recovery | 6.5 |
| Defective Frames | 6.5.1 |
| Timeouts | 6.5.2 |
| Restricted Message Characters | 6.6 |
| For TCP/IP Data Exchange | |
| Physical Layer | 7 |
| Overview | 7.1 |
| Electrical Characteristics | 7.2 |
| Signal Levels | 7.2.1 |
| Character Structure | 7.2.2 |
| Speed | 7.2.3 |
| Interface Connections | 7.2.4 |
| Mechanical Characteristics | 7.3 |
| Connector | 7.3.1 |
| Cable | 7.3.2 |
| Data Link Layer | 8 |
| Overview | 8.1 |
| Establishment Phase (Link Connection) | 8.2 |
| Contention | 8.2.1 |
| Transfer Phase | 8.3 |
| Frames | 8.3.1 |
| Frame Number | 8.3.2 |
| Checksum | 8.3.3 |
| Acknowledgments | 8.3.4 |
| Receiver Interrupts | 8.3.5 |
| Termination Phase (Link Release) | 8.4 |
| Error Recovery | 8.5 |
| Defective Frames | 8.5.1 |
| Timeouts | 8.5.2 |
| Restricted Message Characters | 8.6 |
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