ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations@ governmental and non-governmental@ in liaison with ISO@ also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75% of the member bodies casting a vote.A pilot project between ISO and the IEEE has been formed to develop and maintain a group of ISO/IEEE standards in the field of medical devices as approved by Council resolution 43/2000. Under this pilot project@ IEEE is responsible for the development and maintenance of these standards with participation and input from ISO member bodies.Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of patent rights. Neither ISO nor the IEEE shall be held responsible for identifying any or all such patent rights.ISO/IEEE 11073-20101:2004(E) was prepared by IEEE 1073 Committee of the IEEE Engineering in Medicine and Biology Society.Scope?The scope of this standard is upper layer [i.e.@ the International Organization for Standarization (ISO??s) open systems interconnection (OSI) application@ presentation layer@ and session layer] services and protocols for information exchange under the ISO/IEEE 11073 standards for medical device communications (MDC).This standard is the base standard of the ISO/IEEE 11073-20000 medical device application profiles (MDAP)@ as harmonized through the Committee for European Normalization (CEN) and the ISO.