UNE-EN ISO/IEEE 11073-10419:2023

1.1 Scope

This standard establishes a normative definition of communication between personal telehealth insulin

pump devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set

top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other

ISO/IEEE 11073 standards including existing terminology, information profiles, application profile

standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in

telehealth environments, restricting optionality in base frameworks in favor of interoperability. This

standard defines a common core functionality of personal telehealth insulin pump devices.

In the context of personal health devices (PHDs), an insulin pump is a medical device used for the

administration of insulin in the treatment of diabetes mellitus, also known as continuous subcutaneous

insulin infusion (CSII) therapy.

This standard provides the data modeling according to ISO/IEEE 11073-20601 and does not specify the

measurement method.

1.2 Purpose

This standard addresses the need for an openly defined, independent standard that supports information

exchange to and from PHDs and compute engines (e.g., cell phones, personal computers, personal health

appliances, set top boxes). Interoperability is key to growing the potential market for these devices and to

enabling people to be better informed participants in the management of their health.

1.3 Context

See ISO/IEEE 11073-20601:2016 for an overview of the environment within which this standard is written.

This standard defines the device specialization for the insulin pump, being a specific agent type, and provides

a description of the device concepts, its capabilities, and its implementation according to this standard.

This standard is based on ISO/IEEE 11073-20601:2016, which in turn draw information from both

ISO/IEEE 11073-10201:2004 [B8] and ISO/IEEE 11073-20101:2004 [B9].3 The medical device encoding

rules (MDER) used within this standard are fully described in ISO/IEEE 11073-20601:2016.

This standard reproduces relevant portions of the nomenclature found in ISO/IEEE 11073-10101:2004 [B6]

and ISO/IEEE 11073-10101a:2015 [B7] and adds new nomenclature codes for the purposes of this standard.

Among these standards and ISO/IEEE 11073-20601:2016, all required nomenclature codes for

implementation are documented.

NOTE In this standard, ISO/IEEE 11073-104zz is used to refer to the collection of device specialization standards

that utilize ISO/IEEE 11073-20601, where zz can be any number from 01 to 99, inclusive.4