Hivatkozási szám

MSZ EN ISO 11073-10425:2019

Dokumentumazonosító

173332

Cím

Egészségügyi informatika. Személyi egészségügyi eszközök kommunikációja. 10425. rész: Eszközönkénti részletezés. Folyamatos glükózmonitor (CGM) (ISO/IEEE 11073-10425:2019)

Angol cím

Health informatics. Personal health device communication. Part 10425: Device specialization. Continuous glucose monitor (CGM) (ISO/IEEE 11073-10425:2019)

Alkalmazási terület

1.1 Scope This standard establishes a normative definition of communication between personal health continuous glucose monitor (CGM) 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 of communication functionality of CGM devices. In this context, CGM refers to the measurement of the level of glucose in the body on a regular (typically 5 minute) basis through a sensor continuously attached to the person. 1.2 Purpose This standard addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices (PHDs) and compute engines (e.g., cell phones, personal computers, personal health appliances, set top boxes). Interoperability is the 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.2 This standard defines the device specialization for the CGM, being a specific agent type, and it 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 draws 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

ICS

35.240.80 Informatikai alkalmazások az egészségügyben

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2019-11-01

Forrás

idt EN ISO 11073-10425:2019; idt ISO/IEEE 11073-10425:2019

Előd

MSZ EN ISO 11073-10425:2016

Utód

Módosítás

Kiegészítő információk

SZK-közlemények

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