ISO/IEEE 11073-10424:2016
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Health informatics — Personal health device communication — Part 10424: Device specialization — Sleep apnoea breathing therapy equipment (SABTE)
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03-06-2016
Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of the communication between sleep apnea breathing therapy equipment (SABTE) 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, is established in this standard. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, 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 for SABTE. In this context, SABTE is defined as a device that is intended to alleviate the symptoms of a patient who suffers from sleep apnea by delivering a therapeutic breathing pressure to the patient. SABTE is primarily used in the home health-care environment by a lay operator without direct professional supervision.
Committee |
ISO/TC 215
|
DocumentType |
Standard
|
Pages |
111
|
PublisherName |
International Organization for Standardization
|
Status |
Current
|
Standards | Relationship |
UNI EN ISO 11073-10424 : 2017 | Identical |
NF EN ISO 11073-10424 : 2016 | Identical |
SS-EN ISO 11073-10424 : 2016 | Identical |
SN EN ISO 11073-10424:2016 | Identical |
I.S. EN ISO 11073-10424:2016 | Identical |
PN EN ISO 11073-10424 : 2016 | Identical |
EN ISO 11073-10424:2016 | Identical |
DIN EN ISO 11073-10424:2016-10 | Identical |
NEN EN ISO/IEEE 11073-10424 : 2016 | Identical |
BS EN ISO 11073-10424:2016 | Identical |
UNE-EN ISO 11073-10424:2016 | Identical |
NEN EN ISO/IEEE 11073-10424 : 2016 C1 2018 | Identical |
ONORM EN ISO 11073-10424 : 2018 | Identical |
IEC 80001-1:2010 | Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
ISO/IEEE 11073-20101:2004 | Health informatics — Point-of-care medical device communication — Part 20101: Application profiles — Base standard |
EN 62304:2006/A1:2015 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015) |
IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
ISO/IEEE 11073-20601:2016 | Health informatics — Personal health device communication — Part 20601: Application profile — Optimized exchange protocol |
ISO 14971:2007 | Medical devices Application of risk management to medical devices |
ISO/IEEE 11073-10101:2004 | Health informatics — Point-of-care medical device communication — Part 10101: Nomenclature |
IEEE 11073-20601A : 2010 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 20601: APPLICATION PROFILE - OPTIMIZED EXCHANGE PROTOCOL - AMENDMENT 1 |
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