BS EN ISO 11073-10424:2016
Current
The latest, up-to-date edition.
Health informatics. Personal health device communication Device specialization. Sleep apnoea breathing therapy equipment (SABTE)
10-09-2018
1 Overview
2 Normative references
3 Definitions, acronyms, and abbreviations
4 Introduction to ISO/IEEE 11073 personal health devices
standards
5 SABTE device concepts and modalities
6 Sleep apnoea breathing therapy equipment domain
Information model
7 SABTE service model
8 SABTE communication model
9 Test associations
10 Conformance
Annex A (informative) - Bibliography
Annex B (normative) - Any additional ASN.1 definitions
Annex C (normative) - Allocation of identifiers
Annex D (informative) - Message sequence examples
Annex E (informative) - Protocol data unit examples
Defines a normative definition of the communication between sleep apnoea breathing therapy equipment and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability.
Committee |
IST/35
|
DocumentType |
Standard
|
PublisherName |
British Standards Institution
|
Status |
Current
|
Within the context of the ISO/IEEE11073 family of standards for device communication, this standard establishes a normative definition of the communication between sleep apnoea breathing therapy equipment 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 appropriate portions of existing standards including ISO/IEEE11073 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 sleep apnoea breathing therapy equipment. In this context, sleep apnoea breathing therapy equipment are defined as devices that are intended to alleviate the symptoms of a patient who suffers from sleep apnoea by delivering a therapeutic breathing pressure to the patient. Sleep apnoea breathing therapy equipment are primarily used in the home health-care environment by a lay operator without direct professional supervision.
Standards | Relationship |
EN ISO 11073-10424:2016 | Identical |
ISO/IEEE 11073-10424:2016/Cor 1:2018 | Identical |
ISO/IEEE 11073-10424:2016 | Identical |
EN ISO 11073-10424:2016/AC: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 |
IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
IEEE 11073-20601-2014 REDLINE | IEEE 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 |
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