I.S. EN ISO 11073-10425:2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10425: DEVICE SPECIALIZATION - CONTINUOUS GLUCOSE MONITOR (CGM) (ISO 11073-10425:2016)
Hardcopy , PDF
07-05-2019
English
01-01-2016
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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National Foreword
European foreword
1 Overview
2 Normative references
3 Definitions, acronyms, and abbreviations
4 Introduction to IEEE 11073[TM] personal health devices
5 Glucose monitoring concepts and modalities
6 Continuous glucose monitor domain information model
7 Continuous glucose monitor service model
8 Continuous glucose monitor 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 communication between personal health continuous glucose monitor (CGM) devices (agents) and managers [e.g., cell phones, personal computers (PCs), personal health appliances, set top boxes] in a manner that enables plug-and-play interoperability.
| DocumentType |
Standard
|
| Pages |
90
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ISO/IEEE 11073-10425:2016 | Identical |
| EN ISO 11073-10425:2016 | 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 |
| 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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