EN ISO 11073-10419:2016
Withdrawn
Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump (ISO/IEEE 11073-10419:2016, Corrected version 2018-03)
06-29-2016
12-31-2016
European foreword
1 Overview
2 Normative references
3 Definitions, acronyms, and abbreviations
4 Introduction to ISO/IEEE 11073 personal health
devices
5 Insulin pump device concepts and modalities
6 Insulin pump domain information model
7 Insulin pump service model
8 Insulin pump 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 (normative) - Schedule-store class
Annex F (normative) - Schedule class ASN.1 definitions
Annex G (informative) - The schedule-store concept
Annex H (informative) - Scedule communication model
Annex I (informative) - Protocol data unit examples
ISO/IEEE 11073-10419:2016 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. ISO/IEEE 11073-10419:2016 is based on IEEE Std 11073-20601-2014, which in turn draw information from both ISO/IEEE 11073-10201:2004 [B7]2 and ISO/IEEE 11073-20101:2004 [B8]. The medical device encoding rules (MDERs) used within this standard are fully described in IEEE Std 11073-20601-2014. ISO/IEEE 11073-10419:2016 reproduces relevant portions of the nomenclature found in ISO/IEEE 11073-10101:2004 [B6] and adds new nomenclature codes for the purposes of this standard. Among this standard and IEEE Std 11073-20601-2014, all required nomenclature codes for implementation are documented.
| Committee |
CEN/TC 251
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Withdrawn
|
| Standards | Relationship |
| DS EN ISO 11073-10419 : 2016 | Identical |
| ISO/IEEE 11073-10419:2016 | Identical |
| I.S. EN ISO 11073-10419:2016&LC:2018 | Identical |
| DIN EN ISO 11073-10419:2016-10 | Identical |
| NEN EN ISO/IEEE 11073-10419 : 2016 | Identical |
| PN EN ISO 11073-10419 : 2016 | Identical |
| NF EN ISO 11073-10419:2018 | Identical |
| BS EN ISO 11073-10419:2016 | Identical |
| I.S. EN ISO 11073-10419:2016 | Identical |
| SS EN ISO 11073-10419 : 2016 | Identical |
| ISO/IEEE 11073-10419:2019 | Identical |
| UNE-EN ISO 11073-10419:2016 | 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 |
| 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 |