EN ISO 11073-10419:2016

Name: EN ISO 11073-10419:2016
Brand: CEN

Withdrawn

Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump (ISO/IEEE 11073-10419:2016, Corrected version 2018-03)

Withdrawn date

12-31-2016

Published date

06-29-2016

Publisher

Comite Europeen de Normalisation

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Status	Withdrawn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
EC 1-2020 UNI 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
UNE-EN ISO 11073-10419:2016	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
SN EN ISO 11073-10419 : 2016	Identical
UNI 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