update: ieee 11073 sdc standardization activities...•approved as iso/pwi by iso/tc 215 ieee pocd...
TRANSCRIPT
Anton Keller (Aesculap AG), Martin Kasparick (University of Rostock), Stefan Schlichting (Drägerwerk AG & Co. KGaA)
Update:IEEE 11073 SDC Standardization Activities
Slide 2 IEEE PoCD WGM, 06. - 10. May 2019, Montréal
IEEE 11073 SDC at DMEA Trade Fair 2019 in Berlin, Germany
Slide 3 IEEE PoCD WGM, 06. - 10. May 2019, Montréal
IEEE 11073 SDC Family of Standards
IEEE 11073 SDC
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P11073-10720ModSpecs
P11073-10724Insufflator
P11073-10725Endo Pump
P11073-10723Endo Light
P11073-10722Endo Camera
P11073-10721HF Device
IEEE P11073-10700Base Key Purposes
P11073-10701Metrics
P11073-10702Alerts
P11073-10703External Control
IEEE 11073-20702-2016Medical DPWS
IEEE 11073-10207-2017Domain Information and Service Model
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Slide 4
• Adopted and published:
• ISO/IEEE 11073-20702: Medical DPWS
• ISO/IEEE 11073-10207: Domain Information and Service Model
• IEEE 11073-20701: Architecture and Binding ISO adoption in progress
• Current work: Errata, corrigenda and amendments (discussion can be tracked publically)
• https://sourceforge.net/p/opensdc/ieee11073-10207
• https://sourceforge.net/p/opensdc/ieee11073-20701
• https://sourceforge.net/p/opensdc/ieee11073-20702
IEEE PoCD WGM, 06. - 10. May 2019, Montréal
IEEE 11073 SDC Core Standards
IEEE 11073 SDC
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P11073-10720ModSpecs
P11073-10724Insufflator
P11073-10725Endo Pump
P11073-10723Endo Light
P11073-10722Endo Camera
P11073-10721HF Device
IEEE P11073-10700Base Key Purposes
P11073-10701Metrics
P11073-10702Alerts
P11073-10703External Control
IEEE 11073-20702-2016Medical DPWS
IEEE 11073-10207-2017Domain Information and Service Model
IEEE
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Slide 5 IEEE PoCD WGM, 06. - 10. May 2019, Montréal
IEEE 11073 SDC Core Standards
IEEE PoCD WGM, 06. - 10. May 2019, Montréal
Slide 7
• Active IEEE projects
• IEEE P11073-10700: Base Key Purpose
• IEEE P11073-10701: Metrics
• IEEE P11073-10702: Alerts
• IEEE P11073-10703: External Control
• Approved as ISO/PWI by ISO/TC 215
IEEE PoCD WGM, 06. - 10. May 2019, Montréal
IEEE 11073 SDC Key Purposes
IEEE 11073 SDC
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P11073-10720ModSpecs
P11073-10724Insufflator
P11073-10725Endo Pump
P11073-10723Endo Light
P11073-10722Endo Camera
P11073-10721HF Device
IEEE P11073-10700Base Key Purposes
P11073-10701Metrics
P11073-10702Alerts
P11073-10703External Control
IEEE 11073-20702-2016Medical DPWS
IEEE 11073-10207-2017Domain Information and Service Model
IEEE
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Slide 8
This document describes the concepts
• how Safety and Effectiveness of these Medical Devices and their System Functions Contributions is achieved
• and defines rules for the development of an SDC Participant and for post-production activities of the manufacturer.
IEEE PoCD WGM, 06. - 10. May 2019, Montréal
SDC Conformance Principles
Slide 9 IEEE PoCD WGM, 06. - 10. May 2019, Montréal
SDC Conformance PrinciplesSystem Function Contributions
Slide 10 IEEE PoCD WGM, 06. - 10. May 2019, Montréal
SDC Conformance PrinciplesSystem Function Contributions
IEEE P11073-10701 IEEE P11073-10702 IEEE P11073-10703
Slide 11 IEEE PoCD WGM, 06. - 10. May 2019, Montréal
IEEE P11073-10700 D0„Process Requirements“
Slide 12 IEEE PoCD WGM, 06. - 10. May 2019, Montréal
IEEE P11073-10700 D0Conformance check statements
Slide 13 IEEE PoCD WGM, 06. - 10. May 2019, Montréal
IEEE P11073-10700 D0Considered Risks
Slide 14
• Currently we expect approx. 100 Terms for Operations
• If you have a more Operations, please provide them!
IEEE PoCD WGM, 06. - 10. May 2019, Montréal
IEEE P11073-10107External Control Nomenclature
Slide 15
• IEEE P11073-10107 (External Control Nomenclature)
• Content collection
• IEEE P11073-10700 (Base Purpose)
• Draft 0
• IEEE P11073-10701 (Device Status, Metrics)
• Draft 0
• IEEE P11073-10702 (Alerting)
• Content collection
• IEEE P11073-10703 (External Control)
• Content collection
IEEE PoCD WGM, 06. - 10. May 2019, Montréal
Status of PARs
IEEE PoCD WGM, 06. - 10. May 2019, Montréal
Slide 17
• Device Specializations:
• High Frequency (200 kHz to < 5 MHz) Surgical Equipment
• Endoscopic camera
• Endoscopic light source
• Endoscopic insufflator
• Endoscopic pump
• Module specifications
IEEE PoCD WGM, 06. - 10. May 2019, Montréal
IEEE 11073 SDC Key Purposes
IEEE 11073 SDC
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P11073-10720ModSpecs
P11073-10724Insufflator
P11073-10725Endo Pump
P11073-10723Endo Light
P11073-10722Endo Camera
P11073-10721HF Device
IEEE P11073-10700Base Key Purposes
P11073-10701Metrics
P11073-10702Alerts
P11073-10703External Control
IEEE 11073-20702-2016Medical DPWS
IEEE 11073-10207-2017Domain Information and Service Model
IEEE
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Slide 18 IEEE PoCD WGM, 06. - 10. May 2019, Montréal
DevSpecs and ModSpecs
DevSpec: HF-Gerät
herstellerspez.Channel
herstellerspez.Metric
ModSpec: Koagulation/Schneiden
HF-Gerät(Medical Device System)
Monopolar(Virtual Medical Device)
Bipolar(Virtual Medical Device) ...
... ...
......
ModSpec: Aktivierungselemente
...
...
Fußschalter(Virtual Medical Device)
Pedal 1(Channel) ...
Zustand(Metric)
Zuordnung(Metric) ... ...
Koag/Schneiden(Channel)
Leistung(Metric) .........
Neutralelektrode(Channel)
...
Slide 19
• Strong manufacturer involvement:
• Funded partners: Aesculap, BOWA, embeX, ErbeElektromedizin, Karl Storz, Olympus Winter & Ibe, Open Connections
• Associated partners: Dräger, Schölly Fiberoptic, steuteTechnologies, surgiTAIX
• Academic partners: University of Lübeck, University of Rostock, OFFIS Institute for Information Technology Oldenburg (coordinator)
IEEE PoCD WGM, 06. - 10. May 2019, Montréal
PoCSpec Project – Developing DevSpecs
Slide 20
• Deep discussion between partners
• Evaluation of common and different devices features
• Classification into mandatory, recommended, optional, etc. features
• First steps towards IEEE 11073 SDC DIM modelling
IEEE PoCD WGM, 06. - 10. May 2019, Montréal
PoCSpec Project – Current Work
IEEE PoCD WGM, 06. - 10. May 2019, Montréal
Slide 22 IEEE PoCD WGM, 06. - 10. May 2019, Montréal
IEEE 11073 SDC and HL7Complementing Standards
Martin KasparickOR.NET e.V. Deputy Director of Standardization
Institute of Applied Microelectronics, University of Rostock, Germany
Thank you!