-1Question(s):
28/16
Study Group: 16
Meeting, date:
Working Party:
2/16 Intended type of document(R-C-D-TD):
TD
Source:
Title:
A.5 justification information for draft revised H.810
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Please don't change the structure of this table, just insert the necessary information.
1
Introduction
According to ITU procedures, as described in ITU-T Recommendation A.5, any normative
reference to documentation produced outside the ITU (other than ISO and IEC texts) needs to be
evaluated by the study group or working party before a decision is made to incorporate the
reference in an ITU-T Recommendation.
This TD contains the A.5 justification information for revised H.810.
2
Referred documents and respective justifications
- Bluetooth CGMP (2014): Bluetooth SIG, Continuous Glucose Monitoring Profile, Version 1.0
- Specification approved 2014-11-18.
- The Continuous Glucose Monitoring Profile, Version 1.0, is needed to allow device interconnectivity within the ITU-T H.810 personal area network architecture. This specification
defines a short-range communications system intended to replace the cable(s) connecting
portable and/or fixed electronic devices for continuous Glucose Monitor.
- Complete A.5 justification information can be found in Annex 1.
- Bluetooth CGMS (2014): Bluetooth SIG, Continuous Glucose Monitoring Service, Version 1.0
- Specification approved 2014-11-18.
- The Continuous Glucose Monitoring Service, Version 1.0, is needed to allow device interconnectivity within the ITU-T H.810 personal area network architecture. This specification
defines a short-range communications system intended to replace the cable(s) connecting
portable and/or fixed electronic devices for continuous glucose monitor.
- Complete A.5 justification information can be found in Annex 2.
- Bluetooth POXP (2011): Bluetooth SIG, Pulse Oximeter Profile, Version 1.0.
- Specification approved 2015-07-14.
- The Pulse Oximeter Profile, Version 1.0, is needed to allow device inter-connectivity within the
ITU-T H.810 personal area network architecture. This specification defines a short-range
communications system intended to replace the cable(s) connecting portable and/or fixed
-2electronic devices for pulse oximeter.
- Complete A.5 justification information can be found in Annex 3.
- Bluetooth POXS (2015): Bluetooth SIG, Pulse Oximeter Service, Version 1.0
- Specification approved 2015-07-14.
- The Pulse Oximeter Service, Version 1.0, is needed to allow device inter-connectivity within the
ITU-T H.810 personal area network architecture. This specification defines a short-range
communications system intended to replace the cable(s) connecting portable and/or fixed
electronic devices for pulse oximeter.
- Complete A.5 justification information can be found in Annex 4.
- IEEE 11073-10419 (2014): Health informatics - Personal health device communication Part
10419: Device specialization - Insulin Pump
- Specification approved 2015-02-16.
- This specification defines the medical device system for a Insulin Pump. It constrains the
objects and attributes that are available within the base protocol, IEEE 11073-20601, to a
medical device and describes how the medical device will interoperate with a host device or
system.
- Complete A.5 justification information can be found in Annex 5.
- IEEE 11073-10425 (2014): Health informatics - Personal health device communication Part
10425: Device specialization - Continuous Glucose Monitor (CGM)
- Specification approved 2014-08-21.
- This specification defines the medical device system for a Continuous Glucose Monitor (CGM).
It constrains the objects and attributes that are available within the base protocol, IEEE 1107320601, to a medical device and describes how the medical device will interoperate with a host
device or system.
- Complete A.5 justification information can be found in Annex 6.
- IEEE 11073-20601 (2014): Health informatics - Personal health device communication Part
20601: Application profile – Optimized Exchange Protocol
- Specification approved 2014-08-21.
- This specification defines the complete tool box of features, objects and attributes that are
available to a medical device and describes how the medical device will interoperate with a host
device or system.
- Complete A.5 justification information can be found in Annex 7.
- IETF RFC 5231 (2008): Simple Mail Transfer Protocol (SMTP) Protocol
- Specification approved at 2008-10.
- The Simple Mail Transfer Protocol (SMTP) Protocol, is needed to allow the HIS Sender to send
the ZIP package (created using the HIS Sender – Indirect communication capability class) using
email.
- Complete A.5 justification information can be found in Annex 8.
-3-
Annex 1
A.5 justification information for the reference to Bluetooth CGMP (2014)
1
Clear description of the referenced document:
Bluetooth CGMP (2014): Bluetooth SIG, Continuous Glucose Monitoring Profile, Version 1.0
2
Status of approval:
Specification approved 2014-11-18.
3
Justification for the specific reference:
The Continuous Glucose Monitoring Profile, Version 1.0, is needed to allow device interconnectivity within the ITU-T H.810 personal area network architecture. This specification defines
a short-range communications system intended to replace the cable(s) connecting portable and/or
fixed electronic devices for continuous Glucose Monitor.
4
Current information, if any, about IPR issues:
N/A
5
Other useful information describing the "Quality" of the document:
Specification approved 2014-11-18 and some qualified devices implementing this version of the
specification exist.
6
The degree of stability or maturity of the document:
Specification approved 2014-11-18 and some qualified devices implementing this version of the
specification exist.
7
Relationship with other existing or emerging documents:
See item 5 above.
8
Any explicit references within that referenced document should also be listed:
[1] CGM Service
[2] Bluetooth Core Specification v4.0 as amended by CSA3 and CSS v2 or later
[3] Device Information Service v1.1 or later
[4] Health Device Profile v1.0 or later
[5] Characteristic and Descriptor descriptions are accessible via the Bluetooth SIG Assigned
Numbers
[6] Personal Health Devices Transcoding White Paper v1.2 or later
-4[7] ISO/IEEE Std 11073-20601-2008 Health Informatics - Personal Health Device Communication
- Application Profile - Optimized Exchange Protocol - version 1.0 or later. This also includes
ISO/IEEE Std 11073-20601a-2010 – Amendment 1.
[8] Bond Management Service v1.0 or later
9
Qualification of Bluetooth:
Bluetooth SIG meets the qualifying criteria for normative referencing as per Recommendation ITUT A.5.
10
N/A
Other (for any supplementary information):
-5-
Annex 2
A.5 justification information for the reference to Bluetooth CGMS (2014)
1
Clear description of the referenced document:
Bluetooth CGMS (2014): Bluetooth SIG, Continuous Glucose Monitoring Service, Version 1.0
2
Status of approval:
Specification approved 2014-11-18.
3
Justification for the specific reference:
The Continuous Glucose Monitoring Service, Version 1.0, is needed to allow device interconnectivity within the ITU-T H.810 personal area network architecture. This specification defines
a short-range communications system intended to replace the cable(s) connecting portable and/or
fixed electronic devices for continuous glucose monitor.
4
Current information, if any, about IPR issues:
N/A
5
Other useful information describing the "Quality" of the document:
Specification approved 2014-11-18 and some qualified devices implementing this version of the
specification exist.
6
The degree of stability or maturity of the document:
See item 5 above.
7
Relationship with other existing or emerging documents:
See item 5 above.
8
Any explicit references within that referenced document should also be listed:
[1] Bluetooth Core Specification v4.0 as amended by CSA3 and CSS v2 or later
[2] Health Device Profile v1.0
[3] Characteristic and Descriptor descriptions are accessible via the Bluetooth SIG Assigned
Numbers
[4] ISO/IEEE Std 11073-20601-2008 Health Informatics - Personal Health Device Communication
- Part 20601: Application Profile - Optimized Exchange Protocol - version 1.0 or later. This also
includes ISO/IEEE 11073-20601:2010
[5] ISO/IEEE Std IEEE 11073-10417-2011 Device specialization - Glucose meter
-69
Qualification of Bluetooth:
Bluetooth SIG meets the qualifying criteria for normative referencing as per Recommendation ITUT A.5.
10
N/A
Other (for any supplementary information):
-7-
Annex 3
A.5 justification information for the reference to Bluetooth POXP (2011)
1
Clear description of the referenced document:
Bluetooth POXP (2011): Bluetooth SIG, Pulse Oximeter Profile, Version 1.0.
2
Status of approval:
Specification approved 2015-07-14.
3
Justification for the specific reference:
The Pulse Oximeter Profile, Version 1.0, is needed to allow device inter-connectivity within the
ITU-T H.810 personal area network architecture. This specification defines a short-range
communications system intended to replace the cable(s) connecting portable and/or fixed electronic
devices for pulse oximeter.
4
Current information, if any, about IPR issues:
N/A
5
Other useful information describing the "Quality" of the document:
Specification approved 2015-07-14 and some qualified devices implementing this version of the
specification exist.
6
The degree of stability or maturity of the document:
See item 5 above.
7
Relationship with other existing or emerging documents:
See item 5 above.
8
Any explicit references within that referenced document should also be listed:
[1] Bluetooth Core Specification, Version 4.1 or later
[2] Pulse Oximeter Service, Version 1.0 or later
[3] Characteristic Descriptor descriptions are accessible via the Bluetooth SIG Assigned Numbers
[4] Personal Health Devices Transcoding Whitepaper version 1.TBD or later
[5] ISO/IEEE Std 11073-20601TM-2014 Health Informatics – Personal Health Device
Communication – Application Profile – Optimized Exchange Protocol – version 1.0 or later. This
also includes ISO/IEEE Std 11073-20601TM-2010 – Amendment 1.
[6] Device Information Service, Version 1.1 or later
-8[7] Bond Management Service, Version 1.0 or later
[8] Current Time Service, Version 1.1 or later
[9] Battery Service, Version 1.0 or later
9
Qualification of Bluetooth:
Bluetooth SIG meets the qualifying criteria for normative referencing as per Recommendation ITUT A.5.
10
N/A
Other (for any supplementary information):
-9-
Annex 4
A.5 justification information for the reference to Bluetooth POXS (2015)
1
Clear description of the referenced document:
Bluetooth POXS (2015): Bluetooth SIG, Pulse Oximeter Service, Version 1.0
2
Status of approval:
Specification approved 2015-07-14.
3
Justification for the specific reference:
The Pulse Oximeter Service, Version 1.0, is needed to allow device inter-connectivity within the
ITU-T H.810 personal area network architecture. This specification defines a short-range
communications system intended to replace the cable(s) connecting portable and/or fixed electronic
devices for pulse oximeter.
4
Current information, if any, about IPR issues:
N/A
5
Other useful information describing the "Quality" of the document:
Specification approved 2015-07-14 and many qualified devices implementing this version of the
specification exist.
6
The degree of stability or maturity of the document:
See item 5 above.
7
Relationship with other existing or emerging documents:
See item 5 above.
8
Any explicit references within that referenced document should also be listed:
[1] Bluetooth Core Specification, Version 4.0 (as amended by CSS v4) or later
[2] Characteristic and Descriptor descriptions and UUIDs are accessible via the Bluetooth SIG
Assigned Numbers
[3] ISO/IEEE Std 11073-20601™- 2008 Health Informatics - Personal Health Device
Communication - Application Profile - Optimized Exchange Protocol - version 1.0 or later. This
also includes ISO/IEEE Std 11073-20601a™- 2010 – Amendment 1.
[4] ISO/IEEE Std 11073-10404™ – 2008 – Health Informatics – Personal Health Device
Communication – Part 10404: Device specialization – Pulse Oximeter
[5] Personal Health Devices Transcoding White Paper v1.0 or later
- 10 9
Qualification of Bluetooth:
Bluetooth SIG meets the qualifying criteria for normative referencing as per Recommendation ITUT A.5.
10
N/A
Other (for any supplementary information):
- 11 -
Annex 5
A.5 justification information for the reference to IEEE 11073-10419 (2014)
1
Clear description of the referenced document:
IEEE 11073-10419 (2014): Health informatics - Personal health device communication Part 10419:
Device specialization - Insulin Pump
2
Status of approval:
Specification approved 2015-02-16.
3
Justification for the specific reference:
This specification defines the medical device system for a Insulin Pump. It constrains the objects
and attributes that are available within the base protocol, IEEE 11073-20601, to a medical device
and describes how the medical device will interoperate with a host device or system.
4
Current information, if any, about IPR issues:
N/A.
5
Other useful information describing the "Quality" of the document:
Specification approved 2015-02-16.
6
The degree of stability or maturity of the document:
Specification approved 2015-02-16. PCHA has implemented this within their test tool and source
code.
7
Relationship with other existing or emerging documents:
Similar to other IEEE 11073-104xx standards, this device specialization is also approved by the
IEEE 11073 Personal Health Devices Work Group. It also uses the base protocol IEEE 1107320601.
8
Any explicit references within that referenced document should also be listed:
- IEEE Std 11073-20601-2014, Health informatics-Personal health device communicationApplication Profile-Optimized Exchange Protocol.
- IEC 60601-1:2007, Ed. 3, Medical electrical equipment-Part 1: General requirements for basic
safety and essential performance.8
- IEC 60601-2, Medical electrical equipment-Part 2: Particular requirements for the basic safety and
essential performance for specific device. (See the entire series of standards)
- IEC 62304:2006/EN 62304:2006, Medical device software-Software life-cycle processes.
- IEC 80001-1:2010, Application of risk management for IT-networks incorporating medical
devices-Part 1: Roles, responsibilities, and activities.
- 12 -
- ISO 14971:2007, Medical devices-Application of risk management to medical devices.
- ISO/IEEE 11073-10101:2004, Health informatics-Point-of-care medical device communicationPart 10101: Nomenclature.11
- ISO/IEEE 11073-10201:2004, Health informatics-Point-of-care medical device communicationPart 10201: Domain information model.
- ISO/IEEE 11073-20101:2004, Health informatics-Point-of-care medical device communicationPart 20101: Application profile-Base standard.
- ITU-T Rec. X.680-2002, Information technology-Abstract Syntax Notation One (ASN.1):
Specification of basic notation.
- Miles A. A., M. V. Musset, and W. L. M. Perry, "Third international standard for insulin."
Bulletin of the World Health - Organization, vol. 7, pp. 445–459, 1952. Available:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2554140/pdf/bullwho00630-0071.pdf.7
9
Qualification of IEEE:
The IEEE was recognized under the provisions of ITU-T Recommendation A.5 on 1 November
1999. Qualifying information is on file with TSB.
10
N/A.
Other (for any supplementary information):
- 13 -
Annex 6
A.5 justification information for the reference to IEEE 11073-10425 (2014)
1
Clear description of the referenced document:
IEEE 11073-10425 (2014): Health informatics - Personal health device communication Part 10425:
Device specialization - Continuous Glucose Monitor (CGM)
2
Status of approval:
Specification approved 2014-08-21.
3
Justification for the specific reference:
This specification defines the medical device system for a Continuous Glucose Monitor (CGM). It
constrains the objects and attributes that are available within the base protocol, IEEE 11073-20601,
to a medical device and describes how the medical device will interoperate with a host device or
system.
4
Current information, if any, about IPR issues:
N/A.
5
Other useful information describing the "Quality" of the document:
Specification approved 2014-08-21.
6
The degree of stability or maturity of the document:
Specification approved 2014-08-21. PCHA has implemented this within their test tool and source
code.
7
Relationship with other existing or emerging documents:
Similar to other IEEE 11073-104xx standards, this device specialization is also approved by the
IEEE 11073 Personal Health Devices Work Group. It also uses the base protocol IEEE 1107320601.
8
Any explicit references within that referenced document should also be listed:
- ISO/IEEE 11073-20601:2010, Health informatics - Personal health device communication Application Profile - Optimized Exchange Protocol.
- ISO/IEEE Std 11073-20601a-2010 Health informatics - Personal health device communication Application Profile - Optimized Exchange Protocol Amendment 1.
- IEC 60601-1:2007, Ed. 3, Medical electrical equipment-Part 1: General requirements for basic
safety and essential performance.
- IEC 60601-2, Medical electrical equipment-Part 2: Particular requirements for the basic safety and
essential performance for specific device. (See the entire series of standards)
- 14 - IEC 62304:2006/EN 62304:2006, Medical device software-Software life-cycle processes.
- IEC 80001-1:2010, Application of risk management for IT-networks incorporating medical
devices-Part 1: Roles, responsibilities, and activities.
- ISO 14971:2007, Medical devices-Application of risk management to medical devices.
- ISO/IEEE 11073-10101:2004, Health informatics-Point-of-care medical device communicationPart 10101: Nomenclature.11
- ISO/IEEE 11073-10201:2004, Health informatics-Point-of-care medical device communicationPart 10201: Domain information model.
- ISO/IEEE 11073-20101:2004, Health informatics-Point-of-care medical device communicationPart 20101: Application profile-Base standard.
- ITU-T Rec. X.680-2002, Information technology-Abstract Syntax Notation One (ASN.1):
Specification of basic notation.
9
Qualification of IEEE:
The IEEE was recognized under the provisions of ITU-T Recommendation A.5 on 1 November
1999. Qualifying information is on file with TSB.
10
N/A.
Other (for any supplementary information):
- 15 -
Annex 7
A.5 justification information for the reference to IEEE 11073-20601 (2014)
1
Clear description of the referenced document:
IEEE 11073-20601 (2014): Health informatics - Personal health device communication Part 20601:
Application profile – Optimized Exchange Protocol
2
Status of approval:
Specification approved 2014-08-21.
3
Justification for the specific reference:
This specification defines the complete tool box of features, objects and attributes that are available
to a medical device and describes how the medical device will interoperate with a host device or
system.
4
Current information, if any, about IPR issues:
N/A.
5
Other useful information describing the "Quality" of the document:
Specification approved since 2014-08-21 and many many implementations are been developed
based on this standard.
6
The degree of stability or maturity of the document:
Specification approved since 2014-08-21 and many many implementations are been developed
based on this standard.
7
Relationship with other existing or emerging documents:
This is the base protocol for currently 17 other IEEE 11073-104zz device specializations.
8
Any explicit references within that referenced document should also be listed:
- IEEE Std 802-2014, IEEE Standard for Local and Metropolitan Area Networks: Overview and
Architecture.2,3
- IEEE Std 1541-2002 (Reaff 2008), IEEE Standard for Prefixes for Binary Multiples
- ISO/IEC 80000-13:2008, Quantities and units - Part 13: Information science and technology.
- ITU-T Rec. X.667 (Sept. 2004), Information technology - Open Systems Interconnection Procedures for the operation of OSI Registration Authorities: Generation and registration of
universally unique identifiers (UUIDs) and their use as ASN.1 object identifier components
9
Qualification of IEEE:
The IEEE was recognized under the provisions of ITU-T Recommendation A.5 on 1 November
1999. Qualifying information is on file with TSB.
- 16 10
N/A.
Other (for any supplementary information):
- 17 -
Annex 8
A.5 justification information for the reference to IETF RFC 5231 (2008)
1
Clear description of the referenced document:
IETF RFC 5231 (2008): Simple Mail Transfer Protocol (SMTP) Protocol
2
Status of approval:
Specification approved at 2008-10.
3
Justification for the specific reference:
The Simple Mail Transfer Protocol (SMTP) Protocol, is needed to allow the HIS Sender to send the
ZIP package (created using the HIS Sender – Indirect communication capability class) using email.
4
Current information, if any, about IPR issues:
Information on IPR issues regarding RFCs is available at: https://datatracker.ietf.org/ipr/search/.
Specifically: https://datatracker.ietf.org/ipr/search/?option=rfc_search&rfc_search=5231
5
Other useful information describing the "Quality" of the document:
Specification approved at 2008-10 and many devices implementing this version of the specification
exist.
6
The degree of stability or maturity of the document:
Specification approved at 2012-10.
7
Relationship with other existing or emerging documents:
Specification approved at 2012-10.
8
Any explicit references within that referenced document should also be listed:
[1] Postel, J., "Simple Mail Transfer Protocol", STD 10, RFC 821,August 1982.
[2] Mockapetris, P., "Domain names - implementation and specification", STD 13, RFC 1035,
November 1987.
[3] Braden, R., "Requirements for Internet Hosts - Application and Support", STD 3, RFC 1123,
October 1989.
[4] Resnick, P., "Internet Message Format", RFC 5322, October 2008.
[5] Bradner, S., "Key words for use in RFCs to Indicate Requirement Levels", BCP 14, RFC 2119,
March 1997.
- 18 [6] American National Standards Institute (formerly United States of America Standards Institute),
"USA Code for Information Interchange", ANSI X3.4-1968, 1968.
[7] Crocker, D. and P. Overell, "Augmented BNF for Syntax Specifications: ABNF", STD 68,
RFC 5234, January 2008.
[8] Hinden, R. and S. Deering, "IP Version 6 Addressing Architecture", RFC 4291, February
2006.
[9] Newman, C., "ESMTP and LMTP Transmission Types Registration", RFC 3848, July 2004.
[10] Klensin, J., Freed, N., and K. Moore, "SMTP Service Extension for Message Size
Declaration", STD 10, RFC 1870, November 1995.
[11] Klyne, G., Nottingham, M., and J. Mogul, "Registration Procedures for Message Header
Fields", BCP 90, RFC 3864,September 2004.
9
Qualification of ISOC/IETF:
9.1-9.6 Decisions of ITU Council to admit ISOC to participate in the work of the Sector (June 1995
and June 1996).
9.7
The Internet Engineering Steering Group (IESG) is responsible for ongoing maintenance of
the RFCs when the need arises. Comments on RFCs and corresponding changes are accommodated
through the existing standardization process.
9.8
Each revision of a given RFC has a different RFC number, so no confusion is possible. All
RFCs always remain available on-line. An index of RFCs and their status may be found in the IETF
archives at http://www.rfc-editor.org/rfc.html.
10
None
Other (for any supplementary information):