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1.
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Clear description of the referenced document:
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Name:
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IEEE 11073-10425-2014
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Title:
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Health informatics - Personal health device communication Part 10425: Device specialization - Continuous Glucose Monitor (CGM)
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2.
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Status of approval:
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Specification approved 2014-08-21.
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3.
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Justification for the specific reference:
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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.
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4.
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Current information, if any, about IPR issues:
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N/A.
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5.
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Other useful information describing the "Quality" of the document:
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Specification approved 2014-08-21.
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6.
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The degree of stability or maturity of the document:
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Specification approved 2014-08-21. PCHA has implemented this within their test tool and source code.
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7.
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Relationship with other existing or emerging documents:
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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 11073-20601.
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8.
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Any explicit references within that referenced document should also be listed:
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- 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)/
- 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 communication—Part 10101: Nomenclature.11/
- ISO/IEEE 11073-10201:2004, Health informatics—Point-of-care medical device communication—Part 10201: Domain information model./
- ISO/IEEE 11073-20101:2004, Health informatics—Point-of-care medical device communication—Part 20101: Application profile—Base standard./
- ITU-T Rec. X.680-2002, Information technology—Abstract Syntax Notation One (ASN.1): Specification of basic notation.
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9.
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Qualification of
IEEE:
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The IEEE was recognized under the provisions of ITU-T Recommendation A.5 on 1 November 1999. Qualifying information is on file with TSB.
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10.
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Other (for any supplementary information):
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N/A.
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