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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 11073-10406-2011
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Title:
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Health informatics - Personal health device communication Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG)
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2.
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Status of approval:
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Specification approved 2011-11-30.
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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 Basic Electrocardiograph. 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 2011-11-30.
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6.
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The degree of stability or maturity of the document:
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Specification approved 2011-11-30. Continua 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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This is one device specialization of 14 total currently 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 Std 11073-20601a-2010 Health informatics — Personal health device communication — Application Profile — Optimized Exchange Profile Amendment 1./
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IEEE 100™, The Authoritative Dictionary of IEEE Standards Terms, Seventh Edition, New York, Institute of Electrical and Electronic Engineers, Inc../
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ISO/IEEE Std 11073-10101:2004, Health informatics — Point-of-care medical device communication — Part 10101: Nomenclature./
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ISO/IEEE Std 11073-10201:2004, Health informatics — Point-of-care medical device communication — Part 10201: Domain information model./
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ISO/IEEE Std 11073-20101:2004, Health informatics — Point-of-care medical device communication — Part 20101: Application Profiles – Base Standard./
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ITU-T Rec. X.680-2002, Information technology — Abstract Syntax Notation One (ASN.1): Specification of basic notation. /
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IEC 60601-1 Ed.3 (2005) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance/
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IEC 60601-1-1 Ed.2 (2000): Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems/
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IEC 60601-2-XX Medical electrical equipment - Part 2-XX: Particular requirements for the basic safety and essential performance for specific device/
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EN 62304:2005 Medical device software – Software life-cycle processes/
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ISO 14971:2007 Medical devices – Application of risk management to medical devices/
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IEC 80001-1 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities/
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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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