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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 11073-10418-2011
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Title:
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Health informatics - Personal health device communication Part 10418: Device specialization - International Normalized Ratio (INR) monitor
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2.
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Status of approval:
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Specification approved 2011-11-09.
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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 International Normalized Ratio (Blood Coagulation Monitor). 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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Continua has implemented this specification within both its test tool and its source code.
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6.
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The degree of stability or maturity of the document:
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Specification approved 2011-11-09. Continua has implemented this specification within both its test tool and its 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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IEEE Std 11073-20601aTM-2010, Health informatics—Personal health device communication—Application Profile—Optimized Exchange Protocol—Amendment 1./
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ISO/IEEE 11073-20601:2010, Health informatics—Personal health device communication—Application profile—Optimized Exchange Protocol. /
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IEC 60601-1:2005, Ed. 3, Medical electrical equipment—Part 1: General requirements for basic safety and essential performance. /
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IEC 60601-1-1:2000, Ed. 2, Medical electrical equipment—Part 1-1: General requirements for safety—Collateral standard: Safety requirements for medical electrical systems./
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IEC 60601-1-2:2007, Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic compatibility—Requirements and tests./
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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, Part 2-1 through Part 2-51.)/
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IEC 62304:2006/EN 62304:2006, Medical device software—Software life-cycle processes. /
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IEC 80001-1:2010, Application of risk management for IT-networks incorporating medical devices—Part 1: Roles, responsibilities, and activities./
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ISO 14971:2007, Medical devices—Application of risk management to medical devices. /
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ISO/IEEE 11073-10101:2004, Health informatics—Point-of-care medical device communication—Part 10101: Nomenclature. /
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ISO/IEEE 11073-10201:2004, Health informatics—Point-of-care medical device communication—Part 10201: Domain information model./
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ISO/IEEE 11073-20101:2004, Health informatics—Point-of-care medical device communication—Part 20101: Application profile—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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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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