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IHE-PCD Face-to-Face (@ Oak Brook, ILL) NIST Medical Device Communication Test Effort October 17-19, 2007. Medical Device Test Effort NIST Team Members. John J. Garguilo ( john.garguilo@nist.gov , 301-975-5248) Sandra I. Martinez ( sandra.martinez@nist.gov , 301-975-3579)
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IHE-PCD Face-to-Face(@ Oak Brook, ILL)NISTMedical Device CommunicationTest EffortOctober 17-19, 2007
Medical Device Test EffortNIST Team Members • John J. Garguilo(john.garguilo@nist.gov, 301-975-5248) • Sandra I. Martinez (sandra.martinez@nist.gov, 301-975-3579) • Maria Cherkaoui(maria.cherkaoui@nist.gov, Guest Researcher) • Richard Theimer(richard.theimer@nist.gov, CENTECH Group, Inc., Contractor)
Meeting Goals • NIST Test Tools – Brief Review • ICSGenerator • ValidatePDU (Version 2.x) • PnP Profile – Validation Test Tools • Moving forward…Integration of Validation Test Tools • http://www.nist.gov/medicaldevices
ISO/IEEE 11073 Nomenclature Part 10101 DIM Part 20101 DIMXSchema Compare Devices ICSGenerator HL7/OBXMapping(XML) Device UML Diagram NIST’s ICSGenerator and XSchema
ValidatePDU APDU (XER) Validation Report (DIM-DataTypes.xsd) (APDU Syntax and low level Semantic Validation) ValidatePDU 2.0 (ValidatePDU 1.0 Re-designed) • ValidatePDU 1.0: Performs APDU syntax/structure validation using XML. • ValidatePDU 2.0: Performs APDU syntax/structure and semantic using a MDER Coder/Decoder. Device Profile (xml) ValidatePDU ROSEapdu (MDER) Validation Report (MDER + XER Coder/Decoder) (APDU Syntax and Semantic Validation) APDU (XER)
WIRESHARK Validation Report PnP Profile Test Tool Validation NIST ICSGenerator NIST ValidatePDU Device Profile (XML) X73 APDU (MDER) MDER Extraction Tool “libpcap”file (Non-RT) X73 PDUs PnP MD Manager Simulator PnP MD Agent Simulator PnP PoC RT 11073-30200 11073-30300(G) 11073-20101 11073-2020x
Device Profile Scenario ApduGen Validation Reports PDUs PDUs ASN.1 Module & Type services Communication Services Initial Thinking: Moving forward…Integration of Validation Test Tools NIST ICSGenerator Agent Simulator/ Manager Engine APDUs 110010011101001111110010 110010011101001111110010
Agent/Manager Simulator Components • Device profile • Generated using ICSGenerator. • Used to configure agent/manager simulators • Message Exchange Scenarios • An xml file describing a message exchange. • Using message interaction diagrams and the finite state machine. • Used as input to the simulator to manage messages to be sent. • Engine • Drive entire simulation process • APDUGen • Generates APDUs using a device profile. • Communication Services • Provides presentation, session and transport services. • ASN.1 module and type services • Provides ASN.1 library to decode an encode BER, MDER and XER. • Validation Reports • Report syntax/structure and semantic validation errors • It will also include behavioral validation
Benefits • A non-proprietary x73 simulator that can be used by any x73 implementer. • Helps implementers understand the x73 standard. • Potential for use as a reference implementation for helping others to implement their own version of the standard. • Provides conformance testing capabilities. • Validation against the standard • Leads to vendor integration and interoperation