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Medical Device Test Effort NIST Team Members

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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Medical Device Test Effort NIST Team Members

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  1. IHE-PCD Face-to-Face(@ Oak Brook, ILL)NISTMedical Device CommunicationTest EffortOctober 17-19, 2007

  2. 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)

  3. 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

  4. ISO/IEEE 11073 Nomenclature Part 10101 DIM Part 20101 DIMXSchema Compare Devices ICSGenerator HL7/OBXMapping(XML) Device UML Diagram NIST’s ICSGenerator and XSchema

  5. 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)

  6. 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

  7. 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

  8. 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

  9. 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

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