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Software Diagnostics and Conformance Testing Division Medical Device Communication Test Effort IHE-PCD Face-to-Face Oak Brook, ILL) NIST Medical Device.

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Presentation on theme: "Software Diagnostics and Conformance Testing Division Medical Device Communication Test Effort IHE-PCD Face-to-Face Oak Brook, ILL) NIST Medical Device."— Presentation transcript:

1 Software Diagnostics and Conformance Testing Division Medical Device Communication Test Effort IHE-PCD Face-to-Face (@ Oak Brook, ILL) NIST Medical Device Communication Test Effort October 17-19, 2007

2 Software Diagnostics and Conformance Testing Division Medical Device Test Effort Medical Device Test Effort NIST Team Members John J. Garguilo (john.garguilo@nist.gov, 301-975-5248)john.garguilo@nist.gov Sandra I. Martinez ( sandra.martinez@nist.gov, 301-975-3579) sandra.martinez@nist.gov Maria Cherkaoui (maria.cherkaoui@nist.gov, Guest Researcher)maria.cherkaoui@nist.gov Richard Theimer (richard.theimer@nist.gov,richard.theimer@nist.gov CENTECH Group, Inc., Contractor)

3 Software Diagnostics and Conformance Testing Division 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 Software Diagnostics and Conformance Testing Division DIM XSchema Compare Devices HL7/OBX Mapping (XML) Device UML Diagram ISO/IEEE 11073 DIM Part 20101 Nomenclature Part 10101 ICSGenerator NIST’s ICSGenerator and XSchema

5 Software Diagnostics and Conformance Testing Division (since last WG meetings [Cologne, April 07]) ICSGenerator Enhancements (since last WG meetings [Cologne, April 07]) Added capability to capture a “Top Level”, “General Interoperability, Baseline Profile, Polling Mode” ICSs. Added capability to select the type of device specialization (Manager/Agent). Added capability to id attribute fields as static, fixed or dynamic.

6 Software Diagnostics and Conformance Testing Division 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. ValidatePDU (APDU Syntax and low level Semantic Validation) Validation Report APDU (XER) (DIM-DataTypes.xsd) ValidatePDU (APDU Syntax and Semantic Validation) Device Profile (xml) Validation Report ROSEapdu (MDER) APDU (XER) (MDER + XER Coder/Decoder)

7 Software Diagnostics and Conformance Testing Division ValidatePDU 2.0 Future Enhancements  Add support for FastBufScanReport PDUs for waveform reporting  Add support for behavior type messages.  Add support for Rose RORJapdu – Remote Operation Error  Add support for Rose RORLIVapdu – Linked Invoke  Add semantic validation against polling mode agent/manager device profile.  Update the Message Information display to include event type and action type.

8 Software Diagnostics and Conformance Testing Division APDU MDS System-Type AttrSystem-Model Attr MDSCreateInfo System-TypeSystem-Model EventReport MDSCreateInfo Operation invoke EventReport CMDISE ROSE Medical Device System Common Medical Device Information Service Element Remote Operation Service Element

9 Software Diagnostics and Conformance Testing Division PnP Profile Test Tool Validation NIST ICSGenerator PnP MD Agent Simulator PnP MD Manager Simulator PnP PoC RT 11073-3020011073-30300(G)11073-2010111073-2020x NIST ValidatePDU Device Profile (XML) X73 APDU (MDER) X73 PDUs Validation Report WIRESHARK MDER Extraction Tool “libpcap”file (Non-RT)

10 Software Diagnostics and Conformance Testing Division ApduGen APDUs Engine Communication Services ASN.1 Module & Type services Agent Simulator/ Manager Scenario PDUs 110010011101001111110010 Validation Reports Device Profile 110010011101001111110010 PDUs NIST ICSGenerator Initial Thinking: Moving forward…Integration of Validation Test Tools

11 Software Diagnostics and Conformance Testing Division 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

12 Software Diagnostics and Conformance Testing Division 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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