IEEE 1073 IEEE 1073 TestingTesting

Rick RivelloRick RivelloSandra MartinezSandra Martinez

NISTNISTrivello@nist.govrivello@nist.gov

sandrasandra..martinezmartinez@@nistnist..govgov

Medical Device Testing

Medical Device Tests Atomic Tests Attribute Get’s/Set’s Dynamic Tests Event Reporting Alarm Reporting Scanners

Medical Device Tests Atomic Tests Attribute Get’s/Set’s Dynamic Tests Event Reporting Alarm Reporting Scanners

Test Accelerator Test Definitions Datatype Support Data Value Generation

Test Accelerator Test Definitions Datatype Support Data Value Generation

Schema Definitions:• PDU – Structure• DIM – Medical Data

IEEE Medical Device Specifications

ValidatePDU Tool:

Check messages for:- Syntax- Structure - Correct Data

ICSMaker Tool:

- Device specific data - DIM JTree

DIMDIM

ICS REPORTSDIM MOC, Attribute,Behavior, Notification, etc.

ICS REPORTSDIM MOC, Attribute,Behavior, Notification, etc.

DeviceTest Suites

DeviceTest Suites

DIM MOC ICS FORMATDIM MOC ICS FORMAT

INDEXINDEX MOC-[1-n]MOC-[1-n]

FEATUREFEATURE OBJECT NAME & OBJECT IDOBJECT NAME & OBJECT ID

REFERENCE REFERENCE Reference to the clause in the standard Reference to the clause in the standard where where the Object is definedthe Object is defined

STATUS STATUS ImplementedImplemented

SUPPORT SUPPORT Specify restrictions Specify restrictions

Support for CREATE/DELETESupport for CREATE/DELETE

COMMENT COMMENT Any necessary comments Any necessary comments

MOC ATTRIBUTE ICS FORMATMOC ATTRIBUTE ICS FORMAT

INDEXINDEX ATTR-x-nATTR-x-n

FEATUREFEATURE ATTRIBUTE NAME & ATTRIBUTE IDATTRIBUTE NAME & ATTRIBUTE ID

REFERENCE REFERENCE Reference to the clause in the standard where Reference to the clause in the standard where the Object is definedthe Object is defined

STATUS STATUS M/O/CM/O/C

SUPPORT SUPPORT Access [GET/GET-GRP/SET …etc] Access [GET/GET-GRP/SET …etc]

Value RangesValue Ranges Additional RestrictionsAdditional Restrictions Static/Dynamic ValueStatic/Dynamic Value

COMMENT COMMENT Any necessary comments Any necessary comments

MOC BEHAVIOUR ICS FORMATMOC BEHAVIOUR ICS FORMAT

INDEXINDEX ACT-x-nACT-x-n

FEATUREFEATURE METHOD NAME & METHOD IDMETHOD NAME & METHOD ID

REFERENCE REFERENCE Reference to the clause in the standard Reference to the clause in the standard where where the Object method is definedthe Object method is defined

STATUS STATUS Confirmed/UnconfirmedConfirmed/Unconfirmed

SUPPORT SUPPORT Specify any restrictions for the methodSpecify any restrictions for the method

COMMENT COMMENT Any necessary comments Any necessary comments

MOC NOTIFICATION ICS FORMATMOC NOTIFICATION ICS FORMAT

INDEXINDEX NOTI-x-nNOTI-x-n

FEATUREFEATURE NOTIFICATION NAME & NOTIFICATION IDNOTIFICATION NAME & NOTIFICATION ID

REFERENCE REFERENCE Reference to the clause in the standard Reference to the clause in the standard where where the Event is definedthe Event is defined

STATUS STATUS Confirmed/UnconfirmedConfirmed/Unconfirmed

SUPPORT SUPPORT Specify any restrictions for the Specify any restrictions for the notificationnotification

COMMENT COMMENT Any necessary comments Any necessary comments

..........<Index id="MOC-19"><Index id="MOC-19"><Feature ClassType="Object"><Feature ClassType="Object"><OBJECT_NAME>MDS</OBJECT_NAME><OBJECT_NAME>MDS</OBJECT_NAME><OBJECT_ID>NOM_MOC_VMS_MDS</OBJECT_ID><OBJECT_ID>NOM_MOC_VMS_MDS</OBJECT_ID></Feature></Feature><Reference>clause 7.5.2</Reference><Reference>clause 7.5.2</Reference></Index></Index>..........<Index id="ATTR-19-1" Inherited="No"><Index id="ATTR-19-1" Inherited="No"><Feature><Feature><ATTRIBUTE_NAME>Mds-Status</ATTRIBUTE_NAME><ATTRIBUTE_NAME>Mds-Status</ATTRIBUTE_NAME><ATTRIBUTE_ID>NOM_ATTR_VMS_MDS_STAT</ATTRIBUTE_ID><ATTRIBUTE_ID>NOM_ATTR_VMS_MDS_STAT</ATTRIBUTE_ID></Feature></Feature><Reference>clause 7.5.2</Reference><Reference>clause 7.5.2</Reference><Qual>C</Qual><Qual>C</Qual></Index></Index>..........<Index id="ACT-19-1"><Index id="ACT-19-1"><Feature><Feature><METHOD_NAME>Mds-Set-Status</METHOD_NAME><METHOD_NAME>Mds-Set-Status</METHOD_NAME><METHOD_ID>NOM_ACT_SET_MDS_STATE</METHOD_ID><METHOD_ID>NOM_ACT_SET_MDS_STATE</METHOD_ID></Feature></Feature><Reference>clause 7.5.2.2</Reference><Reference>clause 7.5.2.2</Reference><MODE>confirmed</MODE><MODE>confirmed</MODE></Index></Index>..........<Index id="NOTI-19-1"><Index id="NOTI-19-1"><Feature><Feature><NOTIFICATION_NAME>System-Error</NOTIFICATION_NAME><NOTIFICATION_NAME>System-Error</NOTIFICATION_NAME><NOTIFICATION_ID>NOM_NOTI_SYS_ERR</NOTIFICATION_ID><NOTIFICATION_ID>NOM_NOTI_SYS_ERR</NOTIFICATION_ID></Feature></Feature><Reference>clause 7.5.2.3</Reference><Reference>clause 7.5.2.3</Reference><MODE>unconfirmed</MODE><MODE>unconfirmed</MODE></Index></Index>..........

ICS MakerICS Maker

Uses JAVA, SWING, XERCES, XALAN and Uses JAVA, SWING, XERCES, XALAN and DOMDOM

Creates JTREE representation of Creates JTREE representation of managed object classes for the DIM, managed object classes for the DIM, ATTRIBUTE, BEHAVIOUR and ATTRIBUTE, BEHAVIOUR and NOTIFICATIONNOTIFICATION

Accepts input from implementors for Accepts input from implementors for Support and Comment fieldsSupport and Comment fields

Processes data input and creates MOC Processes data input and creates MOC XML FileXML File

Why ICS MakerWhy ICS Maker

Implementors must use ICS model Implementors must use ICS model based on the DIM Standardbased on the DIM Standard

Prevent errorsPrevent errors Device interoperabilityDevice interoperability Generation of reportsGeneration of reports Identify set of tests based on Identify set of tests based on

implementors ICS informationimplementors ICS information Electronic copy of information that can Electronic copy of information that can

be easily accessedbe easily accessed

ICSMakerICSMaker

ICS MAKER XSLT TRANSFORMATIONSICS MAKER XSLT TRANSFORMATIONS

General ICS TABLE

Service Support ICS TABLE

DIM MOC ICS TABLE

MOC ATTRIBUTE ICS TABLE

MOC NOTIFICATION ICS TABLE

MOC BEHAVIOUR ICS TABLE

ICS MAKERICS MAKER

XSLT TRANFORMATIONSXSLT TRANFORMATIONS

DIM MOC TABLEDIM MOC TABLE ATTRIBUTE MOC TABLEATTRIBUTE MOC TABLE BEHAVIOUR MOC TABLEBEHAVIOUR MOC TABLE NOTIFICATION MOC TABLENOTIFICATION MOC TABLE

ISSUESISSUES

General MOCGeneral MOC Services MOCServices MOC Inherited MethodsInherited Methods DIM ICS vs Demo Document ICSDIM ICS vs Demo Document ICS

NEXT STEPSNEXT STEPS

Refine ICSMaker user interfaceRefine ICSMaker user interface– Load and modify an ICSLoad and modify an ICS– Event driven capabilitiesEvent driven capabilities– Incorporate general and services Incorporate general and services

MOC’sMOC’s– Adjustments based on final ICS Adjustments based on final ICS

modelmodel

NEXT STEPS(Cont)NEXT STEPS(Cont)

Test Development ApproachTest Development Approach– Identify Test CategoriesIdentify Test Categories

Syntax, Structure, Data TestingSyntax, Structure, Data Testing Semantic TestingSemantic Testing Event TestingEvent Testing

– Identify Test Scenarios/FormatIdentify Test Scenarios/Format